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Patients with refractory or relapsed JMML must have had at least one cycle of intensive frontline therapy or at least 2 cycles of a deoxyribonucleic acid (DNA) demethylating agent with persistence of disease, defined by clinical symptoms or the presence of a clonal abnormality; frontline therapy is defined as one cycle of intravenous chemotherapy that includes of any of the following agents: fludarabine, cytarabine, or any anthracycline but specifically excludes oral 6-mercaptopurine; frontline therapy will also include any conditioning regimen as part of a stem cell transplant; patients who transform to acute myeloid leukemia (AML) with more than 20% blasts at relapse are not eligible for this trialXx_NEWLINE_xXPathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), having received at least 1 prior line of systemic therapy, and received no more than 2 prior lines of therapy in the metastatic setting (disease recurrence < 6 months from the last dose of adjuvant therapy in resected patients will be considered the first line of therapy)\r\n* Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not ampulla of vater cancersXx_NEWLINE_xXPatients previously untreated or treated with drug therapy for epithelioid hemangioendothelioma (EHE) are eligible; there is no limit on the number of prior regimens used to be eligibleXx_NEWLINE_xXPatients with prior anthracycline therapy will be excludedXx_NEWLINE_xXHave at least one evaluable and measurable lesion as defined by RECIST v1.1. Subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ?20% growth in size since post-treatment assessment.Xx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatients who have received prior anti-PD1 directed therapy (monoclonal antibody [mAb] or small molecule) are not eligibleXx_NEWLINE_xXParts C, D, and E: patients who have received prior ipilimumab are not eligibleXx_NEWLINE_xXPatients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligibleXx_NEWLINE_xXPatients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disordersXx_NEWLINE_xXPatients may have received prior therapy for the treatment of MDS, including but not limited to: growth factor, transfusion support, immunomodulatory (IMID) therapy, DNA hypomethylating therapy, or cytotoxic chemotherapy prior to enrollment.Xx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXCellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)Xx_NEWLINE_xXRadiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapyXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXFOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.Xx_NEWLINE_xXThe subject has received bevacizumab for their disease unless in the context of primary therapy for newly diagnosed gliomaXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatients who received prior PI3K, AKT or mTOR inhibitors are not allowedXx_NEWLINE_xXINCLUSION CRITERIA\n\n          -  Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx,\n             hypopharynx, or larynx\n\n          -  HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease\n             Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3\n\n          -  No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative\n             intent.\n\n          -  Available tumor samples for submission or willing to undergo further tumor biopsies:\n\n          -  Age ?18 years (?19 in Korea;20 years in Japan and Taiwan).\n\n          -  ECOG Performance Status 0 or 1\n\n          -  Adequate bone marrow function\n\n          -  Adequate renal function\n\n          -  Adequate liver function\n\n          -  Pregnancy test (for patients of childbearing potential) negative at screening\n\n        EXCLUSION CRITERIA\n\n          -  Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti\n             CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically\n             targeting T cell co stimulation or immune checkpoint pathways.\n\n          -  Major surgery 4 weeks prior to randomization.\n\n          -  Prior malignancy requiring tumor-directed therapy within the last 2 years prior to\n             enrollment, or concurrent malignancy associated with clinical instability. Exceptions\n             for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully\n             resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or\n             deemed to not require treatment, ductal IS carcinoma of the breast that has completed\n             curative treatment, adequately treated basal cell or squamous cell skin cancer.\n\n          -  Active autoimmune disease\n\n          -  Any of the following in the 6 months prior to randomization: myocardial infarction,\n             severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic\n             congestive heart failure, cerebrovascular accident, transient ischemic attack, or\n             symptomatic pulmonary embolism.\n\n          -  Active infection requiring systemic therapy.\n\n          -  Use of immunosuppressive medication at time of randomization\n\n          -  Prior organ transplantation including allogenic stem-cell transplantation.\n\n          -  Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or\n             acquired immunodeficiency syndrome (AIDS) related illness.\n\n          -  Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n\n          -  Vaccination within 4 weeks prior to randomization.\n\n          -  Current use of or anticipated need for treatment with other anti-cancer drugs.\n\n          -  Pregnant female patients, breastfeeding female patients, and male patients able to\n             father children and female patients of childbearing potential who are unwilling or\n             unable to use 2 highly effective methods of contraception as outlined in the protocol\n             for the duration of the study and for at least 6 months after the last dose of\n             cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).Xx_NEWLINE_xXDocumented disease progression after at least 1 line of prior systemic therapy.Xx_NEWLINE_xXSubjects with certain mutations that have not been treated with a targeted therapy prior to enrollmentXx_NEWLINE_xXSubjects who need daily oxygen therapyXx_NEWLINE_xXPatients with hormone receptor positive breast cancer as defined above must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression; (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required); hormonal therapy can be initiated prior to or during protocol therapyXx_NEWLINE_xXPatients who are human immunodeficiency virus (HIV)-positive are eligible if: \r\n* CD4+ cell count greater or equal to 250 cells/mm^3\r\n* If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used\r\n* No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts\r\n* Probable long-term survival with HIV if cancer were not presentXx_NEWLINE_xXAny continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomizationXx_NEWLINE_xXPatients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trialXx_NEWLINE_xXCompletely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancerXx_NEWLINE_xXPatients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligibleXx_NEWLINE_xXSTEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permittedXx_NEWLINE_xXSTEP II: Patients must have complete induction without experiencing progression or patients must have received at least 6 cycles on Arm A and 4 cycles on Arm B but stopped induction therapy due to adverse eventsXx_NEWLINE_xXHormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registrationXx_NEWLINE_xXPatients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =< 12 months of re-registration to crossover dual agent therapyXx_NEWLINE_xXThe patient must have met all eligibility criteria (except as detailed below) at the time of crossover\r\n* RECIST defined measurable disease is not required\r\n* Only prior systemic therapy as part of step 1 is allowed; patients who received allowed systemic therapy in the adjuvant setting prior to Step 1 and were eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other eligibility criteria\r\n* Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment\r\n* History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy\r\n* Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who underwent surgery or SRS to CNS metastases need not be off of steroids to start treatment \r\n* There is no restriction on serum LDH at crossover\r\n* Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossoverXx_NEWLINE_xXAny continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomizationXx_NEWLINE_xXPatients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic renal cell carcinoma (RCC); if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registrationXx_NEWLINE_xXPatients may not have received any of the protocol agents within 5 years prior to randomizationXx_NEWLINE_xXPatients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine eligibility to Arm T; the study chair, co-chair, biology co-chair, or a delegate must review the molecular testing and agree that the testing meets eligibility outlined below:\r\n* ROS1 gene rearrangement by fluorescence in situ hybridization (FISH) or deoxyribonucleic acid (DNA) analysis (may have progressed on prior crizotinib therapy)\r\n* MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy)\r\n* MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed)\r\n* RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed)\r\n** Institutions will be notified of the patient’s eligibility status for Arm T within two (2) business days of submission of the molecular testing reports\r\n** If patients do not have tumors with the above molecular alterations noted proceed directly to step 1Xx_NEWLINE_xXPrior malignancy is allowed providing it does not require concurrent therapy\r\n* Exception: active hormonal therapy is allowedXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients must be deemed, in the judgment of the treating physician, to be ineligible for intensive induction therapy, or must have refused intensive induction therapy; rationale for clinical determination or notation of patient decision must be madeXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Prior treatment with hydroxyurea is permitted; prior all-trans retinoic acid (ATRA) for suspected APL and prior intrathecal therapy are permitted, but must plan to be discontinued prior to initiating protocol therapy; patients with signs/symptoms of hyperleukocytosis or white blood cells (WBC) >= 50,000/mcL can be treated with leukapheresis prior to randomization (registration to Step 2)Xx_NEWLINE_xXPatients must have had no prior systemic therapyXx_NEWLINE_xX1-2 prior regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limitXx_NEWLINE_xXPatients must have resolved any serious infectious complications related to therapyXx_NEWLINE_xXCRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapyXx_NEWLINE_xXCRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolvedXx_NEWLINE_xXPatients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing first line bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of bendamustine; relapsed patients must not have received any intervening chemotherapy; patients must have received at least 3 cycles of bendamustine as first line therapy; (note that no minimum dose of bendamustine is required); patients who additionally received any maintenance anti-CD-20 antibody based therapy or consolidative radioimmunotherapy within 2 years of the last dose of the bendamustine therapy are eligible; involved field or involved site radiation is not considered a line of therapy; patients who previously received anthracycline based therapy are excluded; examples of eligible 1st line treatment regimens (note this list is not all inclusive):\r\n* Bendamustine rituximab x 4 cycles\r\n* Bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance\r\n* Bendamustine obinutuzumab x 3 cyclesXx_NEWLINE_xXPatients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowedXx_NEWLINE_xXPrior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowedXx_NEWLINE_xXNo prior taxane therapy =< 6 months, except as a radiosensitizerXx_NEWLINE_xXPatient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0\r\n* For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); post-induction patients with evidence of clinical disease progression are not eligible for preregistration\r\n* Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy; overall, a partial response needs to have been achieved (using studies at the time of diagnosis as the baseline)\r\n**NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimenXx_NEWLINE_xXWith the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse)Xx_NEWLINE_xXPatients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapyXx_NEWLINE_xXTreatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommendedXx_NEWLINE_xXWith the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1Xx_NEWLINE_xX1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)Xx_NEWLINE_xXPatient must have chemosensitive disease as defined by at least a partial response to salvage therapy at their latest assessmentXx_NEWLINE_xXIf primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy.Xx_NEWLINE_xXPatients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy.Xx_NEWLINE_xXPatients receiving targeted therapy (non-cytotoxic, non-immunotherapy based systemic therapy) for NSCLC in the first-line setting. Such designations would include but not be limited to treatments targeting EGFR mutant positive or ALK positive NSCLC in the first-line setting.Xx_NEWLINE_xXPrior bevacizumab therapy is excluded.Xx_NEWLINE_xXPatients judged capable of tolerating a radical course of chemoradiation therapyXx_NEWLINE_xXPatients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)Xx_NEWLINE_xXPatient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step 1Xx_NEWLINE_xXNo prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligibleXx_NEWLINE_xXNo prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBCXx_NEWLINE_xXSingle-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapyXx_NEWLINE_xXCompletion of remission induction therapyXx_NEWLINE_xXRegistration Step 2 – Post-Remission Therapy:Xx_NEWLINE_xXRecovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permittedXx_NEWLINE_xXPatients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).Xx_NEWLINE_xXPersistence of clinically relevant therapy related toxicity from previous anti-cancer therapyXx_NEWLINE_xXSubjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.Xx_NEWLINE_xXPatients on long term (> 6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen; patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required)Xx_NEWLINE_xXPrior exposure to enzalutamide or other investigational AR directed therapyXx_NEWLINE_xXINCLUSION CRITERIA:\n\n          1. ECOG performance status ? 2.\n\n          2. Histopathologically or cytologically confirmed NSCLC.\n\n          3. Disease progression during or after treatment with one or two treatment regimen(s)\n             Treatment regimens can be chemotherapy, targeted therapy, biological therapy, or\n             immunotherapy for advanced (Stage IIIB) or metastatic disease (Stage IV). Modification\n             of a regimen to manage toxicity with a different drug does not constitute a new\n             regimen. Maintenance therapy following platinum-based chemotherapy is not considered\n             as a separate regimen. Adjuvant or neoadjuvant chemotherapy and/or chemo-radiation for\n             early stage disease do not count as prior systemic therapy. Prior radiation therapy is\n             not exclusionary. Prior immunotherapy with a PD-1/PD-L1 inhibitor is not exclusionary.\n             Prior treatment for advanced or metastatic disease must have included a platinum-based\n             regimen. (Treatment of early stage disease [Stage IIIA or earlier] with a\n             platinum-containing therapy does not count).\n\n          4. At least 1 lesion ?10 mm in longest diameter in lung parenchyma.\n\n          5. patients with nonsquamous NSCLC must have been tested for EGFR exon 19 deletion and\n             Exon 21 L858R substitution mutation. Only patients without EGFR sensitizing mutations\n             are eligible, and they must have progressed on platinum-based chemotherapy. Patients\n             with known ALK-rearrangements should be treated with an appropriate tyrosine kinase\n             inhibitor (TKI) before entering the study. The TKI regimen would count as a line of\n             treatment\n\n          6. Patients with active brain metastasis or leptomeningeal involvement with brain\n             metastases who are asymptomatic, and whose lesions by imaging are at least stable and\n             without interim development of new lesions for at least 4 weeks may be enrolled.\n\n          7. All AE's of prior systemic therapy, surgery, or radiotherapy, must have resolved to\n             CTCAE v 4.03 Grade ?2, except for neurological AE's that must have resolved to Grade\n             ?1.\n\n          8. The following laboratory results ?14 days prior to study drug admin:\n\n             Hgb ?9 g/dL independent of transfusion or growth factor support; absolute neutrophil\n             count 1.5x10^9/L independent of growth factor support; platelet count ?100x10^9/L\n             independent of transfusion or growth factor support; Serum total bilirubin ? ULN,\n             unless the patient has a diagnosis of Gilbert's disease then serum bilirubin 3.0 times\n             ULN;\n\n          9. AST & ALT ?2.5 x ULN(?1.5 x ULN if alkaline phosphatase is > 2.5 x ULN), and serum\n             creatinine ?1.5 x ULN.\n\n         10. Life expectancy >12 weeks.\n\n         11. Female patients of childbearing potential have a negative pregnancy test at baseline.\n\n         12. Signed informed consent.\n\n        EXCLUSION CRITERIA: Patients with any of the following:\n\n          1. Administration of chemo, biological, immunotherapy, radiotherapy or investigational\n             agent (therapeutic or diagnostic) ?3 weeks prior to receipt of study medication. Major\n             surgery, other than diagnostic surgery, ?4 weeks before first study drug admin.\n\n          2. Significant cardiac history:\n\n             History of myocardial infarction or ischemic heart disease ?1 year before 1st study\n             drug administration; uncontrolled arrhythmia; history of congenital QT prolongation;\n             ECG findings consistent with acute ischemic heart disease; NYHA Class III-IV cardiac\n             disease; & uncontrolled hypertension: BP consistently >150 mm Hg systolic & 100 mm Hg\n             diastolic in spite of antihypertensive medication\n\n          3. Patients who have received prior treatment with docetaxel.\n\n          4. Prior transient ischemic attack or cerebrovascular accident with in the past year.\n             Neurologic toxicities ?Grade 2 within 3 weeks of randomization.\n\n          5. History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled\n             peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or\n             omeprazole or its equivalent is acceptable.) History of ileus or other significant\n             gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility.\n\n          6. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.\n\n          7. Known infection with human immunodeficiency virus (HIV) or active hepatitis A, B, or\n             C.\n\n          8. Known prior hypersensitivity reaction to any product containing polysorbate 80,\n             Polyoxyethylene 15 hydroxystearate/Macrogol 15 Hydroxystearate (Solutol HS 15).\n\n          9. Female subject who is pregnant or lactating\n\n         10. Second malignancy unless in remission for >5 years. (Non-melanoma skin cancer or\n             carcinoma in situ of the cervix treated with curative intent is not exclusionary.)\n\n         11. Medical conditions that would impose excessive patient risk. Examples: uncontrolled\n             diabetes, infection requiring parenteral anti infective treatment, liver failure,\n             altered mental status or psychiatric condition that would interfere with the\n             understanding of the informed consent.\n\n         12. Unwilling or unable to comply with protocol.Xx_NEWLINE_xXPrior therapy with an anti-CSF1R antibodyXx_NEWLINE_xXGCTs: no limit of prior therapyXx_NEWLINE_xXFor Phase 1b, must have advanced refractory solid tumors in any line of therapy.Xx_NEWLINE_xXFor Phase 2 only, have had disease progression or be refractory or intolerant to 1 prior line of therapy (first line therapy) for recurrent or refractory for NSCLC or HCC and have refused currently approved second-line therapy. First line therapy is defined as therapy used to treat advanced disease. This may include multiple chemotherapeutic, targeted or immunotherapeutic agents with or without radiation therapy and/or surgery. Each subsequent line of therapy is preceded by disease progression. A switch of an agent within the same drug class (eg, cisplatinum to carboplatinum) within a regimen in order to manage toxicity does not define the start of a new line of therapy.Xx_NEWLINE_xXPatients are not required to have received or progressed on a prior therapy.Xx_NEWLINE_xXPrior therapy - prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DM1) are allowed; patients who have received prior therapy with taselisib (GDC-0032) or BYL-719 are excluded; there is no limit on the number of prior lines of therapyXx_NEWLINE_xXSubjects has failed or intolerant to temozolomide therapy.Xx_NEWLINE_xXPart B: More than 6 cycles of prior therapy with carboplatinXx_NEWLINE_xXParts B1, B3, and C: During prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin or cisplatin for toxicity or lack of tolerabilityXx_NEWLINE_xXDiagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior linesXx_NEWLINE_xXSubjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories:Xx_NEWLINE_xXCurrent disease state must be one for which there is currently no known effective therapyXx_NEWLINE_xXAt least 1 prior line of therapyXx_NEWLINE_xXNo prior chemotherapy, radiation therapy, or surgery for this malignancy will be allowed; prior endoscopic procedures for superficial disease (endoscopic mucosal resection, cryotherapy, photodynamic therapy, etc.) will not exclude a patient; prior dilatation is also allowedXx_NEWLINE_xXAny prior therapy for castrate disease is acceptable except prior specific cytochrome P450 family 17 (CYP17) antagonists (e.g. abiraterone acetate, orteronel) or prior second generation AR antagonists (e.g. enzalutamide or ARN509) which are excluded; a minimum washout of 28 days for any other anticancer therapy (with the exception of sipuleucel-T, which does not need a wash out) prior to first dose of study drug is requiredXx_NEWLINE_xXPatients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabineXx_NEWLINE_xXSubjects who have received prior therapy with any hypomethylating agentsXx_NEWLINE_xXAll participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollmentXx_NEWLINE_xXPatients who have received prior therapy with bevacizumab, or related drugs (previous therapy with carboplatin is allowed)Xx_NEWLINE_xXPatient must either have recurrence of CNS GCT or should be refractory to initial therapyXx_NEWLINE_xXCorticosteroid therapy and endocrine replacement therapy (L-thyroxine, testosterone, estrogen, desmopressin acetate [DDAVP]) are permissible; any patient already receiving human growth replacement therapy should discontinue this prior to commencing chemotherapy, and should not restart until 3 years from diagnosisXx_NEWLINE_xXLow grade NHL: with < 6 month duration of CR between courses of conventional therapyXx_NEWLINE_xXWaldenstrom’s macroglobulinemia: must have failed 2 courses of therapyXx_NEWLINE_xXAll patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole must have sirolimus reduced according to the Standard Practice Antifungal Therapy GuidelinesXx_NEWLINE_xXNo intervening anti-cancer therapy between the last course of nivolumab or pembrolizumab and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).Xx_NEWLINE_xXPrior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.Xx_NEWLINE_xXPatients who have received systemic interferon (IFN)? within the previous 6 months prior to enrollment to the study.Xx_NEWLINE_xXPrior CAR T-cell or other genetically-modified T-cell therapyXx_NEWLINE_xXDisease Characteristics and allowable prior therapy:Xx_NEWLINE_xXPatients in dose escalation and all expansion cohorts except first relapse AML may have received up to three prior lines of therapy.Xx_NEWLINE_xXFor Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negativeXx_NEWLINE_xXFor Arm B: must have received at least 2 but not more than 4 prior lines of therapy.Xx_NEWLINE_xXReceived at least 2 cycles of one prior regimen administered with curative intent and one of the following:Xx_NEWLINE_xXHas received pegzilarginase as part of any previous therapyXx_NEWLINE_xXPrior therapy with irinotecan (for expansion phase II only)Xx_NEWLINE_xXNo prior systemic therapy for clear cell renal cancerXx_NEWLINE_xXProgression on at least one prior systemic therapy or progression during an observation phase of no anti-cancer therapy within the prior 3 months; prior taxanes are allowedXx_NEWLINE_xXHave progressed on prior systemic therapyXx_NEWLINE_xXIs expected to require any other form of anti-cancer therapy while in the trial. Zoledronic acid or denosumab as supportive care for bone metastases will be allowed if started prior to study enrollmentXx_NEWLINE_xX-  Relapsed or refractory, pathologically proven mantle cell lymphoma. Must have a\n             current or prior tissue sample that is IHC positive for cyclin D 1 or that is positive\n             by FISH or cytogenetics for t(11;14).\n\n          -  Must have been refractory to and/or relapsed/progressed after at least 1 prior\n             therapy.\n\n          -  Prior autologous or allogeneic transplant are allowed. Patients may not have active\n             grade II-IV acute graft-versus-host disease (GVHD) or moderate/severe chronic GVHD by\n             NIH criteria and may not require immunosuppressive medications and/or corticosteroids\n             for the management of acute or chronic GVHD.\n\n          -  Phase I: Prior proteasome inhibitor and/or Bruton's tyrosine kinase (BTK) inhibitors\n             are allowed but patients may not have been exposed to the combination of proteasome\n             inhibitor and BTK inhibitor. Patients who have progressed on ibrutinib that are felt\n             to be at high risk for rapid progression on this study shall not be eligible for the\n             phase I portion of the study. NOTE: Ibrutinib pre-treated patients must meet all\n             eligibility criteria AND must have discontinued prior ibrutinib at least 3 months\n             prior to starting study therapy.\n\n          -  Phase II: Prior proteasome inhibitor and/or Bruton's tyrosine kinase inhibitors are\n             allowed but patients may not have been exposed to the combination of proteasome\n             inhibitor and BTK inhibitor. NOTE: Patients must have tolerated prior ibrutinib (i.e.,\n             not discontinued therapy due to toxicity).\n\n          -  Age ? 18 years.\n\n          -  Eastern Oncology Oncology Group (ECOG) performance status of 0-2.\n\n          -  Ability to understand and willingness to sign Institutional Review Board\n             (IRB)-approved informed consent.\n\n          -  Willing to provide archived tumor tissue and blood samples for research.\n\n          -  Adequate organ function as measured by the following criteria\n\n               -  Absolute Neutrophil Count (ANC) ? 750/mm³\n\n               -  Platelets ?50,000/mm³\n\n               -  Serum Creatinine ? 2x Upper Limit Normal (ULN)\n\n               -  ALT and AST ? 3x ULN\n\n               -  Total Bilirubin ? 1.5x ULN\n\n          -  Patients must not have received systemic treatment for MCL for at least 14 days prior\n             to enrollment, except for steroids which may be used to manage acute symptoms related\n             to disease up to 48 hours prior to starting study therapy. Radiation therapy must be\n             concluded at least 14 days prior to enrollment.\n\n          -  Women must not be pregnant or breastfeeding since we do not know the effects of\n             ixazomib and ibrutinib on the fetus or breastfeeding child. All sexually active\n             females of childbearing potential must have a blood test to rule out pregnancy within\n             2 weeks prior to registration.\n\n          -  Sexually active women of child-bearing potential with a non-sterilized male partner\n             and sexually active men must agree to use 2 methods of adequate contraception\n             (hormonal plus barrier or 2 barrier forms) OR abstinence prior to study entry, for the\n             duration of study participation, and for 3 months following last dose of study drugs.\n\n          -  Patients must have resolved all prior non-hematologic toxicities assessed as related\n             to prior therapy to ? grade 1.\n\n          -  Patients must have measurable disease (i.e., ? 1.5 cm in largest diameter) by\n             conventional imaging modalities. Patients with spleen or extranodal involvement as the\n             only measurable site of disease must have a discrete splenic lesion ? 1.5 cm in\n             largest diameter.\n\n          -  Patients may not have current/active Central Nervous System (CNS) involvement with\n             mantle cell lymphoma (patients with prior CNS involvement are eligible as long as they\n             have had no evidence of active CNS disease for at least 6 months).\n\n          -  Patients may not have another malignancy that could interfere with the evaluation of\n             safety or efficacy of this combination. Patients with a prior malignancy will be\n             allowed without study chair approval in the following circumstances:\n\n               -  Not currently active and diagnosed at least 3 years prior to the date of\n                  enrollment.\n\n               -  Non-invasive diseases such as low risk cervical cancer or any cancer in situ\n\n               -  Localized disease in which chemotherapy would not be indicated (such as Stage I\n                  colon, lung, prostate or breast cancer). Patients with other malignancies not\n                  meeting these criteria must be discussed with PrECOG prior to enrollment.\n\n          -  Patients requiring long-term anticoagulation must be managed on an anticoagulant\n             besides warfarin. Patients who require warfarin are not eligible.\n\n          -  Patients with a clinically significant bleeding episode as judged by the investigator\n             within 3 months of registration are not eligible, except patients who suffer bleeding\n             due to trauma.\n\n          -  Patients may not have had major surgery within 14 days, or minor surgery within 3\n             days, before registration.\n\n          -  Patients may not have any active infection requiring oral or intravenous antimicrobial\n             therapy at the time of therapy initiation. Patients with a recent self-limited\n             infection that has clinically resolved may complete a prescribed course of\n             antimicrobial therapy after study initiation as long as they are asymptomatic with no\n             clinical evidence of infection for at least 7 days prior to treatment. Patients with a\n             recent serious (grade ? 3) infection requiring hospitalization must have completed all\n             antimicrobial therapy within 14 days of therapy initiation.\n\n          -  Patients may not have evidence of uncontrolled cardiovascular conditions, including\n             uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive\n             heart failure (New York Heart Association (NYHA) class III or higher, unstable angina,\n             or myocardial infarction within the past 6 months. Patients with a history of any\n             significant cardiovascular disease that has been controlled for at least 14 days\n             before registration are allowed (except for patients who have had a myocardial\n             infarction within 6 months).\n\n          -  No systemic treatment, within 14 days before the first dose of ibrutinib with moderate\n             or strong inhibitors of CYP3A (Strong Inhibitors: ketoconazole, itraconazole,\n             voriconazole, posaconazole, clarithromycin, and telithromycin; Moderate Inhibitors:\n             fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir,\n             fosamprenavir, crizotinib, imatinib, verapamil, ciprofloxacin, grapefruit juice\n             products, and Seville oranges) or strong CYP3A inducers for ibrutinib and ixazomib\n             (carbamazepine, rifampin, phenytoin, St. John's wort).\n\n          -  Patients with ongoing or active systemic infection, active hepatitis B or C virus\n             infection, or known Human Immunodeficiency Virus (HIV) positive are not eligible.\n             Testing is not required in absence of clinical suspicion.\n\n          -  Patients with a history of hepatitis B or C must have a negative peripheral blood\n             Polymerase Chain Reaction (PCR) and may not be positive for Hepatitis B surface\n             antigen. Patients with cirrhosis or other evidence of liver damage due to Hepatitis B\n             or C are not eligible.\n\n          -  Patients with any serious medical or psychiatric illness that could, in the\n             investigator's opinion, potentially interfere with the completion of the treatment\n             according to the protocol are not eligible.\n\n          -  Patients with a known allergy to any of the study medications, their analogues, or\n             excipients in the various formulations of any agent are not eligible.\n\n          -  Patients with known gastrointestinal (GI) disease or prior GI procedure that could\n             interfere with the oral absorption or tolerance of ixazomib or ibrutinib including\n             difficulty swallowing are not eligible.\n\n          -  Patients with ? Grade 2 peripheral neuropathy, or Grade 1 peripheral neuropathy with\n             pain on clinical examination during the screening period are not eligible.\n\n          -  Patients may not participate in any other therapeutic clinical trials, including those\n             with other investigational agents not included in this trial throughout the duration\n             of this study.\n\n          -  As ibrutinib will not be provided by the study, the patient must be able to obtain\n             ibrutinib through other means (i.e., commercially or through patient assistance\n             programs). This must be confirmed prior to registration.Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXCohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Prior hormonal therapy: \r\n* Participants may have received any number of previous endocrine / hormonal lines of therapy (including prior fulvestrant) in the metastatic setting, as long as the last dose is >= 14 days prior to first dose of study treatmentXx_NEWLINE_xXCohort A Dose Expansion (Ribociclib + PDR001): Prior hormonal therapy: \r\n* Participants may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting, as long as the last dose is >= 14 days prior to first dose of study treatmentXx_NEWLINE_xXChronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents.Xx_NEWLINE_xXPrior medical therapy is allowed but not requiredXx_NEWLINE_xXNo limit on number of prior therapiesXx_NEWLINE_xXPatients not able or unwilling to travel for proton therapyXx_NEWLINE_xXEscalation Phase: Subjects may be enrolled with ? 2 lines of prior systemic anti-cancer therapy (but no immunotherapy). Subjects who have had no prior systemic anti-cancer therapy (i.e. first-line therapy) or declined first-line treatment are permitted in the Escalation Phase.Xx_NEWLINE_xXCombination/multi-agent cyto-reductive therapyXx_NEWLINE_xXIn dose escalation (Phase I), patients must have histologically or cytologically confirmed metastatic disease from any solid tumor that is incurable and fulfills one of the following criteria:\r\n* Has demonstrated progression of disease following at least one line of effective systemic therapy; prior treatment with anti-CTLA-4 antibody (including ipilimumab) is allowable OR\r\n* For which effective therapy does not existXx_NEWLINE_xXRefractory/relapsed disease following DNMTi failure; refractory disease defined as either 1) failure to achieve an objective response after at least 4 cycles of DNMTi therapy, or 2) failure to achieve an objective response with clear progressive disease on bone marrow biopsy after at least 2 cycles of DNMTi therapy; relapsed disease is defined as having progressive disease after achieving an objective response after at least 2 cycles of DNMTi therapy; previous DNMTi therapy may include 5’azacitidine, decitabine, or DNMTi therapy currently in clinical trials (e.g. SGI-110 [guadecitabine], ASTX727 or CC-486); to be considered DNMTi treatment failure, during each prior treatment cycle, patients must have received minimum dosing of:\r\n* Decitabine 15 mg/m^2 daily x 5 days, or\r\n* 5’azacitidine 50 mg/m^2 IV/SC daily x 5 days,\r\n* SGI-110 (guadecitabine) 60 mg/m^2 SC daily x 5 days, or\r\n* Oral DNMTi therapy with ASTX727 20/100 mg daily x 5 days, or\r\n* Oral DNMTi therapy with CC-486 200 mg daily x 14 daysXx_NEWLINE_xXPatients must not have received prior anti-VEGF therapy including bevacizumab (i.e. patients must be bevacizumab naive)Xx_NEWLINE_xXInclusion Criteria:\n\n        Male or female patients ?18 years of age. For Japan only: written consent is necessary both\n        from the patient and his/her legal representative if he/she is under the age of 20 years.\n\n        Histologically documented advanced or metastatic solid tumors or lymphomas\n\n          -  Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer,\n             urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL),\n             microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or\n             melanoma\n\n          -  Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those\n             with mixed histology, there must be a predominant histology\n\n          -  Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one\n             additional tumor type based on emerging data from part 1 of the study.\n\n        Patient (except for those participating in Japanese safety run-in) must have a site of\n        disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating\n        institution's guidelines. Patient must be willing to undergo a new tumor biopsy at\n        screening, and again during therapy on this study.\n\n        o Part 4: Safety run-in part in Japanese patients can enroll any tumor type included in\n        part 1 and 2.\n\n        The collection of recent sample is permitted under the following conditions (both must be\n        met):\n\n          -  Biopsy was collected ? 3 months before 1st dose of study treatment and available at\n             the site.\n\n          -  No immunotherapy was given to the patient since collection of biopsy.\n\n        Part 1 - 3 only: Patients (other than those with DLBCL) must previously have received at\n        least 1 and no more than 3 prior lines of therapy for their disease, specifically including\n        the following, unless considered inappropriate for the patient (e.g. safety concern, label\n        contraindication):\n\n          -  Patients with NSCLC must have received a prior platinum-based combination.\n\n          -  Patients with EGFR positive NSCLC with a T790M mutation must have progressed on\n             osimertinib or discontinued due to toxicity.\n\n          -  Patients with head and neck cancer must have received a prior platinum-containing\n             regimen.\n\n          -  Patients with bladder cancer must have received a prior platinum-containing regimen or\n             be ineligible for cisplatin.\n\n          -  Patients with renal cell carcinoma must have received a prior VEGF tyrosine kinase\n             inhibitor (TKI).\n\n          -  Patients with MSS colorectal cancer must have received (or be intolerant to) prior\n             therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens.\n\n          -  Patients with triple negative breast cancer must have received a prior\n             taxane-containing regimen.\n\n        Patients with DLBCL should be limited to those with no available therapies of proven\n        clinical benefit\n\n        o Patients should have had prior autologous hematopoietic stem cell transplantation\n        (auto-HSCT) or determined to be ineligible for auto-HSCT.\n\n        Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors;\n        single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except\n        for NSCLC patients enrolled in part 3 and Japanese safety run-in part.\n\n        Patients must have measurable disease, defined as at least one lesion that can be\n        accurately measured in at least one dimension (longest diameter to be recorded for\n        non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques\n        or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI),\n        or calipers by clinical exam.\n\n        Other protocol-defined inclusion criteria may apply.\n\n        Exclusion Criteria:\n\n        Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR\n        inhibitors for non-oncologic indications (e.g. Parkinson's disease) may be considered for\n        enrollment on a case by case basis.\n\n        Current or prior use of immunosuppressive medication within 28 days before the first dose\n        of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic\n        corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of\n        prednisone) History of another primary malignancy except for:\n\n          -  Malignancy treated with curative intent and with no known active disease ?2 years\n             before the first dose of study drug and of low potential risk for recurrence\n\n          -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of\n             disease\n\n          -  Adequately treated carcinoma in situ without evidence of disease Active or prior\n             documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave's\n             disease, or psoriasis not requiring systemic treatment (within the past 2 years) are\n             not excluded.\n\n        More than 3 prior lines of therapy except for Japanese safety run-in part. History of\n        interstitial lung disease or non-infectious pneumonitis Participation in another clinical\n        study with an investigational product during the last 21 days prior to starting on\n        treatment.\n\n        Other protocol-defined exclusion criteria may apply.Xx_NEWLINE_xXInclusion criteria:\n\n        Dose escalation (Part 1A and Part 1B)\n\n          -  Patients with histologically confirmed, advanced unresectable or metastatic solid\n             tumor whom in the opinion of the Investigator does not have a suitable alternative\n             therapy.\n\n        Dose expansion (Part 2A)\n\n          -  Patients with histologically confirmed, advanced unresectable or metastatic melanoma\n             whom in the opinion of the Investigator does not have a suitable alternative therapy.\n\n          -  Patients must have failed a prior therapy based on anti-PD-1 or anti-PD-L1 as defined\n             by disease progression confirmed radiologically within 12 weeks of commencing\n             treatment without any evidence of a response.\n\n          -  Patients must have a site of disease amenable to biopsy and be a candidate for tumor\n             biopsy. Patients must be able to provide mandatory tumor biopsies prior to and during\n             study treatment.\n\n        Dose expansion (Part 2B)\n\n          -  Patients with histologically confirmed advanced unresectable or metastatic melanoma\n             who have failed a prior therapy based on anti-PD-1 or anti-PD-L1 or patients with a\n             specific type of colorectal adenocarcinoma who have progressed after last line of\n             therapy and have no other alternative approved standard therapy or refuse approved\n             standard therapy.\n\n        All cohorts\n\n          -  At least 1 measurable lesion by RECIST v1.1.\n\n          -  Patient understands and has signed Informed Consent form and is willing and able to\n             comply with the requirements of the trial.\n\n        Exclusion criteria:\n\n          -  Age <18 years.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status >1.\n\n          -  Concurrent treatment with any other anticancer therapy (including radiotherapy or\n             investigational agents) or participation in another clinical study.\n\n          -  Washout period of less than 3 weeks to prior anticancer therapy.\n\n          -  Women of reproductive potential and male subjects with female partners of childbearing\n             potential who are not willing to avoid pregnancy by using effective contraceptive.\n\n          -  Pregnant or breast-feeding women.\n\n          -  Unwillingness and inability to comply with scheduled visits, drug administration plan,\n             laboratory tests, other study procedures, and study restrictions.\n\n          -  Significant and uncontrolled concomitant illness, including any psychiatric condition.\n\n          -  Active infections, including unexplained fever (temperature >38.1ºC), or antibiotic\n             therapy within 1 week prior to enrollment.\n\n          -  Any prior organ transplant including allogeneic bone marrow transplant.\n\n          -  History within the last 5 years of an invasive malignancy other than the one treated\n             in this study.\n\n          -  History of known human immunodeficiency virus (HIV), unresolved viral hepatitis.\n\n          -  Any major surgery within the last 28 days.\n\n          -  Patients with primary central nervous system (CNS) tumors and/or metastases.\n\n          -  History of severe, acute or chronic heart diseases.\n\n          -  History of severe, acute or chronic renal diseases or inadequate renal function.\n\n          -  Any of the following within 6 months prior to study enrollment: pulmonary embolism,\n             infectious or inflammatory bowel disease, diverticulitis, intestinal obstruction or\n             perforation and gastrointestinal hemorrhage.\n\n          -  Inadequate hematological or liver function.\n\n          -  Non-resolution of any prior treatment related toxicity to Grade <2.\n\n          -  Prior treatment with any anti-transforming growth factor ? (anti-TGF?) inhibitors.\n\n          -  Known allergies to any component of SAR439459 and/or REGN2810.\n\n          -  Patients who received prior immunotherapy who developed toxicity leading to a\n             permanent discontinuation of immunotherapy.\n\n          -  Ongoing or recent (within 2 years) evidence of significant autoimmune disease that\n             required treatment with systemic immunosuppressive treatments.\n\n          -  Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within\n             4 weeks prior to the first dose of SAR439459 and/or REGN2810 (occasional use of\n             inhaled, intraocular, nasal or topical steroids for symptomatic relief allowed).\n\n          -  History of pneumonitis or bowel perforation.\n\n          -  Patients with underlying cancer predisposition syndromes.\n\n        The above information is not intended to contain all considerations relevant to a patient's\n        potential participation in a clinical trial.Xx_NEWLINE_xXPatients with a history of LVEF decline to below 50% during or after prior trastuzumab or other HER2 directed therapyXx_NEWLINE_xXFor Cohort C only: any prior anti-cancer therapy for advanced melanomaXx_NEWLINE_xXRequirement for concomitant therapy or food that is prohibited during the studyXx_NEWLINE_xXrelapsed and refractory multiple myeloma (RRMM): subjects who have received at least 2 prior regimen, were responsive to at least 1 prior regimen (as defined by IMWG criteria) and then are refractory to their most recent therapy (? 25% response or progression during therapy or within 60 days after completion of therapy). Prior therapies for subjects with PRMM or RRMM must include an immunomodulatory drug (IMiD) and a proteasome inhibitor as separate lines or a combined line of therapy. If prior therapy includes autologous stem cell transplantation (ASCT), then induction/ASCT/maintenance therapies will be considered as one line of therapy altogether. Subjects who have relapsed after ASCT or are unable to receive ASCT are eligible. The interval from ASCT to entry in the study must be ?12 weeks.Xx_NEWLINE_xXFor subjects who have received prior checkpoint inhibitors:Xx_NEWLINE_xXImmune therapy (including monoclonal antibody therapy) -6 weeksXx_NEWLINE_xXPrimary refractory disease (i.e. never responded (? MR) to any prior therapy)Xx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXFor prior cytotoxic therapy, treatment for 1 full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  ? 18 years of age at the time of signing informed consent\n\n          -  Diagnosis of AML according to the World Health Organization (WHO) 2008 criteria\n\n          -  Relapsed or refractory disease meeting the following criteria: (a) Primary refractory,\n             ie, refractory to induction with a standard anthracycline-based regimen or a\n             hypomethylating agent (e.g. decitabine or azacitidine) for patients ineligible for\n             anthracycline-based therapy; (b) First relapse after a first complete remission (CR)\n             lasting less than 12 months; or (c) Second or later relapse. Relapse is defined as the\n             reappearance of leukemic blasts in the peripheral blood or ? 5% leukemic blasts in the\n             bone marrow after prior achievement of a CR or CRi.\n\n          -  Blasts at least 5% in bone marrow\n\n          -  Peripheral white blood cell (WBC) count: no upper limit at Screening, but must be < 10\n             x 109/L on Day 1 prior to treatment; patients with excessive blasts may be treated\n             with hydroxyurea to bring counts down.\n\n          -  Chemistry laboratory parameters within the following range:\n\n               1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2x the\n                  upper limit of normal (ULN)\n\n               2. Total bilirubin ? 1.5x the ULN; patients with Gilbert's syndrome can enroll if\n                  conjugated bilirubin is within normal limits.\n\n               3. Creatinine clearance > 50 mL/min (measured or calculated by Cockcroft-Gault\n                  method)\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with\n             ECOG score of 2 may be included, after discussion with the Sponsor Medical Monitor, if\n             score is influenced by symptoms attributable to underlying AML disease.\n\n          -  Able to read, understand and provide written informed consent\n\n        Exclusion Criteria:\n\n        Patients who meet any of the following criteria will be excluded from the study.\n\n          -  History of, or known, central nervous system (CNS) disease involvement, or prior\n             history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events\n             (CTCAE) Grade ? 3 drug-related CNS toxicity\n\n          -  Prior allogeneic transplant is excluded during Dose Escalation Stage;\n\n          -  Prior solid organ transplantation\n\n          -  Treatment with anti-thymocyte globulin (ATG) within 14 days prior to start date\n\n          -  Treatment with any local or systemic antineoplastic therapy or radiation within 14\n             days prior to the initiation of AMV564 administration (hydroxyurea is exempted if used\n             to reduce total WBC counts)\n\n          -  Clinically significant cardiac disease,\n\n          -  Pulmonary, renal, hepatic, gastrointestinal, neurological or psychiatric disease that\n             would limit compliance with study requirements\n\n          -  Evidence of active, uncontrolled, viral, bacterial, or systemic fungal infection.\n             Prophylactic therapy according to institutional protocols is acceptable.\n\n          -  Known positive test result for human immunodeficiency virus (HIV) or acquired immune\n             deficiency syndrome (AIDS)\n\n          -  Active hepatitis C virus (HCV) or hepatitis B virus (HBV).\n\n          -  Second primary malignancy that has not been in remission for greater than 3 years.\n             Exceptions that do not require a 3-year remission include: non-melanoma skin cancer;\n             cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on\n             Papanicolaou (PAP) smear; localized prostate cancer (Gleason score < 6); or resected\n             melanoma in situ.\n\n          -  Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse),\n             dementia or altered mental status or any issue that would impair the ability of the\n             patient to understand informed consent or that in the opinion of the investigator\n             would contraindicate the patient's participation in the study or confound the results\n             of the study.\n\n          -  Ability to become pregnant. However, female patients who have a negative serum or\n             urine pregnancy test before enrollment and agree to use two highly effective forms of\n             contraception (oral, injected or implanted hormonal contraception and condom;\n             intrauterine device and condom; diaphragm with spermicidal gel and condom) during the\n             trial and for 90 days afterward (90 days after the end of AMV564 treatment) are\n             considered eligible.\n\n          -  Male patients with partners of childbearing potential.\n\n          -  Pregnant or breastfeeding womenXx_NEWLINE_xXPatient’s current disease state must be one for which there is not known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPhase 1: Subjects with a RET rearrangement must have had disease progression after at least one prior line of systemic therapy; subjects with an ALK rearrangement may be either treatment naive or may have received prior treatment, and must have CNS disease present at baseline; subjects cannot have received more than one prior RET TKI (such as, but not limited to, vandetanib, sorafenib, sunitinib, ponatinib, or cabozantinib); subjects enrolling to the phase 1 portion of the trial must not have received prior alectinib therapyXx_NEWLINE_xXPhase 2:\r\n* Cohort A: RET-positive NSCLC subjects must have received at least one prior line of therapy, but must be RET TKI-naive\r\n* Cohort B: RET-positive NSCLC that has previously been treated with one RET TKI; subjects cannot have received more than one prior RET TKI and must not have received prior alectinib\r\n* Cohort C: RET-positive thyroid cancer, must be radioactive iodine refractoryXx_NEWLINE_xXPhase 1: Subjects who have received prior alectinib therapyXx_NEWLINE_xXMust have been treated with at least 2 prior systemic therapies.Xx_NEWLINE_xXLVEF within normal limits if patient received prior anthracycline therapy [Period 1].Xx_NEWLINE_xXPatients must not have received any of the specified therapies as stated in the protocol in the time period prior to registrationXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapy.Xx_NEWLINE_xXMust have one of the following cancers, for which the patient has either received or been intolerant to all therapy known to confer clinical benefitXx_NEWLINE_xXReceived other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (or have not yet recovered from any actual toxicities of the most recent therapy) prior to the first scheduled dose of MM-310Xx_NEWLINE_xXHave high-risk relapsed or refractory Hodgkin lymphoma (HL), defined as at least one of the following:\r\n* Primary refractory disease to front-line therapy\r\n* Relapse within 1 year of completing front-line therapy\r\n* Extranodal involvement at the time of pre-ASCT relapse\r\n* B symptoms at pre-ASCT relapse\r\n* More than one type of pre-ASCT salvage therapy requiredXx_NEWLINE_xXAdministration of any antineoplastic therapy within 5 half-lives of the antineoplastic therapy before the first dose of ORH-2014, with the exception of hydroxyurea that should be discontinued 1 day prior to the first dose of ORH-2014Xx_NEWLINE_xXSubjects with positive HBV core antibody or surface antigen are eligible as long as they have an undetectable HBV DNA PCR, and receive concurrent antiviral therapy with entecavir, tenofovir, or lamivudine, and continued for a minimum of 6 months after completion of therapy.Xx_NEWLINE_xXPrior bevacizumabXx_NEWLINE_xXAll hematologic, gastrointestinal, and genitourinary chemotherapy toxicities must be less than Grade 2 at the time study therapy is to begin. (Note: Transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.Xx_NEWLINE_xXHCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCCXx_NEWLINE_xXINCLUSION CRITERIA FOR SECOND-LINE THERAPY: Actively on first line therapy for metastatic pancreatic cancerXx_NEWLINE_xXINCLUSION CRITERIA FOR SECOND-LINE THERAPY: Patients may be actively on “maintenance” therapy, such as maintenance capecitabine up to starting first line therapy for metastatic diseaseXx_NEWLINE_xXPhase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.Xx_NEWLINE_xXKRAS Wild Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody, such as cetuximab, panitumumab or others.Xx_NEWLINE_xXRecovery from significant toxicities from previous therapies and sufficient time since last dose of previous therapyXx_NEWLINE_xXConcomitant therapy with valproic acid/valproate-containing therapiesXx_NEWLINE_xXOngoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomyXx_NEWLINE_xXCOHORT A: Patients with newly diagnosed, previously untreated primary tumors that present with brain metastases should not forego available therapy that has demonstrated a definitive overall survival benefit as first line therapy for metastatic disease; therefore, in cases of previously untreated systemic solid tumors only those patients for whom there is no available therapy with definitive overall survival benefit, those that have failed at least one line of prior therapy for their primary tumor, or those refusing standard therapy will be eligible for this study; specifically, for patients with previously untreated primary tumors, the following diagnoses will be excluded: HER2-positive breast cancer; small cell lung cancer; non-small cell lung carcinoma (NSCLC) with targetable genomic tumor aberrations (e.g. EGFR, ALK)Xx_NEWLINE_xXCOHORT B: Progressive brain metastases after prior local CNS-directed therapy such as radiation or surgery as defined by:\r\n* Untreated measurable lesions in patients that have received surgery and/or SRS to one or more other lesions\r\n* Residual or progressive lesions after surgery if asymptomatic\r\n* Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed are eligible; lesions treated with SRS may be eligible if there is unequivocal evidence of progressionXx_NEWLINE_xXPrior exposure to enzalutamide, ARN-509, or other investigational androgen receptor (AR)-directed therapyXx_NEWLINE_xXBiopsy-proven intermediate or high-grade non-Hodgkin’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):\r\n* In partial remission\r\n* Relapsed after initial complete remission\r\n* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)\r\n* In complete remission with high-risk features as specified by the International Prognostic IndexXx_NEWLINE_xXBiopsy-proven advanced stage follicular lymphoma, that have failed at least two lines of therapy multi-agent chemotherapy, but responds to salvage therapy (i.e., chemosensitive disease) (timeline 8 months prior to enrollment)Xx_NEWLINE_xXBiopsy-proven Hodgkin’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment)\r\n* In first, or greater relapse after initial complete remission\r\n* In partial remission\r\n* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)Xx_NEWLINE_xXBiopsy-proven Burkitt’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):\r\n* In second complete remission after relapse following initial complete remission\r\n* Failed induction therapy, but responds (very good partial remission, complete remission, or near complete remission) to salvage therapy (i.e., chemosensitive disease)Xx_NEWLINE_xXNOTE: Patients meeting the following criteria are exempt from the 8 month timeline and do not require additional biopsy:\r\n* Patients who have never achieved a complete remission on the last biopsy-proven site of disease and went on to the next therapy then achieved a complete remission\r\n* Patients who relapsed quickly (within 3 months of their last chemotherapy) and now have achieved a complete remission with salvage therapyXx_NEWLINE_xXRelapsed or refractory disease, defined by failure to achieve a partial response within 6 months of initiation of therapy, or a 50% increase of baseline disease measurements after achieving a clinical responseXx_NEWLINE_xXPrior cytoreductive therapy.Xx_NEWLINE_xXSAFETY RUN-IN: Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatinXx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to their enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatinXx_NEWLINE_xXOn Androgen Deprivation Therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study;Xx_NEWLINE_xXInclusion Criteria:\n\n        To be eligible for participation in the study, patients must meet all of the following\n        inclusion criteria:\n\n          1. Patients enrolled in the Phase 1a study must:\n\n               1. Have a histologically confirmed diagnosis of advanced metastatic or progressive\n                  solid tumor\n\n               2. Be refractory to, or intolerant of, established therapy known to provide clinical\n                  benefit for their condition\n\n          2. Patients enrolled in the Phase 1b study must meet criteria for one of the following\n             tumor types:\n\n               1. Have tumors that have progressed despite immunotherapy and are felt to be\n                  appropriate for this type of treatment*\n\n               2. Have EGFR+ NSCLC and have progressed on ?2 lines of oral TKIs and are felt to be\n                  appropriate for this type of treatment*\n\n                  *Patients with immunotherapy-resistant tumors or EGFR+ NSCLC who are enrolled in\n                  these expansion cohorts will continue treatment with their previous immunotherapy\n                  or TKI regimens, respectively, and add TP-0903. The rationale is based on\n                  preclinical data that has shown that the combination is superior in patients who\n                  have progressed on prior immunotherapy or a TKI.\n\n               3. Have BRAF-, KRAS-, or NRAS-mutated CRC for whom there is no standard therapy\n                  remaining\n\n               4. Have persistent/recurrent ovarian cancer who would be platinum refractory/\n                  resistant and have had any number of lines of prior therapy\n\n               5. Have BRAF-mutated melanoma that has not responded to immunotherapy or a\n                  combination BRAF/MEK inhibitor\n\n          3. Have one or more tumors measurable or evaluable as outlined by modified RECIST v1.1\n\n          4. Have an Eastern Cooperative Oncology Group (ECOG) (World Health Organization [WHO])\n             performance of ?1\n\n          5. Have a life expectancy ?3 months\n\n          6. Be ?18 years of age\n\n          7. Have a negative pregnancy test (if female of childbearing potential)\n\n          8. Have acceptable liver function:\n\n               1. Bilirubin ?1.5x upper limit of normal (ULN)\n\n                  *Patients receiving immunotherapy should have a bilirubin level <3.0x ULN.\n\n               2. Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and\n                  alkaline phosphatase ?2.5x upper limit of normal (ULN)\n\n                    -  If liver metastases are present, then ?5x ULN is allowed.\n\n                    -  Patients receiving immunotherapy should have AST and ALT levels <5.0x ULN.\n\n          9. Have acceptable renal function:\n\n             a. Calculated creatinine clearance ?30 mL/min\n\n         10. Have acceptable hematologic status:\n\n               1. Granulocyte ?1500 cells/mm3\n\n               2. Platelet count ?100,000 (plt/mm3)\n\n               3. Hemoglobin ?9 g/dL\n\n         11. Have no clinically significant abnormalities on urinalysis\n\n         12. Have acceptable coagulation status:\n\n               1. Prothrombin time (PT) within 1.5x normal limits\n\n               2. Activated partial thromboplastin time (aPTT) within 1.5x normal limits\n\n         13. Be nonfertile or agree to use an adequate method of contraception. Sexually active\n             patients and their partners must use an effective method of contraception (hormonal or\n             barrier method of birth control; or abstinence) prior to study entry and for the\n             duration of study participation and for at least 30 days after the last study drug\n             dose (see Section 4.6.3). Should a woman become pregnant or suspect she is pregnant\n             while participating in this study, she should inform her treating physician\n             immediately.\n\n         14. Have read and signed the IRB-approved informed consent form prior to any study related\n             procedure. (In the event that the patient is re-screened for study participation or a\n             protocol amendment alters the care of an ongoing patient, a new informed consent form\n             must be signed.)\n\n         15. Patients enrolled in each of the five Expansion Cohorts must be willing to consider\n             pre-study and on-study biopsies, if safe and medically feasible, as determined by\n             local interventional radiology (3 to 5 core samples requested at each biopsy\n             timepoint)\n\n        Patients meeting any one of these exclusion criteria will be prohibited from participating\n        in this study:\n\n          1. Have New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial\n             infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence\n             of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days\n             prior to Day 1 (Appendix C)\n\n          2. Have a corrected QT interval (QTcF, Fridericia's method) of >450 msec in men and 470\n             msec in women\n\n          3. Have a seizure disorders requiring anticonvulsant therapy\n\n          4. Presence of symptomatic central nervous system metastatic disease or disease that\n             requires local therapy such as radiotherapy, surgery, or increasing dose of steroids\n             within the prior 2 weeks\n\n          5. Have severe chronic obstructive pulmonary disease with hypoxemia (defined as resting\n             O2 saturation of ?88% breathing room air)\n\n          6. Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to\n             Day 1\n\n          7. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic\n             therapy\n\n          8. Are pregnant or nursing\n\n          9. Received treatment with radiation therapy, surgery, chemotherapy, or investigational\n             therapy within 28 days or 5 half lives, whichever occurs first, prior to study entry\n             (6 weeks for nitrosoureas or Mitomycin C)\n\n             a. This exclusion criterion is not applicable for patients with EGFR+ NSCLC or\n             immunotherapy-resistant tumors who are enrolled in expansion cohorts at the MTD.\n\n         10. Are unwilling or unable to comply with procedures required in this protocol\n\n         11. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or\n             hepatitis C. Patients with history of chronic hepatitis that is currently not active\n             are eligible\n\n         12. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other\n             conditions) that could compromise protocol objectives in the opinion of the\n             investigator and/or the sponsor\n\n         13. Are currently receiving any other investigational agent\n\n         14. Have exhibited allergic reactions to a similar structural compound, biological agent,\n             or formulation\n\n         15. Have undergone significant surgery to the gastrointestinal tract that could impair\n             absorption or that could result in short bowel syndrome with diarrhea due to\n             malabsorption\n\n         16. Have a history of severe adverse reaction (eg, hypersensitivity reaction, anaphylaxis)\n             to sulfonamidesXx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while on study.Xx_NEWLINE_xXInclusion criteria. Patients may be entered in the study only if they meet all of the\n        following criteria:\n\n        1. Adults at least 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG)\n        performance status ?1. 3.\n\n          1. Subjects with histopathologically or cytologically confirmed diagnosis of cutaneous\n             Melanoma, RCC or NSCLC, for whom the use of nivolumab is indicated. NSCLC subjects\n             with EGFR or ALK genomic aberrations in tumor should have disease progression on\n             FDA-approved therapy for these aberrations prior to receiving nivolumab (Phase 1b).\n\n          2. Subjects with histopathologically or cytologically confirmed diagnosis of cutaneous\n             Melanoma, or NSCLC, for whom the use of nivolumab is indicated. NCSLC subjects with\n             EGFR or ALK genomic aberrations in tumor should have disease progression on\n             FDA-approved therapy for these aberrations prior to receiving nivolumab (Phase 2\n             expansion).\n\n          3. Cutaneous melanoma and NSCLC patients whose disease has progressed after achieving PR\n             or CR on previous treatment with antagonists to PD1-PD-L1 axis, or patients whose\n             disease remains stable on previous treatment with antagonists to PD1-PD-L1 axis and\n             modification to treatment is being considered. NSCLC patients with EGFR or ALK genomic\n             aberrations in tumor should have disease progression on FDA-approved therapy for these\n             aberrations prior to receiving nivolumab (Phase 2 expansion).\n\n             4. Subject must have at least one measurable target lesion as defined by Response\n             Evaluation Criteria in Solid Tumors (RECIST) v.1.1.\n\n             5. All prior systemic therapy (chemotherapy, mutation targeting therapy, immune\n             checkpoint therapy), surgical or radiation treatment must have been completed at least\n             4 weeks before study drug administration (2 weeks for palliative radiotherapy, 1 week\n             for minor surgery) pending full recovery from therapy.\n\n             6. The following laboratory results within 7 days prior to study drug administration:\n             Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings as defined\n             below: WBC ?3000/?L, Neutrophils ?1500/?L, Platelets ?100x103/?L, Hemoglobin ?9.0g/dL\n             independent of transfusion, Creatinine ?1.5mg/dL, AST and ALT ?3x ULN, Alkaline\n             phosphatase ?2.5x ULN unless bone metastases present, Bilirubin ?1.5x ULN (unless\n             known Gilbert's disease where it must be ?3x ULN) and serum albumin ?3.0g/dL.\n\n             7. Life expectancy ?12 weeks. 8. A negative serum pregnancy test at baseline for women\n             of childbearing potential.\n\n             9. Are willing to abstain from heterosexual activity or practice physical barrier\n             contraception prior to time of study entry to at least 5 months after the last day of\n             treatment.\n\n             10. Have the ability to understand and the willingness to sign a written informed\n             consent document.\n\n             Exclusion criteria. Subjects who fulfill any of the following criteria at screening\n             will not be eligible for admission into the study:\n\n               1. History of Grade 3 or above hypersensitivity reactions to other monoclonal\n                  antibodies.\n\n               2. Subjects with a history of a cardiovascular illness including: QTcF >450ms in\n                  male, and >470ms in female, congenital long QT syndrome, congestive heart failure\n                  (New York Heart Association Grade III or IV); unstable angina or myocardial\n                  infarction within the previous 6 months; or symptomatic cardiac arrhythmia\n                  despite medical management.\n\n               3. Uncontrolled hypertension, SBP >160 or DBP >100.\n\n               4. Subjects with untreated, or treated brain metastasis, unless stable for 4 weeks\n                  or more and not requiring steroids.\n\n               5. Presence of leptomeningeal disease.\n\n               6. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled\n                  peptic ulcer disease or recurrent pleural effusion requiring repetitive\n                  palliative thoracentesis within 3 months prior to study entry, except for\n                  subjects with a pleurex port. and immune-mediated toxicity leading to treatment\n                  discontinuation\n\n               7. Active, known, or suspected autoimmune disease, except for type I diabetes\n                  mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such\n                  as vitiligo, psoriasis, or alopecia).\n\n               8. Active uncontrolled bacterial, viral, or fungal infection requiring systemic\n                  therapy.\n\n               9. Known history of testing positive for human immunodeficiency virus (HIV), known\n                  acquired immunodeficiency syndrome (AIDS).\n\n              10. Active hepatitis B (serum hepatitis B surface antigen [HBV sAg] positive), or\n                  hepatitis C (HCV antibody test or serum hepatitis C RNA positive) indicating\n                  acute or chronic infection.\n\n              11. Subjects with a condition requiring systemic treatment with either\n                  corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive\n                  medications within 14 days of study drug administration. Inhaled or topical\n                  steroids are permitted.\n\n              12. Use of other investigational agent (drug not marketed for any indication) within\n                  28 days or at least 5 half-lives (whichever is longer) before study drug\n                  administration.\n\n              13. Pregnant or breast-feeding women.\n\n              14. Second malignancy unless in remission for 2 years, except for non-melanomatous\n                  skin cancer, carcinoma in situ of the cervix treated with curative intent.\n\n              15. Underlying medical conditions that, in the Investigator's opinion, will make the\n                  administration of study drug hazardous or obscure the interpretation of toxicity\n                  determination or adverse events.\n\n              16. Unwilling or unable to comply with procedures required in this protocol.Xx_NEWLINE_xXINCLUSION CRITERIA: -Pathologically documented, multiple myeloma relapsed or refractory\n        disease after at least 2 lines of therapy, -Must be willing and able to undergo bone marrow\n        biopsy at screening, -Measurable disease per the IMWG response criteria, -Eastern\n        Cooperative Oncology Group (ECOG) performance status of ? 2, -Satisfactory hematological\n        function without transfusion or growth factor support, -Subjects should not have received\n        platelet transfusions for at least 1 week prior to screening, -Hemoglobin > 8 g/dL,\n        -Subjects may receive RBC transfusions or receive supportive care), -Other Inclusion\n        Criteria May Apply.\n\n        EXCLUSION CRITERIA: -Previously received an allogeneic stem cell transplant within 6 months\n        OR having received immunosuppressive therapy within the last three months OR having signs\n        or symptoms of acute or chronic graft-versus-host disease, -Autologous stem cell transplant\n        less than 90 days prior to study day 1, -Multiple myeloma with IgM subtype, -POEMS\n        syndrome, -Existing plasma cell leukemia, -Waldenstrom's macroglobulinemia, -Amyloidosis,\n        -Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to\n        starting treatment, -Topical or inhaled corticosteroids are permitted, -Infection requiring\n        intravenous anti-infective treatments within 1 week of study enrollment (day 1), -Other\n        exclusion Criteria May Apply.Xx_NEWLINE_xXPrior HCT (allograft or prior autograft)Xx_NEWLINE_xXPatients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimensXx_NEWLINE_xXPatients who have had more than 12 months of prior therapy; patients outside of this window may be considered for inclusion; please contact the sponsor’s representative in Poland or the lead primary investigator as appropriate on a case-by-case basisXx_NEWLINE_xXPatients who progressed after initial therapy\r\n* Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression\r\n* No more than two regimens will be allowed excluding dexamethasone aloneXx_NEWLINE_xXAny number of prior chemotherapies and targeted therapies are allowedXx_NEWLINE_xXPatients must have received at least one prior line of targeted therapyXx_NEWLINE_xXPrior therapy with abemaciclibXx_NEWLINE_xXAny number of prior systemic therapies.Xx_NEWLINE_xXCRC - No more than four different prior lines of systemic therapy for advanced diseaseXx_NEWLINE_xXPatients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapyXx_NEWLINE_xXPatients with known (testing is not part of the protocol) active hepatic disease (i.e., hepatitis B or C) due to risk of drug interactions with anti-viral therapyXx_NEWLINE_xXSubjects with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, and subjects with tumors that carry a poor prognosis and have no known standard curative therapy are eligible;\r\n* Brain tumors of all World Health Organization (WHO) grades except diffuse intrinsic pontine glioma (DIPG); patients with DIPG are not eligible\r\n* Extracranial solid tumors including histiocytoses (e.g. Langerhans cell histiocytosis [LCH], juvenile xanthogranuloma [JXG], histiocytic sarcoma)Xx_NEWLINE_xXSubject’s current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXInclusion Criteria (Part 2 Only):\n\n          -  Histological or cytological diagnosis of locally advanced or metastatic NSCLC or\n             urothelial carcinoma who have progressed on or were intolerant to standard of care\n             systemic therapy, or for whom standard of care systemic therapy was refused (refusal\n             must be documented) or unavailable.\n\n          -  No prior treatment with anti-PD-1 or anti-PD-L1 therapy.\n\n          -  NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have\n             progressed on or after no more than 1 prior line of platinum-containing systemic\n             therapy or were intolerant or refused standard of care systemic therapy.\n\n          -  NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received\n             prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting\n             drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must\n             have progressed on or after both types of therapies.\n\n          -  Urothelial carcinoma patients must have received up to 2 lines of prior systemic\n             therapy and progressed on or after, experienced disease recurrence within 12 months of\n             neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused\n             platinum-containing systemic therapy.\n\n          -  Provide archived tumor tissue sample taken within the past 2 years or provide a fresh\n             tumor biopsy sample.\n\n          -  At least one measurable lesion as defined by RECIST version 1.1.\n\n          -  Adequate renal, liver, thyroid and bone marrow function.\n\n          -  Performance status 0 or 1.\n\n          -  Patient is capable of receiving study treatment for at least 8 weeks.\n\n        Exclusion Criteria (Part 2 Only)\n\n          -  Active brain or leptomeningeal metastases.\n\n          -  Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes\n             mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone\n             replacement, psoriasis not requiring systemic treatment, or conditions not expected to\n             recur in the absence of an external trigger are permitted to enroll. Diagnosis of\n             prior immunodeficiency or organ transplant requiring immunosuppressive therapy or\n             prior allogeneic bone marrow or hematopoietic stem cell transplant.\n\n          -  Patients with a condition requiring systemic treatment with either corticosteroids\n             (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14\n             days of study drug administration. Inhaled or topical steroids, and adrenal\n             replacement doses >10 mg daily prednisone equivalents are permitted in the absence of\n             active autoimmune disease.\n\n          -  Patients with a history of interstitial lung disease, non-infectious pneumonitis, or\n             active pulmonary tuberculosis. Those with active lung infections requiring treatment\n             are also excluded.\n\n          -  History of Grade ?3 immune mediated AE (including AST/ALT elevations that where\n             considered drug related and cytokine release syndrome) that was considered related to\n             prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory\n             agents, etc.) and required immunosuppressive therapy.\n\n          -  Active hepatitis B or C, HIV/AIDS.\n\n          -  Other potentially metastatic malignancy within past 5 years.Xx_NEWLINE_xXExperienced weight loss > 10% over approximately 2 months prior to first dose of study therapyXx_NEWLINE_xXHas experienced documented objective radiographic or clinical disease progression during or after receiving more than 1 line of therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n          1. Male and female subjects at least 18 years at the time of screening\n\n          2. Adequate organ function within 14 days of enrollment confirmed by laboratory results\n\n          3. Off immunosuppressive medications including, but not limited to, systemic\n             corticosteroids at doses exceeding 10 mg/day prednisone or equivalent\n\n        Additional Inclusion Criteria for Part 1:\n\n          1. Metastatic/locally advanced solid tumor malignancy that has progressed on, is\n             refractory to, or for which there is no standard of care therapy\n\n          2. At least one lesion that is easily accessible for injection (subjects enrolled prior\n             to Amendment 3 only)\n\n          3. At least one deep-seated lesion suitable for intervention (subjects enrolled in the\n             deep-seated lesion expansion portion only)\n\n          4. At least 2 lesions (for subjects enrolled to evaluate addition of concurrent\n             palliative radiation to MEDI9197 therapy)\n\n        Additional Inclusion Criteria for Subjects in Part 2\n\n          1. Clinical diagnosis of CTCL, including documentation of a skin biopsy with histological\n             findings consistent with CTCL\n\n          2. Stage IB, IIA or IIB disease: T1, T2 or T3 (patches, plaques or tumors) with\n             measurable lesions\n\n          3. Previous treatment with at least one standard therapy used to treat the stage of\n             disease at study entry\n\n          4. At least 2 lesions amenable to response assessment\n\n        Additional Inclusion Criteria for Subjects in Part 3A and 3B\n\n        1. Metastatic/locally advanced solid tumor malignancy that has progressed on, is refractory\n        to, or for which there is no standard of care therapy\n\n        Exclusion Criteria:\n\n        Any of the following would exclude the subject from participation in the study:\n\n          1. Subjects who have received prior immunotherapy are NOT permitted to enroll unless all\n             of the following apply:\n\n               1. Prior anti-CTLA 4 inhibitor last dose administered at least 100 days ago. Other\n                  prior immunotherapies, the last dose administered at least 28 days prior to\n                  planned first dose of MEDI9197\n\n               2. Must not have experienced a toxicity that led to permanent discontinuation of\n                  prior immunotherapy\n\n               3. All AEs while receiving prior immunotherapy must have resolved to ? Grade 1 or\n                  baseline prior to screening for this study. Must not have experienced a ? Grade 3\n                  AE or neurologic, pneumonitis or ocular AE of any grade while receiving prior\n                  immunotherapy\n\n               4. Must not have required the use of additional immunosuppression other than\n                  corticosteroids for the management of an AE, not have experienced recurrence of\n                  an AE if re-challenged, and not currently require maintenance doses of > 10 mg\n                  prednisone or equivalent per day\n\n          2. Pregnant or lactating\n\n          3. Active bacterial, fungal, or viral infections\n\n          4. Active autoimmune disease, chronic inflammatory condition, conditions requiring\n             concurrent use of any systemic immunosuppressants or steroids\n\n          5. Immune-deficiency states - myelodysplastic disorders, marrow failures, human\n             immunodeficiency virus (HIV) infection, history of solid organ transplant or bone\n             marrow allograft, or recent pregnancy\n\n          6. Requires continuous anticoagulation or antiplatelet therapy.\n\n          7. History of coagulopathy resulting in uncontrolled bleeding.\n\n          8. Rapidly progressing disease\n\n          9. Untreated or uncontrolled central nervous system (CNS) involvement.\n\n         10. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer\n             treatment\n\n         11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to\n             NCI CTCAE v4.03 Grade 0 or 1, with exception of alopecia, vitiligo and laboratory\n             values listed per inclusion criteria\n\n         12. Chronic active hepatitis B or C\n\n         13. Known allergy to sesame oil and/or nuts\n\n         14. Cardiac exclusions: New York Heart Association Class 3 or 4 congestive heart failure,\n             uncontrolled hypertension, unstable angina pectoris, clinical important cardiac\n             arrhythmia, mean QTC interval corrected for heart rate >500ms\n\n         15. Major surgery within 4 weeks prior to study entry or still recovering from prior\n             surgery\n\n         16. Receipt of live, attenuated vaccine within 28 days prior to study entry.\n\n         17. Receipt of any systemic anticancer therapy not mentioned above within the last 2 weeks\n             or 5 half-lives\n\n         18. Subjects with CTCL, must not have had prior therapy with Imiquimod, total body\n             electron beam radiation, investigational drugs or treatments within 8 weeks. They must\n             not have had prior therapy with local radiation, UBV therapy, PUVA, any topical\n             chemotherapy, photopheresis, systemic retinoids, corticosteroids, immune response\n             modifiers, IFN inducers, chemotherapeutic agents or biological agents or any topical\n             treatment within 4 weeks. They must not have a known history or positive test for\n             infection with HTLV-1.\n\n         19. Cognitive disorder such that informed consent cannot be obtained directly from the\n             subject\n\n         20. Subjects who have previously participated in this study and received MEDI9197.\n\n         21. Subjects who have received prior TLR agonists, both systemic and topical.\n\n         22. Patients who have received prior therapeutic radiation within 28 days of dosing. All\n             toxicities from prior radiotherapy must have resolved to ? Grade 1 or baseline prior\n             to dosing.Xx_NEWLINE_xXPrior therapy is allowed provided the following are met: at least 4 weeks since prior locoregional therapy including surgical resection, radiotherapy, or ablation; provided target lesion has increased in size by 25% or more or the target lesion was not treated with locoregional therapyXx_NEWLINE_xXPatient who has received previous systemic therapy or transarterial chemoembolization (TACE) for HCCXx_NEWLINE_xXAny physical condition that can prevent ability to tolerate oral therapyXx_NEWLINE_xXPatients treated with first generation anti-androgen as most recent systemic therapy (bicalutamide, nilutamide) must have at least 4 weeks elapsed from treatment discontinuation to start of protocol therapy with evidence of disease progression by Prostate Cancer Working Group 2 (PCWG2) criteria following discontinuation of prior anti-androgenXx_NEWLINE_xXPatients may have received prior trastuzumab therapy alone or in combination with chemotherapy; a 2 week washout period is required between trastuzumab treatment and first dose of afatinibXx_NEWLINE_xXPrior taxane is allowed (as long as the patient is not experiencing grade > 1 neuropathy and had no history of disease progression on a taxane therapy within 3 months prior to study enrollment)Xx_NEWLINE_xXRelapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects must have received conventional therapy as a prior therapy.Xx_NEWLINE_xXReceived at least one prior line of therapy for incurable or metastatic NSCLC. Up to one prior line of checkpoint inhibitor therapy is permitted (must have received at least 6 months of treatment).Xx_NEWLINE_xXOngoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.Xx_NEWLINE_xXPrior therapy for metastatic TNBC (chemotherapy, hormone therapy or biological therapy), Patients may receive bisphosphonates and other therapies to treat bone metastases, however if used, bone lesions will not be considered as measurable disease.Xx_NEWLINE_xXPartial Inclusion criteria:\n\n        Evidence of histologically or cytologically confirmed diagnosis of locally advanced or\n        metastatic EGFRm (del 19 or L858R) NSCLC:\n\n          1. As detected by local EGFR mutation test that includes QIAGEN therascreen EGFR RGQ PCR\n             kit, Roche cobas® EGFR Mutation Test or a sponsor-approved laboratory developed test\n             that is validated in a CLIA laboratory (with tissue submitted for central laboratory\n             confirmation via FDA approved QIAGEN therascreen RCQ PCR kit).\n\n          2. T790M disease as follows:\n\n             Phase 1 If a repeat biopsy was performed on the tumor following prior EGFR TKI\n             therapy, then T790M positive disease must be present. Patients of unknown T790M status\n             following EGFR TKI progression (ie, no post EGFR TKI progression biopsy was performed)\n             are eligible.\n\n             In the PK sub-studies involving food/antacid and CYP3A4 effects, patients with EGFRm\n             (del 19 or L858R) with any T790M status are eligible to enroll.\n\n             Studies at RP2D Cohort 1: Patients may have de novo T790M mutation, but it is not\n             required. Cohort 2 and Cohort 3: Patients must have EGRFm (del 19 AND T790M or L858R\n             AND T790M) NSCLC tumors as detected by local EGFR mutation test that includes QIAGEN\n             Therascreen EGFR RGQ PCR kit, Roche cobas® EGFR Mutation Test or a sponsor-approved\n             laboratory developed test that is validated in a CLIA laboratory, which will then be\n             retrospectively confirmed by the central validated Thermo Fisher Scientific Oncomine\n             Next Generation Sequencing (NGS) cancer panel test. Patients will also be enrolled if\n             they solely test positive for EGFR (del 19 AND T790M or L858R AND T790M) NSCLC in\n             plasma detected by local EGFR mutation test that includes QIAGEN Therascreen EGFR\n             Plasma RGQ kit, Roche cobas® EGFR mutation test v2 (US-IVD) or Sysmex Inostic's\n             OncoBEAMTM EGFR test or a sponsor-approved laboratory developed test that is validated\n             in a CLIA laboratory, which will then be retrospectively confirmed by a validated\n             cfDNA test as determined by the Sponsor.\n\n          3. Prior treatment for EGFRm NSCLC as follows:\n\n        Phase 1 Has progressed after at least 1 prior line of therapy including and EGFR TKI.\n        Patients may have also received other lines of therapy before or after the EGFR TKI.\n\n        Studies at RP2D Cohort 1: no prior treatment for locally advanced or metastatic EGFRm\n        NSCLC. Cohorts 2 and 3: must have had disease progression on treatment with an approved 1st\n        or 2nd generation EGFR TKI. Patients who have been treated with a 3rd generation EGFR TKI\n        are ineligible for this study. Patients may have had multiple lines of therapy; however,\n        the last therapy prior to study treatment must have been an approved EGFR TKI and received\n        within 6 weeks prior to study registration.\n\n        Patients must have at least one measurable lesion as defined by RECIST version 1.1 that has\n        not been previously irradiated.\n\n        Tumor tissue available. Requesting formalin fixed paraffin embedded (FFPE) block or 15\n        unstained sections (5 micron). If a lesser amount of tissue is available, contact the\n        sponsor. An archival specimen is acceptable for Phase 1; a de novo specimen is required for\n        Cohorts 2, and 3 if the T790M status was confirmed by tissue biopsy.\n\n        Partial Exclusion Criteria:\n\n        For All Phases/Cohorts Previously diagnosed brain metastases, unless the patient has\n        completed the treatment that is clinically indicated, if any, and has recovered from the\n        acute effects of any treatment that was delivered prior to study registration, have\n        discontinued corticosteroid treatment for these metastases prior to registration, and are\n        neurologically stable.\n\n        Major surgery within 2 weeks prior to registration.\n\n        Radiation therapy, excluding stereotactic radiosurgery (SRS), within 1 week prior to\n        registration.\n\n        Systemic anti cancer therapy within 2 weeks or 5 half-lives (whichever is longer) of\n        registration excluding EGFR TKIs. Patients on EGFR TKIs must discontinue the agent for a\n        minimum of:\n\n          -  2 days prior to registration for erlotinib or afatinib, or 3 days for gefitinib if\n             they will be part of the lead-in single dose PF-06747775 PK study (Phase 1 Dose\n             Escalation Single and Multiple dose PK and ECG Assessments; Phase 1 Sildenafil at MTD;\n             and Phase 1b/2 First-Line Single Agent). Please contact the Sponsor for direction for\n             any other EGFR TKI.\n\n          -  5 half-lives or 5 days (whichever is longer) prior to registration if they will be\n             starting on continuous PF-06747775 dosing directly (Phase 1 PK sub-studies at RP2D;\n             Phase 1b/2 Combination with Palbociclib; Phase 1b Combination with Avelumab).\n\n        Partial Exclusions for Cohort 2A and 2B (Palbociclib combo):\n\n        Prior treatment with a CDK 4/6 inhibitor.\n\n        Partial Exclusions for Cohort 3 (Avelumab combo):\n\n        Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T\n        lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or\n        any other antibody or drug specifically targeting T cell co stimulation or immune\n        checkpoint pathways).\n\n        Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.\n        Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not\n        requiring immunosuppressive treatment are eligible\n\n        Use of immunosuppressive medication at time of randomizationXx_NEWLINE_xXInclusion Criteria:\n\n          1. Written informed consent in accordance with federal, local, and institutional\n             guidelines.\n\n          2. Age ? 18 years at the time of informed consent\n\n          3. Histologically confirmed diagnosis, measurable disease and evidence of disease\n             progression of MM, as described below.\n\n          4. Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease as\n             defined by at least one of the following:\n\n               1. Serum M-protein ? 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA\n                  myeloma, by quantitative IgA\n\n               2. Urinary M-protein excretion at least 200 mg/24 hours\n\n               3. Serum FLC ? 100 mg/L, provided that FLC ratio is abnormal\n\n               4. If serum protein electrophoresis is felt to be unreliable for routine M-protein\n                  measurement (e.g., for IgA MM), then quantitative Ig levels by nephelometry or\n                  turbidometry are acceptable.\n\n          5. Any non-hematological toxicities (except for peripheral neuropathy as described in\n             exclusion criterion #24) that patients experienced from treatments in previous\n             clinical studies must have resolved to ? Grade 2 by Cycle 1 Day 1.\n\n          6. Eastern Cooperative Oncology Group (ECOG) Performance Status of ? 2.\n\n          7. Adequate hepatic function within 21 days prior to C1 D1:\n\n               -  For SPd and SRd: Total bilirubin < 2x ULN (except patients with Gilbert's\n                  syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin\n                  of ? 3x ULN) and both AST and ALT < 2.5x ULN)\n\n               -  For SVd, SPVd and SDd): Total bilirubin of ? 1.5x ULN (except patients with\n                  Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total\n                  bilirubin of ? 3x ULN) and both AST and ALT < 2.0x ULN)\n\n          8. Adequate renal function within 21 days prior to C1 D1:\n\n               -  Estimated creatinine clearance of (calculated using the formula of Cockroft and\n                  Gault):\n\n               -  ? 20 mL/min for SVd, SPVd, and SDd Arms\n\n               -  ? 45 mL/min for SPd Arm (as requested by the manufacturer)\n\n               -  > 50 mL/min for SRd Arm\n\n          9. Adequate hematopoietic function within 21 days prior to C1 D1: total white blood cell\n             (WBC) count ? 1,500/mm3, ANC ? 1000/mm3, hemoglobin (Hb) ? 8.0 g/dL, and platelet\n             count ? 75,000/mm3. For expansion cohorts only, platelet counts > 50,000/mm3; for\n             patients in whom ? 50% of bone marrow nucleated cells are plasma cells, platelets or ?\n             30,000/mm3 are acceptable for expansion cohorts. Patients receiving hematopoietic\n             growth factor support, including erythropoietin (EPO), darbepoetin, granulocyte-colony\n             stimulating factor (G-CSF), granulocyte macrophagecolony stimulating factor (GM-CSF),\n             and platelet stimulators (e.g., eltrombopag or romiplostim) may continue to do so.\n             However, patients in the escalation cohorts must be platelet transfusion independent\n             for > 1 week in order to be enrolled in the study.\n\n         10. Female patients of child-bearing potential must agree to use dual methods of\n             contraception and have a negative serum pregnancy test at Screening. Male patients\n             must use an effective barrier method of contraception if sexually active with a female\n             of child-bearing potential. Acceptable methods of contraception are condoms with\n             contraceptive foam, oral, implantable or injectable contraceptives, contraceptive\n             patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is\n             surgically sterilized or post-menopausal. For both male and female patients, effective\n             methods of contraception must be used throughout the study and for three months\n             following the last dose.\n\n             SPd (Arm 1) Only:\n\n         11. Relapsed and refractory MM with:\n\n               1. Documented evidence of PD after achieving at least SD for ? 1 cycle during a\n                  previous MM regimen (i.e., relapsed MM)\n\n               2. ? 25% response (i.e., patients never achieved ? MR) or PD during or within 60\n                  days from the end of the most recent MM regimen (i.e., refractory MM)\n\n               3. Previously undergone ? 2 cycles of lenalidomide and a proteasome inhibitor (in\n                  separate therapeutic regimens [not for maintenance] or in combination)\n\n               4. In the expansion arm at RP2D, patients must not be pomalidomide refractory\n\n             SVd (Arm 2) Only:\n\n         12. Relapsed or refractory MM with\n\n               1. Documented evidence of relapse after ? 1 previous line of therapy\n\n               2. Not refractory to bortezomib in their most recent line of therapy\n\n             SRd in RRMM (Arm 3) Only:\n\n         13. Patients who received ? 1 prior therapeutic regimen (prior lenalidomide is allowed as\n             long as patient's MM was not refractory to prior lenalidomide; patients whose MM was\n             refractory to lenalidomide maintenance regimens will be allowed in this cohort).\n\n             SPVd (Arm 4) Only:\n\n         14. Patients whose MM is relapsing after ? 1 prior therapy with progression on their last\n             therapy.\n\n             SDd (Arm 5) Only:\n\n         15. Patients who received ? 3 prior lines of therapy, including a PI and an IMiD, or\n             patients with MM refractory to both a PI and an IMiD.\n\n         16. Patients must not have received prior daratumumab therapy (Cohort 5.3 ONLY - dose\n             expansion at RP2D).\n\n             SKd (Arm 6) Only:\n\n         17. Patients may have received prior bortezomib or carfilzomib therapy, however their MM\n             must NOT be refractory to carfilzomib.\n\n             SRd in NDMM (Arm 7) Only:\n\n         18. Patients must have symptomatic myeloma per IMWG guidelines with either CRAB criteria\n             or Myeloma Defining Events and need systemic therapy.\n\n         19. No prior systemic therapy for NDMM is permitted other than pulse dose dexamethasone\n             (maximum dose of 160 mg).\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following exclusion criteria are not eligible to enroll in this\n        study:\n\n          1. Smoldering MM\n\n          2. MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and\n             quantitative immunoglobulin levels cannot be used instead\n\n          3. Documented active systemic amyloid light chain amyloidosis\n\n          4. Active plasma cell leukemia\n\n          5. Blood (or blood product) transfusions and blood growth factors within 7 days of C1D1\n             (only for patients enrolling into the Expansion Phase)\n\n          6. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ? 2 weeks\n             prior to C1D1, and radio-immunotherapy within 6 weeks prior to C1D1. Patients on\n             long-term glucocorticoids during Screening do not require a washout period. Prior\n             radiation is permitted for treatment of fractures or to prevent fractures as well as\n             for pain management\n\n          7. Patients with history of SCC with residual paraplegia (Dose Escalation Phase only).\n\n          8. Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1D1\n\n          9. Prior autologous stem cell transplantation < 1 month, or allogeneic stem cell\n             transplantation < 3 months prior to C1D1\n\n         10. Active graft versus host disease after allogeneic stem cell transplantation\n\n         11. Life expectancy < 3 months\n\n         12. Major surgery within 4 weeks prior to C1D1\n\n         13. Active, unstable cardiovascular function:\n\n               1. Symptomatic ischemia, or\n\n               2. Uncontrolled clinically-significant conduction abnormalities (e.g., patients with\n                  ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree\n                  atrioventricular (AV) block or asymptomatic left anterior fascicular block/right\n                  bundle branch block (LAFB/RBBB) will not be excluded), or\n\n               3. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ? 3, or\n\n               4. Myocardial infarction (MI) within 3 months prior to C1D1\n\n               5. Ejection fraction (EF) < 50% at Screening\n\n         14. Uncontrolled active hypertension\n\n         15. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or\n             antifungals within one week prior to first dose\n\n         16. Known active hepatitis A, B or C\n\n         17. Known HIV infection or HIV seropositivity\n\n         18. Any active gastrointestinal dysfunction that prevents the patient from swallowing\n             tablets or interferes with absorption of study treatment\n\n         19. Currently pregnant or breastfeeding\n\n         20. A serious psychiatric or medical condition which, in the opinion of the Investigator,\n             could interfere with treatment\n\n         21. Hypersensitivity to any of the treatments for the Arm in which the patient is enrolled\n\n         22. In the SVd (Arm 2) only: Prior history of neuropathy Grade > 2, or Grade 2 neuropathy\n             with pain at screening (within 21 days prior to C1D1)\n\n         23. Prior exposure to a SINE compound, including selinexorXx_NEWLINE_xXARM 1: Must have prior exposure to an immunomodulatory drug (IMiD) and proteasome inhibitor (PI) and have had 2 prior regimens/lines of therapy; but there is no maximum number of prior regimens, and prior autologous bone marrow transplant is acceptable if > 12 weeks from transplantation; patients may have received prior carfilzomib (sensitive, relapsed and refractory [having progressed while receiving carfilzomib or within 60 days of stopping carfilzomib] are all eligible), but must be > 4 weeks from last dosing of carfilzomibXx_NEWLINE_xXARM 2: Must have had at least 1 but no more than 3 prior lines of anti-myeloma therapy; may be refractory to lenalidomide but sensitive to carfilzomib; prior exposure to carfilzomib is allowed but may not be refractory to carfilzomib; subjects must be >= 8 weeks from last carfilzomib therapyXx_NEWLINE_xXA line of therapy is defined as a course of therapy that is not interrupted by progressive disease; for example, induction therapy, autologous stem cell transplantation, and maintenance therapy without intervening progressive disease is one line of therapyXx_NEWLINE_xXConfirmed evidence of relapse/disease progression from immediately prior MM therapy or relapsed and refractory to the immediately prior treatment; relapsed and refractory disease is defined as those who are non-responsive (< minimal response) on salvage therapy or experience disease progression within 60 days of last therapy in patients who have achieved an MR or better to previous therapy; relapsed disease is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy but does not meet IMWG criteria for relapsed and refractoryXx_NEWLINE_xXPatients may have received prior carfilzomib (sensitive, relapsed and refractory all eligible);  response and duration of prior carfilzomib therapy must be knownXx_NEWLINE_xXPrior radioisotope therapyXx_NEWLINE_xXChronic immunosuppressive therapyXx_NEWLINE_xXAnti-platelet therapy, except low-dose aspirin for cardioprotectionXx_NEWLINE_xXAt least 4 months since completion of curative therapy, if given previouslyXx_NEWLINE_xXPrior systemic therapy for incurable diseaseXx_NEWLINE_xXAny prior therapy targeted against PSMAXx_NEWLINE_xXChronic immunosuppressive therapyXx_NEWLINE_xXPatients must not have received prior systemic therapy for PTCL (except for corticosteroids for 10 or fewer days at any dose, no washout period required as long as they discontinue prior to starting study therapy); NOTE: topical treatment may have been given for prior existence of cutaneous lymphoma that has since become systemic PTCL; however, these topical therapies should be stopped at time of registrationXx_NEWLINE_xXFor patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other patients, at least 14 weeks must have elapsed since their most recent systemic anti-DLBCL therapy.Xx_NEWLINE_xXParticipants may have received any number of prior therapies, from 0 to > 10; prior treatment with phosphatidylinositol 3 (PI3)-kinase or mTOR inhibitors is not permitted, unless they were given as adjuvant therapy without undue toxicity, and without suggestion of resistance to therapyXx_NEWLINE_xXMust have relapsed or refractory disease after 2 or more prior lines of therapy; 1 line of therapy is allowed, if it included an autologous stem cell transplant and at least 12 weeks have elapsed from day 0; a line of therapy is defined as a course of therapy that is not interrupted by progressive diseaseXx_NEWLINE_xXTransplant eligible (as determined by referring physician) patients who have failed one prior salvage therapy or transplant ineligible (as determined by referring physician) patients who have failed one prior therapyXx_NEWLINE_xXPart 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ? 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment. Part 2:Histologically confirmed MZL including splenic, nodal, and extranodal sub- typesXx_NEWLINE_xXBRAF mutation-positive (V600 E or K) melanoma for Parts 1, 2 and 3, or for Parts 1, 2, 4 and 5 only BRAF mutation-negative (wild type) melanoma with documented progression of >=1 measurable lesion after prior therapy (if prior therapy was received). The inclusion criterion does not apply to participants with solid tumors in Parts 4 and 5 (dose confirmation only).Xx_NEWLINE_xXPrior systemic therapy (for participants who are BRAF mutation-positive), or BRAF mutation-negative and has received >1 prior systemic therapy for metastatic melanomaXx_NEWLINE_xXBRAF mutation-positive and has received prior systemic therapy with ipilimumab or other anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies. The BRAF exclusion criterion does not apply to participants with solid tumor in Parts 4 and 5 (dose confirmation only).Xx_NEWLINE_xXExpected to require any other form of systemic or localized antineoplastic therapy while in this studyXx_NEWLINE_xXInclusion Criteria:\n\n        For Advanced GI Malignancies (Dose Escalation and MTD Cohorts):\n\n          1. Advanced histologically proven GI cancer.\n\n          2. First line or progressive disease if already treated with any form of therapy,\n             including but not limited to chemotherapy, radiotherapy, local therapy, surgery or\n             immuno-therapy. Patients with HCC who failed sorafenib, with documented PD or AEs that\n             resulted in discontinuance of that agent. Patients with pancreatic cancer (dose\n             escalation only) who have progressed following a gemcitabine based regimen. Subjects\n             failing prior platinum containing regimens are eligible. Gastric cancer subjects that\n             express tumor HER-2 amplification must be treated with trastuzumab prior to\n             enrollment, unless trastuzumab is not available for those indications in a particular\n             country.\n\n          3. Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable\n             lesion must be present. Subjects who have received local-regional therapy such as (but\n             not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy,\n             percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery\n             are eligible, provided that they have either a target lesion which has not been\n             treated with local therapy and/or the target lesion(s) within the field of the local\n             regional therapy has shown an increase of ? 20% in size. Local-regional therapy must\n             be completed at least 4 weeks prior to the baseline CT scan.\n\n          4. ECOG performance status of 0 - 1.\n\n          5. Expected survival of at least 3 months.\n\n        For HCC (Dose Escalation and MTD Expansion):\n\n        19. Prior treatment with sorafenib, with documented PD or AEs that resulted in\n        discontinuance of that agent. Patient may have been treated with other lines off therapy as\n        well excluding ADI-PEG 20.\n\n        20. Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on\n        clinical findings and laboratory data during the screening period (Appendix C). Subjects on\n        Coumadin anti-coagulants are to receive only 1 point for their INR status.\n\n        21. Serum albumin level ? 2.8 g/dl. 22. Prothrombin time (PT)-international normalized\n        ratio (INR): PT <6 seconds above control or INR <1.7. Subjects on Coumadin anti-coagulants\n        are to receive only 1 point for their INR status.\n\n        23. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such\n        treatment, except for interferon.\n\n        Exclusion Criteria:\n\n          1. Serious infection requiring treatment with systemically administered antibiotics at\n             the time of study entrance, or an infection requiring systemic antibiotic therapy\n             within 7 days prior to the first dose of study treatment.\n\n          2. Pregnancy or lactation.\n\n          3. Expected non-compliance.\n\n          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure (New York Heart Association Class III\n             or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit\n             compliance with study requirements.\n\n          5. Subjects who have had any anticancer treatment prior to entering the study and have\n             not recovered to baseline (except alopecia) or ? Grade 1 AEs, or deemed irreversible\n             from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a\n             safety risk by the Sponsor and investigator may be allowed upon agreement with both.Xx_NEWLINE_xXFor Part A (LY2835219 + letrozole): Except for ongoing therapy with letrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.Xx_NEWLINE_xXFor Part B (LY2835219 + anastrozole): Except for ongoing therapy with anastrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.Xx_NEWLINE_xXFor Part C (LY2835219 + tamoxifen): The participant may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen.Xx_NEWLINE_xXFor Part D (LY2835219 + exemestane): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane.Xx_NEWLINE_xXFor Part E (LY2835219 + exemestane + everolimus): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus.Xx_NEWLINE_xXFor Part I (abemaciclib + endocrine therapy): The participant must have demonstrated evidence of disease progression on a Cyclin Dependent Kinase 4 (CDK4) and Cyclin Dependent Kinase 6 (CDK6) inhibitor (either palbociclib or ribociclib) plus endocrine therapy for advanced or metastatic disease as the most recent therapy immediately preceding study entry. The participant should remain on the current endocrine therapy while receiving abemaciclib.Xx_NEWLINE_xXPHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progressionXx_NEWLINE_xXAchieved at least a partial response (PR) to therapyXx_NEWLINE_xXEligible participants must have received at least one line of prior therapy; note: patients will be eligible for participation despite prior treatment with known RET tyrosine kinase inhibitors (TKIs) (e.g. vandetanib, sorafenib, XL-184)Xx_NEWLINE_xXFor patients with LABC, no prior therapy is allowedXx_NEWLINE_xXLVEF < 50% during previous trastuzumab therapyXx_NEWLINE_xXENDOCRINE RESISTANT COHORT: Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy; if Ki67 is > 10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study pathologist to confirm eligibility (discuss with study chair); for patients external to Washington University, please contact the Washington University coordinator by email so that a screening identification (ID)# can be assigned prior to shipment of the slides\r\n* Note that prior neoadjuvant endocrine therapy could include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant) alone or in combination, or endocrine therapy in combination with any investigational agent that is not a Cdk 4/6 inhibitor\r\n* Patients who had a day 17 Ki67 > 10% from the NCI9170 trial are eligible for the endocrine resistant cohort\r\n* Note that enrollment to the endocrine resistant cohort will depend on the funding availability; please contact the study chair before enrolling patients to this cohortXx_NEWLINE_xXCurrent use of anticoagulation therapyXx_NEWLINE_xXRelapsed or refractory to the most recently received therapy.Xx_NEWLINE_xXTREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximabXx_NEWLINE_xXPatients may NOT have received prior mTor inhibitorsXx_NEWLINE_xXIncurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.Xx_NEWLINE_xXPatients must have failed at least 2 lines of stand therapy as outlined for the specific diseasesXx_NEWLINE_xXThe majority of the anticipated target volume (> 50%) must have been previously treated to >= 40 Gy; prior radiation therapy (RT) must have been completed > 6 months prior to initiation of IMRT reirradiation; if previous RT records are unavailable, investigators can estimate the dose to previously treated tissues based on completion notes or other treatment historyXx_NEWLINE_xXMust not have received more than 4 lines of cytotoxic chemotherapy. A line of therapy is defined as being preceded by disease progression. Discontinuation of a regimen without progression (for example, due to toxicity) or a switch of an agent within the same drug class (for example from cisplatin to carboplatin) will not be considered a new line of therapy. Similarly, maintenance therapy (continuation maintenance or switch maintenance) will not be considered a new line of treatment.Xx_NEWLINE_xXAll patients must have experienced disease progression on or after their most recent systemic therapy.Xx_NEWLINE_xXColorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecean, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.Xx_NEWLINE_xXFor patients with SCCHN or NSCLC, ongoing anticoagulant therapyXx_NEWLINE_xXPrior systemic therapy:\r\n* Participants must have discontinued systemic therapy at least 14 days prior to initiating protocol therapy.\r\n* There is no limit to the number of prior lines of systemic therapy. Participants who have not received any systemic therapy for metastatic disease are also eligible.\r\n* Participants may initiate or continue bisphosphonate therapy on studyXx_NEWLINE_xXBe able to undergo protocol therapy, including necessary surgery.Xx_NEWLINE_xXHas received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.Xx_NEWLINE_xXConcurrent administration of other anti-cancer therapy during the course of this study is not allowed; note that concurrent use of supportive care medications (e.g. anti-resorptive agents, pain medications) is allowedXx_NEWLINE_xXNo washout is required for endocrine therapy; if a patient has been on endocrine therapy within 28 days of study entry, that same endocrine therapy is permitted to be continued during protocol therapy, at the investigator’s discretion, as is continuation of ovarian suppression in premenopausal women; starting a new endocrine therapy during protocol therapy is not permittedXx_NEWLINE_xXPatient must have progressed on their most recent line of therapy. Progression must have been demonstrated by radiological or clinical assessment.Xx_NEWLINE_xXCohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.Xx_NEWLINE_xXCohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.Xx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXConcurrent administration of systemic therapy for HCCXx_NEWLINE_xXIf prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy.Xx_NEWLINE_xXPrior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel.Xx_NEWLINE_xXPreviously treated with an anti-DKK1 therapyXx_NEWLINE_xXGlucocorticoid therapy allowed.Xx_NEWLINE_xXIs expected to require any non-protocol antineoplastic therapy while on study.Xx_NEWLINE_xXDuring Phase 2, subjects with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.Xx_NEWLINE_xXPatients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the studyXx_NEWLINE_xXPHASE II EXCLUSION CRITERIA: Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the studyXx_NEWLINE_xXPatients who have previously received gemcitabine plus oxaliplatin therapyXx_NEWLINE_xXNot a candidate for potentially curative therapy at the time of enrollmentXx_NEWLINE_xXHas received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).Xx_NEWLINE_xXUse hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior 3 monthsXx_NEWLINE_xXNo prior systemic therapy for HCCXx_NEWLINE_xXHave received at least 1 prior line of therapy and meets at least one of the following criteria:Xx_NEWLINE_xXwere unable to tolerate the prior first-line regimenXx_NEWLINE_xXHave received no more than 2 prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens.Xx_NEWLINE_xXOngoing immunosuppressive therapy.Xx_NEWLINE_xXParticipant must have progressed on the most recent therapy.Xx_NEWLINE_xXtwo prior hormonal therapies;Xx_NEWLINE_xXSubjects with lymphoma must have progressed, had stable disease (SD), or recurred after initial treatment regimens that include an anthracycline and an anti-CD20 monoclonal antibody; subjects who relapse >= 12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplantXx_NEWLINE_xXSubjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if < 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometryXx_NEWLINE_xXWomen taking estrogen containing contraceptives or Hormone Replacement Therapy (HRT) must discontinue the treatment a minimum of 6 months prior to the screening mammogram. Progestin only contraceptives are permitted.Xx_NEWLINE_xXAny remission after chimeric antigen receptor (CAR)-T cell therapyXx_NEWLINE_xXChronic bronchitis or emphysema requiring oxygen therapy within the last 6 monthsXx_NEWLINE_xXReceived any previously systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways; other previous targeted therapies are permitted if stopped at least 28 days prior to start of treatmentXx_NEWLINE_xXSubjects must be refractory to or intolerant of existing cancer therapy(ies) known to provide clinical benefit.Xx_NEWLINE_xXprogressive disease while receiving androgen deprivation therapyXx_NEWLINE_xXmore than one sequential second generation AR-directed therapyXx_NEWLINE_xXNo limit to number of prior therapiesXx_NEWLINE_xXA) Patients enrolled into the dedifferentiated liposarcoma cohort do not require prior systemic therapy (may be naive to systemic therapy); B) leiomyosarcoma patients must have had at least 1 prior systemic therapy (does not include adjuvant/neoadjuvant therapy in a curative setting). There are no limits on prior number of therapies for either cohortXx_NEWLINE_xXRadiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollmentXx_NEWLINE_xXNo prior Y90 radioembolization for HCC is permitted; therapies below are allowed but must be completed 4 weeks prior to baseline scan:\r\n* Prior transarterial embolization (TAE) or transarterial chemoembolization (TACE)\r\n* One treatment of stereotactic body radiation therapy (SBRT)\r\n* Liver resection\r\n* Ablation therapyXx_NEWLINE_xXThere is no limit to number of prior therapiesXx_NEWLINE_xXPatients may be newly diagnosed or have received any number of lines of prior anticancer therapy; however, patients are required to have received available therapies for their primary disease, as deemed appropriate by the treating investigatorXx_NEWLINE_xXPatients may continue therapy with a targeted agent if CNS disease developed while receiving the agent, and for defined regimens that have been deemed safe when combined with anti-PD-1 therapyXx_NEWLINE_xXPatients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapyXx_NEWLINE_xXPatients who have PSA recurrence after local salvage therapy may participate in this studyXx_NEWLINE_xXPatients with hormone sensitive disease who received prior androgen deprivation therapy as part of primary/salvage local treatment or patients receiving intermittent androgen deprivation therapy will be allowed to participateXx_NEWLINE_xXPrior radiation therapy to the liver including 90Y , I131 based loco regional therapy. Prior loco regional therapy, including resection, based on other technology for ICC, if any, must have been completed at least 4 weeks prior to baseline imaging.Xx_NEWLINE_xXPatients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.Xx_NEWLINE_xXSubjects on long term (>= 6 months) first generation anti-androgen therapy (e.g. flutamide, bicalutamide, nilutamide) will need to discontinue anti-androgen therapy for 4 weeks prior to registration (wash out period) and show evidence of disease progression off the anti-androgen; subjects that have been on a first generation anti-androgen 6 months or less will need to discontinue therapy prior to registration (no wash out period required)Xx_NEWLINE_xXSubjects on second generation anti-androgen therapy (enzalutamide) or androgen bio-synthesis inhibitor (abiraterone acetate) will need to discontinue therapy 2 weeks prior to registration (wash out period)Xx_NEWLINE_xXMore than one prior line of therapy with a second generation anti-androgen (enzalutamide, ARN-509, etc.) or androgen bio-synthesis inhibitor (abiraterone acetate, etc.); subject may have had one second generation anti-androgen or androgen bio-synthesis inhibitor but not both sequentially; subjects that have received combination therapy with second generation anti-androgen plus an androgen bio-synthesis inhibitor would be eligible (e.g., enzalutamide plus abiraterone acetate as one line of therapy on a clinical trial)Xx_NEWLINE_xXPrior isotope therapy with strontium-89, samarium or RAD223Xx_NEWLINE_xXHuman immunodeficiency virus (HIV) positive subjects with 1 or more of the following:\r\n* Not receiving highly active antiretroviral therapy\r\n* A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor on exclusion criterion below; a change is made to avoid a potential drug-drug interaction with the study drug)\r\n* Receiving antiretroviral therapy that may interfere with the study drug (consult the sponsor for review of medication prior to enrollment)\r\n* CD4 count < 350 at screening\r\n* An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screeningXx_NEWLINE_xXSubjects must not have received any previous androgen deprivation therapy (LHRH agonist or LHRH antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting\r\n* Exceptions\r\n** Patients may have received no more than 30 days of anti-androgen (e.g. bicalutamide) in the metastatic setting prior to the start of study treatment.Xx_NEWLINE_xXInclusion Criteria (Solid Tumor Patients):\n\n          1. Patients ?18 years of age,\n\n          2. Must have progressed on all available therapies known to confer benefit for disease\n\n          3. Must have tissue source of tumor cells\n\n          4. Must have 1 measurable lesion according to RECIST Version 1.1\n\n          5. Must have objective evidence of progression of lesions that have been previously\n             irradiated\n\n          6. Must have ECOG performance status of 0-1\n\n          7. Bone Marrow Function: absolute neutrophil count (ANC) ?1500/µL; hemoglobin ?9 g/dL;\n             platelet count ?75,000/µL\n\n          8. Hepatic Function: Total serum bilirubin ?1.5 times the upper limit of normal (ULN;\n             except for patients with known Gilbert syndrome);); serum aspartate aminotransferase\n             (AST)/alanine aminotransferase (ALT), ?32.5×ULN (?5×ULN in the presence of hepatic\n             metastases)\n\n          9. Renal Function: Serum creatinine ?1.5×ULN or creatinine clearance ?50 mL/min based\n             either on urine collection or Cockcroft-Gault estimation\n\n         10. Coagulation Profile: Prothrombin time (PT) - international normalized ratio\n             (INR)/partial thromboplastin time (PTT) ?1.5xULN5×ULN.\n\n        Inclusion Criteria (Hematologic Malignancies):\n\n          1. Patients ?18 years of age, except for patients with ALL who can be ?16 years of age\n\n          2. Morphologically documented relapsed/refractory myelodysplastic syndrome (MDS), acute\n             myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and chronic lymphocytic\n             leukemia (CLL) as defined by World Health Organization (WHO) criteria\n\n          3. Patients with relapsed/refractory MDS, AML, ALL must have progressed on least 1 prior\n             therapy and cannot be a candidate for any available therapies in patients with a\n             rationale for known to confer clinical benefit\n\n          4. For patients with MDS, AML, ALL, or CLL, must have cells obtained either by bone\n             marrow biopsy or blood collection to use for biomarkers that may enrich for DCC-3014\n             response or provide PD information\n\n          5. For CLL, must have measurable disease per International Workshop on Chronic\n             Lymphocytic Leukemia (IWCLL) criteria (Hallek criteria) to allow evaluation of\n             response\n\n          6. May have primary phagocytic malignancies including histocytoses, including Erdheim\n             Chester Disease (as diagnosed in Diamond et al 2014) and Langerhans histiocytoses are\n             eligible if refractory to or unsuitable for other therapies.\n\n          7. ECOG PS of 0-2\n\n          8. Bone Marrow Function: ANC ?1000/µL; hemoglobin ?8 g/dL; platelet count ?75,000/?L.\n\n          9. Hepatic Function: Total serum bilirubin <1.5×ULN; serum AST and ALT <2.5×ULN (?5×ULN\n             in the presence of hepatic metastases).\n\n         10. Renal Function: Serum creatinine <2xULN1.5×ULN, or glomerular filtration rate >2050\n             mL/hr as calculated by CockgroftCockroft-Gault formula.\n\n         11. Serum potassium, magnesium and calcium (corrected for albumin) that are within\n             institutional normal limits or can be corrected with supplementation.\n\n         12. Total serum bilirubin <2xULN (except for patients with known Gilbert syndrome).\n\n         13. Serum AST and ALT <5xULN.\n\n         14. Coagulation Profile: Prothrombin time (PT) - international normalized ratio\n             (INR)/partial thromboplastin time (PTT) ?1.5×ULN.\n\n        Exclusion Criteria (Solid Tumors):\n\n          1. Treatment with anticancer therapy, including investigational therapy, within 2 weeks\n             prior to the administration of study drug. For immediately prior therapies with a\n             half-life longer than 3 days, or if the half-life is not available, the interval must\n             be ?28 days prior to the first administration of study drug.\n\n          2. Unresolved toxicity according to National Cancer Institute Common Terminology Criteria\n             for Adverse Events (NCI-CTCAE), Version 4.03 (ie, >Grade 1 or baseline) from previous\n             anticancer therapy, excluding alopecia.\n\n          3. The patient has known active CNS metastases. Patients with previously treated brain\n             metastases may participate provided that:\n\n               -  They are stable (ie, without evidence of progression by magnetic resonance\n                  imaging [MRI]) for ?4 weeks prior to the first dose of study drug),\n\n               -  All neurologic symptoms have returned to baseline, and\n\n               -  Patients do not require continued steroid therapy or use of enzyme-inducing\n                  antiepileptic drugs. Patients can be switched to a non-enzyme inducing\n                  antiepileptic drug. If signs or symptoms suggest CNS metastases, a brain MRI must\n                  be performed to confirm absence of detectable CNS disease within 2 weeks prior to\n                  receiving study drug.\n\n          4. New York Heart Association class III or IV heart disease, active ischemia or any other\n             uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac\n             arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.\n\n          5. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident\n             (including ischemic attacks) or hemoptysis within 6 months prior to the start of study\n             drug.\n\n          6. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial\n             events (eg, pulmonary embolism) within the 1 month prior to the start of study drug.\n             Patients with venous thrombotic events before the start of study drug on stable\n             anticoagulation therapy are eligible.\n\n          7. Baseline prolongation of the rate-corrected QT interval based on repeated\n             demonstration of QT interval corrected (QTc) >450 ms or history of long QTc syndrome.\n\n          8. Left ventricular ejection fraction (LVEF) <50%.\n\n          9. Concurrent treatment with proton-pump inhibitor. Other medications that increase\n             gastric pH, ie, histamine H2 receptor antagonists and antacids may be taken provided\n             they are not administered within 2 hours before or after administration of study drug.\n\n         10. Major surgery within 2 weeks of the first dose of study drug; following major\n             surgeries >2 weeks prior to the first dose of study drug, all surgical wounds must be\n             healed and free of infection or dehiscence.\n\n         11. Any other clinically significant comorbidities, such as uncontrolled pulmonary\n             disease, active infection, or any other condition, which in the judgment of the\n             Investigator, could compromise compliance with the protocol, interfere with the\n             interpretation of study results, or predispose the patient to safety risks.\n\n         12. Malabsorption syndrome or other illness that could affect oral absorption.\n\n         13. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active\n             mycobacterium tuberculosis infection.\n\n         14. If female, the patient is pregnant or lactating.\n\n         15. Known allergy or hypersensitivity to any component of the study drug.\n\n         16. Patients with known Gilbert's disease.\n\n        Exclusion Criteria (Hematologic Malignancies):\n\n          1. Concurrent active malignancy with expected survival of less than 1 year.\n\n          2. Graft versus host disease (GVHD) that is not well-controlled on a stable treatment\n             regimen for at least 3 weeks prior to initial dose of study drug.\n\n          3. Cancer-directed therapy within 2 weeks prior to starting treatment, with the exception\n             of hydroxyurea, which is allowed to control white blood cell count.\n\n          4. History of, or current, central nervous system involvement with MDS, AML, or CLL.\n\n          5. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident\n             (including ischemic attacks) or hemoptysis within 2 months prior to the start of study\n             drug.\n\n          6. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial\n             events (eg, pulmonary embolism) within the 1 month prior to the start of study drug.\n             Patients with venous thrombotic events before the start of study drug on stable\n             anticoagulation therapy are eligible.\n\n          7. Clinically significant coagulation disorder, such as disseminated intravascular\n             coagulation.\n\n          8. New York Heart Association class III or IV heart disease, active ischemia or any other\n             uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac\n             arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.\n\n          9. Baseline prolongation of the rate-corrected QT interval based on repeated\n             demonstration of QTc >450 ms or history of long QTc syndrome.\n\n         10. LVEF <50%.\n\n         11. Concurrent treatment with proton-pump inhibitor.\n\n         12. Major surgery within 2 weeks of the first dose of study drug; following major\n             surgeries >2 weeks prior to the first dose of study drug, all surgical wounds must be\n             healed and free of infection or dehiscence.\n\n         13. Any other clinically significant comorbidities, such as uncontrolled pulmonary\n             disease, active infection, or any other condition, which in the judgment of the\n             Investigator, could compromise compliance with the protocol, interfere with the\n             interpretation of study results, or predispose the patient to safety risks.\n\n         14. Malabsorption syndrome or other illness that could affect oral absorption.\n\n         15. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, active\n             cytomegalovirus (CMV), or active mycobacterium tuberculosis infection.\n\n         16. Active infection that is not well-controlled by antibacterial or antiviral therapy.\n\n         17. If female, the patient is pregnant or lactating.\n\n         18. Known allergy or hypersensitivity to any component of the study drug.\n\n         19. Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype).\n\n         20. Unwillingness to receive infusion of blood products.\n\n         21. Patients with known Gilbert's disease.Xx_NEWLINE_xXU.S. ONLY: For all Cohorts, patients who refuse approved therapy for which they are a suitable candidate are not eligible for enrollment on this trial.Xx_NEWLINE_xXPrior exposure to CWP232291.Xx_NEWLINE_xXPrior afatinib therapy, unless patient received an intervening third generation EGFR TKI after concluding prior afatinib and before enrollment on this clinical studyXx_NEWLINE_xXPrior systemic therapy:\r\n* Participant must be at least 14 days from the last dose of prior chemotherapy, endocrine therapy, biological agents (including small molecule targeted therapy) or any investigational drug product with adequate recovery of toxicity to baseline, or grade 1 (with the exception of alopecia and hot flashes) at the time of registration\r\n* There is no limit to the number of prior lines of therapy, including endocrine or cytotoxic agents; systemic treatment naive patients for metastatic disease are also eligible\r\n* Participants may initiate or continue bisphosphonate therapy on study\r\n* Continuation of ovarian suppression is allowedXx_NEWLINE_xXPatients must have histologically documented metastatic solid tumors which have progressed after one line of therapy, or lymphoma which has progressed after all Food and Drug Administration (FDA)-approved therapyXx_NEWLINE_xXPrior therapy with topoisomerase I inhibitors is allowedXx_NEWLINE_xXPatients who have received other cell therapiesXx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while on study.Xx_NEWLINE_xXOne prior systemic therapy in the metastatic setting is allowed, but patients who have not had any prior systemic therapies in the metastatic setting are also eligible\r\n* Note: patients who were started on endocrine therapy monotherapy as their 1st line or 2nd line systemic therapy in the metastatic setting for no more than 28 days and without clinical progression prior to the initiation of the study drug therapy are allowed to enroll on the study as their 1st line or 2nd line therapy, respectivelyXx_NEWLINE_xXRadiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapyXx_NEWLINE_xXMust have had at least two (2) prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)Xx_NEWLINE_xXClinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary)Xx_NEWLINE_xXConcurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol)Xx_NEWLINE_xXPatient must have disease that has either relapsed or is refractory to prior therapXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatients must not have received prior exposure to VX15/2503Xx_NEWLINE_xXTreating physician intends to put participant on anticoagulation therapy for at least three months.Xx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXDuration of prior HMA therapy ? 9 months and/or total ? 9 cycles of prior HMA therapy in ? 12 monthsXx_NEWLINE_xXLimited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapyXx_NEWLINE_xXPatients with prior therapy, other than therapy specified aboveXx_NEWLINE_xXPrior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ? 36 months.Xx_NEWLINE_xXPrior therapy: No line limit but no more than 1 prior regimens in the platinum resistant setting; no prior treatment targeting the ATR/checkpoint kinase 1 (CHK1) pathway and no prior gemcitabine as single agent; hormonal therapies immunotherapy, and antiangiogenic therapies (as single agents) do not count as lines; poly (adenosine diphosphate [ADP]-ribose) polymerases (PARP)-inhibitors count as a line of therapy unless given in the maintenance setting; PARP-inhibitors given as maintenance after platinum therapy do not count as a line of therapy; prior carboplatin/gemcitabine is allowed provided that there was no disease progression within 12 months after completion of the carboplatin/gemcitabine regimen; subjects may begin protocol treatment at least 4 weeks or 5 half-lives, whichever is shorter, after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligibleXx_NEWLINE_xXPart E only: Patients with biopsy-proven DLBCL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies, including any anti-CD20 monoclonal antibody and chemotherapy with curative intentXx_NEWLINE_xXALK+ ALCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen including an anthracycline, if not contraindicated, and prior brentuximab; prior crizotinib or other ALK inhibitor therapy, while recommended, is not mandatory; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplantXx_NEWLINE_xXMCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen and prior ibrutinib or other BTK inhibitor therapy; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplantXx_NEWLINE_xXPatients with primary plasma cell leukemia in VGPR or better at the time of enrollment with no prior disease progression and within 18 months prior to initiation of anti-myeloma therapy which may include single or planned tandem autologous transplant .Xx_NEWLINE_xXClinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist \r\n* Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible\r\n* Patients who refuse surgery are eligible\r\n* Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible\r\n* Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligibleXx_NEWLINE_xXPart C) Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);Xx_NEWLINE_xXPart D) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; orXx_NEWLINE_xXNab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.Xx_NEWLINE_xXPrior treatment with one additional second line hormone therapy is permittedXx_NEWLINE_xXPatients must be weaned off prednisone and be off therapy for >= 1 week prior to starting therapyXx_NEWLINE_xXThere is no limitation on the number of prior lines of systemic therapyXx_NEWLINE_xXNote: HER2 mutation testing may be performed while the patient is receiving active systemic therapy for metastatic breast cancer so that the result can be used to determine eligibility for study drug therapy in the futureXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): The patient must have completed radiation therapy and be at least 1 week from the last systemic therapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinibXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): The patient must have completed radiation therapy and be at least 1 week from the last systemic therapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinibXx_NEWLINE_xXInclusion Criteria (Preliminary Screening)\n\n          1. Signed Preliminary Screening Informed Consent Form obtained prior to any study\n             specific assessments and procedures\n\n          2. Age ?18 years (or per national guidelines)\n\n          3. Participants must have histologically confirmed invasive breast cancer that is\n             metastatic or not amenable for resection or radiation therapy with curative intent.\n             Histological documentation of metastatic/recurrent breast cancer is not required if\n             there is unequivocal evidence for recurrence of the breast cancer.\n\n          4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+\n             and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be\n             performed according to institutional guidelines, in a CLIA-approved setting in the US\n             or certified laboratories for Non-US regions. Cut-off values for positive/negative\n             staining should be in accordance with current ASCO/CAP (American Society of Clinical\n             Oncology/College of American Pathologists) guidelines.\n\n          5. Patients must agree to provide a representative formalin-fixed paraffin-embedded\n             (FFPE) tumor tissue block (preferred) from primary breast or metastatic site\n             (archival) OR at least 15 freshly cut unstained slides from such a block, along with a\n             pathology report documenting HER2 positivity and hormone receptor positivity.\n\n          6. Patients should be willing to provide a representative tumor specimen obtained from\n             metastatic disease if clinically feasible. This is a recommended but optional research\n             biopsy.\n\n             Inclusion Criteria (Randomization Screening)\n\n          7. Signed Main Informed Consent Form obtained prior to any study specific assessments and\n             procedures\n\n          8. Age ? 18 years (or per national guidelines)\n\n          9. ECOG performance status 0-1\n\n         10. Patients must be able and willing to swallow and retain oral medication without a\n             condition that would interfere with enteric absorption.\n\n         11. Serum or urine pregnancy test must be negative within 7 days of randomization in women\n             of childbearing potential. Pregnancy testing does not need to be pursued in patients\n             who are judged as postmenopausal before randomization, as determined by local\n             practice, or who have undergone bilateral oophorectomy, total hysterectomy, or\n             bilateral tubal ligation. Women of childbearing potential and male patients randomized\n             into the study must use adequate contraception for the duration of protocol treatment\n             and for 6 months after the last treatment with palbociclib if they are in Arm A and\n             for 7 months after last treatment with trastuzumab if in either Arm A or Arm B\n             Adequate contraception is defined as one highly effective form (i.e. abstinence,\n             (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom /\n             occlusive cap with spermicidal foam / gel / film / cream / suppository).\n\n         12. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy\n             regimen to NCI CTCAE version 4.0 Grade ?1 (except alopecia or other toxicities not\n             considered a safety risk for the patient at investigator's discretion) 12 weeks\n             between last dose of chemotherapy-anti-HER2therapy and randomization are allowed.\n             Endocrine therapy could start before study randomization.\n\n         13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory\n             tests, and other study procedures\n\n             Prior Treatment Specifics\n\n         14. Patients may or may not have received neo/adjuvant therapy, but must have a\n             disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis ?6\n             months.\n\n         15. Patients must have received an acceptable, standard, chemotherapy containing anti-HER2\n             based induction therapy for the treatment of metastatic breast cancer prior to study\n             enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only\n             for trastuzumab-based regimen). Eligible patients are expected to have completed 6\n             cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles\n             of treatment is acceptable for patients experiencing significant toxicity associated\n             with treatment as long as they are without evidence of disease progression (i.e. CR,\n             PR or SD). The maximum number of cycles is 8. Patients can randomize immediately\n             following completion of their induction therapy, or for those who have already\n             completed induction, a gap of 12 weeks between their last infusion/dose of induction\n             therapy and the C1D1 visit is permitted. Patients are eligible provided they are\n             without evidence of disease progression by local assessment (i.e. CR, PR or SD).\n\n         16. Participants with a history of treated CNS metastases are eligible, provided they meet\n             all of the following criteria:\n\n               -  Disease outside the CNS is present.\n\n               -  No evidence of interim progression between the completion of CNS-directed therapy\n                  and the screening radiographic study\n\n               -  No history of intracranial hemorrhage or spinal cord hemorrhage\n\n               -  Not requiring anti-convulsants for symptomatic control\n\n               -  Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and\n                  recovery from significant (Grade ? 3) acute toxicity with no ongoing requirement\n                  for corticosteroid\n\n             Baseline Body Function Specifics\n\n         17. Absolute neutrophil count ? 1,000/mm3\n\n         18. Platelets ? 100,000/mm3\n\n         19. Hemoglobin ? 10g/dL\n\n         20. Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin\n             within normal range in patients with documented Gilbert's Syndrome.\n\n         21. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ?\n             3 × institutional ULN (?5 x ULN if liver metastases are present).\n\n         22. Serum creatinine within normal institutional limits or creatinine clearance ? 60\n             mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.\n\n         23. Left ventricular ejection fraction (LVEF) ? 50% at baseline as determined by either\n             ECHO or MUGA\n\n        Exclusion Criteria (Randomization)\n\n          1. Concurrent therapy with other Investigational Products.\n\n          2. Prior therapy with any CDK 4/6 inhibitor.\n\n          3. History of allergic reactions attributed to compounds of chemical or biologic\n             composition similar to palbociclib.\n\n          4. Patients receiving any medications or substances that are strong inhibitors or\n             inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for\n             list of strong inhibitors or inducers of CYP3A isoenzymes).\n\n          5. Uncontrolled current illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\n             arrhythmia, diabetes, or psychiatric illness/social situations that would limit\n             compliance with study requirements. Ability to comply with study requirements is to be\n             assessed by each investigator at the time of screening for study participation.\n\n          6. Pregnant women, or women of childbearing potential without a negative pregnancy test\n             (serum or urine) within 7 days prior to randomization, irrespective of the method of\n             contraception used, are excluded from this study because the effect of palbociclib on\n             a developing fetus is unknown. Breastfeeding must be discontinued prior to study\n             entry.\n\n          7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are\n             ineligible because of the potential for pharmacokinetic interactions or increased\n             immunosuppression with palbociclib.\n\n          8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or\n             Torsade de Pointes.\n\n          9. Patients with clinically significant history of liver disease, including viral or\n             other known hepatitis, current alcohol abuse, or cirrhosisXx_NEWLINE_xXInclusion Criteria:\n\n        Part A:\n\n          -  Subjects must have signed written informed consent.\n\n          -  Male or female subjects age greater than equals to (>=)18 years.\n\n          -  Subjects must have histologically or cytologically proven metastatic or locally\n             advanced solid tumors for which no standard therapy exists, standard therapy has\n             failed, subject is intolerant of established therapy known to provide clinical benefit\n             for their condition, or standard therapy is not acceptable to the subject.\n\n          -  Subjects who have been treated previously with a checkpoint inhibitor may enroll\n             (except as outlined below for expansion cohorts).\n\n          -  At least 1 unidimensional radiographically measurable lesion based on Response\n             Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), except for subjects\n             with metastatic castration-resistant prostate cancer (CRPC) or metastatic breast\n             cancer who may be enrolled with objective evidence of disease without a measureable\n             lesion.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening\n\n          -  Estimated life expectancy of more than 12 weeks\n\n          -  Adequate hematological function as defined below:\n\n               -  White blood cells (WBC) count >= 3.0 × 10^9 per liter (/L)\n\n               -  Absolute neutrophil count >= 1.5 × 10^9/L\n\n               -  Lymphocyte count >= 0.5 × 10^9/L\n\n               -  Platelet count >= 100 × 10^9/L\n\n               -  Hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)\n\n          -  Adequate hepatic function as defined below:\n\n               -  A total bilirubin level lass than equals to (<=) 1.5 × the upper limit of normal\n                  (ULN) range • Aspartate aminotransferase (AST) levels <= 2.5 × ULN (? 3 × ULN for\n                  expansion cohorts)\n\n               -  Alanine aminotransferase (ALT) levels <= 2.5 × ULN (? 3 × ULN for expansion\n                  cohorts)\n\n               -  Subjects with documented Gilbert disease are allowed if total bilirubin > 1.5 but\n                  less than 3 × ULN\n\n          -  Adequate renal function as defined by an estimated creatinine clearance >= 50\n             milliliter per minute (mL/min) according to the Cockcroft-Gault formula\n\n          -  Negative blood pregnancy test at Screening for women of childbearing potential. For\n             the purposes of this trial, women of childbearing potential are defined as all female\n             subjects after puberty unless they are postmenopausal for at least 1 year, are\n             surgically sterile or are sexually inactive.\n\n          -  Highly effective contraception (ie, methods with a failure rate of less than 1% per\n             year) must be used before the start of treatment, for the duration of the trial\n             treatment, and for at least 50 days after stopping study treatment for both men and\n             women if the risk of conception exists. The effects of avelumab and NHS-IL12 on the\n             developing human fetus are unknown; thus, women of childbearing potential and men must\n             agree to use highly effective contraception.\n\n        Part B:\n\n          -  Urothelial carcinoma (UC) post-platinum: Histologically or cytologically confirmed\n             locally advanced or metastatic transitional cell carcinoma of the urothelium\n             (including renal pelvis, ureters, urinary bladder, and urethra). Subjects must have\n             progressed after treatment with at least 1 platinum containing regimen for inoperable\n             locally advanced or metastatic UC or disease recurrence. Availability of either tumor\n             archival material (< 6 months old)or fresh biopsies (obtained within 28 days) is\n             acceptable with one of these being mandatory. For formalin-fixed paraffin-embedded\n             samples, either block or sections (> 15) may be provided. Tumor biopsies and tumor\n             archival material must be suitable for biomarker assessment.\n\n          -  Non-small cell lung cancer (NSCLC), first-line metastatic: Stage IV (per seventh\n             International Association for the Study of Lung Cancer classification) histologically\n             confirmed NSCLC. Subjects must not have received treatment for their metastatic\n             disease. Subjects could have received adjuvant chemotherapy or loco-regional treatment\n             that included chemotherapy for locally advanced disease, as long as disease recurrence\n             occurred at least 6 months after the completion of the last administration of\n             chemotherapy. Only epidermal growth factor receptor (EGFR) and anaplastic lymphoma\n             kinase (ALK) wild-type are allowed (ie, EGFR mutation and ALK translocation / re\n             arrangement excluded). Non squamous cell histologies and never / former light smoker\n             (< 15 pack years) squamous cell carcinoma subjects (per local standard of care)\n             require testing if status is unknown. Subjects must have low tumor PD-L1 expression\n             defined as < 50% tumor proportion score determined using PD-L1 IHC 22C3 pharmDx test\n             or an equivalent Food and Drug Administration (FDA)- approved PD-L1 test. Availability\n             of either tumor archival material or fresh biopsies within 28 days is acceptable with\n             one of these being mandatory. For FFPE samples, either block or sections (> 15) may be\n             provided. Tumor biopsies and tumor archival material must be suitable for biomarker\n             assessment. This cohort will not be opened for enrollment in Belgium, Czech Republic,\n             Germany, Hungary, Italy, Netherlands, Spain, and United Kingdom.\n\n          -  Colorectal cancer (CRC): Histologically or cytologically confirmed recurrent or\n             refractory metastatic CRC (according to American Joint Committee on Cancer /\n             International Union Against Cancer Tumor Node Metastasis [TNM] Staging System seventh\n             edition) after failure of prior therapy containing oxaliplatin / fluoropyrimidine and\n             / or irinotecan / fluoropyrimidine and, if eligible, cetuximab (Erbitux®) and\n             bevacizumab (Avastin®). Only subjects with microsatellite instability (MSI)-low or\n             microsatellite stable (MSS) metastatic CRC are eligible. Subjects without existing MSI\n             test results will have MSI status performed locally by a Clinical Laboratory\n             Improvement Amendments (CLIA)-certified IHC or polymerase chain reaction (PCR)-based\n             test (PCR based MSI test is preferred). Subjects must be willing to undergo an\n             on-treatment biopsy procedure. Availability of either tumor archival material or fresh\n             biopsies within 28 days is acceptable with one of these being mandatory. For FFPE\n             samples, either block or sections (> 15) may be provided. Tumor biopsies and tumor\n             archival material must be suitable for biomarker assessment. For Belgium, Czech\n             Republic, Germany, Hungary, Italy, Netherlands, Spain, and United Kingdom, subjects in\n             the second-line setting should have exhausted or be considered ineligible or\n             intolerant (in the opinion of the Investigator) of available second-line chemotherapy\n             options.\n\n          -  Renal cell carcinoma (RCC), primary immune checkpoint inhibitor failure:\n             Histologically or cytologically documented metastatic RCC with a component of clear\n             cell subtype. Subjects must have had progressive disease (PD) within 6 months or best\n             overall response of stable disease (SD) for ? 6 months following start of therapy with\n             any antibody / drug targeting T cell co-regulatory proteins (immune checkpoints) such\n             as anti-PD-1, anti-PD-L1, or anticytotoxic T lymphocyte antigen-4 (CTLA-4) for\n             advanced or metastatic disease (either as monotherapy or combination therapy, in any\n             line). Availability of a fresh tumor biopsy is mandatory for eligibility in the RCC\n             cohort. The biopsy or surgical specimen should be collected within 28 days prior to\n             the first IMP administration. Subjects must also be willing to undergo an on-treatment\n             biopsy procedure.\n\n        Exclusion Criteria:\n\n          -  Concurrent treatment with a non-permitted drug/intervention (listed below)\n\n               -  Anticancer treatment (eg, cytoreductive therapy, radiotherapy, immune therapy,\n                  cytokine therapy, monoclonal antibody, targeted small molecule therapy) or any\n                  investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior\n                  to start of trial treatment, or not recovered from adverse event (AE) related to\n                  such therapies, with the following exceptions: Palliative radiotherapy delivered\n                  in a normal organ-sparing technique is permitted; Erythropoietin and\n                  darbepoetin-? are permitted; Hormonal therapies acting on the\n                  hypothalamic-pituitary-gonadal axis are permitted (i.e. luteinizing\n                  hormone-releasing hormone agonist/antagonists). No other hormonal anticancer\n                  therapy is permitted.\n\n               -  Major surgery (as deemed by Investigator) for any reason, except diagnostic\n                  biopsy, within 4 weeks prior to start of trial treatment, or not fully recovered\n                  from surgery within 4 weeks prior to start of trial treatment\n\n               -  Subjects receiving immunosuppressive agents (such as steroids) for any reason\n                  should be tapered off these drugs before start of trial treatment, with the\n                  following exceptions: Subjects with adrenal insufficiency, may continue\n                  corticosteroids at physiologic replacement dose, equivalent to ? 10 mg prednisone\n                  daily; Administration of steroids through a route known to result in a minimal\n                  systemic exposure (topical, intranasal, intra-ocular, or inhalation) is\n                  permitted; Previous or ongoing administration of systemic steroids for the\n                  management of an acute allergic phenomenon is acceptable as long as it is\n                  anticipated that the administration of steroids will be completed in 14 days, or\n                  that the dose after 14 days will be equivalent to <= 10 mg prednisone daily.\n\n          -  Any prior treatment with any form of interlukin-12 (IL-12)\n\n          -  For the NSCLC, CRC, and UC expansion cohorts, prior therapy with any antibody / drug\n             targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1,\n             anti-PD-L1, or anticytotoxic T lymphocyte antigen-4 (CTLA-4) antibody is prohibited.\n\n          -  Intolerance to checkpoint inhibitor therapy, as defined by the occurrence of an AE\n             requiring drug discontinuation.\n\n          -  Active or history of primary or metastatic central nervous system tumors\n\n          -  Prior organ transplantation, including allogeneic stem-cell transplantation\n\n          -  Previous malignant disease (other than the indication for this trial) within the last\n             5 years (except adequately treated non-melanoma skin cancers, carcinoma in situ of\n             skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission\n             without further recurrence was achieved at least 2 years prior to trial entry and the\n             subject was deemed to have been cured with no additional therapy required or\n             anticipated to be required.\n\n          -  Significant acute or chronic infections requiring systemic therapy including, among\n             others:\n\n               -  History of testing positive test for human immunodeficiency virus (HIV) or known\n                  acquired immunodeficiency syndrome\n\n               -  Hepatitis B or C infection (HBV surface antigen positive and HBV core antibody\n                  positive with reflex to positive HBV deoxy ribonucleic acid (DNA) or HBV core\n                  antibody positive alone with reflex to positive HBV DNA or positive hepatitis C\n                  virus [HCV] antibody with reflex to positive HCV ribonucleic acid [RNA]).\n                  Subjects with history of infection must have polymerase chain reaction\n                  documentation that infection is cleared.\n\n          -  Active or history of autoimmune disease that might deteriorate when receiving an\n             immuno-stimulatory agent. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or\n             hyperthyroid disease not requiring immunosuppressive treatment are eligible if they\n             are stable on other medical treatment and do not fulfill exclusion criterion including\n             Uncontrolled intercurrent illness\n\n          -  Known severe hypersensitivity reactions to monoclonal antibodies (Grade>= 3 National\n             Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03, or\n             uncontrolled asthma (ie, 3 or more features of partially controlled asthma)\n\n          -  History of allergic reaction to methotrexate (trace methotrexate may be present in\n             NHS-IL12 as a part of the manufacturing process) or history of severe hypersensitivity\n             reaction to any other ingredient of the study drug(s) and / or their excipients. Since\n             NHS-IL12 contains sucrose as an excipient, subjects suffering from hereditary fructose\n             intolerance are also excluded\n\n          -  Persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v4.03 with the\n             following exceptions:\n\n               -  Neuropathy Grade <= 2 is acceptable.\n\n               -  All grades of alopecia are acceptable.\n\n               -  Endocrine dysfunction on replacement therapy is acceptable.\n\n          -  Pregnancy or lactation\n\n          -  Known alcohol or drug abuse as deemed by the Investigator\n\n          -  Uncontrolled intercurrent illness including, but not limited to:\n\n               -  Hypertension uncontrolled by standard therapies (not stabilized to 150/90\n                  millimeter of mercury (mm Hg) or lower)\n\n               -  Uncontrolled active infection\n\n               -  Uncontrolled diabetes (eg, glycosylated hemoglobin [HgbA1c] >= 8%)\n\n          -  Clinically significant (or active) cardiovascular disease: cerebral vascular\n             accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months\n             prior to enrollment), unstable angina, congestive heart failure (New York HeXx_NEWLINE_xXPreviously untreated NSCLC patients. To be eligible for this study, patients must have received and progressed on EGFR TKI therapy.Xx_NEWLINE_xXPatients must have been treated with at least one prior systemic regimen for sarcoma; adjuvant systemic therapy qualifies as prior therapy for the purposes of this study; there is no upper limit on previous lines of therapy received; a prior line of systemic therapy may include prior investigational agents received as part of other clinical studiesXx_NEWLINE_xXPreviously treated for advanced cancer with no additional therapy options available known to prolong survival.Xx_NEWLINE_xXMust have received at least one prior systemic therapyXx_NEWLINE_xXPatients, who relapsed 6 months after bone marrow transplant and have no evidence of active graft versus host disease and are off systemic immunosuppressant medications for at least 2 months and have received hypomethylating agents (HMA) therapy before or after transplant and meet other eligibility criteria of progression after at least 4 months of DNMTi therapy, are eligible to be enrolled in this clinical trialXx_NEWLINE_xXPatients with known active cancers who are on therapy for those cancers at time of screeningXx_NEWLINE_xXAdult subjects with advanced MDS or CMML requiring therapy who were previously treated with either azacitidine or decitabine for at least 4 cycles and deemed to have failed therapy due to progression of disease using International Working Group (IWG) criteria (“refractory”) or losing their previously documented response to the therapy (“relapsed”) and who are ineligible for allogeneic stem cell transplantXx_NEWLINE_xXSubject must be non-refractory to bortezomib (Refractory is defined: progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy).Xx_NEWLINE_xXAny prior immunologic cancer therapy with systemic inhibitors of the PD-1 or CTLA-4 pathwayXx_NEWLINE_xXFailed at least one trial of immunosuppressive therapy (IST) by being refractory or having relapsed. IST could have included ATG based regimens, calcineurin inhibitors and/or other higher dose therapy directed at the treatment of primary SAA.Xx_NEWLINE_xXPrior anti-CD19-directed therapiesXx_NEWLINE_xXHave not used exogenous hormone replacement therapy or oral contraception in the year prior to diagnosis; the use of non-systemic estrogen (such as vaginal estrogen use) is allowedXx_NEWLINE_xXProgression on a prior line of therapy that contained a fluoropyrimidine and oxaliplatin or irinotecan for unresectable metastatic colorectal adenocarcinomaXx_NEWLINE_xXMore than one prior line of systemic therapy for advanced CRCXx_NEWLINE_xXPrevious androgen deprivation therapy lasting more than 6 monthsXx_NEWLINE_xXPatients must be refractory to, or not a candidate for, established therapy known to provide clinical benefit for their malignancy.Xx_NEWLINE_xXHaving gotten prior PD1 therapy is allowed for, especially if they have previously progressed on it; progression may include extra-cranial as well as intra-cranial progression; after progressing on PD1 therapy, intervening chemotherapy and/or targeted therapy (BRAF inhibitors [BRAFi], etc) is allowed; if they are on intervening chemotherapy and/or targeted therapy (BRAFi, etc), they have to have progression intra-cranially and/or extra-cranially and must be off intervening therapy for at least 2 weeksXx_NEWLINE_xXParticipants who have had prior local regional therapy including radiation therapy, transarterial therapy, or ablative therapyXx_NEWLINE_xXReceiving glucocorticoid therapy and calcineurin therapy or glucocorticoid therapy alone for cGVHD at study entry. Subjects on calcineurin therapy only, without glucocorticoid therapy, are not eligible. Subjects also receiving other therapies thought not to be immunosuppressive (such as extracorporeal photopheresis; ECP), will be considered for enrollment in this study on a case-by-case basis.Xx_NEWLINE_xXFor patients who have received prior radiation, cryotherapy, radiofrequency ablation, TheraSphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:\r\n* 28 days have elapsed since that therapy\r\n* Lesions that have not been treated with local therapy must be present and measureableXx_NEWLINE_xXPrevious therapy with Bruton's tyrosine kinase (BTK) inhibitionXx_NEWLINE_xXMust have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:Xx_NEWLINE_xXPrior infusion of a genetically modified therapyXx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while on study.Xx_NEWLINE_xXMust have received at least 1 cycle of induction therapy for front-line AML including cytarabine continuous infusion + anthracycline +/- cladribine or etoposide for 1 or 2 cycles, high dose cytarabine with or without fludarabine, cladribine or clofarabine, >= 4 cycles of azacitidine/decitabine or the equivalent experimental therapy (the latter as confirmed by the principal investigator [PI])Xx_NEWLINE_xXThe patient has received 1 to 3 prior lines of therapy; by definition, a single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy; radiotherapy, bisphosphonate, or a single short course of steroids (i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days) would not be considered prior lines of therapyXx_NEWLINE_xXPatients must be castrate-resistant (i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy). Patients receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during this study.Xx_NEWLINE_xXPatients with prior ? Grade 3, serious, or life threatening immune-mediated reactions following prior anti-PD-1 or other immune-oncology therapiesXx_NEWLINE_xXHave received prior gene therapy or therapy with cytolytic virus of any typeXx_NEWLINE_xXNaive to anti-EGFR therapy (cetuximab or panitumumab)Xx_NEWLINE_xXOther form(s) of antineoplastic therapy anticipated during the period of the study.Xx_NEWLINE_xXAt least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of therapy.Xx_NEWLINE_xX1 to 4 prior lines of therapyXx_NEWLINE_xXAny episode of recurrent disease following completion of aggressive multi-drug frontline therapy.Xx_NEWLINE_xXAny episode of progressive disease during aggressive multi-drug frontline therapy.Xx_NEWLINE_xXCurrent disease state must be one for which there is currently no known curative therapyXx_NEWLINE_xXDocumented disease progression per RECIST v.1.1 during or immediately after last therapy according to any of the aforementioned criteria.Xx_NEWLINE_xXEXPANSION COHORT: Histologically or cytologically confirmed diagnosis of advanced pancreatic adenocarcinoma; \r\n* Maintenance group (n=10): Patients must be stable on front-line therapy (defined as at least 4 months stable disease on nab-paclitaxel + gemcitabine)\r\n* Second-line group (n=10): Patients must have failed or could not tolerate the front-line fluorouracil (5FU)-based therapy for advanced pancreatic cancerXx_NEWLINE_xXEXPANSION COHORT: No more than one line of prior systemic therapy for advanced pancreatic adenocarcinoma allowedXx_NEWLINE_xXPrior regimen within 6 monthsXx_NEWLINE_xXStatus post 1 or more unmatched systemic therapy regimens for enrollment to group 3Xx_NEWLINE_xXPatients must have histologically confirmed adenocarcinoma of the prostate without previous therapy for PC\r\n* Treatment-naive AND\r\n* Undergoing RP as initial, locally definitive therapy for PC AND\r\n* Eligible for RP in a 3 month timeframe AND\r\n* Consentable for RPXx_NEWLINE_xXNo other investigational anti-neoplastic therapy for one month prior to entry in this studyXx_NEWLINE_xXNo other investigational anti-neoplastic therapy for one month prior to entry in this studyXx_NEWLINE_xXTreatment with steroids or immunosuppressive therapy such as cyclosporine, tacrolimus, anti-thymocyte globulin (ATG) within 6 months of registrationXx_NEWLINE_xXDisease has progressed through at least one systemic therapy or through local irradiation within the preceding 6 months.Xx_NEWLINE_xXPersistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician.Xx_NEWLINE_xXPatients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity, or if a patient with a surgical option refuses surgery\r\n* Since there is no standard effective chemotherapy for patients with NF1 and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, or other VEGFR inhibitors are eligible for enrollment\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and no prior radiation therapy should have been directed at the target PN\r\n* At least 4 weeks must have elapsed since receiving medical therapy directed at the PN\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing\r\n* Patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) before entering this studyXx_NEWLINE_xXPresence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 yearsXx_NEWLINE_xXProgressive disease and no effective therapy existsXx_NEWLINE_xXno effective conventional therapy existsXx_NEWLINE_xXMust have completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitive-intent local therapyXx_NEWLINE_xXSubject who has undergone platelet receptor GP IIb/IIIa antagonist therapy less than 48 hours prior to surgery.Xx_NEWLINE_xXPatients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of anti-epileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable doseXx_NEWLINE_xXRegular immunosuppressive therapyXx_NEWLINE_xXPrior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of >= 5% by flow cytometry)Xx_NEWLINE_xXReceived prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of MLA treatmentXx_NEWLINE_xXRelapse or progression after at least 1 systemic therapyXx_NEWLINE_xXPatients must have received at least one prior therapy for CLL or NHL, need additional treatment (or have need for cytoreduction as mentioned above), and meet criteria for relapsed or refractory disease; they may not be a candidate for curative therapy; relapsed disease is defined as a patient who previously achieved a complete remission (CR) or a partial remission (PR), but after a period of six or more months demonstrates evidence of disease progression; refractory disease is defined as progression within six months of the last anti-leukemic or anti-lymphoma therapy, or any response less than a CR or PRXx_NEWLINE_xXPROCUREMENT INCLUSION CRITERIA: Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or survivin) with:\r\n* Active disease after first line therapy;\r\n* Refractory disease;\r\n* As adjuvant therapy for high risk disease (high risk disease is a disease that has a > 50% risk of progression within 5 years)Xx_NEWLINE_xXAny patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or survivin) with:\r\n* Active disease after first line therapy;\r\n* Refractory disease;\r\n* As adjuvant therapy for high risk disease (high risk disease is disease that has a > 50% risk of progression within 5 years)Xx_NEWLINE_xXPatients should have been off conventional therapy for at least 1 week prior to entry in this study; PD1/PDL1 inhibitors will be allowed if medically indicatedXx_NEWLINE_xXNo prior anti-leukemic therapy except the following are allowed: < 1 week of corticosteroids, or hydroxyurea or emergent leukapheresis; longer steroid use for diseases other than leukemia is permittedXx_NEWLINE_xXPatients who have had prior (within 8 weeks of initiation of UC-961) or concurrent antibody therapy directed against CLL (i.e., Rituxan® and Campath®)Xx_NEWLINE_xXPatients will be excluded from Arms A and C if they have received a previous myeloablative transplant; patients who have received a prior HCT at least 6 months prior may be considered for inclusion on Arms B or D after discussion with the principal investigator (PI)Xx_NEWLINE_xXPrior systemic therapyXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXThere is no limit on the number of prior therapiesXx_NEWLINE_xXAML relapsed or refractory to prior therapy, or ? 60 years of age and not a candidate for other therapies Phase 2a:Xx_NEWLINE_xXMDS/CMML, relapsed from, or refractory to, prior HMA therapy; the latter defined as failure to achieve clinical remission (CR), partial remission (PR) or hematologic improvement (HI) after previous HMA therapy (? 4 cycles of azacitidine or decitabine), or progression during, or toxicity to previous HMA therapy precluding further HMA treatment, and,Xx_NEWLINE_xXPatients may have received previous NY-ESO-1 vaccine therapy; patients who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy (at least 4 weeks for prior taxane or prior bevacizumab) prior to randomization and recovered from toxicities to less than grade 2Xx_NEWLINE_xXDocumented disease progression following prior therapy, as assessed by the Investigator.Xx_NEWLINE_xXPrevious and concomitant therapy that precludes enrollment, as defined in the protocolXx_NEWLINE_xXAll patients must have had at least one appropriate first line systemic therapy and progressedXx_NEWLINE_xXOther investigational drugs or investigational therapy if the patient is currently taking those drugs/therapy, or if they have received the drugs/therapy within 1 month.Xx_NEWLINE_xXPrior therapy with afatinibXx_NEWLINE_xXOngoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration); patients who have not had an orchiectomy must maintain effective GnRH-analogue therapy for the duration of the trialXx_NEWLINE_xXA minimum of 4 weeks elapsed off of anti-androgen therapy prior to enrollment for flutamide and 6 weeks for bicalutamide and nilutamide without evidence of an anti-androgen withdrawal response; patients who NEVER HAD A PSA decline with the most recent anti-androgen therapy or in whom the response to the most recent anti-androgen was for < 3 months require only a 2 week washout period prior to first dose of study drugXx_NEWLINE_xXPatients who have previously received PGG-Betafectin (Betafectin) or Imprime PGGXx_NEWLINE_xXPatients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial.Xx_NEWLINE_xXNo other investigational antitumor therapy for one month prior to entry in this studyXx_NEWLINE_xXPatients must be free from active graft versus host disease (GVHD) and off immunosuppressive GVHD therapy for 4 weeks prior to enrollmentXx_NEWLINE_xXNo prior genetically modified cell therapy that is still detectable or virotherapy allowed; patients who are otherwise eligible but have detectable circulating CAR T cells of < 5% will be eligible, but will be evaluated as a separate strata from CAR-naive patients in the phase 2 portion of the studyXx_NEWLINE_xXPatients may have had no more than 3 prior lines of systemic therapy; prior therapy with a MET inhibitor is allowed as long as the patient has not had progressive disease while receiving the agentXx_NEWLINE_xXPatients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).Xx_NEWLINE_xXER+ and/or PR+ (Note: This group of patients must have received at least 1 and up to 3 prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER2+ patients in this group must have received a minimum of 2 lines of HER2-directed therapy in the advanced setting.) This group of patients may be pre-menopausal with ovarian suppression or post-menopausal. LHRH agonists maybe used to render ovarian suppression with post-menopausal ranges of estradiol or FSH per institutional guidelines.Xx_NEWLINE_xXPrior anti-androgen therapyXx_NEWLINE_xXPatients who have received prior therapy targeting EGFR with small molecule tyrosine kinase inhibitors or monoclonal antibodies are NOT eligibleXx_NEWLINE_xXIn Part 1 and, Part 2, subjects must have AML, MM, or NHL. Subjects with AML, are eligible if they • have relapsed and/or refractory disease, OR are>=65 years of age and not candidates for or have refused standard chemotherapy. Subjects with multiple myeloma are eligible if they have progressed despite therapy with an alkylating agent, proteasome inhibitor, and immunomodulatory agent, either as individual regimens or in combination. Subjects with NHL are eligible if they have received at least two prior lines of systemic therapy, including at least one line of immunochemotherapy with an anti-CD20 antibody (if their tumor expresses CD20). In Part 2, the NHL cohort will separately enrol subjects with double- and triple hit lymphoma, so that a minimum of 10 subjects with this subset of disease will be enrolled. To be eligible for this sub-cohort, tumor sample from the subject must demonstrate rearrangement and/or overexpression of MYC and either BCL2 and/or BCL6 genes. Evaluation of double- or triple-hit status may be performed via appropriate local testing, and the determination of double- or triple-hit diagnosis will be at the discretion of the investigator and GSK Medical Monitor.Xx_NEWLINE_xXBiopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy (Note: extracorporeal photopheresis will be considered a systemic therapy for this study)Xx_NEWLINE_xXPrior therapy for the treatment of solitary plasmacytoma is permitted, but > 14 days should have elapsed from the last day of radiation; NOTE: prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigatorXx_NEWLINE_xXPhase II: histologically confirmed colorectal adenocarcinoma post at least two lines of therapy, NSCLC post at least two lines of therapy, or granulosa cell ovarian cancer post at least one line of therapy; patients must have measurable diseaseXx_NEWLINE_xXPatients who have received any prior immunotherapyXx_NEWLINE_xXPatients with advanced adenocarcinoma of the colon or rectum not curable with surgery or radiotherapy and have been previously treated for their disease with FOLFIRI plus bevacizumab in the first line metastatic setting; patients will only be eligible if their last line of therapy prior to enrolling onto the study was FOLFIRI and bevacizumab received no more than 6 months prior to enrolling in this study; they should have been treated with FOLFIRI plus bevacizumab until disease progression is radiographically documentedXx_NEWLINE_xXPatients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), or any systemic corticosteroid, must discontinue the agent for at least four weeks prior to ipilimumab treatment; progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist)Xx_NEWLINE_xXPrior treatment with an anti-CTLA-4 antibody treatment; the course of sipuleucel-T therapy (i.e. three treatments) leading up to this investigational trial must be the first course of therapy these patients have receivedXx_NEWLINE_xXDiagnosis of multiple myeloma previously treated with at least one prior line of therapy. Induction therapy followed by stem cell transplant and maintenance therapy will be considered a single line of therapy. For Safety Expansion, subjects must have been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide). For Venetoclax-Dexamethasone Combination, subjects must have been been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide) AND have t(11;14)-positive multiple myeloma per the central lab testing. For Phase 2, subjects must have documented MM positive for t(11;14) translocation. If testing has been performed by non-central lab, retesting must be confirmed by central lab. Subjects must have evidence of disease progression on or within 60 days of last dose of most recent previous treatment based on IMWG criteria AND subjects must have previously received at least 2 lines of therapy, including an immunomodulatory drug, a proteasome inhibitor, daratumumab, and glucocorticosteroids. Daratumumab combination regimen must be one of the prior lines of therapy (for this study, daratumumab plus corticosteroids will not be considered a combination regimen) given alone or in combination, OR, subjects must be refractory to glucocorticosteroid and to the most recent immunomodulatory drug, proteasome inhibitor and daratumumab given alone or in combination.Xx_NEWLINE_xXDocumented BCG-refractory disease defined as failure to achieve a tumor free state after at least 2 prior induction courses of intravesical BCG therapy; NOTE: For patients with residual non-invasive tumors (i.e. Ta, T1, Tis) after an initial 6-week induction course of intravesical BCG therapy, a second induction course of intravesical BCG therapy is required; patients with persistent non-invasive tumors (i.e. Ta, T1, Tis) despite an initial 6-week and second induction intravesical BCG therapy course are considered BCG-refractory and, therefore, eligible for study; patients with non-invasive tumor recurrences (i.e. Ta, T1, Tis) after only an initial 6-week induction course of intravesical BCG therapy are considered BCG-resistant and not eligible for study until persistent non-invasive tumor (i.e. Ta, T1, Tis) is demonstrated after a second induction course of intravesical BCG therapy has been administered; there is no maximum limit on the number of prior BCG therapy courses; in addition, there is no maximum limit on the number of prior non-BCG intravesical therapy courses (i.e. gemcitabine, valrubicin, interferon, mitomycin C, etc.)Xx_NEWLINE_xXThere is no waiting period for participants who relapse while receiving frontline therapy and are free from side effects attributable to such therapyXx_NEWLINE_xXPhase I and expansion cohort: Up to two prior non-taxane chemotherapy regimens for metastatic disease are permitted for patients enrolled on the phase I portion of the trial; patients with HER2/neu positive breast cancer are not eligible; patients treated with prior anthracycline therapy as neoadjuvant, adjuvant, or metastatic therapy are not eligible unless the following conditions are met: (a) prior cumulative doxorubicin dose is =< 240 mg/m^2 (or epirubicin dose is =< 400 mg/m^2), and (b) left ventricular ejection fraction (LVEF) obtained at baseline is at least 50% (or >= 5% above lower institutional limits of normal whichever is higher); patients with estrogen receptor (ER)-positive disease are required to have relapse or progression on at least one line of endocrine therapyXx_NEWLINE_xXPrior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permittedXx_NEWLINE_xXNo prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments. For Cohort 5, patients must have failed to respond or relapsed after 1 or more treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected. For Cohort 7, patients who are receiving ibrutinib with stable disease and now have the cysteine 481 mutant clone present at levels of >1%. For Cohort 8, have refractory or relapsed PTCL after one or more prior therapies.Xx_NEWLINE_xXFor Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preferenceXx_NEWLINE_xXCOHORT B, GROUP 2: PANCREATIC CANCER: Patients must have failed a minimum of one previous line of therapy for advanced diseaseXx_NEWLINE_xXCOHORT B, GROUP 5: MESOTHELIOMA: Patients must have failed a minimum of one previous line of systemic therapy for advanced diseaseXx_NEWLINE_xXCOHORT B, GROUP 7: GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: Patients must have failed a minimum of one previous line of systemic therapy for advanced diseaseXx_NEWLINE_xXPatients treated with prior Interleukin-2 will be allowed to be in this studyXx_NEWLINE_xXPatients who have received prior systemic therapy for metastatic RCC or have previously received IL-2 are not eligible; patients on hydroxychloroquine (HCQ) in neoadjuvant protocols or in the past for clinical indications ARE eligibleXx_NEWLINE_xXScheduled for induction BCG intravesical therapyXx_NEWLINE_xXOral estrogen, progesterone, testosterone therapy within last 3 monthsXx_NEWLINE_xXConcomitant medications: drugs that are considered category D (consider therapy modification) and X (avoid combination) using the Lexicomp database are prohibited; concomitant drugs that fall into categories A (no known interaction), B (no action needed) and C (monitor therapy) are allowedXx_NEWLINE_xXPrior immune therapy (e.g. related vaccinia and fowlpox vaccines or antigen-specific peptides) is allowedXx_NEWLINE_xXThere is no limit on prior systemic or IT therapiesXx_NEWLINE_xXConcurrent systemic steroid therapy; (NOTE: Patients with recurrent glioblastoma who require steroids for clinical indications are eligible)Xx_NEWLINE_xXNo more than two prior regimens targeting the VEGF pathway; no prior bevacizumab therapyXx_NEWLINE_xXHigh risk for poor compliance with therapy or follow-up as assessed by investigatorXx_NEWLINE_xXNo prior purine analog therapy except up to 1 prior course of either cladribine or pentostatinXx_NEWLINE_xXPatients who have received Y-90 ibritumomab (Zevalin) or I-131 tositumomab (Bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplantXx_NEWLINE_xXHaving progressed on at least one prior line of therapy, histologically or cytologically confirmed diagnosis of one of the following: \r\n* Dose escalation and expansion cohorts:\r\n** Checkpoint inhibitor naive non-small cell lung cancer patients must have progressed on front-line therapy cytotoxic chemotherapy and may have received up to two prior treatment regimens provided no regimens included an anti-PD1 or PD-L1 agent or an oral VEGF TKI. Prior bevacizumab or ramucirumab is allowed.\r\n** Progressed on checkpoint inhibitor non-small cell lung cancer patients must have progressed on front-line checkpoint inhibitor therapy and may have received up to two prior treatment regimens provided no regimens included an oral VEGF TKI. Prior bevacizumab or ramucirumab is allowed.\r\n** Thymic carcinoma patients must not be eligible for surgical resection at the time of enrollment and may have received any number of prior lines of therapy provided no regimens included an anti-PD1 or PD-L1 agent or an oral VEGF TKI. Prior bevacizumab or ramucirumab is allowed.Xx_NEWLINE_xXHas received four or more systemic anticancer regimens for mCRPC. Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC. A ‘line’ is a regimen. Combinations of hormones and other types of therapies count as single linesXx_NEWLINE_xXAUTOLOGOUS APHERESIS: CD19+ ALL with any of the following:\r\n* Minimal residual disease (MRD) >= 1% at end of up-front induction therapy\r\n* Hypodiploid (< 44 chromosomes or < 0.95 deoxyribonucleic acid [DNA] index) CD19+ ALL with detectable disease at the end of up-front induction therapy \r\n* Increase in disease burden any time after the completion of up-front induction therapy\r\n* Primary refractory disease despite 2 cycles of an intensive chemotherapy regimen designed to induce remission\r\n* Refractory disease despite salvage therapy\r\n* 1st or greater relapse\r\n* Note: if patient meets CD19+ ALL disease criteria, subsequent receipt of cancer directed therapy that eradicates disease does not preclude them from proceeding with this studyXx_NEWLINE_xXMANUFACTURING SJCAR19: CD19+ ALL with any of the following:\r\n* Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission\r\n* Refractory disease despite salvage therapy\r\n* 2nd or greater relapse\r\n* Any relapse after allogeneic hematopoietic cell transplantation \r\n* 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCTXx_NEWLINE_xXPart-1 Escalation Phase [Key Inclusion]:\n\n          -  Histologically or cytologically confirmed diagnosis of solid tumor malignancy or\n             lymphoma that is not responsive to standard therapies, are unfit for standard\n             chemotherapy or for which there is no approved or curative therapy.\n\n          -  ECOG score of 0 or 1.\n\n          -  Able to swallow and retain oral medication.\n\n          -  Adequate organ system function.\n\n        Part-2 Expansion Phase [Key Inclusion]:\n\n          -  Part-1 Escalation Phase inclusion criteria.\n\n          -  (a) Thymic carcinoma, thymoma, pancreatic cancer, or breast cancer (TNBC); or (b) any\n             other cancer with histologically or cytologically or genomically confirmed diagnosis\n             of NTRK1 (TrkA) mutation, or fusion, or overexpression, translocation, amplification\n             or other alterations that may interfere with TrkA (NTRK1) signaling, as previously\n             identified with prior testing as routinely performed at Clinical Laboratory\n             Improvement Amendments (CLIA)-certified or other similarly-certified laboratories.\n\n        Part-3 Pharmacodynamic Activity (Eligible subjects in Part-2 may enroll in Part-3):\n\n          -  Part-2 Expansion Phase inclusion criteria.\n\n          -  Tumor with readily accessible lesion that is amenable to biopsy and consent to pre-and\n             post-dose biopsy.\n\n        Key Exclusion Criteria (Part-1, -2 and -3):\n\n          1. Received chemotherapy having delayed toxicity within the last 21 days (six weeks for\n             prior nitrosourea or mitomycin C).\n\n          2. Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or\n             tumor embolization within the past 2 weeks.\n\n          3. Received an investigational anti-cancer drug within 21 days or 5 half-lives of the\n             investigational agent prior, whichever is shorter, to the first dose of VMD-928.\n\n          4. Unresolved toxicity from previous anti-cancer therapy ? CTCAE Grade 1 (except alopecia\n             or anemia) unless agreed to by both the Investigator and Sponsor.\n\n          5. Known active infections including HIV disease.\n\n          6. Currently pregnant, nursing, or planning to become pregnant during the course of the\n             study.\n\n          7. QTcF interval ? 480 msec.\n\n          8. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA)\n             functional classification system.\n\n          9. Acute coronary syndromes (including unstable angina), coronary angioplasty, or\n             stenting within the past 24 weeks.\n\n         10. Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would\n             compromise the patient's safety or interfere with assessment of the drug.\n\n         11. Psychological, familial, sociological, geographical or other concurrent conditions\n             that would interfere with safety evaluation, limit the subject's ability to follow the\n             procedures in the protocol or otherwise jeopardize compliance with the protocol.\n             Subjects with uncontrolled major depression, bipolar disorder, or severe anxiety\n             disorder are excluded.\n\n             Key Exclusion Criteria (For Part-1 Escalation Phase only):\n\n         12. Any current medical condition that would alter the absorption, distribution,\n             metabolism or excretion of VMD-928 including but not limited to:\n\n               -  Severe uncontrolled nausea or vomiting\n\n               -  Severe uncontrolled diarrhea The intended population for VMD-928 are expected to\n                  have had bowel resections and these subjects will be eligible for Part-1 Dose\n                  Escalation phase.Xx_NEWLINE_xXPrior therapy:\r\n* Patients may have received unlimited prior treatment for the dose escalation part\r\n* For the expansion cohort patients must have ? 4 prior lines of chemotherapy\r\n* Hormonal therapy does not count towards total lines of therapy\r\n* Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued\r\n* Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgeryXx_NEWLINE_xXPrior malignancies requiring systemic therapy within the last 3 years (as prior therapy can increase toxicity of current chemo regimen, those patients should be excluded).Xx_NEWLINE_xXHas received no more than 5 previous lines of chemotherapy and has received at least one line of therapy with an endocrine therapy or endocrine therapy combination.Xx_NEWLINE_xXDemonstrated disease progression during, or after discontinuation, of the most recent line of systemic therapyXx_NEWLINE_xXHave received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting, and including a platinum containing regimen)Xx_NEWLINE_xXPatient who has received previous systemic therapy for HCCXx_NEWLINE_xXALL patient refractory to their first induction only or their first relapse, will be excluded; they must be refractory to at least one salvage therapy, or relapse after first salvage, to be eligibleXx_NEWLINE_xXALL patients refractory to liposomal vincristine as defined by progression while on therapy or relapse within 3 months of completion of therapy with liposomal vincristineXx_NEWLINE_xXPrior immuno-oncology therapyXx_NEWLINE_xXPrior allogeneic transplant performed ? 6 months prior to first dose of AMV564 is allowed provided there is no evidence of active graft-versus-host disease (GVHD) and the patient has been off immunosuppressive therapy for ? 4 weeks.Xx_NEWLINE_xXAt least 42 days must have elapsed since chimeric antigen receptor (CAR)-T cell therapyXx_NEWLINE_xXReceived at least one systemic therapy for advanced disease, with no further approved treatment options that provide proven clinical benefit.Xx_NEWLINE_xXHave relapsed or treatment refractory disease with ? 10% CD138+ malignant plasma cells immunohistochemistry (IHC) on BM core biopsy, either: \r\n* Following autologous stem-cell transplantation (ASCT)\r\n* Or, if a patient has not yet undergone ASCT, the individual must:\r\n** Be transplant ineligible, due to age, comorbidity, patient choice, insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician, and,\r\n** Demonstrate disease that persists after > 4 cycles of induction therapy and that is double refractory (persistence/progression) after therapy with both a proteasome inhibitor and immunomodulatory drug (IMiD) administered either in tandem, or in sequence, or demonstrate intolerance to both classes of agents (IMiD and proteasome inhibitor [PI])Xx_NEWLINE_xXPatients may not have received more than 3 prior regimens, where the regimen intent was to induce remissionXx_NEWLINE_xXRefractory to or intolerant of existing therapy(ies) known to provide clinical benefit.Xx_NEWLINE_xXHistory of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapyXx_NEWLINE_xXMust receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administrationXx_NEWLINE_xXFinancial coverage for proton therapyXx_NEWLINE_xXPatients must agree to continue to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analogue/antagonist or bilateral orchiectomyXx_NEWLINE_xXOne to four prior lines of therapyXx_NEWLINE_xXPrimary refractory disease (i.e. never responded with ? MR to any prior therapy)Xx_NEWLINE_xXKnown intolerance to the required dose and schedule of steroid therapy as determined by the investigatorXx_NEWLINE_xXPrior therapy with at least one first-line standard of care treatment or second-line treatment of proven effectiveness; patients must have progressive disease after prior treatment; prior first-line or second-line treatments would include the following:\r\n* Patients with metastatic melanoma: receipt of a checkpoint inhibitor as first-line therapy\r\n* Patients with metastatic melanoma with an activating mutation of KIT: receipt of imatinib\r\n* Patients with a BRAF V600 activating mutation: receipt of appropriate targeted therapy\r\n* Patients with metastatic gastrointestinal cancer: receipt of up to two forms of approved first- and/or second-line chemotherapy regimens\r\n* Patients with metastatic genitourinary cancers: receipt of a first- or second-line therapy appropriate for their histologic subtypeXx_NEWLINE_xXAny prior therapy with daratumumabXx_NEWLINE_xXPatients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.Xx_NEWLINE_xXHistory of Grade 4 anaphylactic reaction to monoclonal antibody therapy.Xx_NEWLINE_xXPrior therapy with etoposide and cyclophosphamide is allowedXx_NEWLINE_xXPatients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy; maintenance therapy with Food and Drug Administration (FDA)-approved targeted therapies (e.g. tyrosine kinase inhibitors for Philadelphia chromosome [Ph] positive [+] acute lymphoblastic leukemia [ALL], and FLT inhibitors for FLT3+ patients) will be allowed after day 60 disease assessmentXx_NEWLINE_xXAny subject who is a candidate for intensive induction therapy and agrees to receive this therapyXx_NEWLINE_xXPrevious intrapleural therapy for MPE on the same sideXx_NEWLINE_xXHas received prior therapy with an indoleamine-pyrrole 2,3-dioxygenase (IDO) inhibiting agentXx_NEWLINE_xXStarted antiandrogen therapy (ADT) no longer than 6 months prior to randomizationXx_NEWLINE_xXReceived ADT for more than 6 months prior to randomizationXx_NEWLINE_xXGreater than 2 lines of prior systemic therapy for CRPCXx_NEWLINE_xXCurrent anticoagulant or antiplatelet aggregation therapy except for aspirin or non-steroidal anti-inflammatory drugsXx_NEWLINE_xXPatients must have received at least one prior therapy for CLL comprised of the following:\r\n* ? 1 regimen containing an anti-CD20 antibody (e.g., rituximab, obinutuzumab) administered for ? 2 doses\r\n* ? 1 regimen containing ? 1 cytotoxic agent (eg, bendamustine, fludarabine, chlorambucil, cyclophosphamide) administered for ? 2 cyclesXx_NEWLINE_xXOsteosarcoma cohort only: Subjects with osteosarcomas must have relapsed or become refractory to conventional therapy and have received a regimen including some combination of high-dose methotrexate, doxorubicin, cisplatin, and/or ifosfamide.Xx_NEWLINE_xXPrior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of ? 5% in peripheral blood by flow cytometry)Xx_NEWLINE_xXHistory of severe (defined as grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodiesXx_NEWLINE_xXIO therapy resistant or insensitive tumorsXx_NEWLINE_xXPatients with B-lineage ALL in CR2 and beyond with molecular failure at any time point after 2 months of salvage therapy are allowedXx_NEWLINE_xXPatients must be either refractory to or relapsed after 1 line of therapyXx_NEWLINE_xXAny prior systemic therapy for HCCXx_NEWLINE_xXSymptomatic hypothyroidism without replacement\r\n* Patients may be rescreened after initiating adequate replacement therapyXx_NEWLINE_xXReceived investigational therapy (e.g. small molecule or biologic) within 30 days prior to the start of CMP-001 dosing on W1D1. However, if an investigational therapy has a short half-life, a reduced wash out period may be acceptable with Sponsor approval. Acceptable washout periods include:Xx_NEWLINE_xXReceived prior 2nd generation anti-androgen and require urgent disease response or stabilizationXx_NEWLINE_xXOngoing or anticipated therapy with hormone therapy (other than LHRH antagonist), including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) or received abiraterone within 28 days prior to the first dose of enzalutamide and/or CORT125281Xx_NEWLINE_xXPrior therapy with LMB-100Xx_NEWLINE_xXConcomitant therapy with any other experimental drugXx_NEWLINE_xXDocumented progression to prior therapies: a) Cohort A: Disease progression following prior immune checkpoint blockade therapy; b) Cohort B: Progression or intolerance to at least 2 prior lines of standard therapy for unresectable or metastatic CRC; c) Cohort C: Disease progression following prior immune checkpoint blockade therapy.Xx_NEWLINE_xXCohort B only: prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC.Xx_NEWLINE_xXRecipient of CAR-T cell therapy outside of this protocol.Xx_NEWLINE_xXAny cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)Xx_NEWLINE_xXRequirement for systemic immunosuppressive therapy (e.g. graft-versus-host disease [GVHD] therapy within 12 weeks before the first dose of study drug)Xx_NEWLINE_xXParticipants may have had prior immuno-oncology (IO) therapy (including but not limited to anti-CTLA4 and anti-PD1/L1) excluding prior CSF1R directed agents for the study arm containing cabiralizumabXx_NEWLINE_xXOff all mycosis fungoides (MF)-directed therapy at the time of enrollment, with the exception of ruxolitinibXx_NEWLINE_xXPatient shouldn’t have received any anti-cancer therapy for glioblastoma in pastXx_NEWLINE_xXLeukemic blast cell count >50 × 109/L before the start of study therapy and despite the use hydroxyurea.Xx_NEWLINE_xXPrior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant; the complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implantXx_NEWLINE_xXPatients requiring anti-coagulant therapyXx_NEWLINE_xXPatients must be cetuximab-resistant by fulfilling at least one of the criteria defined below:\r\n* Disease persistence or recurrence within 6 months of completing definitive radiotherapy for locally advanced disease; radiation must have included concurrent cetuximab; induction chemotherapy, if given, may or may not have included cetuximab\r\n* Disease progression during, or within 6 months, of cetuximab treatment in the recurrent/metastatic setting\r\n* Prior cetuximab exposure may have occurred in any line of therapy (first line, second line, etc.) and cetuximab is not required to be the most recent therapy receivedXx_NEWLINE_xXPrior therapy: Patients must have been receiving single agent ibrutinib therapy at the time of disease progression. Patient may have received other therapy in combination with ibrutinib earlier in the treatment course. Patients may have received other therapies after ibrutinib but stopped based on the defined wash-out periods and still meet iwCLL criteria for treatmentXx_NEWLINE_xXPrimary ibrutinib resistance, defined by progressive disease within the first 2 months of first initiating ibrutinib therapyXx_NEWLINE_xXPrior cognitive-behavioral therapyXx_NEWLINE_xXPrior therapy, including everolimus, octreotide, surgery, chemoradiation, is all permitted after being properly noted; this prior therapy must have been completed at least 28 days prior to study enrollmentXx_NEWLINE_xXMCL has been previously treated and has relapsed after or progressed during prior therapy.Xx_NEWLINE_xXPatients may not have received prior cell therapyXx_NEWLINE_xXRadiologically documented disease progression on or after most recent antitumor therapy.Xx_NEWLINE_xXSystemic steroid therapy required, except for patients with glioblastoma (cohort 4)Xx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonistsXx_NEWLINE_xXHas not received any prior therapy for the diseaseXx_NEWLINE_xXBiopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy\r\n* Note: extracorporeal photopheresis will be considered a systemic therapy for this studyXx_NEWLINE_xXPatients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy; patients with isolated extramedullary AML are eligibleXx_NEWLINE_xXPatients with high-risk MDS, and chronic myelomonocytic leukemia (CMML) with bone marrow blasts between 10% and 20%, relapsed or refractory to prior hypomethylating agent (HMA) therapy, defined as prior receipt of 4 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapyXx_NEWLINE_xXPrior treatment with, contra-indication to or refusal of a fluoropyrimidine, irinotecan, oxaliplatin and an anti-EGFR targeted therapy (if RAS wild-type [wt])Xx_NEWLINE_xXSubjects must have relapsed/refractory DLBCL or relapsed/refractory FL\r\n* For DLBCL, patients must have relapsed after, declined, or considered ineligible for high-dose chemotherapy and autologous stem cell transplantation\r\n* For FL, in addition to relapsed/refractory disease status, patients must have received therapy with CD20 antibody-directed therapy, and must have an indication for treatment; FL eligibility also requires patients have no standard options with curative potential, nor options with more favorable risk/benefit ratio in the judgment of the investigatorXx_NEWLINE_xXAll stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.Xx_NEWLINE_xXPrior systemic therapy for current diagnosis of HNSCCXx_NEWLINE_xXINCLUSION CRITERIA:\n\n          1. Age: Men and women aged ? 18 years,\n\n          2. Signed written informed consent,\n\n          3. Any histologic type of locally advanced or metastatic NSCLC,\n\n          4. Life expectancy of ? 12 weeks,\n\n          5. Measurable or evaluable (cytologically or radiologically detectable disease such as\n             ascites, peritoneal deposits, or lesions which do not fulfill RECIST 1.1 criteria for\n             measurable disease) lesions according to RECIST v1.1 criteria for phase 1 portion. For\n             phase 2, all patients must have RECIST 1.1 measurable disease,\n\n          6. Physiologic function:\n\n               -  Hematologic function: Absolute neutrophil count (ANC) ? 1.5 × 109/L, platelet\n                  count ? 100 × 109/L, and hemoglobin ? 9 g/dL (may have been transfused),\n\n               -  Hepatic function: Total bilirubin level ? 1.5 × the upper limit of normal (ULN)\n                  range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\n                  levels ? 2.5 × ULN,\n\n               -  Renal function: Estimated creatinine clearance ? 30 mL/min according to the\n                  Cockcroft-Gault formula (or local institutional standard method).\n\n          7. Pregnancy and contraception:\n\n               -  Pregnancy test: Negative serum or urine pregnancy test at screening for women of\n                  childbearing potential,\n\n               -  Contraception: Highly effective contraception for both male and female subjects\n                  throughout the study and for 90 days after last avelumab treatment administration\n                  if the risk of conception exists.\n\n          8. Ability to comply with protocol requirements,\n\n          9. Willingness to consent and ability to undergo a trucut biopsy to obtain a fresh\n             metastasis or primary tumor biopsy in case no adequate tumoral tissue is available,\n             and to undergo fibroscopy to obtain a biopsy from normal bronchial mucosa,\n\n         10. No serious or medically uncontrolled concomitant conditions that are likely to make\n             the patient unfit for SPRING combination therapy, as per investigator assessment,\n\n         11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\n        EXCLUSION CRITERIA:\n\n          1. Patients with documented oncogenic aberrations at enrollment: EGFR, ALK, ROS1 when\n             available, MET exon 14 skipping when available.\n\n             Note: For Phase 1 portion, all patients with adenocarcinoma histology must have\n             documentation of results for druggable oncogenic aberrations (EGFR mutations, ALK\n             rearrangements, and ROS1 when available) prior to enrollment on the study.\n\n          2. For Phase 1 portion, >2 lines of prior therapy in the metastatic setting.\n\n          3. For the dose escalation phase of the study or until the MTD for the combination\n             regimen has been determined, patients with moderate hepatic impairment defined as AST,\n             ALT, alkaline phosphatase (ALP) >5 times ULN, which would be grade 3 or higher.\n             However patients with liver metastases with AST/ALT ? 5 x ULN can be included in the\n             study.\n\n          4. For Phase 2 portion, any prior therapy in the metastatic setting.\n\n        Clinical exclusion criteria for Phase 1 and Phase 2 studies:\n\n          1. Documented untreated central nervous system metastases (indicated by clinical\n             symptoms, cerebral edema, steroid requirement, or progressive disease in the prior\n             four weeks),\n\n          2. Participants with a history of myocardial infarction within the last 2 years or with\n             significant cardiac arrhythmias uncontrolled by medication or pacemaker,\n\n          3. Participants with any history of interstitial lung disease,\n\n          4. Prior clinically significant toxicities from anticancer agents or radiotherapy which\n             have not regressed to Grade ? 1 severity (NCI-CTCAE version 4.03) apart from\n             peripheral neuropathy and alopecia,\n\n          5. History of any second malignancy in the last two years; patients with prior history of\n             in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a\n             history of other malignancies are eligible if they have been continuously disease-free\n             for at least two years,\n\n          6. Autoimmune condition requiring medical intervention,\n\n          7. Uncontrolled concomitant illness, active infection requiring i.v. antibiotics,\n\n          8. Participants who are at risk for, or who have a history of arterial thromboembolic\n             events within the past 12 months and/or venous thromboembolic events within the past 6\n             months, or have had any recent active gastrointestinal bleeding,\n\n          9. Prior > G3 hemoptysis, major blood vessel involvement, and/or central cavitations,\n\n         10. Known or suspected drug hypersensitivity to any drug used in the combination,\n\n         11. Difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or\n             conditions that may hamper compliance and/or absorption of the oral drugs,\n\n         12. Any condition (e.g., known or suspected poor compliance, psychological instability,\n             geographical location, etc.) that, in the judgment of the investigator may affect the\n             patient's ability to sign the informed consent and undergo study procedures,\n\n         13. Taking another experimental drugs within 28 days prior to day 1 of the protocol\n             medications in this study,\n\n         14. Pregnant or breast-feeding women,\n\n         15. Both male and female patients of reproductive potential must agree to use a reliable\n             method of birth control, during the study and for 3 months following the last dose of\n             study drug,\n\n         16. Patients currently taking strong CYP3A4 inducers and inhibitors.\n\n         17. Patients currently taking proton pump inhibitors due to their impact on the\n             disposition of palbociclib during the dose escalation phase,\n\n         18. Other anticancer agents and anticoagulants are excluded (except for low doses of\n             anticoagulants used for access lines)\n\n         19. A time period of at least three weeks or five drug half-lives, whichever is shorter\n             must have elapsed from last non-investigational therapy before day 1 of treatment on\n             this study,\n\n         20. Specific exclusion criteria for administration of avelumab, in combination:\n\n               -  IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the\n                  following: a. intranasal, inhaled, topical steroids, or local steroid injection\n                  (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic\n                  doses ? 10 mg/day of prednisone or equivalent; c. Steroids as premedication for\n                  hypersensitivity reactions (e.g., CT scan premedication).\n\n               -  AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when\n                  receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo,\n                  psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive\n                  treatment are eligible.\n\n               -  ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell\n                  transplantation.\n\n               -  INFECTIONS: Active infection requiring systemic therapy.\n\n               -  HIV/AIDS: Known history of testing positive for HIV or known acquired\n                  immunodeficiency syndrome.\n\n               -  HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at\n                  screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening\n                  test positive).\n\n               -  VACCINATION: Vaccination within 4 weeks of the first dose of avelumab and while\n                  on trials is prohibited except for administration of inactivated vaccines.\n\n               -  HYPERSENSITIVITY TO STUDY DRUG: Known prior severe hypersensitivity to\n                  investigational product or any component in its formulations, including known\n                  severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade\n                  ? 3).\n\n               -  CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular\n                  disease: cerebral vascular accident/stroke (< 6 months prior to enrollment),\n                  myocardial infarction (< 6 months prior to enrollment), unstable angina,\n                  congestive heart failure (? New York Heart Association Classification Class II),\n                  or serious cardiac arrhythmia requiring medication.\n\n               -  OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI\n                  CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ? 2, or\n                  other Grade ? 2 not constituting a safety risk based on investigator's judgment\n                  are acceptable.\n\n               -  Other severe acute or chronic medical conditions including colitis, inflammatory\n                  bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions\n                  including recent (within the past year) or active suicidal ideation or behavior;\n                  or laboratory abnormalities that may increase the risk associated with study\n                  participation or study treatment administration or may interfere with the\n                  interpretation of study results and, in the judgment of the investigator, would\n                  make the patient inappropriate for entry into this study.Xx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXLast dose of any prior therapy administered by the following time intervals before the first dose of study drug:Xx_NEWLINE_xXIn the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior treatment line is allowed.Xx_NEWLINE_xXPrior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.Xx_NEWLINE_xXSubjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.Xx_NEWLINE_xXNaive to prior systemic anti-cancer therapy for melanomaXx_NEWLINE_xXHas received no prior systemic therapy for advanced RCC.Xx_NEWLINE_xXNo prior therapy for this diseaseXx_NEWLINE_xXPatients with disease progression prior to enrollmentXx_NEWLINE_xXPatients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.Xx_NEWLINE_xXRelapsed or refractory disease after first or later salvage therapyXx_NEWLINE_xXPrior medication:Xx_NEWLINE_xXPrior CD19 directed therapy other than blinatumomabXx_NEWLINE_xXPrior treatment with blinatumomab or CD-directed CAR T-cell therapyXx_NEWLINE_xXHistological or cytological diagnosis of advanced/metastatic solid tumor. Measurable disease by RECIST 1.1 with at least 1 measurable lesion that has not been previously irradiated. Availability of tumor specimen taken within 1 year prior to study entry, with no intervening systemic anti-cancer therapy. No prior PD-1/PDL-1 therapy allowed. Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. 1st line NSCLC must demonstrate to express PD-L1. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination B: Phase 1b, patients with advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, or SCCHN. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN, NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either inoperable or requires extensive resection. Prior treatment with agents targeting CSF-1/CSF-1R not allowed. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination D: NSCLC, melanoma, SCCHN, bladder cancer. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed.Xx_NEWLINE_xXPrior exposure to immune-mediated therapyXx_NEWLINE_xXThere is no limitation of amount or the type of prior therapy or drugsXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;Xx_NEWLINE_xXPatients/subjects who need daily oxygen therapyXx_NEWLINE_xXChimeric Antigen Receptor (CAR)-T cell therapy.Xx_NEWLINE_xXAt least 1 line of taxane-based chemotherapy for the treatment of prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant settingXx_NEWLINE_xXAt least 1 line of androgen receptor (AR)-targeted therapy (for example {e.gXx_NEWLINE_xXArm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;Xx_NEWLINE_xXAntibody therapyXx_NEWLINE_xXPrior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapyXx_NEWLINE_xXProgression after prior treatment with an EGFR TKI; in addition to this one prior line of therapy, any additional prior lines of therapy are permitted; prior treatment with a third-generation EGFR TKI is allowed for the dose escalation phase, but is not permitted for the expansion cohortXx_NEWLINE_xXAny number of prior therapies are allowedXx_NEWLINE_xXPrior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.Xx_NEWLINE_xXMust have received 4 or more prior lines or therapy in the metastatic settingXx_NEWLINE_xXAt least 4 weeks away from any previous antineoplastic or investigational agent; patients may receive hydroxyurea or glucocorticoids for suppression of leukocytosis, but these must be stopped at least 24 hours (h) prior to initiation of therapyXx_NEWLINE_xXRelapse after SCT is allowed but no active graft-versus-host disease (GVHD) as per treating physician; also must not exceed the number of prior induction regimens listed above; SCT does not count as line of therapyXx_NEWLINE_xXMalignancy requiring systemic therapy; Note: Kaposi sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapyXx_NEWLINE_xXPatients must have relapsed or refractory cancers for which there is no known curative option or other available therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXLaboratory values must be no older than seven (7) days prior to the start of therapy; if a test that is repeated after registration and prior to therapy is outside the limits for eligibility, it must be rechecked within 48 hours prior to the start of therapy; if laboratory values still fail to meet eligibility criteria, the patient may not receive protocol therapyXx_NEWLINE_xX(Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-directed therapy such as lenalidomide is allowedXx_NEWLINE_xX(Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapyXx_NEWLINE_xXReceived at least one line of therapy with sorafenib and/or regorafenib with evidence of disease progression clinically or radiographically as deemed by investigator, or refused therapy with sorafenib and/or regorafenib; no more than two lines of prior therapy are allowedXx_NEWLINE_xXMust have biopsy-proven primary refractory disease or relapsed disease after front-line chemo-immunotherapy (with anti-CD20 monoclonal antibody [mAb]) in combination with anthracycline-based chemotherapy) or at least one of the following\r\n* For subjects with DLBCL: relapsed or refractory disease after ? 2 prior line(s) of therapy; for both de novo and transformed disease, patients must have received at least 1 prior regimen with anti-CD20 mAb and anthracycline\r\n* For subjects with FL or SLL: relapsed or refractory disease after ? 2 prior line(s) of therapy\r\n* For subjects with CLL: must be relapsed or refractory disease and\r\n** with no unfavorable cytogenetics and have failed ? 3 prior line(s) of therapy\r\n** with unfavorable cytogenetics including del17p/mutated p53 or unmutated immunoglobulin heavy chain variable region relapsed or refractory disease after ? 2 prior line(s) of therapy which must have included ibrutinib\r\n* For subjects with MCL: relapsed or refractory disease after at least 1 prior regimen with chemoimmunotherapy\r\n* For subjects with Burkitt’s: relapsed or refractory disease after at least 1 prior line of therapy\r\n* Any patient, with subtypes listed above, having either failed autologous HSCT after at least 1 prior regimen, or those patients ineligible for, but not an appropriate candidate, or not consenting to autologous HSCTXx_NEWLINE_xXPrior treatment\r\n* With any prior anti-CD19/anti-CD19 CAR-T or cellular therapy (prior blinatumomab therapy is allowed)\r\n* Treatment with any prior gene therapy\r\n* Prior allogeneic hematopoietic stem cell transplant\r\n* Received chemotherapy, radiation or surgical resection of malignancy within 2 weeks prior to the start of lymphodepleting chemotherapy (day -10 to -5)Xx_NEWLINE_xXPatients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years; patients with prior in situ carcinomas are eligible provided there was complete removalXx_NEWLINE_xXCurrent treatment with anti-viral therapy for HBV.Xx_NEWLINE_xXPatients must have progressed on at least one prior line of chemotherapy, targeted therapy, palliative radiation and/or biological therapy regimen for their recurrent and/or metastatic HNSCC; however, if patients are likely to be intolerant to standard first-line systemic chemotherapy, the patients are eligible to enroll to this study as the first-line therapyXx_NEWLINE_xXPrior therapy with other HER2 targeted agents is not required, such as T-DM1 or pertuzumabXx_NEWLINE_xXPatients refractory to prior therapy with trastuzumab are eligibleXx_NEWLINE_xXInitiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy\r\n* Only luteinizing hormone-releasing hormone (LHRH) agonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not countXx_NEWLINE_xXPreviously untreated MDS with isolated del5q (for which lenalidomide is approved an approved therapy) and chronic myelomonocytic leukemia (CMML) with rearrangements of the PDGF receptor (for which imatinib is approved therapy), unless they have previously failed these approachesXx_NEWLINE_xXHave received any number of prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use (any formulation and/or duration) in the adjuvant or metastatic disease settings is permitted; vaccine therapy will be counted as systemic therapyXx_NEWLINE_xXExpected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXFor Combination Therapy cohort only: Prior therapy with MEK inhibitors.Xx_NEWLINE_xXEstimated creatinine clearance < 30 mL/min or use of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy, peritoneal dialysis) within 7 days prior to Day 1Xx_NEWLINE_xXReceived any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.Xx_NEWLINE_xXHave relapsed or treatment refractory disease with >= 10% CD138+ malignant plasma cells (IHC) on bone marrow (BM) core biopsy, either:\r\n* Following autologous stem cell transplant (ASCT)\r\n* Or, if a patient has not yet undergone ASCT, the individual must:\r\n** Be transplant ineligible, due to age, comorbidity, patient choice, insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician, and,\r\n** Demonstrate disease that persists after > 4 cycles of induction therapy and that is double refractory (persistence/progression) after therapy with both a proteasome inhibitor and immunomodulatory drug (IMiD) administered either in tandem, or in sequence.Xx_NEWLINE_xXOngoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomyXx_NEWLINE_xXPatients must have had at least 4 prior lines of therapyXx_NEWLINE_xXPatient may be enrolled at any time from last line of therapyXx_NEWLINE_xXPatients must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab; if RAS wild type, patients should have received and progressed or become intolerant to the above as well as cetuximab or panitumumab containing therapies; prior therapy with regorafenib and/or TAS 102 is allowedXx_NEWLINE_xXPrior therapy with ibrutinib or other BTK inhibitorsXx_NEWLINE_xXNo prior genetically modified cell therapy that is still detectable or virotherapy allowedXx_NEWLINE_xXA requirement for systemic immunosuppressive therapy for any reasonXx_NEWLINE_xXSystemic therapy is allowed but SBRT cannot begin until >= 7 days after the last cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated until >= 7 days after SBRT; there will be no limit on prior lines of systemic therapyXx_NEWLINE_xXHas a diagnosis of immunodeficiency and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (subjects may receive steroids before or after SRS to prevent or manage cerebral edema; inhalational steroids are permitted)Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXNo active auto-immune disease and not on therapy for auto-immune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligibleXx_NEWLINE_xXHas had prior systemic anti-cancer therapy for the treatment of bladder cancer. Prior intravesical therapies, whether Bacillus Calmette-Guerin (BCG) (including but not limited to: persistent high-grade disease or recurrence within 6 months of receiving at least two courses of intravesical BCG [at least five of six induction doses and at least two of three maintenance doses]; or T1 high-grade disease at the first evaluation following induction BCG alone [at least five of six induction doses]), chemotherapy or otherwise, will remain eligible.Xx_NEWLINE_xXPARPi naive or prior exposure to PARPi therapy\r\n* Patients in Arm 1 of the Dose Expansion cohort cannot have prior exposure to PARPi therapy\r\n* Patients in Arm 2 of the Dose Expansion cohort cannot be PARPi naiveXx_NEWLINE_xXPatients must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomyXx_NEWLINE_xXInvestigational therapy, defined as any drug that has not been approved for marketing for any indication in cGVHD will be restricted from the studyXx_NEWLINE_xXAny evidence of mucositis/stomatitis or previous history of severe (?Grade 3) mucositis from prior therapy.Xx_NEWLINE_xXNo limit is placed on prior systemic treatment, but subjects must be eligible for immune checkpoint inhibitors therapy, for a Food and Drug Administration (FDA) approved indicationXx_NEWLINE_xXPatients can have any number of prior therapies and any amount of time period from the last therapy as long as they have complete response as seen in PET/CT at the time of enrolmentXx_NEWLINE_xXAny contraindication to therapy with nivolumabXx_NEWLINE_xXHistory of anaphylactic reaction to monoclonal antibody therapyXx_NEWLINE_xXMore than 1 month of prior hormone exposure or hormone exposure within 30 days of enrollment (up to 1 month of prior luteinizing hormone-releasing hormone (LHRH) agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed); prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK700 for prostate cancer are prohibited; prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed; all investigational agents are prohibited within 30 days of enrollmentXx_NEWLINE_xXRefractory to or intolerant of existing therapy(ies) known to provide clinical benefit.Xx_NEWLINE_xXHistory of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapyXx_NEWLINE_xXPrior therapy with rituximab is permitted, even in the setting of rituximab-refractory diseaseXx_NEWLINE_xXHormone replacement therapy or vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollmentXx_NEWLINE_xXMen who have had gonadotrophin releasing hormone (LHRH) agonist or antagonist hormone therapy in the prior six monthsXx_NEWLINE_xXPhase 2a: Patients with various solid tumors or NHL who have received prior therapy.Xx_NEWLINE_xXAny line of prior therapy allowed.Xx_NEWLINE_xXPrior systemic therapy directed at MIBC – prior systemic therapy directed at non-muscle invasive disease (i.e. superficial bladder cancer [T1]) is permitted provided treatments within this study’s exclusion criteria were not used (cisplatin, anti-PD1) / anti-PD-L1 antibodies, etc.)Xx_NEWLINE_xXPatients in the six patient safety run-in cohort may have had a prior EGFR TKI in the metastatic setting (to allow for patients who started initial therapy at an outside hospital), but treatment duration must have been less than three months; after the initial six-patient safety run-in, no prior EGFR TKI therapy in the metastatic setting is allowed; an EGFR TKI given in the adjuvant setting (i.e. with no measurable disease at the time of administration) is allowable provided the subject has been off of EGFR TKI therapy for at least six months at the time of enrollmentXx_NEWLINE_xXSubjects must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options are also eligible. a) Subjects with relapsed and/or refractory lymphoma must have had at least 2 prior lines of systemic therapy and are not candidates for high dose therapy/autologous stem cell transplant.Xx_NEWLINE_xXPrior therapy with a compound of the same mechanism as PF-05082566 (immunomodulation of 4-1BB)Xx_NEWLINE_xXAdult patients stage IV lung cancer or melanoma receiving commercial supply immune checkpoint inhibitor therapy with progression of disease, and for whom an additional 4-6 weeks of current therapy (post-progression therapy) is acceptable as standard therapyXx_NEWLINE_xXSSA therapy is recommended by physician for disease management, and has not yet begunXx_NEWLINE_xXChronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;Xx_NEWLINE_xXPatient may not have received definitive salvage therapy for their post-transplant relapse; use of hydroxyurea is permittedXx_NEWLINE_xXPrior therapy targeted to EGFRvIIIXx_NEWLINE_xXPatients may have received one prior depot injection of LHRH agonist or LHRH antagonist (degarelix) within 30 days prior to study entry. Patients who have received any other prior hormonal therapy or any chemotherapy for prostate cancer will be excluded. (Patients who have discontinued finasteride or dutasteride or testosterone supplement for at least 2 weeks will be allowed to enroll).Xx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH agonists/antagonists (Note: LHRH allowed if begun within 1 month of day 1).Xx_NEWLINE_xXHistological confirmation of advanced biliary tract cancers including cancers originating in gallbladder who have received at least one line of systemic anticancer therapy; \r\n* Note: Patients who have either progressed or intolerant to the prior therapy can be included in this studyXx_NEWLINE_xXPrior use of an immunotherapy such as (but not limited to) a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapyXx_NEWLINE_xXReceived at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapyXx_NEWLINE_xXConcurrent, malignant disease for which patient is on active therapyXx_NEWLINE_xXPatients must have had two or more lines of prior therapy (chemo or hormonal) in the metastatic settingXx_NEWLINE_xXIndication for initiation of therapyXx_NEWLINE_xXCandidate for potentially curative antibiotic therapy for gastric mucosa-associated lymphoid tissue (MALT); (gastric MALT lymphoma patients with stage I/II helicobacter [H.] pylori positive lymphoma must fail therapy with H.-pylori directed therapy before being considered for this study)Xx_NEWLINE_xXT cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollmentXx_NEWLINE_xXHas experienced weight loss > 10% over 2 months prior to first dose of study therapyXx_NEWLINE_xXIn dose expansion, patients must have received prior anti-EGFR therapyXx_NEWLINE_xXNo prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.); patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least 6 weeks prior to enrollment; patients who have received prior luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is > 50 mg/dlXx_NEWLINE_xXHistory of anaphylactic reaction to monoclonal antibody therapyXx_NEWLINE_xXRelapsed/refractory disease, or inadequate response to at least 6 cycles of hypomethylating therapy. Subjects must not have received any MDS or MAL directed therapy for >28 days prior to receiving the study treatment.Xx_NEWLINE_xXSubjects must have progression within 6 months of platin exposure during definitive or palliative therapy.Xx_NEWLINE_xXPrior therapy with anti-CD137 or ISA101.Xx_NEWLINE_xXSubject is actively on anticoagulation therapy.Xx_NEWLINE_xXBiological (anti-neoplastic) therapy: ? 7 days prior to screening.Xx_NEWLINE_xXHave received prior abiraterone and/or enzalutamideXx_NEWLINE_xXLow grade NHL–with < 6 month duration of CR between courses of conventional therapyXx_NEWLINE_xXWaldenstrom’s macroglobulinemia – must have failed 2 courses of therapyXx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXParticipant's current disease state must be one for which there is no known curative therapy.Xx_NEWLINE_xXPhase 1: Received prior therapy with eribulin mesilate within 6 months prior to study drug administration.Xx_NEWLINE_xXPhase 2: Received prior therapies with eribulin mesilate or irinotecan.Xx_NEWLINE_xXNo prior genetically modified cell therapy that is still detectable >= 5% in the peripheral bloodXx_NEWLINE_xXNo prior virotherapy allowedXx_NEWLINE_xXHEALTHY SUBJECT: Not taking regularly prescribed medication such as steroids, hormone therapy or immunosuppressive agentsXx_NEWLINE_xXPrior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugsXx_NEWLINE_xXConcurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation; bisphosphonates or denosumab are allowedXx_NEWLINE_xXSubjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if < 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometryXx_NEWLINE_xXPatients with lung cancers harboring sensitizing EGFR or ALK mutations for whom tyrosine kinase inhibitors (TKIs) are approved for first line therapyXx_NEWLINE_xXReceived at least one prior line of cancer therapy for the treatment of NSCLC; this should include at least one of the following: platinum (carboplatin or cisplatin) doublet chemotherapy (acceptable combinations include: paclitaxel, docetaxel, abraxane, pemetrexed, gemcitabine, vinorelbine, or etoposide), anti-PD1/PDL1 therapy (pembrolizumab, nivolumab, or atezolizumab), or appropriate targeted therapy in patients with activating EGFR (osimertinib, erlotinib, gefitinib, or afatinib), ALK (alectinib, crizotinib, ceritinib, brigatinib, or loralatinib), or ROS-1 (crizotininb or entrectinib) alterations; therapy may be given as monotherapy or in combination with other cancer therapy (e.g. bevacizumab, ipilumimab)Xx_NEWLINE_xXRelapsed or refractory AML, who require salvage therapyXx_NEWLINE_xXConfirmation of the presence or absence of EGFR mutations and ALK gene fusions prior to study enrollment in all subjects. Subjects with known EGFR sensitizing mutational status or ALK fusion must have been treated and progressed on EGFR tyrosine kinase inhibitors (TKIs) or ALK-directed therapy, or with tumors harboring EGFR T790M mutation to have received and progressed on therapy directed at the T790M mutation (e.g. osimertinib). Subjects with known ROS1 translocation must have been treated and progressed on ROS1-directed therapyXx_NEWLINE_xXAny number of prior therapies is allowedXx_NEWLINE_xXPatients with TNBC may be enrolled in dose expansion cohort A with any number of prior lines of therapy (patients will be allowed to enroll in frontline setting)Xx_NEWLINE_xXNo prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 1000 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be availableXx_NEWLINE_xXPatients must not have received prior anticancer therapy with anti-CLTA-4 or anti-PD1 for HCC. Patients receiving any concomitant systemic therapy for HCC are excludedXx_NEWLINE_xXUnlimited prior therapies allowedXx_NEWLINE_xXMore than 5 lines of prior systemic therapy in the preceding three yearsXx_NEWLINE_xX131I therapy < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 mCi of 131I is not considered 131I therapyXx_NEWLINE_xXPathologically confirmed stage IV unresectable relapsed, or unresectable refractory abdominal neuroendocrine tumor from the last biopsy available which may be the initial diagnostic biopsy; relapsed disease is defined as progressive disease following systematic therapy with lanreotide or equivalent and either sunitinib or everolimus or both; refractory disease is defined as disease not responding to or having progressed within 1 month of the last dose of most recent systemic therapy to include lanreotide or an analog and either sunitinib or everolimus; (Note, small cell carcinoma and large cell undifferentiated neuroendocrine tumors will be excluded from this trial)Xx_NEWLINE_xXPatients, who have previously received in vivo anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging, are eligible unless they have had an anaphylactic reaction attributed to anti-GD2 therapyXx_NEWLINE_xXHistory of anaphylaxis attributed to prior anti-GD2 therapyXx_NEWLINE_xXPatients may have received an unlimited number of prior therapiesXx_NEWLINE_xXCurrently on therapy for active chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); prophylactic therapy is allowedXx_NEWLINE_xXPrior anti-tumoral radionuclide therapy with unsealed sources; prior therapy with sealed radioactive sources such as brachytherapy will be allowedXx_NEWLINE_xXPatients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy); however, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrollment; patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy; those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptorXx_NEWLINE_xXPrior systemic therapies for HCC are allowed but not requiredXx_NEWLINE_xXFor the expansion cohort: patients must have had disease progression on alectinib (including patients who received alectinib as first-line treatment); subsequent anti-neoplastic therapy (including other ALK inhibitors or chemotherapy) after progression on alectinib is not permitted; Note: patients in the dose-finding portion of the study may have received other anti-neoplastic therapy after progression on alectinibXx_NEWLINE_xXFor participants in the dose-finding phase, a minimum washout period of at least 5 half-lives between the last dose of tyrosine kinase inhibitors (TKI) therapy and the first dose of study treatment is required; for patients on crizotinib, a 7 day washout is sufficient; a shorter washout period may be considered in the event of disease flare, after discussion with the sponsor; no washout is required if the most recent anti-neoplastic therapy is alectinibXx_NEWLINE_xXPatients must have had at least two, but not more than four prior lines of therapy for their disease, with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this periodXx_NEWLINE_xXPrior treatment with more than 2 lines of therapy (combination treatments are considered 1 line of therapy)Xx_NEWLINE_xXPregnant and nursing: female patients must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapyXx_NEWLINE_xXMust have progressed on at least one line of prior therapy for metastatic disease, or be intolerant to that therapy if they have not progressed, and for HER2+ disease should have received prior trastuzumabXx_NEWLINE_xXHas had prior therapy with indoleamine-pyrrole 2,3-dioxygenase (IDO)-inhibitorsXx_NEWLINE_xXPrior treatment with a taxane is not permitted in the dose-expansion phase. Patients in the dose escalation component may have received a taxane in the peri-operative setting, provided they developed disease recurrence >6 months after the completion of this therapyXx_NEWLINE_xXFailure or intolerance to at least one prior therapy for the current diseaseXx_NEWLINE_xXAny cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)Xx_NEWLINE_xXRequirement for systemic immunosuppressive therapy (e.g. graft-versus-host disease [GVHD] therapy within 12 weeks before the first dose of study drug)Xx_NEWLINE_xXbiopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapyXx_NEWLINE_xXmust have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:Xx_NEWLINE_xXPatients must be free from active graft versus host disease (GVHD) and off immunosuppressive GVHD therapy for 4 weeks prior to enrollmentXx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intent.Xx_NEWLINE_xXHas received prior therapy with an immunomodulatory agent.Xx_NEWLINE_xXRelapse following first line immunotherapy or chemoimmunotherapy; there is no upper limit to the number of therapies received prior to study entry; prior therapies may include high-dose therapy with autologous stem cell rescueXx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists.Xx_NEWLINE_xXPatients may have received prior immunotherapyXx_NEWLINE_xXPatients with known ROS1 mutations who have not received prior targeted therapyXx_NEWLINE_xXAt least one measurable intracranial target lesion for which all of the following criteria are met: a) Previously untreated or progressive after previous local therapy b) Immediate local therapy clinically not indicated or patient is not a suitable candidate to receive immediate local therapy c) Largest diameter of >= 0.5 cm, but =< 3 cm as determined by contrast-enhanced MRIXx_NEWLINE_xXPatients must not have received zoledronic acid (ZA) for any reason prior to the studyXx_NEWLINE_xXUse of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapyXx_NEWLINE_xXPrior allogenic bone marrow transplantation in any prior line of therapy or prior autologous SCT in the last prior line of therapy.Xx_NEWLINE_xXFor estrogen receptor (ER)-positive breast cancer, patients must be considered refractory to endocrine therapy, having received and progressed through at least one prior line of endocrine therapy, or are intolerant of endocrine therapyXx_NEWLINE_xXPatients with R/R PTCL who have received at least one and no more than three previous lines of therapy are eligible to be enrolled in this studyXx_NEWLINE_xXPrior Therapy (for patients with R/R PTCL):\r\n* Exposure to any agent targeting PD-1, PD-L1 or CTLA-4\r\n* Previous therapy with any of the drugs contained in the regimen the patient is assigned to receive; in this case, the patient will be enrolled in the next treatment arm that does not contain such drugs, according to the sequence Arm A -> Arm B -> Arm C ->Arm D\r\n* Exposure to biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation therapy within 2 weeks prior to entering the study or lack of resolution of adverse events (AE) due to previously administered antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0\r\n* Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab; the following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent for at least 5 days prior to the start of the study drugs\r\n* Prior allogeneic SCTXx_NEWLINE_xXPrior treatment with any CD19-directed therapy (e.g. blinatumomab, CD19-directed chimeric antigen receptor T-cell therapy, anti-CD19 antibodies)Xx_NEWLINE_xXHave relapsed or refractory disease after at least 1 prior regimen, including: \r\n* Recurrence of disease after a documented complete response (CR) \r\n* Progression of disease after a partial response (PR) to the prior regimen \r\n* Partial response (PR), stable disease (SD) or progressive disease (PD) at the completion of the prior treatment regimen; if a patient has PR to prior regimen without PD, there must be biopsy-proven residual disease that is measurableXx_NEWLINE_xXParticipants previously treated with BRAF inhibitors (vemurafenib, dabrafenib, encorafenib), MEK inhibitors (selumetinib, trametinib, binimetinib, cobimetinib), and/or anti-PD1/PDL1 monoclonal antibodies for metastatic or unresectable disease; any other prior therapy will be allowed (including ipilimumab, adjuvant anti-PD1 therapy, high-dose IL-2)Xx_NEWLINE_xXAllowed prior therapy:\r\n* Newly diagnosed DLBCL and low grade B cell lymphoma: No prior therapy is allowed except steroids equivalent to maximum of prednisone 20 mg once daily for maximum of seven days prior to registration\r\n* Relapsed/refractory low grade B cell lymphoma (only allowed in phase I): A minimum and maximum of one line of prior non-anthracycline containing therapy is allowed; prior localized radiation therapy is not considered a line\r\n* For patients who have had prior chemotherapy or immunotherapy, at least 2 weeks must have elapsed between last dose and initial dose of RCHOP-selinexor; for patients treated with radio-immunotherapy, at least 12 weeksXx_NEWLINE_xXPatients with DLBCL who have received chemotherapy or immunotherapy (except one week of steroids as described above) at any time point in the past for therapy of the DLBCL; patients with low grade B cell lymphomas who have received more than one prior line of chemotherapy or any anthracycline-containing therapy in the past for their low grade B cell lymphoma; localized radiation therapy does not count as a line of therapyXx_NEWLINE_xXPrior therapy with single-agent gemcitabine.Xx_NEWLINE_xXPrior treatment with any therapy that is targeted to B cell maturation antigen (BCMA) or any other CD3-redirecting drugXx_NEWLINE_xXPatients may have received any prior therapy deemed necessary for them to be eligible to HDT/ASCT except for patients whom have progressed while on Zydelig. Patients who have responded to Zydelig previously are eligible for enrollment on the protocolXx_NEWLINE_xXPatients must not have had leukemia therapy for 14 days prior to starting palbociclib. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of studyXx_NEWLINE_xXPatients must have a diagnosis of CLL/SLL and EITHER have high-risk cytogenetic features or molecular features, defined as: del(17p), del(11q), mutated TP53, complex metaphase karyotype (defined as >=3 unrelated chromosomal abnormalities, present in at least 2 metaphases on conventional, stimulated cytogenetic analysis) OR have developed a BTK or PLCG2 mutation, detected by sequencing and have not developed disease progression during ibrutinib therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria OR B2M has not normalized after at least 1 year (yr) on ibrutinib therapy\r\n* Note: some patients treated with ibrutinib may no longer have detectable fluorescence in situ hybridization (FISH), karyotypic or molecular abnormalities after 12 months of therapy. These patients will be eligible if they fulfill the above criteria on a bone marrow biopsy or peripheral blood specimen taken within the 3 months prior to starting ibrutinib or at some time during their ibrutinib therapy and analyzed at a Clinical Laboratory Improvement Act (CLIA)-accredited laboratoryXx_NEWLINE_xXFOR ALL PHASES (Ib AND II): Current therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer; subjects must have discontinued therapies for at least 28 days prior to first baseline biopsyXx_NEWLINE_xXFOR ALL PHASES (Ib AND II): Chronic oxygen therapyXx_NEWLINE_xXMust have received at least one but not more than two prior anti-angiogenic therapy regimens (including, but not limited to, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) in the advanced or metastatic RCC setting; prior cytokine therapy (eg, IL-2, IFN-alpha), vaccine therapy, or treatment with cytotoxics is also allowedXx_NEWLINE_xXPatients in partial or complete remission following cell therapy will also be eligibleXx_NEWLINE_xXMale who has a pregnant partner, and is not willing to use a condom during sexual activity while receiving protocol-specified therapy and for 3 months after the last dose of protocol-specified therapy.Xx_NEWLINE_xXAvailability of and patient acceptance of curative therapyXx_NEWLINE_xXNo prior therapy, or limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy (e.g., to the mediastinum, head and neck, orbit, etc.) and one dose of intrathecal chemotherapyXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXPatients with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study.Xx_NEWLINE_xXPatients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study.Xx_NEWLINE_xXPrior therapy with oxaliplatinXx_NEWLINE_xXPatients may be treated on this trial without having received prior medical therapy directed at their GIST, patients who have had prior GIST-directed surgery may enroll provided they have measurable diseaseXx_NEWLINE_xXPatients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, imatinib or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the plexiform neurofibromas (PN) and patients who received previous GIST-directed therapy must either demonstrate progression as defined by RECIST, or be unable to tolerate their previous therapy; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 before entering this studyXx_NEWLINE_xXPrior systemic therapy for advanced RCC; however, treatment with immunotherapy (i.e., high-dose bolus IL-2, ipilimumab + nivolumab, etc.) is allowedXx_NEWLINE_xX(For cohort A): No limit on prior therapies for metastatic disease. (Relapse of disease within 6 months of adjuvant or neoadjuvant chemotherapy is considered 1 line of therapy for metastatic disease). (For cohort B): received at least one dose of an anthracycline-based NACT. Patients are eligible if therapy was discontinued due to disease progression or therapy intolerance. Patients with disease progression on anthracycline-based therapy should be evaluated by the surgical team. If the patient is deemed inoperable at the time of evaluation, the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable. If the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location, the patient will be considered ineligible for study and will be recommended to go to surgeryXx_NEWLINE_xXDocumentation of CD19 expression on any prior or current tumor biopsy; patients who have received previous CD19-targeted therapy must have CD19-positive disease confirmed on a biopsy since completing the prior CD19-targeted therapyXx_NEWLINE_xXCRITERIA FOR SCREENING: For patients in stage 1 only, prior treatment with any CD19 CAR T-cell therapy is excludedXx_NEWLINE_xXInclusion Criteria\n\n        Part A Dose Escalation: Patients must have histological or cytological confirmation of a\n        solid tumour known to harbour KRAS mutations (e.g., NSCLC, mCRC, pancreatic or\n        cholangiocarcinoma), and have progressed despite standard therapy(ies), or are intolerant\n        to standard therapy(ies), or have a tumour for which no standard therapy(ies) exists.\n\n        Part B Expansion: Patients in Part B must have measurable disease as measured by Response\n        Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1\n\n        Group 1. Patients must have histological or cytological confirmation of locally advanced or\n        metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is\n        available.\n\n        Group 2. Patients must have histological or cytological confirmation of locally advanced or\n        metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is\n        available. At study entry patients must be clinically suitable for mandatory baseline and\n        on-treatment tumour biopsies.\n\n          1. Signed written informed consent\n\n          2. ? 18 years old\n\n          3. All patients must have KRAS mutations identified in tumour tissue samples from a prior\n             test conducted by a clinical laboratory that has received international or country\n             specific certification. Mutations may include but are not limited to:\n\n             NSCLC KRAS mutations in codons G12/13, Q61, and A59\n\n             mCRC KRAS mutations in codons G12/13 (Exon 2), Q61, A59 (Exon 3), K117, and A146 (Exon\n             4)\n\n             Patient must agree to the collection of archival tumour tissue sample for biomarker\n             analysis. If an archived tumour sample is not available a fresh tumour biopsy can be\n             used.\n\n          4. Adequate organ system function as indicated by:\n\n               1. Absolute neutrophil count (ANC) ? 1.5 x 10^9/L\n\n               2. Platelets ? 100 x 10^9/L\n\n               3. Haemoglobin ? 9g/dL\n\n               4. Activated partial thromboplastin time (aPTT) ? 1.5 times the upper limit of\n                  normal (ULN)\n\n               5. Total bilirubin ? 1.5 mg/dL\n\n               6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 3.0 times\n                  the ULN if no liver involvement or ? 5 times the ULN with liver involvement.\n\n               7. Creatinine ? 1.5 times the ULN or creatinine clearance ? 60 mL/min as calculated\n                  by the Cockcroft-Gault method, or 24 hour measured urine creatinine clearance ?\n                  60 mL/min.\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\n          6. Life expectancy ? 12 weeks\n\n          7. Male patients with female partners of child-bearing potential must be willing to use\n             one highly effective form of contraception and must use a condom during their\n             participation in this study and for 7 months following the last dose of the study\n             drug. Male patients must refrain from donating sperm during their participation in the\n             study and at least for 7 months after the last treatment.\n\n          8. Female patients must use a highly effective contraceptive measure from screening until\n             18 weeks after the last dose of drug. All methods of contraception (with the exception\n             of total abstinence) should be used in combination with the use of a condom by a male\n             sexual partner for intercourse. Female patients should not be breast-feeding and must\n             have a negative pregnancy test prior to start of dosing if of childbearing potential\n             or must have evidence of non-childbearing potential by fulfilling one of the following\n             criteria at screening:\n\n        Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12\n        months following cessation of all exogenous hormonal treatment.\n\n        Documentation of irreversible surgical sterilisation by hysterectomy, bilateral\n        oophorectomy, or bilateral salpingectomy, but not tubal ligation.\n\n        Exclusion Criteria:\n\n          1. Patients who have received chemotherapy, radiotherapy, hormonal therapy, immunotherapy\n             or investigational drugs within 21 days or 5 half lives (whichever is shorter) from\n             enrolment.\n\n          2. With the exception of alopecia, any unresolved toxicities from prior therapy greater\n             than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events\n             (CTCAE) Grade 1 at the time of enrolment.\n\n          3. Unresolved immunotherapy-related hepatotoxicity from previous therapy.\n\n          4. Major surgery (excluding placement of vascular access) ? 21 days from beginning of the\n             enrolment or minor surgical procedures ? 7 days. No waiting is required following\n             implantable port and catheter placement.\n\n          5. Patients receiving full-dose anti-coagulation therapies.\n\n          6. Has active or prior documented autoimmune disease within the past 2 years with the\n             exception of vitiligo, Grave's disease, and/or psoriasis not requiring systemic\n             treatment.\n\n          7. Has a history of atypical Haemolytic Uremic Syndrome.\n\n          8. Patients with leptomeningeal metastases.\n\n          9. Previously untreated brain metastases. Patients who have received radiation or surgery\n             for brain metastases are eligible if therapy was completed at least 3 weeks prior to\n             enrolment and there is no evidence of central nervous system disease progression or\n             mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.\n\n         10. Evidence of severe or uncontrolled systemic diseases, including uncontrolled\n             hypertension, active bleeding diatheses, or active infection including hepatitis B,\n             hepatitis C and human immunodeficiency virus (HIV).\n\n         11. Any of the following cardiac criteria:\n\n               1. Congestive heart failure (CHF) per New York Heart Association (NYHA)\n                  classification > Class II.\n\n               2. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n\n               3. Unstable angina or new-onset angina.\n\n               4. QT interval (QTcF) >470 ms on screening electrocardiogram (ECG) by Fridericia's\n                  formula.\n\n         12. History of hypersensitivity to active or inactive excipients of AZD4785 or drugs with\n             a similar chemical structure or class to AZD4785.\n\n         13. Judgment by the Investigator that the patient should not participate in the study if\n             the patient is unlikely to comply with study procedures, restrictions and\n             requirements.\n\n         14. Psychological, familial, sociological, or geographical conditions that do not permit\n             compliance with the protocol.Xx_NEWLINE_xXTreatment with the following within the 4 weeks prior to the screening visit: radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy) to the target area, local hyperthermia, levulinic acid, 5-fluorouracil, high potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, imiquimod;Xx_NEWLINE_xXAt least one and up to two previous lines of systemic cytotoxic therapy for advanced NSCLC, of which one must have been a platinum-based doublet therapy. Up to four total previous lines of systemic therapy (including immunotherapy and molecularly targeted therapy)Xx_NEWLINE_xXRadiographic or clinical disease recurrence or progression during or after the last line of systemic therapyXx_NEWLINE_xXPatients can or cannot have receive prior therapy with hypomethylating agent but will be allocated to specific patient cohorts based on their prior exposure. Patients that had received prior hypomethylating agent therapy should have at least received 6 cycles of therapy and not achieved any response or had progressed after any given number of cyclesXx_NEWLINE_xXPatients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:\r\n* Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,\r\n* Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapseXx_NEWLINE_xXPatients with diagnosis of solid tumor with lung metastases and patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXAdditional prior systemic treatments not allowedXx_NEWLINE_xXSubjects must be receiving endocrine therapy consisting of 1) letrozole +/- palbociclib; or 2) exemestane +/ everolimus; or 3) fulvestrant +/- palbociclib; or 4) anastrozole; or 5) tamoxifen; pre-menopausal women must also be receiving a gonadotrophin releasing hormone (LHRH) agonist with endocrine therapy options 1 through 4; option 5 can be used without LHRH agonists for pre-menopausal womenXx_NEWLINE_xXPatients must have completed at least 2 months of their current endocrine therapy prior to registrationXx_NEWLINE_xXRelapsed disease after at least 2 lines of therapyXx_NEWLINE_xXOne prior line of therapy is allowed.Xx_NEWLINE_xXNo prior therapy with AR antagonists including but not limited to bicalutamide, enzalutamide, abiraterone and orteronel.Xx_NEWLINE_xXNo prior therapy with any CDK 4/6 inhibitors.Xx_NEWLINE_xXThe following ongoing treatments are permitted:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Hormone therapy for primary prevention of breast cancerXx_NEWLINE_xXEvidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); orXx_NEWLINE_xXIn the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy;Xx_NEWLINE_xXPreviously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ? 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;Xx_NEWLINE_xXCetuximab-naive patients may not have received cetuximab therapy in the recurrent/metastatic setting (treatment in curative setting permitted)Xx_NEWLINE_xXMust have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.Xx_NEWLINE_xXPrevious intravesical therapy within 6 months of study entry.Xx_NEWLINE_xXAnticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-? reductase inhibitors) prior to surgeryXx_NEWLINE_xXPatients must have histologically confirmed MM by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologist, with MM cells expressing BCMA, previously treated with 2+ prior lines of therapy including an immunomodulatory imide drug (IMiD) and a PI, either with refractory, persistent, or progressive diseaseXx_NEWLINE_xXPatients with a prior allogeneic transplant ARE eligible UNLESS previously or currently experienced graft versus host disease (GvHD) that required systemic steroids or other systemic lymphotoxic therapyXx_NEWLINE_xXSubjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); prior adjuvant therapy will not count provided it was completed more than 6 months previouslyXx_NEWLINE_xXPatients who require anticoagulation, systemic steroids, statin therapy or beta-blocker therapy. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Hypertension controlled by other agents does not disqualify, provided other criteria are met.Xx_NEWLINE_xXPatients must be previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease; previously untreated patients are eligible only if EGFR Exon 20 mutation is confirmed using an FDA approved device: cobas EGFR mutation test v2 or therascreen EGFR RGQ polymerase chain reaction (PCR) Kit prior to study enrollmentXx_NEWLINE_xXNo known Food and Drug Administration (FDA) -approved therapy available that is expected to prolong survival by greater than 3 monthsXx_NEWLINE_xXInability to tolerate first-line treatment with sorafenib (e.g., unacceptable toxicity), tumor progression on sorafenib, patient preference to stop sorafenib and for alternative therapy/trial, or patient preference to forgo sorafenib for alternative therapy/trialXx_NEWLINE_xXPatients must not have a history of the following immunosuppressive conditions: bone marrow transplantation and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with a history of chronic lymphoid or leukemic malignancies which are not under active therapy (no active therapy within the last 3 months) will be eligible; patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three monthsXx_NEWLINE_xXUse of prohibited medications that cannot be changed to an alternative therapyXx_NEWLINE_xX>= 2 months since last therapy for HSILXx_NEWLINE_xXPatient is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXPatients who have been treated on other protocols of genetically-modified T cells at the NIH only are potentially eligible under these conditions:\r\n* At least 6 months have elapsed since the last genetically-modified T-cell therapy that the patient received and there is no evidence of replication-competent retroviruses (evidence must be provided from prior NIH gene-therapy protocol principal investigator) and persisting genetically-modified T cells are not detectable in the patient’s blood (evidence must be provided by prior NIH gene-therapy protocol principal investigator)Xx_NEWLINE_xXSubjects with prior hypomethylating agent therapy exposure may be eligible based on discussion with the principal investigator (PI)Xx_NEWLINE_xXPrior androgen deprivation therapy (ADT) in the past 6 months; prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (> 150 ng/dl); the total duration of prior ADT should not exceed 24 monthsXx_NEWLINE_xXSTEP II (THERAPY)Xx_NEWLINE_xXPrior or ongoing systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)\r\n* CYP-17 inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. enzalutamide, ARN-509)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Note: may be enrolled if has recently initiated hormone therapy (< 90 days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollmentXx_NEWLINE_xXNon-resectable, recurrent, or metastatic well- or moderately-differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NETs) with disease progression within the last 12 months; (patients who have received prior local therapy, including but not limited to embolization, chemoembolization, radiofrequency ablation, radiation therapy, are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of > 20% in the size; prior local therapy must be completed at least 4 weeks prior to the baseline scan)Xx_NEWLINE_xXDiagnosis of relapsed/refractory advanced malignancies; specifically:\r\n* Patients relapsed refractory acute myeloid leukemia that have failed at least one line of prior therapy, \r\n* Patients with myelodysplastic syndrome that have failed hypomethylating agents, \r\n* Patients with myelofibrosis that have failed or are ineligible to receive ruxolitinib\r\n* Patients that have myelofibrosis on maximal tolerated doses of ruxolitinib, who are unable to discontinue ruxolitinib, are eligible if;\r\n** They have been on stable dose for 1 month and continue to have residual symptoms, splenomegaly or inadequately controlled blood countsXx_NEWLINE_xXPatients should be previously untreated or have only been treated with single agent ibrutinib therapy for a period of < 3 months and were deemed ibrutinib intolerantXx_NEWLINE_xXRelapsed or refractory to any prior rituximab-containing regimen.Xx_NEWLINE_xXReceived prior obinutuzumab.Xx_NEWLINE_xXPatients who received prior local therapy (e.g., transarterial chemoembolization [TACE]) are eligibleXx_NEWLINE_xXPatient with aggressive NHL must have received prior therapy – at a minimum:\r\n* Anti-CD20 monoclonal antibody unless tumor is CD20 negative and\r\n* An anthracycline containing regimen\r\n* Transformed FL must have had therapy for FL and be refractory to chemotherapy for DLBCLXx_NEWLINE_xXThere is no limit on number of prior therapiesXx_NEWLINE_xXSubjects who received combined androgen blockade as their first-line hormonal therapy with an antiandrogen must have shown PSA progression after discontinuing the antiandrogen for >= 6 weeks prior to study treatment; no washout is needed after abiraterone or enzalutamide are discontinued; first generation antiandrogens such as bicalutamide must be withdrawn if given as first-line therapyXx_NEWLINE_xXRefractory to or intolerant of lenalidomide maintenance following first autologous stem cell transplantation; refractory is defined as disease relapse/progression on therapy or within 60 days of completing therapy; intolerance is defined as the inability to administer >= 10 mg per day due to toxicityXx_NEWLINE_xXReceived systemic multiple myeloma therapy post-relapse/progression; patients that received 1-2 cycles of salvage therapy, local radiation, and/or corticosteroids post-relapse/progression are eligible if there was no further disease progression following administrationXx_NEWLINE_xXHas received prior therapy with pembrolizumabXx_NEWLINE_xXPatients who have previously received a-PD-1 and/or anti-CTLA-4 will be eligible, unless they have ongoing > grade 2 adverse event (AE) side effects of such therapy. Ongoing physiologic replacement doses for adrenal and thyroid insufficiency are allowed on protocolXx_NEWLINE_xXHormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens)Xx_NEWLINE_xXAny prohibited prior or concomitant therapyXx_NEWLINE_xXPatients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)Xx_NEWLINE_xXPatients must have failed at least one regimen of chemo or radiation therapy; NOTE: There is no limit to the number or types of prior therapyXx_NEWLINE_xXRefractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded.Xx_NEWLINE_xXProgressive disease (PD) as best response to first-line therapyXx_NEWLINE_xXStable disease (SD) as best response after at least 4 cycles of first-line therapyXx_NEWLINE_xXPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ? 12 months from initiation of therapyXx_NEWLINE_xXRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ? 12 months of initiating first-line therapyXx_NEWLINE_xXSubjects must have received adequate first-line therapy including at a minimum:Xx_NEWLINE_xXReceived more than one line of therapy for DLBCLXx_NEWLINE_xXHistory of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7Xx_NEWLINE_xXPrior therapy for DLBCL, with the exception of nodal biopsyXx_NEWLINE_xXKey Inclusion Criteria:\n\n        For Phase 1\n\n          -  Patients with a locally advanced or metastatic solid tumor who:\n\n               -  have progressed on or are intolerant to standard therapy, or\n\n               -  no standard therapy exists, or in the opinion of the Investigator, are not\n                  candidates for or would be unlikely to tolerate or derive significant clinical\n                  benefit from standard therapy, or\n\n               -  decline standard therapy\n\n          -  Prior MKIs with anti-RET activity are allowed. However, prior treatment with a\n             selective RET inhibitor(s) is prohibited.\n\n          -  A RET gene alteration is not required initially. Once adequate PK exposure is\n             achieved, evidence of RET gene alteration in tumor and/or blood is required as\n             identified through molecular assays, as performed for clinical evaluation.\n\n          -  Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as\n             appropriate to tumor type.\n\n          -  Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.\n\n          -  Adequate hematologic, hepatic and renal function.\n\n          -  Life expectancy of at least 3 months.\n\n        For Phase 2\n\n        As for phase 1 with the following modifications:\n\n          -  For Cohorts 1 and 3 Subjects must have received prior standard therapy appropriate for\n             their tumor type and stage of disease, or in the opinion of the Investigator, would be\n             unlikely to tolerate or derive clinical benefit from appropriate standard of care\n             therapy.\n\n          -  Cohorts 1-4: enrollment will be restricted to patients with evidence of a RET gene\n             alteration in tumor. However, a positive germline DNA test for a RET gene mutation is\n             acceptable in the absence of tumor tissue testing for patients with MTC.\n\n          -  Cohorts 1-4: at least one measurable lesion as defined by RECIST 1.1 or RANO, as\n             appropriate to tumor type and not previously irradiated.\n\n          -  Cohort 4: radiographic PD within the previous 14 months.\n\n        Note: Patients otherwise eligible for cohort 4 who do not demonstrate radiographic PD\n        within the previous 14 months may be enrolled to cohort 5 if a compelling rationale is\n        provided by the investigator and approved by the Sponsor.\n\n        Cohort 5: (up to 50 patients):\n\n          -  Cohorts 1-4 without measurable disease;\n\n          -  MTC not meeting the requirements for Cohorts 3 or 4;\n\n          -  Other RET-altered solid tumor or other RET alteration/activation (any solid tumor,\n             excluding synonymous, frameshift, or nonsense mutations);\n\n          -  cfDNA positive for a RET gene alteration not known to be present in a tumor sample.\n\n        Key Exclusion Criteria (Phase 1 and Phase 2):\n\n          -  Phase 2 Cohorts 1-4: an additional known oncogenic driver.\n\n          -  Prior treatment with a selective RET inhibitor\n\n          -  Investigational agent or anticancer therapy within 5 half-lives or 2 weeks (whichever\n             is shorter) prior to planned start of LOXO-292. In addition, no concurrent\n             investigational anti-cancer therapy is permitted. LOXO-292 may be started within less\n             than 5 half-lives or 2 weeks of prior therapy if considered by the Investigator to be\n             safe and within the best interest of the patient, with prior Sponsor approval.\n\n          -  Major surgery (excluding placement of vascular access) within 4 weeks prior to planned\n             start of LOXO-292.\n\n          -  Radiotherapy with a limited field of radiation for palliation within 1 week of planned\n             start of LOXO-292, with the exception of patients receiving radiation to more than 30%\n             of the bone marrow or with a wide field of radiation, which must be completed at least\n             4 weeks prior to the first dose of study treatment.\n\n          -  Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of\n             starting study treatment with the exception of alopecia and Grade 2, prior\n             platinum-therapy related neuropathy.\n\n          -  Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated\n             spinal cord compression. Patients are eligible if neurologically stable and without\n             increase in steroid dose for 14 days prior to the first dose of LOXO-292 and no CNS\n             surgery or radiation has been performed for 28 days, 14 days if stereotactic\n             radiosurgery.\n\n          -  Clinically significant active cardiovascular disease or history of myocardial\n             infarction within 6 months prior to planned start of LOXO-292 or prolongation of the\n             QT interval corrected (QTcF) > 470 msec on all 3 ECGs during Screening.\n\n          -  Required treatment with certain strong CYP3A4 inhibitors or inducers.Xx_NEWLINE_xXPrior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.Xx_NEWLINE_xXPatients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil are not eligibleXx_NEWLINE_xXPatients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy; this includes use for prophylactic reasons, including treatment of osteoporosis or cancer prevention with tamoxifen, raloxifene, or aromatase inhibitors (AI)Xx_NEWLINE_xXUse of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or betterXx_NEWLINE_xXInclusion Criteria Part 1 (CMP-001 + pembrolizumab):\n\n          1. Histopathologically confirmed diagnosis of metastatic, or unresectable, malignant\n             melanoma. Ocular melanoma subjects are not eligible.\n\n          2. Male and female subjects age 18 or older\n\n        3a. Subjects who are currently receiving treatment with any anti-PD-1/PD-L1 antibody,\n        either alone or in combination and who are progressing. Subjects must have received at\n        least 4 doses of anti-PD-1/PD-L1 before enrolling into the CMP-001-001 study.\n\n        OR\n\n        3b. Subjects who have previously received any anti-PD-1/PD-L1 therapy, alone or in\n        combination and progressed, regardless of the best overall response to prior\n        anti-PD-1/PD-L1 based therapy. Subjects must have received at least 4 doses of\n        anti-PD-1/PD-L1.\n\n        4. Subjects must have at least one tumor lesion with a longest diameter of ?0.5 cm that can\n        be easily palpated or detected by ultrasound to facilitate intratumoral injection of\n        CMP-001 (i.e., tumor in skin, muscle, subcutaneous tissue or accessible lymph node).\n\n        5. Subjects must have measurable disease by RECIST Version 1.1. 6. Capable of understanding\n        and complying with protocol requirements. 7. A life expectancy of greater than 24 weeks at\n        Screening. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9.\n        Most recent laboratory values (within 3 weeks prior to Week 1 Day 1 (W1D1)) before study\n        entry meet the following standards:\n\n          -  Bone marrow function: neutrophil count ?1,000/mm3, platelet count ? 75,000/mm3 and\n             hemoglobin concentration > 8.0 g/dL.\n\n          -  Liver function: total bilirubin ? 1.5 times the upper limit of normal (ULN) ranges of\n             each institution, with the following exception: patients with Gilbert Disease serum\n             bilirubin > 3X ULN AND aspartate aminotransferase (AST) and alanine aminotransferase\n             (ALT) ? 3 times the ULN range of each institution.\n\n          -  LDH ?2.0 times the ULN range of each institution\n\n          -  Renal function: serum creatinine ? 1.5 times the ULN range of each institution. 10.\n             The subject must sign a written informed consent form prior to the initiation of any\n             study procedures. Adult subjects unable to provide written informed consent on their\n             own behalf will not be eligible for the study.\n\n        Part 1 Dose Expansion Phase subjects must also meet the following inclusion criterion:\n\n        11. At least one additional lesion that is measurable and is not intended for injection (to\n        allow an assessment of systemic antitumor effect). These lesions not intended for injection\n        may be located in any metastatic site.\n\n        Exclusion Criteria Part 1 (CMP-001 + pembrolizumab):\n\n          1. Pregnant or breastfeeding.\n\n          2. Received investigational therapy (e.g. small molecule or biologic) within 30 days\n             prior to the start of CMP-001 dosing on W1D1. However, if an investigational therapy\n             has a short half-life, a reduced wash out period may be acceptable with Sponsor\n             approval.\n\n          3. Received treatment with anti-CTLA-4 antibody within 30 days prior to the start of\n             CMP-001 dosing on W1D1.\n\n          4. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or\n             hepatitis C virus (HCV). If there is no known or documented history of HIV, Hepatitis\n             B or Hepatitis C, the site is not required to do additional testing for these values\n             at Screening.\n\n          5. Developed autoimmune disorders of Grade 4 while on prior immunotherapy. Subjects who\n             developed autoimmune disorders of Grade ? 3 may enroll if the disorder has resolved to\n             Grade ? 1 and the subject has been off systemic steroids at doses > 10mg/day for at\n             least two weeks.\n\n          6. Require systemic pharmacologic doses of corticosteroids greater than the equivalent of\n             10 mg/day; replacement doses, topical, ophthalmologic and inhalational steroids are\n             permitted. Subjects who have a history of adrenal insufficiency and are receiving\n             greater than 10 mg/day coticosteroid may be eligible but only after Sponsor\n             consultation. Subjects who are currently receiving steroids at a dose of ?10 mg/day do\n             not need to discontinue steroids prior to enrollment.\n\n          7. Active (i.e., symptomatic or growing) central nervous system (CNS) metastases. However\n             subjects with active CNS metastases are eligible for the trial if\n\n               -  the metastases have been treated by surgery and/or radiotherapy,\n\n               -  the subject is off corticosteroids > 10 mg/day and is neurologically stable for\n                  at least 2 weeks prior to Screening.\n\n               -  brain MRI completed within 3 months of screening (required for all subjects).\n\n          8. Any concurrent uncontrolled illness, including mental illness or substance abuse,\n             which in the opinion of the Investigator, would make the subject unable to cooperate\n             or participate in the trial.\n\n          9. Severe uncontrolled cardiac disease within 6 months of Screening, including but not\n             limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or\n             cerebrovascular accident (CVA).\n\n         10. Requires prohibited treatment (i.e., non-protocol specified anticancer\n             pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant\n             tumor).\n\n         11. Women of child-bearing potential who are unable or unwilling to use an acceptable\n             method of contraception.\n\n        Inclusion Criteria - Part 2: CMP-001 Monotherapy\n\n        Subjects must meet all of the following inclusion criteria to be eligible:\n\n          1. Histopathologically confirmed diagnosis of metastatic, or unresectable, malignant\n             melanoma. Ocular melanoma subjects are not eligible.\n\n          2. Male or female subjects age 18 or older.\n\n          3. Previously received any anti-PD-1/PD-L1 therapy, alone or in combination. Subjects\n             must have received a minimum of 4 doses of anti-PD-1/PD-L1 therapy prior to study\n             entry.\n\n          4. Subjects must have at least one tumor lesion with a longest diameter of ?0.5 cm that\n             can be easily palpated or detected by ultrasound to facilitate intratumoral injection\n             of CMP-001 (i.e., tumor in skin, muscle, subcutaneous tissue or accessible lymph\n             node).\n\n          5. Subjects must have measurable disease by RECIST Version 1.1.\n\n          6. Capable of understanding and complying with protocol requirements.\n\n          7. A life expectancy of greater than 24 weeks at Screening.\n\n          8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to\n\n          9. Most recent laboratory values (within 3 weeks prior to first CMP-001 injection at Week\n             1 Day 1 (W1D1)) before study entry meet the following standards:\n\n               -  Bone marrow function: neutrophil count ?1,000/mm3, platelet count ?75,000/mm3 and\n                  hemoglobin concentration > 8.0 g/dL.\n\n               -  Liver function: total bilirubin ? 1.5 times the upper limit of normal (ULN)\n                  ranges of each institution, aspartate aminotransferase and alanine\n                  aminotransferase ? 3 times the ULN range of each institution.\n\n               -  LDH ?2.0 times the ULN range of each institution.\n\n               -  Renal function: serum creatinine ?1.5 times the ULN range of each institution.\n\n         10. The subject must sign a written informed consent form prior to the initiation of any\n             study procedures. Adult subjects unable to provide written informed consent on their\n             own behalf will not be eligible for the study.\n\n        Exclusion Criteria Part 2: (CMP-001 Monotherapy)\n\n          1. Pregnant or breastfeeding.\n\n          2. Received investigational therapy (e.g. small molecule or biologic) within 30 days\n             prior to the start of CMP-001 dosing on W1D1. Received prior therapy with an\n             anti-PD1/PD-L1 or anti-CTLA-4 within 45 days prior to the start of CMP-001 dosing on\n             W1D1. However, if an investigational therapy has a short half-life, a reduced wash out\n             period may be acceptable with Sponsor approval.\n\n          3. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or\n             hepatitis C virus (HCV). If there is no known or documented history of HIV, Hepatitis\n             B or Hepatitis C, the site is not required to do additional testing for these values\n             at Screening.\n\n          4. Subjects who developed autoimmune disorders of Grade ? 3 may enroll if the disorder\n             has resolved to Grade ?1 and the subject has been off systemic steroids at doses >10\n             mg/day for at least 2 weeks.\n\n          5. Require systemic pharmacologic doses of corticosteroids greater than the equivalent of\n             10 mg/d; replacement doses, topical, ophthalmologic and inhalational steroids are\n             permitted. Subjects who have a history of adrenal insufficiency and are receiving\n             greater than 10 mg/day of corticosteroid may be eligible but only after Sponsor\n             consultation. Subjects who are currently receiving steroids at a dose of ? 10 mg/day\n             do not need to discontinue steroids prior to enrollment.\n\n          6. Active (i.e., symptomatic or growing) central nervous system (CNS) metastases.\n             However, subjects with active CNS metastases are eligible for the trial if:\n\n               -  the metastases have been treated by surgery and/or radiotherapy.\n\n               -  the subject is off corticosteroids >10 mg/day and is neurologically stable for at\n                  least 2 weeks prior to Screening.\n\n               -  brain MRI completed within 3 months of screening (required for all subjects).\n\n          7. Any concurrent uncontrolled illness, including mental illness or substance abuse,\n             which in the opinion of the Investigator, would make the subject unable to cooperate\n             or participate in the trial.\n\n          8. Severe uncontrolled cardiac disease within 6 months of Screening, including but not\n             limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or\n             cerebrovascular accident (CVA).\n\n          9. Requires prohibited treatment (i.e., non-protocol specified anticancer\n             pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant\n             tumor).\n\n         10. Women of childbearing potential who are unable or unwilling to use an acceptable\n             method of contraception.Xx_NEWLINE_xXDuring cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor typeXx_NEWLINE_xXMCL cohort: MCL (diagnosis must be confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization [FISH], or PCR) with relapsed or refractory disease after at least 1 prior line of MCL therapyXx_NEWLINE_xXParticipants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy.Xx_NEWLINE_xXPrior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR017 treatment in this protocol for subjects receiving retreatmentXx_NEWLINE_xXDisease progression by IWG Working Group or ICML criteria since last therapyXx_NEWLINE_xXReceipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, E)Xx_NEWLINE_xXReceipt of >/=2 prior lines of therapy and progressed on treatment with an anti-CD38 monoclonal antibody and are refractory to both a PI and IMiD (Cohort D3)Xx_NEWLINE_xXReceipt of >/=4 lines of prior therapy and are refractory to the last line of treatment (Cohort F)Xx_NEWLINE_xXPrior treatment with anti-CD38 therapy including daratumumab (Cohorts D1, D2, E, F)Xx_NEWLINE_xXPrior therapy: eligible subjects must have had at least one line of platinum-based chemotherapy; this may be adjuvant therapy or first line of cytotoxic therapy for metastatic disease; prior hormonal therapy for metastatic/recurrent disease, prior targeted therapy, and prior radiotherapy are allowed; no maximum number of previous lines of chemotherapies; concomitant chemo-radiation is not considered as previous line of systemic chemotherapyXx_NEWLINE_xXPreviously untreated or treated subjects with no limit on prior lines of systemic therapies are allowedXx_NEWLINE_xXPrior use of systemic checkpoint inhibitors for the management of metastatic RCC is excluded; prior IFN-alpha or IL-2 is allowedXx_NEWLINE_xXPatients must discontinue antiandrogen therapy (i.e., flutamide, bicalutamide, nilutamide) for at least 4 weeks prior to registration with no evidence of a falling PSA after washoutXx_NEWLINE_xXHave had a histologic diagnosis of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma either at diagnosis or relapse\r\n* Patients must have experienced relapse after front-line therapy, or have had documented disease progression during front-line therapyXx_NEWLINE_xXPatients/subjects who need daily oxygen therapyXx_NEWLINE_xXOne prior anti-cancer therapy that did not workXx_NEWLINE_xXPathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line of systemic therapyXx_NEWLINE_xXBe at first or second relapse; Note: relapse is defined as progression following initial therapy (i.e., radiation +/- chemotherapy); for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapseXx_NEWLINE_xXParticipants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.Xx_NEWLINE_xXPatient's cancer must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options availableXx_NEWLINE_xXClear cell subject: must have received at least 2 prior systemic regimens, one of which is an anti-VEGF agent.Xx_NEWLINE_xXNon-clear cell subject: must have received at least one prior anti-VEGF regimenXx_NEWLINE_xXCompletion of major surgery, chemotherapy, targeted therapy (such as everolimus or experimental agents or radiation within 14 days prior to starting investigational drug or has not recovered from major side effects; there is no required washout period from completion of prior anti-estrogen therapy (either scenario) or prior CDK 4/6 inhibitor (if scenario 2) to initiation of ribociclib/placebo and anti-estrogen on trialXx_NEWLINE_xXSubject has received at least one line of prior therapyXx_NEWLINE_xXAvailability of and patient acceptance of curative therapyXx_NEWLINE_xXReceived any previous gene therapy using an integrating vector within 6 monthsXx_NEWLINE_xXPatients must be either refractory to or relapsed after only induction therapy; patients who do not achieve CR after induction therapy are considered primary refractory and are allowed to enter studyXx_NEWLINE_xXCELL PROCUREMENT: Received anti-CD19 antibody-based therapy OR cytotoxic chemotherapy not described as maintenance therapy within 2 weeks of procurementXx_NEWLINE_xXLYMPHODEPLETION: Subjects who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to lymphodepletion on this studyXx_NEWLINE_xXWilling and able to receive adequate prophylaxis and/or therapy for thromboembolic eventsXx_NEWLINE_xXPrior treatment\r\n* Phase I: exposure to 2-3 prior lines of therapy or no therapeutic options\r\n* Phase II: previously untreated for symptomatic MM\r\n* EXCEPTION: =< 7 days with pulse steroids or localized radiation therapy, without curative intent, for a myeloma-related complication prior to registration is allowed, as considered necessary by the treating physicianXx_NEWLINE_xXPatients must be either refractory to or relapsed after 1 line of therapy; exception: in the expansion cohort only, no BV refractory patients will be allowedXx_NEWLINE_xXPreviously untreated for myeloma or have received no more than one cycle of any treatment regimen; NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted; prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigatorXx_NEWLINE_xXAny skin-directed therapy within 14 days prior to initiating protocol therapyXx_NEWLINE_xXNeed for ongoing therapy with proton pump inhibitors; H2 antagonists are allowedXx_NEWLINE_xXPrior systemic therapy with an anthracycline for any indicationXx_NEWLINE_xXPatients with chronic GVHD requiring systemic therapy are eligibleXx_NEWLINE_xXPatients with steroid refractory cGVHD typically have received salvage with multiple lines of therapy; hence in this trial there will be no restriction in terms of prior lines of therapy received; prior ECP exposure is allowed, however prior IL-2 use is excludedXx_NEWLINE_xXAny line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)Xx_NEWLINE_xXCompletion of local therapy, such as radiation, surgical resection, injectable immunebased therapy, or topical pro-inflammatory agent, 21 days prior to first dose of protocol therapy.Xx_NEWLINE_xXAny prior severe adverse event attributed to prior anti-PD1 therapy that, in the Principal investigator's opinion, would contraindicate pembrolizumab administration such as:Xx_NEWLINE_xXFor Combination therapy, participant must not have had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based drug.Xx_NEWLINE_xXAt least one prior systemic treatment (including neoadjuvant therapy) for their tumor of the small intestine, with intolerance to prior therapy, failure of the most recent therapy (of any line) or recurrent diseaseXx_NEWLINE_xXPrior therapy with second line hormonal therapy is allowed (i.e. bicalutamide, nilutamide, flutamide, ketoconazole, abiraterone, enzalutamide, ARN-509)Xx_NEWLINE_xXPrior interferon or interleukin-2 therapy is NOT allowedXx_NEWLINE_xXwith relapsed or refractory disease without established alternative therapy orXx_NEWLINE_xXSubjects must have received no prior therapies for this diseaseXx_NEWLINE_xXThe number of prior therapies is restricted as follows:\r\n* Zero or one prior therapies during the preceding one year; this serves to limit the treatment cohort to patients with either only slowly progressive disease, or up to one prior therapy\r\n* No prior PD-1 or PD-L1 antibody therapies are allowed\r\n* Prior IL-2 is allowed, if it finished more than 1 year priorXx_NEWLINE_xXA minimum of 2 weeks elapsed off of antiandrogen therapy prior to registration (i.e. flutamide, nilutamide, and bicalutamide) without evidence of an anti-androgen withdrawal response; an anti-androgen withdrawal response is a PSA level at 2 weeks (or more) off of anti-androgen equal or higher than PSA level when anti-androgen therapy stoppedXx_NEWLINE_xXSubjects must have a histologically determined B cell NHL subtype as defined in the bullets below. In addition, they must have disease that is primary refractory after initial therapy or have relapsed disease.Xx_NEWLINE_xXPrimary refractory (at least 1 prior line of therapy)Xx_NEWLINE_xXResponded to initial therapy for ? 1 year and relapsed after 2 or more lines of therapy, including an anti-CD20 monoclonal antibodyXx_NEWLINE_xXAt least 1 prior line of therapy if primary refractory or relapsed within 1 year. Subjects who respond to initial therapy for greater than or equal to 1 year must have had at least 2 prior lines of therapy including an anti-CD20 monoclonal antibody.Xx_NEWLINE_xXContraindication to any concomitant medication, including pre-medications or hydration given prior to therapyXx_NEWLINE_xXAny prior number of prior therapies, including prior immunotherapy, is allowedXx_NEWLINE_xXPrevious therapy for any malignancy with an anthracycline or taxane for Cohorts A and B and carboplatin for Cohort AXx_NEWLINE_xXPreviously received at least one line of prior systemic therapy for metastatic disease; if the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient must have received at least one prior targeted therapy for metastatic disease (ie, EGFR tyrosine kinase inhibitor [TKI] therapy or ALK TKI therapy, respectively); there is no limit on prior therapies allowed; patients must have completed previous treatment (including other investigational therapy) in greater than or equal to the following times prior to initiation of trial treatment:\r\n* Anti-cancer monoclonal antibody (mAb) therapy must be completed >= 3 weeks prior to trial treatment\r\n* Chemotherapy administered in a daily or weekly schedule must be completed >= 1 week prior to trial treatment\r\n* Chemotherapy administered in an every 2-week schedule must be completed >= 2 weeks prior to trial treatment\r\n* Chemotherapy administered in an every 3-week schedule must be completed >= 3 weeks prior to trial treatment\r\n* Targeted small molecule therapy must be completed >= 1 week prior to trial treatment OR\r\n* Have not received prior systemic therapy for their cancer in recurrent or metastatic setting, AND have a tumor with tumor proportion score (TPS) >= 50% as measured by 22C3 PD L1 immunohistochemistry (IHC) test, AND no evidence of a sensitizing EGFR mutation or ALK rearrangementXx_NEWLINE_xXSystemic estrogens or androgens within 14 days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfortXx_NEWLINE_xXPatients requiring oxygen therapyXx_NEWLINE_xXTumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such targeted therapyXx_NEWLINE_xXSystemic estrogens or androgens within 14 days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfortXx_NEWLINE_xXAny hormonal therapy being taken as a treatment for cancer must be discontinued at least one week prior to registration; continuation of hormone replacement therapy e.g. thyroid hormone replacement therapy is permittedXx_NEWLINE_xXHas progressed on prior therapy with ibrutinib or other BTK inhibitorsXx_NEWLINE_xXPatients with advanced (metastatic) NSCLC, whose disease progressed during or after platinum-based chemotherapy; patients with EGFR or ALK genomic tumor aberrations (testing required for adenocarcinoma patients) should have disease progression on Food and Drug Administration (FDA) approved therapy for these aberrations prior to receiving nivolumab; these patients are eligible regardless of line of therapyXx_NEWLINE_xXPatients requiring oxygen therapyXx_NEWLINE_xXTumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such therapyXx_NEWLINE_xXNon-small cell lung cancer: 1) we will enroll non-small cell lung cancer patients with documented EGFR mutation who failed treatment with anti-EGFR therapy (e.g. erlotinib or afatinib) and tested negative for EGFR T790M mutation; we will allow patients with positive EGFR T790M mutation if they have progressed on third generation anti-EGFR therapy (e.g. CO-1686 or AZD9291) or medically not suitable/candidate for the third generation anti-EGFR therapy; failure from anti-EGFR therapy will be defined as progressive disease by RECIST (version 1.1) after at least two months of therapyXx_NEWLINE_xXHad prior systemic therapy for HCC other than sorafenib, or intercurrent local therapy to the liver tumor between sorafenib and study drugXx_NEWLINE_xXHas untreated active hepatitis B; Note: to qualify for enrollment, antiviral therapy for HBV must be given for at least 3 months prior to first dose of study drug, and HBV viral load must be less than 100 IU/mL prior to first dose of study drug; those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study treatment; those subjects who are anti-HBc (+) and negative for HBsAg, Anti-HBs, and HBV viral load do not require HBV prophylaxis, but need close monitoring for reactivationXx_NEWLINE_xXTime interval for last local therapy (radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to registrationXx_NEWLINE_xXMore than one line of prior systemic therapy for HCCXx_NEWLINE_xXPrior antiestrogen therapyXx_NEWLINE_xXPrevious pelvic irradiation therapyXx_NEWLINE_xXPatients must agree to continue to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomyXx_NEWLINE_xXNo systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowedXx_NEWLINE_xXPatient must have failed at least one prior therapyXx_NEWLINE_xXHad prior systemic therapy for pancreatic cancerXx_NEWLINE_xXInclusion Criteria:\n\n        Dose Escalation and Dose Expansion Cohorts\n\n        Patients must meet all of the following criteria to be eligible for participation in the\n        study:\n\n          1. Female patients, ? 18 years of age at the time of obtaining informed consent.\n\n          2. Patients with a documented (histologically- or cytologically-proven) breast cancer\n             that is locally advanced or metastatic.\n\n          3. Patients with a malignancy that is either relapsed/refractory to standard therapy or\n             for which no standard therapy is available.\n\n          4. Patients with a malignancy that is currently not amenable to surgical intervention due\n             to either medical contraindications or non-resectability of the tumor.\n\n          5. Patients with measurable or non-measurable disease according to the Response\n             Evaluation Criteria In Solid Tumor (RECIST, v1.1).\n\n          6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of\n             0 or 1 (see APPENDIX B: Performance Status Evaluation).\n\n          7. Life expectancy of greater than or equal to 3 months.\n\n          8. Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1\n             severity or lower, except for stable sensory neuropathy (less than or equal to Grade\n             2).\n\n          9. Patients who are either not of childbearing potential or who agree to use a medically\n             effective method of contraception during the study and during 3 months after the last\n             dose of study drug. (See Appendix H: Forms of contraception).\n\n         10. Patients with the ability to understand and give written informed consent for\n             participation in this trial, including all evaluations and procedures as specified by\n             this protocol.\n\n        Dose expansion Cohort - TNBC\n\n          1. Patients with conditions as follows:\n\n               -  ER <10%, PR <10% by IHC assay; And\n\n               -  HER2 negative based on ASCO CAP guideline\n\n          2. Patients with measurable disease according to the response evaluation criteria in TNBC\n             (RECIST, v1.1)\n\n          3. Patients with measurable disease that can be easily accessed for biopsy.\n\n          4. Relapsed (recurrence or disease progression after achieving a documented clinical\n             response to first- or second-line treatment) or refractory (disease progression while\n             receiving first line or second line treatment). In the case of TNBC, prior initial\n             therapy with at least one known active regimen for TNBC including, but not limited to,\n             any combination of anthracyclines, taxanes, platinum agents, Ixabepilone, and/or\n             cyclophosphamide is required.\n\n        Exclusion Criteria:\n\n        Dose Escalation and Dose Expansion Cohorts Patients meeting any of the following criteria\n        are ineligible for participation in the study.\n\n          1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not\n             using adequate birth control see Appendix H: Forms of contraception.\n\n          2. Patients with known central nervous system (CNS) or leptomeningeal metastases not\n             controlled by prior surgery, radiotherapy or requiring corticosteroids to control\n             symptoms, or patients with symptoms suggesting CNS involvement for which treatment is\n             required.\n\n          3. Patients with primary brain tumors.\n\n          4. Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma,\n             and multiple myeloma.\n\n          5. Patients with any of the following hematologic abnormalities at baseline. (Patients\n             may have received a red blood cell product transfusion prior to study, if clinically\n             warranted.):\n\n               -  Absolute neutrophil count (ANC) < 1,500 per mm3\n\n               -  Platelet count < 100,000 per mm3\n\n               -  Hemoglobin < 8.0 gm/dL\n\n          6. Patients with any of the following serum chemistry abnormalities at baseline:\n\n               -  Total bilirubin ? 1.5 × the ULN for the institution value\n\n               -  AST or ALT ? 3 × the ULN for the institution value (? 5 × if due to hepatic\n                  involvement by tumor)\n\n               -  Creatinine ? 1.5 × ULN for the institution value (or a calculated creatinine\n                  clearance < 60 mL/min/1.73 m2* )\n\n          7. Patients with a significant active cardiovascular disease or condition, including:\n\n               -  Congestive heart failure (CHF)requiring therapy\n\n               -  Need for antiarrhythmic medical therapy for a ventricular arrhythmia\n\n               -  Severe conduction disturbance\n\n               -  Unstable angina pectoris requiring therapy\n\n               -  QTc interval > 450 msec (males) or > 470 msec (females)\n\n               -  QTc interval ? 300 msec\n\n               -  History of congenital long QT syndrome or congenital short QT syndrome\n\n               -  LVEF < 50% as measured by echocardiography or MUGA scan\n\n               -  Uncontrolled hypertension (per the Investigator's discretion)\n\n               -  Class III or IV cardiovascular disease according to the New York Heart\n                  Association's (NYHA) Functional Criteria (see APPENDIX C: New York Heart\n                  Association's Functional Criteria).\n\n               -  Myocardial infarction (MI) within 6 months prior to first study drug\n                  administration\n\n          8. Patients with a known or suspected hypersensitivity to any of the components of\n             OTS167.\n\n          9. Patients with a known history of human immunodeficiency virus (HIV) or active\n             infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).\n\n         10. Patients with any other serious/active/uncontrolled infection, any infection requiring\n             parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study\n             drug administration.\n\n         11. Patients with inadequate recovery from any prior surgical procedure, or patients\n             having undergone any major surgical procedure within 4 weeks prior to first study drug\n             administration.\n\n         12. Patients with any other life-threatening illness, significant organ system\n             dysfunction, or clinically significant laboratory abnormality, which, in the opinion\n             of the Investigator, would either compromise the patient's safety or interfere with\n             evaluation of the safety of the study drug.\n\n         13. Patients with a psychiatric disorder or altered mental status that would preclude\n             understanding of the informed consent process and/or completion of the necessary\n             studies.\n\n         14. Patients with the inability or with foreseeable incapacity, in the opinion of the\n             Investigator, to comply with the protocol requirements.\n\n         15. Any anti-neoplastic agent or monoclonal antibody therapy for the primary malignancy\n             (standard or experimental) within 2 weeks prior to first study drug administration.\n\n         16. Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a\n             limited field of radiation for palliation within 1 week of the first dose of study\n             treatment. If acute symptoms of radiation have fully resolved, the extent and timing\n             of radiotherapy for eligibility can be discussed between Investigator and Sponsor.\n\n         17. Patients requiring surgery for the primary or metastatic primary malignancy.\n\n         18. Herbal preparations or related over the counter (OTC) preparations/supplements\n             containing herbal ingredients within 1 week prior to first study drug administration\n             and during study.\n\n         19. Systemic hormonal therapy which is not related to breast cancer treatment (standard or\n             experimental) within 1 week prior to first study drug administration and during study.\n             The following therapies are allowed:\n\n               -  Hormonal therapy (e.g., Megace) for appetite stimulation\n\n               -  Nasal, ophthalmic, inhaled, and topical glucocorticoid preparations\n\n               -  Oral replacement glucocorticoid therapy for adrenal insufficiency\n\n               -  Low-dose maintenance steroid therapy for other conditions (excluding steroid\n                  tapers for brain edema/metastases/radiation)\n\n               -  Hormonal contraceptive therapy (for WOCBP must be combined with non-hormonal\n                  contraceptive equivalent to a double-barrier method)\n\n         20. Any other investigational treatments during study. This includes participation in any\n             medical device or therapeutic intervention clinical trials.\n\n             Dose expansion Cohort - TNBC\n\n         21. Patients with only lesions that cannot be accessed for biopsy.Xx_NEWLINE_xXAt least 1 line of prior androgen receptor (AR) targeted therapyXx_NEWLINE_xXThrombocytopenia <100 x 103/ml, not resulting from therapyXx_NEWLINE_xXPrior exposure to BP1001Xx_NEWLINE_xXPrior therapy exclusions:\r\n* Prior therapy with fulvestrant\r\n* Prior therapy with tamoxifen in the metastatic setting\r\n* More than 3 prior lines of endocrine therapy in the metastatic setting\r\n* More than one prior line of chemotherapy in the metastatic settingXx_NEWLINE_xXPatients must have no more than one prior systemic therapeutic regimen. This includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment. This does not include any therapies given in the adjuvant setting. No prior anti-CTLA4 therapy. Prior anti PD-1 or anti-PDL-1 antibody therapy is acceptable.Xx_NEWLINE_xXPatients are excluded if they have had prior hepatic arterial embolization therapyXx_NEWLINE_xXPrior therapies for metastatic melanoma are allowed, including chemo-, cytokine-, immuno, biological and vaccine-therapy as long as they did not include BRAFi, MEKi; prior ipilimumab or PD-1 directed therapy will be allowed with a washout period of 4 weeks and if all autoimmune adverse events have resolved to grade 1 (except endocrine abnormalities that require continuous replacement)Xx_NEWLINE_xXPatients must have either:\r\n* Symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease): patients who are receiving high-dose melphalan and AHCT as part of their initial therapy require at least a partial response (PR) as defined by the International Myeloma Working Group uniform response criteria for MM; patients who are receiving high-dose melphalan and AHCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease; there is no limit on the number of prior regimens received by the patient; OR\r\n* Light chain (AL) amyloidosis who may be newly diagnosed or previously treatedXx_NEWLINE_xXHave documented objective radiographic progression after stopping treatment with first-line therapy; Note: the same image acquisition and processing parameters should be used throughout the study for a given subjectXx_NEWLINE_xXFailure of first-line anti-cancer therapy with an oxaliplatin and bevacizumab-based regimen (either radiological documentation of disease progression or due to toxicity) or subsequent relapse of disease following first-line therapy; patients relapsing within 12 months of completing adjuvant fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX) will also be considered eligibleXx_NEWLINE_xXReceived more than 1 line of systemic treatment for advanced/metastatic CRC and/or a patient whose first line therapy did not contain oxaliplatin and bevacizumabXx_NEWLINE_xXPatients on concurrent anti-cancer therapy, unless specifically agreed to by the patient's medical oncologist and consenting professionalXx_NEWLINE_xXConsideration for neoadjuvant therapyXx_NEWLINE_xXMetastatic renal cell cancer patients (any histologic subtype) with measurable and/or evaluable disease who have completed at least one line of prior systemic therapy are potentially eligible for this trial; any number of prior systemic therapies are allowed, including prior nivolumabXx_NEWLINE_xXNeed or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, stereotactic body radiation therapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression; adjuvant systemic therapy before and after the protocol therapy, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol is allowed; at least 4 weeks must have passed since the last directed intervention to the protocol-treated lesionXx_NEWLINE_xXSubjects with acute myeloid leukemia (AML) should have failed any prior induction therapy regimen or have relapsed after prior therapy (defined as patients in first relapse and less than 12 months from diagnosis [short first remission] or in second or later relapse; refractory defined as failure to achieve complete response [CR] to standard induction therapy, such as \7 and 3\, high dose ara-C-containing regimen or a hypomethylating agent): dose-escalation phase: subjects with confirmed relapsed or refractory AML and no available treatment options with known benefit; expansion phase: subjects with relapsed/refractory AML who have failed therapy with up to one prior salvage regimen and no available treatment options with known benefit; exception: stem cell transplant (SCT) or stem cell therapy for subjects who previously underwent SCT/stem cell therapy, and are currently in remission will not be considered a salvage regimenXx_NEWLINE_xXCML with accelerated or blast phase with < 20% blasts after therapyXx_NEWLINE_xXPersons with an infection that is not responding to antimicrobial therapyXx_NEWLINE_xXIs expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC or radiation therapy)Xx_NEWLINE_xXPHASES 1 AND 2: patient participants with AML that has relapsed after, or is refractory to, first-line therapy, with or without subsequent additional therapy, and are currently considered unfit for, or unlikely to respond to, cytotoxic chemotherapyXx_NEWLINE_xXPatient is a candidate for a maximum of one further line of established therapy (prior to treatment with ACTolog).Xx_NEWLINE_xXPatients have a history of prior therapy with carboplatinXx_NEWLINE_xXPrior conventional antitumor therapy, other than steroids, radiation therapy (RT) or TMZ therapy given for glioblastomaXx_NEWLINE_xXPatients must have an advanced solid tumor malignancy with no remaining standard treatment options or for whom single agent capecitabine is an acceptable therapy; patients with colorectal cancer must have progressed on at least one line of fluoropyrimidine containing therapy; receipt of either oxaliplatin or irinotecan in combination with a fluoropyrimidine is required in the front line setting for all colorectal cancer patients unless either of these agents are otherwise contraindicated in the opinion of the treating physician; prior regorafenib or TAS-102 therapy is not requiredXx_NEWLINE_xXPHASE II: Patients must have received and progressed on fluoropyrimidine or fluoropyrimidine based therapy; receipt of either oxaliplatin or irinotecan in combination with a fluoropyrimidine is required in the front line setting unless either of these agents are otherwise contraindicated in the opinion of the treating physician in which case a fluoropyrimidine only may be used; prior regorafenib or TAS-102 therapy is not requiredXx_NEWLINE_xXParticipant may have received prior investigational therapy (including immune therapy)Xx_NEWLINE_xXParticipant may have received prior hormonal therapyXx_NEWLINE_xXPatients with complete response (CR) or stringent CR after induction therapy as defined by International Response Criteria after most recent therapyXx_NEWLINE_xXPrior or ongoing systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (for example [e.g.] leuprolide, goserelin, triptorelin, degarelix)\r\n* Cytochrome P450 (CYP)-17 inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. enzalutamide, apalutamide)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)Xx_NEWLINE_xXAny number of prior therapies (including none) is permitted; the last dose of systemic therapy (include targeted therapies) must have been given at least 4 weeks prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapyXx_NEWLINE_xXSubjects must have received 1 or more prior therapies for this disease and have had stable disease or progressive disease based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, or intolerable toxicities precluding further therapy with a prior regimenXx_NEWLINE_xXPrior therapy with cabazitaxel or to other drugs formulated with polysorbate 80Xx_NEWLINE_xXSince there is no standard effective chemotherapy for patients with NF1 and cutaneous neurofibromas, patients may be treated on this trial without having received prior medical therapy directed at their plexiform neurofibromas (PN)Xx_NEWLINE_xXPatients with exposure to prior immunotherapy are not eligibleXx_NEWLINE_xXPatient with previous administration of immunosuppressive therapy for SAAXx_NEWLINE_xXPatients on androgen deprivation therapy (ADT) are allowedXx_NEWLINE_xXPatients may not have received prior HER2 directed therapiesXx_NEWLINE_xXPrior therapy\r\n* Arm A: Rebastinib plus paclitaxel: up to two prior non-taxane chemotherapy regimens for metastatic or incurable locally advanced disease permitted (no prior paclitaxel or eribulin); patients with estrogen receptor (ER)-positive disease are required to have relapse or progression on at least one line of endocrine therapy\r\n* Arm B: Rebastinib plus eribulin: up to three prior chemotherapy regimens for metastatic or incurable locally advanced disease permitted (no prior eribulin, but prior paclitaxel allowed): patients with ER-positive disease are required to have relapse or progression on at least one line of endocrine therapyXx_NEWLINE_xXAny of the disease stages listed below\r\n* Stage IB disease that meets ALL of the following criteria:\r\n** Plaque disease (ie,T2b staging)\r\n** Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)\r\n** Not appropriate for treatment with focal therapies\r\n** One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)\r\n* Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:\r\n** Patient is a candidate for treatment with low-dose TSEB\r\n** Patient is a candidate for systemic therapy\r\n* IIIB or IVA disease requiring systemic therapy\r\n* Transformed cutaneous T-cell lymphoma (CTCL)Xx_NEWLINE_xXPrevious TSEB therapy with total dose > 20 GyXx_NEWLINE_xXPatients must have disease that is not amenable to potentially curative resection, transplantation or ablation; HCC patients must have progressed on, been intolerant to, or refused prior sorafenib therapy; patients with BTC must have received, been intolerant of or refused at least one line of chemotherapyXx_NEWLINE_xXPrior therapy with microtubule destabilizing agents for NSCLC (i.e. vinorelbine)Xx_NEWLINE_xXAt least 1 prior line of chemoimmunotherapy if primary refractory or relapsed within one year; subjects who respond to initial therapy for greater than one year must have had at least 2 prior lines of therapy including one line with chemoimmunotherapy including an anti-CD20 monoclonal antibodyXx_NEWLINE_xXActive GVHD requiring systemic steroid therapy; medications for GVHD prophylaxis are acceptableXx_NEWLINE_xXSystemic steroid therapy unless for physiologic replacementXx_NEWLINE_xXTreated with appropriate maximal medical therapy for pulmonary toxicityXx_NEWLINE_xXSubjects must not have received paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapyXx_NEWLINE_xXSubjects must have received or be receiving, at time of enrollment, “RVD” therapy (combination therapy with lenalidomide, bortezomib, and dexamethasone); patients must have received =< 6 cycles of RVD at time of enrollment and must not have progressed (by IMWG criteria) on RVD; patients may have received other regimens prior to RVD if such therapy was limited to =< 3 cycles; patients may have received radiation therapy prior to enrollment; patients must not have received infusional chemotherapy (e.g., bortezomib/thalidomide/dexamethasone-cisplatin/doxorubicin/cyclophosphamide/etoposide [VTD-PACE] or similar regimen) prior to enrollmentXx_NEWLINE_xXHave received prior gene therapy or gene-modified cellular immunotherapyXx_NEWLINE_xXHave had disease progression, be refractory or intolerant to no more than 2 prior systemic regimens.Xx_NEWLINE_xXPatients may have received prior targeted therapy such as bevacizumabXx_NEWLINE_xXPatients should have discontinued therapy with imatinib, dasatinib, nilotinib, ponatinib, omacetaxine or other anti-leukemia therapy (except hydroxyurea) >= 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade =< 1; hydroxyurea may be received up to the time of enrollment and for the first 6 weeks of study treatment if necessaryXx_NEWLINE_xXPrior therapy with bosutinib or axitinibXx_NEWLINE_xXEligible for LDAC therapy, based on Investigator assessmentXx_NEWLINE_xXPrior exposure to BP1001Xx_NEWLINE_xXMust have received at least one prior anti-angiogenic therapy (or inability to tolerate, as above) in the advanced or metastatic setting; prior cytokine therapy (eg, IL-2, IFN-alpha), vaccine therapy, or treatment with cytotoxics is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathwaysXx_NEWLINE_xXSubjects must have received frontline standard therapy for high-risk neuroblastoma and meet one of the following three conditions for recurrent/progressive, refractory, or persistent disease\r\n* Recurrent/progressive disease at any time prior to enrollment (regardless of overall response to frontline therapy)\r\n* Refractory disease: persistent sites of disease after achieving a best overall response of stable disease to frontline therapy after a minimum of 4 cycles of induction therapy AND patient has never had recurrent/progressive disease\r\n* Persistent disease: persistent sites of disease after achieving a best overall response of partial response to frontline therapy after a minimum of 4 cycles of induction therapy AND patient has never had recurrent/progressive diseaseXx_NEWLINE_xXSubject’s current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXPART 2 GROUP 1 EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapyXx_NEWLINE_xXPART 2 GROUP 2A EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapyXx_NEWLINE_xXPART 2 GROUP 3 EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapyXx_NEWLINE_xXEight weeks must have elapsed from the time of any antibody therapy that could affect an anti-cancer immune response, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA 4) therapy, at the time the patient receives the preparative regimen to allow antibody levels to decline; Note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsiesXx_NEWLINE_xXPHASE II SCLC: Radiographic evidence of disease progression after initial therapy should have been documentedXx_NEWLINE_xXUROTHELIAL CARCINOMA EXPANSION COHORT: Prior antiangiogenic therapy are permitted (2-week washout from therapy is required)Xx_NEWLINE_xXReceipt of therapies or procedures prior to first dose including:Xx_NEWLINE_xXBevacizumab® or other anti-angiogenic therapy.Xx_NEWLINE_xXPatients with histologically confirmed, by the National Cancer Institute (NCI) Laboratory of Pathology or by Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing or cobas EGFR mutation test v1/2 at an outside institution, advanced lung adenocarcinoma with EGFR-sensitizing somatic mutations or a germline T790M mutation (detected histologically or via ctDNA analysis using a CLIA assay) with:\r\n* No prior EGFR tyrosine kinase inhibitor (TKI) therapy (cohort 1)\r\nOR\r\n* Progressive disease after 1st or 2nd generation EGFR TKI therapy harboring somatic T790M mutation (cohort 2)\r\nOR\r\n* Progressive disease after treatment with osimertinib who are eligible for local ablative therapy (cohort 3)Xx_NEWLINE_xXHas undergone cytotoxic induction therapyXx_NEWLINE_xXAll lines of prior therapy accepted; subjects with prior hepatic or extra-hepatic resections of metastatic disease will be includedXx_NEWLINE_xXIn their treating physician’s opinion is a good candidate for BCG therapyXx_NEWLINE_xXNot pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapyXx_NEWLINE_xXPatients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapyXx_NEWLINE_xXCurrently on the following concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study drug(s); the use of the following medications should be discontinued prior to initiation of protocol therapy and should be avoided during protocol therapy if reasonable alternatives exist\r\n* Sorafenib\r\n* Irinotecan\r\n* Corticosteroids: Patients requiring corticosteroids that have not been on a stable or decreasing dose of corticosteroid for 7 days prior to enrollment are not eligibleXx_NEWLINE_xXPatients must be either refractory to or relapsed after 1 line of therapyXx_NEWLINE_xXPatient must be either refractory to or relapsed after 1 line of therapyXx_NEWLINE_xXPatients must have achieved at least partial response (PR) prior to autologous HCT and must not have progressive disease (PD) prior to the initiation of maintenance therapyXx_NEWLINE_xXThe subject has a prior history of unrelated neoplastic disease, and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluationXx_NEWLINE_xXPatients having prior therapy with Laser Induced Thermal Therapy (LITT) is allowed, but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrenceXx_NEWLINE_xXPrior therapy with lomustineXx_NEWLINE_xXPrior therapy with bevacizumabXx_NEWLINE_xXCurrent history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the PIXx_NEWLINE_xXPrior systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)\r\n* CYP-17 inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. abiraterone, enzalutamide)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Note: may be enrolled if hormone therapy was recently initiated of any kind (< 90 days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollmentXx_NEWLINE_xXPatients with HM who have undergone myeloablative systemic therapy are ineligible to participate in this study.Xx_NEWLINE_xXHistologically documented diagnosis of squamous cell carcinoma of the head/neck including nasopharyngeal carcinomas (lymphepithelioma histology is ok if criteria 2 is met)\r\n* Patients must have progressed on prior platinum based therapy (or have become intolerant) prior to enrollment on this studyXx_NEWLINE_xXConsent to undergo a fresh biopsy in case of benefit from therapy and subsequent progressionXx_NEWLINE_xXPrior treatment with any CD19 CAR T-cell therapyXx_NEWLINE_xXCLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody, or who have failed tyrosine kinase or phosphatidylinositol 3 (PI3) kinase inhibitors, or who were not eligible for or declined such therapy; patients with fludarabine refractory disease are eligibleXx_NEWLINE_xXINCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients with non-small cell lung cancer that is metastatic or inoperable and who have been treated with at least one line of prior therapy or declined conventional therapyXx_NEWLINE_xXTreatment within 28 days of cycle1 day1: any other systemic therapy for prostate cancer (with the exception of luteinizing hormone-releasing hormone [LHRH] agonists and LHRH antagonists for testosterone suppression, and bisphosphonates and RANK-ligand inhibitors for bone metastases which are allowed); any other investigational productXx_NEWLINE_xXMPNST for which standard therapy is not curative, including patients with surgically unresectable lesions, progression (WHO criteria) or recurrence of an MPNST in a previously radiated field (if it has been at least 4 weeks prior to registration since the last dose of radiation); Note: patients with metastatic disease also are eligible for participationXx_NEWLINE_xXPatients must have received at least 1 prior regimenXx_NEWLINE_xXPatients must be appropriate candidates for letrozole therapy in any line of therapy or for fulvestrant for second line of therapy or beyondXx_NEWLINE_xXPRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusionXx_NEWLINE_xXCurrently on the following concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study drug(s); the use of the following medications should be discontinued prior to initiation of protocol therapy and should be avoided during protocol therapy if reasonable alternatives exist\r\n* Erlotinib\r\n* TemozolomideXx_NEWLINE_xXUse of any anti-leukemic agents after relapse is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance) for cohorts 1 and 2Xx_NEWLINE_xXUse of any of the following after transplantation and prior to starting study therapy for cohort 3:\r\n* Investigational agents/therapies\r\n* Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance)Xx_NEWLINE_xXPrior therapy with ado-trastuzumab emtansine (patients who had prior trastuzumab or other HER2 targeted agents are eligible)Xx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)Xx_NEWLINE_xXPrevious exposure to toll-like receptor (TLR) agonist therapyXx_NEWLINE_xXPatient population (histological or cytologically confirmed diagnosis):\r\n* Untreated elderly (> 60 years) AML if in the intermediate and poor-risk cytogenetic group and not candidates (as judged by treating doctor of medicine [MD]) for or willing to undergo standard induction therapy (i.e. elderly unfavorable cytogenetic AML) or any untreated AML age > 65 years\r\n** Note: previous therapy with a hypomethylating agent (HMA) for a diagnosis of MDS is allowed\r\n* Relapsed or refractory AML (>= 18 years)\r\n* Any MDS (>= 18 years) having failed or been intolerant to prior hypomethylating agent (HMA) treatment\r\n** Failure is defined as any disease progression while on HMA, relapse after HMA treatment or no response after 4 cycles of 5-Azacitidine or decitabine\r\n** Patients with isolated 5q-/5q- syndrome must have failed, not tolerated, or lenalidomide in addition to having failed or been intolerant to HMA treatment\r\n*** Note: patients with chronic myelomonocytic leukemia (CMML) and MDS/myeloproliferative neoplasms (MPN) overlap are allowed if meeting other study eligibility criteria\r\n*** Note: for all patient groups, therapy as part of a plan as a bridge to transplant is allowedXx_NEWLINE_xXPrior antitumor therapy for glioma (other than steroids)Xx_NEWLINE_xXPHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION AND IN NEWLY DIAGNOSED GBM: Has received prior therapy with any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathwaysXx_NEWLINE_xXPatients who have been treated on other protocols of genetically-modified T cells at the NIH only are potentially eligible under these conditions:\r\n* At least 6 months have elapsed since the last genetically-modified T-cell therapy that the patient received and there is no evidence of replication-competent retroviruses (evidence must be provided from prior NIH gene-therapy protocol principal investigator) and persisting genetically-modified T cells are not detectable in the patient’s blood (evidence must be provided by prior NIH gene-therapy protocol principal investigator)Xx_NEWLINE_xXGroup I: KS requiring systemic therapy (no prior therapy required) and:\r\n* Group I patients should have one or more of the following:\r\n** T1 KS, KS on skin sufficiently widespread that it is not amenable to local therapy, or KS affecting quality of life due to local symptoms or psychological distress\r\n** KS patients with an inadequate response to pomalidomide (either progressive disease or stable disease requiring additional therapy after 4 months)\r\n** KS patients with an inadequate response to liposomal doxorubicin, paclitaxel, or other systemic chemotherapy (either progressive disease or stable disease requiring additional therapy after 6 cycles)\r\n* Group I will exclude patients eligible for Group II (below); patients with a history of multicentric Castleman disease (MCD) in the absence of any active disease (as assessed by the PI) are eligible for Group I\r\n* A wash out period off treatment of 3 weeks will be required, except in the case of patients with progressive, severe disease in which delay of treatment cannot be justified (i.e. symptomatic pulmonary KS)Xx_NEWLINE_xXSubjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapyXx_NEWLINE_xXPatients who have had prior systemic therapy with a PD-1 blocking antibody will be excludedXx_NEWLINE_xXPatients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have \2\ prior therapiesXx_NEWLINE_xXPatients must have received last dose of either fluorouracil, oxaliplatin, leucovorin calcium, and irinotecan hydrochloride (FOLFIRINOX) based or gemcitabine/abraxane based chemotherapy for 4-8 cycles with last dose of therapy between 2-5 weeks of study enrollment, with no evidence of metastatic diseaseXx_NEWLINE_xXPatients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapyXx_NEWLINE_xXPatients who have previously taken mebendazole as part of any experimental anti-cancer protocol, and have failed this therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Subject must meet all of the following applicable inclusion criteria to participate in this\n        study:\n\n          -  Written informed consent and HIPAA authorization for release of protected health\n             information obtained from the subject prior to performing any protocol-related\n             procedures, including screening evaluations. NOTE: HIPAA authorization may be included\n             in the informed consent or obtained separately.\n\n          -  Age ? 18 years at the time of consent.\n\n          -  ECOG Performance Status of 0-1 within 28 days prior to registration for protocol\n             therapy.\n\n          -  Females of childbearing potential and males must be willing to use an effective method\n             of contraception (hormonal or barrier method of birth control; abstinence) from the\n             time consent is signed until 12 weeks after treatment discontinuation.\n\n          -  Females of childbearing potential must have a negative serum pregnancy test within 14\n             days prior to registration for protocol therapy. NOTE: Female subjects are considered\n             of child bearing potential unless they are surgically sterile (they have undergone a\n             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are ?60\n             years old and naturally postmenopausal for at least 12 consecutive months.\n\n          -  Histological evidence of persistent residual esophageal adenocarcinoma including\n             gastroesophageal junction adenocarcinoma following definitive concurrent\n             chemoradiotherapy (carboplatin and paclitaxel or cisplatin and 5-FU) in the surgical\n             sample (esophagus or lymph node or both) obtained at the time of esophagectomy. NOTE:\n             Persistent residual disease is defined as follows (modified from College of American\n             Pathologists Guidelines):\n\n               -  No residual tumor (Grade 0, complete response, 0% tumor). This group will not be\n                  included in this study.\n\n               -  Marked response (Grade 1, 0-<10% residual tumor)\n\n               -  Moderate response (Grade 2, 10-50% residual tumor)\n\n               -  No definite response (Grade 3, >50% residual tumor)\n\n          -  Minimum of 1 month and maximum of 3 months from surgical resection with no evidence of\n             disease progression at the time of enrollment.\n\n          -  Must have adequately recovered from surgery as judged by the treating investigator.\n\n          -  Subject is willing and able to comply with the protocol for the duration of the study\n             including undergoing treatment and scheduled visits and examinations including follow\n             up.\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the criteria below may not participate in the study:\n\n          -  Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or cancer-specific vaccine\n             therapy.\n\n          -  Evidence of active autoimmune disease requiring systemic treatment within preceding 3\n             months or a documented history of clinically severe autoimmune disease, or a syndrome\n             that requires systemic steroids or immunosuppressive agents. Exceptions to this rule\n             include vitiligo, resolved childhood asthma/atopy, requirement of intermittent\n             bronchodilators or local steroid injections, hypothyroidism stable on hormone\n             replacement, psoriasis not requiring systemic treatment (within the past 2 years),\n             Graves's disease and Sjogren's syndrome.\n\n          -  Prior malignancy is not allowed except for adequately treated basal cell or squamous\n             cell skin cancer, in situ cervical cancer, Gleason score ? 7 prostate cancers, or\n             other cancer for which the subject has been disease-free for at least 3 years.\n\n          -  Active or prior documented inflammatory bowel disease (e.g. Crohn's disease,\n             ulcerative colitis).\n\n          -  Presence of interstitial lung disease or history of pneumonitis requiring treatment\n             with corticosteroids.\n\n          -  Patients with diagnosis of primary immunodeficiency.\n\n          -  Patients receiving chronic systemic corticosteroid therapy or other immunosuppressive\n             therapy within 28 days prior to registration for protocol therapy. Exceptions include\n             intranasal and inhaled corticosteroids or systemic corticosteroids at physiological\n             doses, which are not to exceed 10 mg/day of prednisone, or an equivalent\n             corticosteroid.\n\n          -  History of allogeneic organ or stem cell transplant.\n\n          -  Receipt of live attenuated vaccine within 30 days prior to registration for protocol\n             therapy.\n\n          -  Mean QT interval corrected for heart rate (QTc) > 470 msec calculated from 3 ECGs by\n             Bazett's Correction.\n\n          -  Ventricular arrhythmias requiring medication(s).\n\n          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic\n             congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac\n             arrhythmia, active peptic ulcer disease or gastritis, or active bleeding diatheses.\n\n          -  History of psychiatric illness/social situations that would limit compliance with\n             study requirements or compromise the ability of the subject to give written informed\n             consent.\n\n          -  Known HIV infection or chronic hepatitis B or C.\n\n          -  Known history of previous clinical diagnosis of tuberculosis.\n\n          -  Clinically significant infections as judged by the treating investigator. Clinically\n             significant is defined as an active infection requiring IV antibiotics.\n\n          -  Because there is an unknown but potential risk for adverse events in nursing infants\n             secondary to treatment of the mother, breastfeeding should be discontinued. In\n             addition, breast milk cannot be stored for future use while the mother is being\n             treated on study.\n\n          -  Treatment with any investigational agent within 28 days prior to registration for\n             protocol therapy.\n\n          -  History of hypersensitivity to durvalumab or any excipient.\n\n          -  Any condition that, in the opinion of the investigator, would interfere with\n             evaluation of study treatment or interpretation of patient safety or study results.\n\n          -  Previous enrollment in the present study.Xx_NEWLINE_xXPatients enrolled on the phase II randomized trial, who have had prior treatment with a PD1 or PDL1 inhibitor, anti-CTLA 4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway (i.e. not “immune therapy naive”)\r\n* Note: for those enrolled in the phase I dose escalation, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is allowed; for those enrolled in the phase IB, prior use of a PD1 or PDL1, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway is required; for all patients in all phases, prior use of a vaccine for treatment of cancer is allowedXx_NEWLINE_xXFor patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:\r\n* 28 days have elapsed since that therapy\r\n* Lesions that have not been treated with local therapy must be present and measurableXx_NEWLINE_xXPatients must have relapsed after at least 1 but at most 3 prior lines of therapy, including rituximab-based immunochemotherapy and alkylating agents. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cyclesof polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to other PI3Ki is acceptable provided there is no resistance.Xx_NEWLINE_xXRituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen including rituximab maintenance)Xx_NEWLINE_xXPrior liver-directed radiation therapy in cohort 1 (advanced cirrhosis group) or cohort 2 (low functional volume group)Xx_NEWLINE_xXPrior yttrium-90 therapy for patients in cohorts 1 or 2Xx_NEWLINE_xXSubjects with second or subsequent relapse, any relapse refractory to salvage, or with persistent disease after at least two lines of therapy\r\n* Subjects with relapsed disease after prior allogeneic HCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and\r\n** Have experienced graft rejection (no evidence of donor cells by short tandem repeat [STR] analysis on 2 occasions separated by at least 1 month), OR\r\n** Donor cells are present but there is no active graft-versus-host disease (GVHD), subject does not require immunosuppression and is more than 6 months from transplant\r\n** Have relapsed after prior syngeneic HCT and is more than 3 months from transplant\r\n* Subjects with relapsed disease after prior autologous HCT will be eligible if they meet all other inclusion criteria and it has been more than 3 months from transplantXx_NEWLINE_xXFour weeks must have elapsed from the time of any antibody therapy that could affect an anti-cancer immune response at the time the patient receives the preparative regimen to allow antibody levels to declineXx_NEWLINE_xXThe subject must be deemed appropriate for neoadjuvant endocrine therapy by the referring medical oncologistXx_NEWLINE_xXPrior anti-estrogen therapy within the last 5 yearsXx_NEWLINE_xXPatients can have received up to 4 lines of systemic treatment; psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapyXx_NEWLINE_xXPrior therapy with TAS-102Xx_NEWLINE_xXSECOND COHORT: Concurrent therapy with enzalutamide will be permitted and is a requirement for enrollmentXx_NEWLINE_xXPatients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvest; vaccination will not take place until at least one line of standard chemotherapy is givenXx_NEWLINE_xXOngoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapyXx_NEWLINE_xXPatients must have received at least one dose of an anthracycline based neoadjuvant regimen; patients are eligible if therapy was discontinued due to disease progression or therapy intoleranceXx_NEWLINE_xXPatients with a history of prior therapy with paclitaxel and/or carboplatinXx_NEWLINE_xXPrior therapy with anti-PD1 antibodyXx_NEWLINE_xXExpected to require any other form of systemic antineoplastic therapy while receiving pembrolizumabXx_NEWLINE_xXHistory of pneumonitis requiring hospitalization or systemic immune suppressive therapyXx_NEWLINE_xXActive acute or chronic graft-versus-host disease (GVHD) requiring systemic therapyXx_NEWLINE_xXBe eligible for curative-intent concurrent chemoradiation therapyXx_NEWLINE_xXSubjects must not have evidence of cerebellar dysfunction at baseline or during prior cytarabine therapyXx_NEWLINE_xXSubjects must have had at least three lines of therapy for their disease, including a proteasome inhibitor and immunomodulatory drug (e.g., lenalidomide), with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this periodXx_NEWLINE_xXPHASE II:\r\n* Patients must have received at least one course of platinum-based chemotherapy for the management of primary disease including carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted agents, or extended therapy administered after surgical or non-surgical assessment\r\n* There are no restrictions on the total number of prior regimens patients may have receivedXx_NEWLINE_xXPHASE I: Hormonal therapy directed at treatment for the cancer must be discontinued at least one week prior to enrollment; hormone replacement therapy for symptom management is permittedXx_NEWLINE_xXPHASE II: Hormonal therapy directed at treatment for the cancer must be discontinued at least one week prior to enrollment; hormone replacement therapy for symptom management is permittedXx_NEWLINE_xXPHASE II: Patients who have previously received anti-CTLA-4 antibody therapyXx_NEWLINE_xXPatients must have had front line therapy for their diseaseXx_NEWLINE_xXOngoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapyXx_NEWLINE_xXParticipants who received at least only one line of previous therapy and achieved either complete response (CR) or partial response (PR) for at least 24 weeks (from the last day of the last cycle) after their first line of therapy, but are not eligible for high dose chemotherapy with autologous stem cell transplantation (HD-ASCT)Xx_NEWLINE_xXParticipants who received more than one line of previous therapy (including HD-ASCT), and have achieved a duration of response (CR or PR) of at least 8 weeks (from the last day of the last cycle) after their last line of therapyXx_NEWLINE_xXParticipants who have received prior therapy with other anti-CD37-targeting therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n        For a subject to be eligible for this study, she must meet all of the following criteria:\n\n          1. Female subjects 18 years of age or older\n\n          2. Subjects may be enrolled with previous histologically proven diagnosis of the\n             following:\n\n             a. Endometrial Cancer: Patients must have recurrent or persistent endometrial\n             carcinoma, which is refractory to curative therapy or established treatments.\n\n             i. Histologic diagnosis will be reviewed by the treating institution ii. Patients with\n             the following histologic epithelial cell types are eligible: Endometrioid\n             adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell\n             adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified,\n             mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.\n\n             iii. Initial treatment may have included chemotherapy, chemotherapy and radiation\n             therapy, and/or consolidation/maintenance therapy; antiangiogenic therapy (e.g.\n             bevacizumab) as part of adjuvant therapy is allowed. Chemotherapy administered in\n             conjunction with primary radiation as a radio-sensitizer will be counted as a systemic\n             chemotherapy regimen.\n\n             iv. Patients should have received no more than two prior cytotoxic or non-cytotoxic\n             therapies for management of recurrent or persistent disease (excluding endocrine\n             therapies which will not count in the number of regimens)\n\n             b. Ovarian cancer: Patients must have recurrent or persistent ovarian, fallopian tube\n             or primary peritoneal cancer, which is refractory to established treatments.\n\n             i. Patients with the following histologic epithelial cell types are eligible:\n             Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear\n             cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise\n             specified.\n\n             ii. Patients must have received at least one prior platinum-based chemotherapeutic\n             regimen for the management of primary disease containing carboplatin, cisplatin, or\n             another organoplatinum compound.\n\n             iii. This initial therapy may have included high-dose therapy, consolidation, or\n             extended therapy administered after surgical or non-surgical assessment.\n\n             iv. Antiangiogenic therapy (e.g. bevacizumab) as part of adjuvant therapy is allowed.\n\n             v. Patients should have received no more than two prior cytotoxic or non-cytotoxic\n             therapies for management of recurrent or persistent disease\n\n             c. Cervix cancer: Subjects diagnosed with histologically confirmed squamous cell\n             carcinoma of the cervix.\n\n             i. Patients must have received at least one prior platinum based chemotherapeutic\n             regimen for the management of primary disease containing carboplatin, cisplatin or\n             another organoplatinum compound. The initial therapy may have included high-dose\n             therapy, consolidation or extended therapy administered after surgical or non-surgical\n             assessment. Antiangiogenic therapy (e.g. bevacizumab) as part of adjuvant therapy is\n             allowed. Chemotherapy administered in conjunction with primary radiation as a\n             radio-sensitizer will be counted as a systemic chemotherapy regimen.\n\n             ii. Patients should have received no more than two prior cytotoxic or non-cytotoxic\n             standard therapies for management of recurrent or persistent disease.\n\n             d. Other uterine cancers: Subjects diagnosed with other uterine cancers, such as\n             Leiomyosarcoma, and have received no more than two prior cytotoxic or non-cytotoxic\n             standard therapies for management of recurrent or persistent disease.\n\n          3. For Phase 2a only, all patients must express at least one FGFr 1, 2 or 3 amplification\n             (or mutation) from archived tissue or new biopsy. For non-amplified patients, approval\n             of the site coordinator or the sponsor is required prior to enrollment.\n\n          4. All patients must have measurable disease. Measurable disease is defined as at least\n             one lesion that can be accurately measured in at least one dimension (longest\n             dimension to be recorded). Each lesion must be ? 20mm when measured by conventional\n             techniques, including palpation, plain x-ray, CT, and MRI, or ? 10mm when measured by\n             spiral CT.\n\n          5. Life expectancy ? 3 months\n\n          6. Subject must be suitable for oral administration of study medication\n\n          7. Patients must have signed an approved informed consent and authorization permitting\n             release of personal health information.\n\n          8. Patient must have adequate:\n\n               1. Bone Marrow Function: Absolute neutrophil count (ANC) greater then or equal to\n                  1,500/mm3, equivalent to Common Toxicity Criteria (CTC) grade 1. Platelets\n                  greater than or equal to 100,000/mm3\n\n               2. Renal Function: Creatinine less than or equal to 1.5 x institutional upper limit\n                  normal (ULN), CTC grade 1. Note: If creatinine is greater than 1.5 x ULN,\n                  creatinine clearance must be greater than >50 mL/min.\n\n               3. Hepatic Function: Bilirubin less than or equal to 1.5 x ULN (CTC grade 1) or less\n                  than or equal to 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT less\n                  than or equal to 3.0 ×ULN.\n\n               4. Coagulation profile: PT such that international normalized ratio (INR) is ? 1.55\n                  (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of\n                  therapeutic warfarin or low molecular weight heparin) and a PTT < 1.2 times\n                  control.\n\n          9. ECOG performance status ? 2.\n\n         10. Subjects of child-bearing potential must agree to use contraceptive measures starting\n             1 week before the administration of the first dose of AL3818 until 4 weeks after\n             discontinuing study drug.\n\n         11. Subjects of child-bearing potential must have a negative serum pregnancy test prior to\n             study entry and cannot be lactating.\n\n         12. Ability and willingness to comply with the study protocol for the duration of the\n             study and with follow-up procedures.\n\n        Exclusion Criteria\n\n        Subjects who meet any of the following criteria will be excluded from participation in the\n        study:\n\n          1. Subjects who have received prior treatment with an FGFr inhibitor or antagonist of\n             FGFr. Prior anti-VEGF or anti-angiogenic therapy is allowed in the adjuvant treatment\n             setting Prior anti-VEGF or anti-angiogenic therapy for the treatment of recurrent\n             disease is not allowed.\n\n          2. Patients who have received prior antiangiogenic therapy, including bevacizumab,\n             sorafenib, sunitinib, in the setting of advanced disease.\n\n          3. Patients with serious, non-healing wound, ulcer or bone fracture.\n\n          4. Patients with active bleeding or pathologic conditions that carry high risk of\n             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major\n             vessels.\n\n          5. Patient with history or evidence upon physical examination of CNS disease, including\n             primary brain tumor, seizures not controlled with standard medical therapy, any brain\n             metastases or history of cerebrovascular accident (CVA, stroke) transient ischemic\n             attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment\n             on this study.\n\n          6. However, patients with metastatic CNS tumors may participate in this trial, if the\n             patient is > 4 weeks from therapy completion (including radiation and/or surgery), is\n             clinically stable at the time of study entry and is not receiving corticosteroid\n             therapy.\n\n          7. Patients with proteinuria. Patients discovered to have a urine protein of 1+ on\n             dipstick or ? 30 mg/dl at baseline should undergo a 24-hour urine collection, which\n             must be an adequate collection and must demonstrate < 1000 mg protein/24 hr to allow\n             participation in the study.\n\n          8. Patients with clinically significant cardiovascular disease; this includes:\n             Uncontrolled hypertension; Myocardial infarction or unstable angina within 6 months\n             prior to registration; New York Heart Association (NYHA) Grade II or greater\n             congestive heart failure (Appendix F); Serious cardiac arrhythmia requiring\n             medication; Grade II or greater peripheral vascular disease (Appendix F).\n\n          9. Patients who are pregnant or nursing. To date, no fetal studies of AL3818 in animals\n             or humans have been performed. Therefore, AL3818 should not be administered to\n             pregnant women. Subjects will be apprised of the large potential risk to a developing\n             fetus. It is not known whether AL3818 is excreted in human milk. Because many drugs\n             are excreted in human milk, AL3818 should not be administered to nursing women. Women\n             of childbearing potential must agree to use contraceptive measures during study\n             therapy and for at least 3 months after completion of AL3818 therapy. Because many\n             drugs are excreted in human milk.\n\n         10. Patients with uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.\n\n         11. Hemoptysis within 3 months prior to first scheduled dose of AL3818.\n\n         12. Patients with acute or chronic liver disease, active hepatitis A or B with known\n             cirrhosis or liver dysfunction.\n\n         13. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in\n             cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of AL3818\n             or a major surgical procedure within 28 days or minor surgical procedure performed\n             within 7 days prior to first scheduled dose of AL3818.\n\n         14. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19\n             who cannot be switched to other alternative medications (See Appendix E).\n\n         15. Known history of human immunodeficiency virus infection (HIV).\n\n         16. Subjects with active bacterial infections (other than uncomplicated urinary tract\n             infection) and/or receiving systemic antibiotics.\n\n         17. Patients with other invasive malignancies, with the exception of non-melanoma skin\n             cancer, who had (or have) any evidence of other cancer present within the last 5 years\n             or whose previous cancer treatment contraindicates this protocol therapy.\n\n         18. History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer\n             disease within the past 3-months that in the opinion of the investigator may place the\n             patient at risk of side effects on an anti-angiogenesis product.\n\n         19. History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).\n\n         20. Intra-abdominal abscess within the last 3 months.\n\n         21. History of uncontrolled hypertension that is not well managed by medication, as\n             documented by 2 baseline evaluations taken one hour apart with systolic blood pressure\n             >160 mm or diastolic blood pressure >90 mm Hg pressure, or that in the opinion of the\n             investigator may place the patient at risk when taking a VEGF inhibitor.\n\n         22. Pre-existing uncontrolled hypertension as documented by 2 baseline BP readings taken\n             at least one hour apart, defined as systolic bloodpressure (BP) >160 mm Hg or\n             diastolic BP > 90 mm Hg pressure.\n\n         23. QTcF>470 msec on screening ECG.\n\n         24. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family\n             history of Long QT Syndrome).\n\n         25. The use of concomitant medications that prolong the QT/QTc interval.\n\n         26. Baseline echocardiogram (within 2 months) with left ventricular ejection fraction\n             (LVEF) < 50%.\n\n         27. History of difficulty swallowing, malabsorption, active partial or complete bowel\n             obstruction, or other chronic gastrointestinal disease or condition that may hamper\n             compliance and/or absorption of AL3818.\n\n         28. History of pancreatitis and/or renal disease that includes histologically confirmed\n             glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy,\n             or other renal insufficiencies.\n\n         29. Treatment with an investigational agent within the longest time frame of either 5\n             half- lives or 30 days of initiating study drug.\n\n         30. Known recreational substance abuse.\n\n         31. Known hypersensitivity to anti-angiogenic agents.Xx_NEWLINE_xXPatients with malignant solid tumors must have relapsed after or failed to respond to frontline therapy and there must be no other known curative therapies available. Patients with desmoid fibromatosis must have relapsed after or failed to respond to at least one prior line of therapy, and in the opinion of the treating physician surgical resection of the tumor must not be possible without an amputation or other surgery predicted to result in an unacceptable functional deficit.Xx_NEWLINE_xXSubjects who have received prior Doxil and progressed on this therapy are not eligible, but subjects may have received prior doxorubicin.Xx_NEWLINE_xXSubjects must not have received prior gene therapy or gene-modified cellular immunotherapy; subject may have received, however, non-gene-modified autologous T-cells in association with an anti-myeloma vaccine (e.g., human telomerase reverse transcriptase [hTERT] or melanoma-associated antigen 3 [MAGEA3]) or vaccination against infectious agents (e.g., influenza or pneumococcus) as was performed on our previous studiesXx_NEWLINE_xXNo more than 3 prior progressionsXx_NEWLINE_xXPrior treatment for CaP by surgery, irradiation, local ablative (e.g. cryosurgery or high intensity focused ultrasound) or androgen deprivation therapy.Xx_NEWLINE_xXCurrent therapy with other systemic anti-neoplastic or anti-neoplastic investigational agentsXx_NEWLINE_xXPhase II FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory patients: patients should have a diagnosis of AML (de novo or transformed from hematologic malignancies); patients with high-risk myelodysplastic syndrome (MDS) (defined as having >= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (CMML) (having >= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (PI); the patients should have one of the following features: 1. patients with AML should have failed any prior induction therapy or have relapsed after prior therapy; 2. patients with high-risk MDS or high-risk CMML should have failed any prior therapy for the MDS or CMML; 3. patients with MDS or CMML who received therapy for the MDS or CMML and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML; the World Health Organization (WHO) classification will be used for AMLXx_NEWLINE_xXPatients must be eligible for one of two cohorts: cohort 1 (FLT3 and/or FLT3-D835 inhibitor failure cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens (stem cell transplant [SCT] or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) and have previously been exposed at least one prior FLT3 inhibitor; cohort 2 (FLT3 inhibitor naive cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory who have failed therapy with up to two prior salvage regimens (SCT or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) with no prior exposure to any FLT3 inhibitorXx_NEWLINE_xXPatients with MDS (up to 20% blasts) of any risk as defined as:\r\n* Previously untreated\r\n* Previously treated with hypomethylating agent (HMA) agent; patients need to have relapsed or progressed after any number of cycles of HMA therapy; patients that do not respond to HMA therapy will also be allowed in the study; relapse or progression will be measured by International Working Group (IWG) 2006 criteria; no response will be lack of clinical benefit after at least 6 cycles of HMA therapyXx_NEWLINE_xXCurrent therapy with other systemic anti-neoplastic or anti-neoplastic investigational agentsXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.Xx_NEWLINE_xXHave relapsed or refractory MM after at least one line of therapyXx_NEWLINE_xXPrior therapy with ceritinibXx_NEWLINE_xXPrior therapyXx_NEWLINE_xXMyelosuppressive therapy- At least 14 days must have elapsed since the administration of previous therapy. Six weeks must have elapsed from the administration of nitrosureas or mitomycin C. For patients with ALL on maintenance therapy, they may be eligible if 7 days have elapsed and they are recovered from the toxic effects of the chemotherapy. This restriction does not include intrathecal chemotherapy, which is permitted.Xx_NEWLINE_xXHas primary refractory disease (this is, those whose tumors have progressed at the first restaging during first line therapy)Xx_NEWLINE_xXContraindications for transdermal nicotine patch therapy (TNP)Xx_NEWLINE_xXAny number of lines of prior hormone therapy are allowed\r\n* Patients with clear progression on either tamoxifen or fulvestrant should receive the alternate agent if feasible; if a patient has received both agents in the past, the drug received while on study is at the discretion of the treating physicianXx_NEWLINE_xXFor Part II (Arm C): Patients can have either locally advanced or metastatic pancreas adenocarcinoma; up to two prior treatment regimens are permissible (excluding a prior PARP inhibitor) for either localized or metastatic pancreas adenocarcinoma; prior combined chemotherapy and radiotherapy is permissible provided the patient has measurable disease outside the radiation port; prior therapy must have been completed at least 3 weeks prior to starting study therapyXx_NEWLINE_xXPatients with non-clear cell histology must have received at least one prior anti-cancer therapy; prior rapalogues are allowedXx_NEWLINE_xXHave received CAR-T therapy;Xx_NEWLINE_xXCriteria:\n\n          -  Histologically and/or cytologically confirmed malignant pleural mesothelioma.\n\n          -  Unresectable disease (defined as the participant not being a candidate for curative\n             surgery).\n\n          -  Measurable disease, defined as at least 1 lesion (measurable) that can be accurately\n             assessed at baseline by computed tomography (CT) or magnetic resonance imaging (MRI)\n             and is suitable for repeated assessment (modified RECIST for pleural mesothelioma).\n\n          -  Available unstained archived tumor tissue sample in sufficient quantity to allow for\n             analyses. At least fifteen unstained slides or a tumor block (preferred). NOTE: A fine\n             needle aspiration sample is not sufficient to make the patient eligible for\n             enrollment. Given the complexity of mesothelioma pathological diagnosis and that these\n             will be newly diagnosed patients it is expected that they will have a core needle\n             biopsy or surgical tumor biopsy as part of their initial diagnostic work up.\n\n          -  Age ? 18 years.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\n          -  Ability to understand and willingness to sign Institutional Review Board\n             (IRB)-approved informed consent.\n\n          -  Willing to provide archived tumor tissue and blood samples for research.\n\n          -  Adequate organ function as measured by the following criteria, obtained ? 2 weeks\n             prior to registration:\n\n               -  Absolute Neutrophil Count (ANC) ? 1500/mm³\n\n               -  Hemoglobin ?9.0 g/dL\n\n               -  Platelets ?100,000/mm³\n\n               -  Serum creatinine clearance (CL)>60 mL/min by the Cockcroft-Gault formula or by\n                  24-hour urine collection for determination of creatinine clearance. NOTE:\n                  Patients with a creatinine Cl ? 45 mL/min however ? 60 mL/min may be considered\n                  for enrollment provided they fulfill all other eligibility criteria, these\n                  subjects will receive pemetrexed carboplatin concurrent with durvalumab during\n                  the combination phase of treatment. Patients with a creatinine CL<45 mL/min\n                  should not be enrolled.\n\n               -  Albumin ? 2.8 g/dL\n\n               -  Total Bilirubin ? 1.5x Upper Limit of Normal (ULN)\n\n               -  Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ? 2.5x ULN (? 5x\n                  ULN in patients with liver metastases)\n\n          -  Women must either be of non-reproductive potential or must have a negative serum\n             pregnancy test upon study entry.\n\n          -  Women must not be pregnant or breastfeeding.\n\n          -  Patient is willing and able to comply with the protocol for the duration of the study\n             including undergoing treatment and scheduled visits and examinations including\n             follow-up.\n\n          -  Patient must not have involvement in the planning and/or conduct of the study. No\n             previous enrollment in the present study.\n\n          -  Patients may not have participated in another clinical study with an investigational\n             product during the last 4 weeks.\n\n          -  Patients must not have any prior systemic therapy (chemotherapy, immunotherapy,\n             endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal\n             antibodies, and other investigational agent) for mesothelioma.\n\n          -  No previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or any other\n             agent targeting immune checkpoints.\n\n          -  Patients must not have non-pleural mesothelioma e.g. mesothelioma arising in\n             peritoneum, tunica vaginalis or any serosal surface other than the pleura.\n\n          -  Patients must not have an active second malignancy other than non-melanoma skin cancer\n             or cervical carcinoma in situ.\n\n          -  Patients must not have mean QT interval corrected for heart rate (QTc) ?470 ms\n             calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction.\n\n          -  Patients must not have symptomatic or uncontrolled brain metastases requiring\n             concurrent treatment, inclusive of but not limited to surgery, radiation and/or\n             corticosteroids (prednisone >10 mg or equivalent). Surgery, radiation and/or\n             corticosteroids (any dose >10 mg prednisone equivalent) must have been completed ? 2\n             weeks prior to registration.\n\n          -  Patients must not have uncontrolled seizures.\n\n          -  Patients must not have current or prior use of immunosuppressive medication within 28\n             days before the first dose of durvalumab, with the exceptions of intranasal and\n             inhaled corticosteroids or systemic corticosteroids at physiological doses, which are\n             not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Standard\n             steroid premedication given prior to chemotherapy or as prophylaxis for imaging\n             contrast allergy should not be counted for this criterion.\n\n          -  No active or prior documented autoimmune or inflammatory disorders (including\n             inflammatory bowel disease, diverticulitis with the exception of diverticulosis,\n             celiac disease, irritable bowel disease; Wegner syndrome) within the past 2 years.\n             Subjects with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic\n             treatment (within the past 3 years) are not excluded.\n\n          -  No history of primary immunodeficiency.\n\n          -  No history of allogeneic organ transplant.\n\n          -  No history of hypersensitivity to durvalumab, cisplatin, carboplatin, pemetrexed or\n             any of their excipients.\n\n          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable\n             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active\n             bleeding diatheses including any subject known to have psychiatric illness/social\n             situations that would limit compliance with study requirements or compromise the\n             ability of the subject to give written informed consent.\n\n          -  No active infection including tuberculosis (clinical evaluation including: physical\n             examination findings, radiographic findings, positive PPD test, etc.), hepatitis B\n             (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human\n             immunodeficiency virus (positive HIV 1/2 antibodies as defined by a positive ELISA\n             test). Patients with a past or resolved HBV infection (defined as the presence of\n             hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients\n             positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction\n             is negative for HCV RNA. HIV testing is not required in absence of clinical suspicion.\n\n          -  No known history of leptomeningeal carcinomatosis.\n\n          -  Patients must not have received live attenuated vaccination within 30 days prior to\n             study entry or within 30 days of receiving durvalumab.\n\n          -  Patients must not have any condition that, in the opinion of the investigator, would\n             interfere with evaluation of study treatment or interpretation of patient safety or\n             study results.Xx_NEWLINE_xXPrior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitorsXx_NEWLINE_xXPrior therapy(ies), if applicable, must be completed according to the criteria below:Xx_NEWLINE_xXHave Chronic Phase Chronic Myeloid Leukemia (CP-CML) and have received at least two prior tyrosine-kinase inhibitor (TKI) therapies and have demonstrated resistance to treatment OR have documented history of presence of T3151 mutation after receiving any number of prior TKI a. The diagnosis of CML will be made using standard hematopathologic and cytogenetic criteria; CP-CML will be defined by all of the following: i) < 15% blasts in bone marrow ii) < 30% blasts plus promyelocytes in bone marrow iii) < 20% basophils in peripheral blood iv) ? 100 × 109/L platelets (? 100,000/mm^3) v) No evidence of extramedullary disease except hepatosplenomegaly vi) No prior diagnosis of accelerated phase (AP-CML), and blastic phase (BP-CML) b. Cytogenetic assessment at screening must demonstrate the BCR-ABL1 fusion by presence of the t(9;22) Philadelphia chromosome i) Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques c. Resistance to prior TKI therapy is defined as follows (participants must meet at least 1 criterion): i) Three months after the initiation of prior TKI therapy: No cytogenetic response (> 95% Ph+) or failure to achieve complete hematologic response (CHR) or new mutation ii) Six months after the initiation of prior TKI therapy: BCR-ABL1IS >10% and/or Ph+ >65% or new mutation iii) Twelve months after the initiation of prior TKI therapy: BCR ABL1IS >10% and/or Ph+ >35% or new mutation. iv) At any time after the initiation of prior TKI therapy, the development of a new BCR-ABL1 kinase domain mutation(s). v) At any time after the initiation of prior TKI therapy, the development of new clonal evolution vi) At any time after the initiation of prior TKI therapy, the loss of CHR, or complete cytogenic response (CCyR), or the confirmed loss of molecular response rate (MRR) in 2 consecutive tests, one of which has a BCR-ABL1IS transcript level of ?1% or new mutation d. > 1% of BCR-ABL1IS as shown by real-time polymerase chain reactionXx_NEWLINE_xXCompleting SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)Xx_NEWLINE_xXMaintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization. No cancer vaccine therapy is allowed.Xx_NEWLINE_xXKnown allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) responseXx_NEWLINE_xXInclusion Criteria:\n\n        Adult male or female subjects with pathologically confirmed MDS who failed to respond,\n        relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG\n        performance status of 0 - 2, and adequate organ and marrow function.\n\n        Exclusion Criteria:\n\n        Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment,\n        prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current\n        immunosuppressive medication or autoimmune or inflammatory disease.Xx_NEWLINE_xXPrior CAR therapy or other genetically modified T cellsXx_NEWLINE_xXInadequate washout from prior therapyXx_NEWLINE_xXSteroid therapy for anti-neoplastic intent within 5 daysXx_NEWLINE_xXMust have evidence of either RECIST 1.1 defined disease progression or stable disease 1 year after initiating nivolumab therapyXx_NEWLINE_xXInclusion Criteria:\n\n        To be eligible for the study, patients must meet ALL of the following criteria prior to\n        enrollment in the study:\n\n          1. Must be ? 18 years of age at the time of consent.\n\n          2. Must have recurrent, metastatic, or persistent squamous cell carcinoma, adenosquamous\n             carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment\n             with surgery and/or radiation therapy and for which no other therapies are expected to\n             have significant benefit, in the opinion of the Investigator.\n\n          3. Must have at least 1 lesion that is resectable for TIL generation. The resected TIL\n             generating lesion(s) should yield at least 1.5 cm in diameter post-resection of tumor\n             tissue. Following resection for TIL generation, must have a remaining measurable\n             target lesion as defined by RECIST v1.1\n\n          4. Must have had at least 1 and no more than 3 prior systemic chemotherapeutic treatments\n             (such as carboplatin/cisplatin, paclitaxel, and bevacizumab except where there are\n             contraindications) for cervical carcinoma. Patients must have progressive disease\n             while receiving or after the completion of the most recent prior treatment.\n\n          5. Any prior therapy directed at the malignant tumor must be discontinued at least 28\n             days prior to tumor resection. Radiation therapy may have been received up to 28 days\n             prior to tumor resection for lesions not expected to be used for TIL generation or\n             target lesions.\n\n          6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n          7. Patients must be seronegative for the human immunodeficiency virus (HIV). Patients\n             with positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis B core\n             antibody (anti-HBc), or hepatitis C virus (anti-HCV) indicating acute or chronic\n             infection may be enrolled if the viral load by polymerase chain reaction (PCR) is\n             undetectable with/without active treatment.\n\n          8. Patients of childbearing potential must be willing to practice an approved method of\n             birth control starting at the time of informed consent and for 1 year after the\n             completion of the study treatment regimen.\n\n        Exclusion Criteria:\n\n          1. Patients who have received an organ allograft or prior cell transfer therapy except\n             for prior LN-145 therapy.\n\n          2. Patients who are on a systemic steroid therapy > 10 mg of prednisone daily or other\n             steroid equivalent.\n\n          3. Patients who currently have prior therapy-related toxicities greater than Grade 1\n             according to NCI-CTCAE v4.03; except for peripheral neuropathy, alopecia, or vitiligo\n             prior to enrollment/resection.\n\n          4. Patients who have a contraindication to or history of hypersensitivity reaction to any\n             component or excipients of the TIL therapy and the other study drugs.\n\n          5. Patients with active systemic infections, coagulation disorders or other active major\n             medical illnesses of the cardiovascular, respiratory, or immune system.\n\n          6. Patients with symptomatic and/or untreated brain metastases (of any size and any\n             number).\n\n          7. Patients who have any form of primary or acquired immunodeficiency syndrome, such as\n             severe combined immunodeficiency disease or acquired immune deficiency syndrome\n             (AIDS).\n\n          8. Patients who have a diagnosis of end-stage renal disorder requiring hemodialysis.\n\n          9. Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New\n             York Heart Association (NYHA) Class 2 or higher.\n\n         10. Patients who have a forced expiratory volume in 1 second (FEV1) of less than or equal\n             to 60% of predicted normal.\n\n         11. Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD\n             regimen.\n\n         12. Patients whose cancer requires immediate treatment or who would otherwise suffer a\n             disadvantage by participating in this study.\n\n         13. Patients who have received prior treatment with immunotherapy (eg, anti-PD-1\n             anti-PD-L1, or anti-CTLA4 antibodies)Xx_NEWLINE_xXPatients must meet one of the three treatment history criteria:\r\n* Relapsed AML who have failed at least 1 line of salvage therapy\r\n* De novo AML who have not achieved CR after 2 lines of therapy\r\n* AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agent or induction chemotherapy\r\n* Patients who have relapsed after allogeneic hematopoietic cell transplant (HCT) are eligible if they are at least 3 months after HCT, do not have active graft vs. host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg/day or less)Xx_NEWLINE_xXFor the combination cohorts (cohorts 5 and 6 in Part 1) and Part 2, subjects with metastatic melanoma or NSCLC do not need to have received prior therapyXx_NEWLINE_xXSubjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent or planned systemic anti-cancer therapy, with the exception of immunotherapy in the combination cohorts (Cohorts 5 and 6 in Part 1 and all subjects in Part 2).Xx_NEWLINE_xXRefractory or relapsed myeloma, defined as one or more of the following: \r\n* Treated with first-line therapy including at least 2 cycles of lenalidomide, bortezomib or thalidomide, and one or more of the following: \r\n** Less than partial response (PR) to first-line therapy\r\n** Relapse after first (1st) line therapy\r\n* High-risk cytogenetics, defined by deletion (del)(13q) by conventional cytogenetics, or by del(17p), t(4;14), t(14;16), t(14;20) or 1q+ by fluorescence in situ hybridization (FISH)\r\n* Relapse after a prior autologous stem cell transplant (ASCT)\r\n* Plasma cell leukemia\r\n* Soft tissue plasmacytomaXx_NEWLINE_xXFailure of at least one line of systemic anti-cancer therapy for advanced NSCLC defined as either of the following: \r\na) Radiological documentation of disease progression (or failure to achieve a response) or \r\nb) Discontinuation due to toxicityXx_NEWLINE_xXPatients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.Xx_NEWLINE_xXAny antibiotic therapy or evidence of infection within 1 week of registrationXx_NEWLINE_xXNOTE: There is no exclusion for prior immune-based therapy; this includes patients previously treated on Arms 1 or 2 who are otherwise eligible for treatment on Arm 3 or 4Xx_NEWLINE_xXAny concurrent active malignancies, defined as malignancies requiring any therapy other than expectant observation, since adverse events resulting from these malignancies or their treatment may confound our assessment of the safety of adoptive T cell therapy for ovarian cancerXx_NEWLINE_xXARM B COHORT 3: Patients must have failed one prior line of systemic therapy for the treatment of advanced non-small cell lung cancer; prior adjuvant therapy with subsequent recurrence within 6 months of completion of therapy will count as one prior line of systemic therapy and such patients will be eligibleXx_NEWLINE_xXARM B COHORT 3: Patients must not have had more than one prior line of systemic therapy for advanced non-small cell lung cancer (including treatment with a targeted agent); prior adjuvant therapy completed more than 6 months prior to disease recurrence will not count as a prior line of systemic therapy for advanced diseaseXx_NEWLINE_xXNewly diagnosed Philadelphia chromosome-positive (Ph+) ALL, previously untreated, except for the below allowances:\r\n* Previously received hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone (HyperCVAD) cycle 1A +/- cycle 1B\r\n* Previously received induction phase I +/- induction phase II of Berlin-Frankfurt-Munster (BFM)-modeled (pediatric or pediatric-inspired) ALL regimen\r\n* Previously received other representative (modified from HyperCVAD, BFM, or AML-like) ALL induction course, including ABL tyrosine-kinase inhibitor (TKI) plus corticosteroid\r\n* If the patient has received any of the above prior therapy, they may be enrolled, regardless of remission statusXx_NEWLINE_xXUnable to tolerate anti-viral and anti-Pneumocystis jirovecii prophylaxis while on pre-phase and remission induction therapyXx_NEWLINE_xXUnable to tolerate gastrointestinal prophylaxis therapy with sucralfate while on pre-phase and remission induction therapy; or severe pre-existing gastrointestinal (GI) disorder that requires peptidylprolyl isomerase (PPI) or histamine H2 (H2) receptor antagonist therapy be uninterruptedXx_NEWLINE_xXPlanned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapyXx_NEWLINE_xXOngoing treatment with hormonal agents (e.g. finasteride, dutasteride, ketoconazole, hormonal birth control, estrogen replacement therapy, testosterone replacement therapy) or herbal products that may have hormonal activity (saw palmetto, black cohosh); patients taking these agents are eligible for screening, but must be willing to undergo a washout period of 4 weeks prior to starting study treatmentXx_NEWLINE_xXAny hormonal therapy directed at the malignant tumor must be discontinued at least 7 days prior to registration; continuation of hormone replacement therapy is permittedXx_NEWLINE_xXPrior therapy with monoclonal antibody (mAb) against CTLA-4Xx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients are allowed to have received prior PARP inhibitors (PARPi), and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible; for this study, BSI-201 (iniparib) is not considered as PARPiXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients are allowed to have received prior anti-angiogenesis therapy with the exception of prior cediranibXx_NEWLINE_xXSystemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y therapy doseXx_NEWLINE_xXAbsence of human anti?mouse monoclonal antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)Xx_NEWLINE_xXNo known effective therapy options are availableXx_NEWLINE_xXPrior GEM therapy is acceptable as long as the last dose was >= 3 months from registration on this studyXx_NEWLINE_xXFor subjects enrolled in the Anastrozole Arm, prior hormonal therapy (including, but not limited to, tamoxifen, megestrol acetate, fulvestrant, and GnRH analogs) for the treatment of recurrent/advanced endometrial cancer are not allowedXx_NEWLINE_xXPrevious therapy with regorafenibXx_NEWLINE_xXPatients with recurrent/relapsed AA will be eligible for the trial as long as they were not previously refractory to hATG-based therapy and the relapse occurred > 3 months after response.Xx_NEWLINE_xXMore than three lines of prior therapy.Xx_NEWLINE_xXKnown HIV-positivity on combination antiretroviral therapy because of the unknown potential for pharmacokinetic interactions with indoximod, or docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy.Xx_NEWLINE_xXReceived at least one dose of an anthracycline-based NACT; patients are eligible if therapy was discontinued due to disease progression or therapy intoleranceXx_NEWLINE_xXPrior therapy with bevacizumab, liposomal doxorubicin, or everolimusXx_NEWLINE_xXSubject has any acute infection that requires specific therapy; acute therapy must have been completed within seven days prior to study enrollmentXx_NEWLINE_xX< grade 2 acute graft versus host disease (GVHD) at time of the first NK cell-enriched DLI; patients with treated acute GVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned NK cell-enriched DLIs); the dosage/level of immunosuppressive therapy at the time of NK-DLIs should be no greater than 20mg of prednisone daily or mycophenolate 500 mg bid daily or cyclosporine with a target level of 200 ng/mL or tacrolimus with a target level of 10 ng/mlXx_NEWLINE_xXHave had second-line hormonal therapy (abiraterone, ketoconazole, and/or Tak-700, etc.) within two weeks prior to the first dose of study drug; patients require a two-week wash out; patients may continue standard supportive dosing of prednisone and hydrocortisone for abiraterone and ketoconazole, respectively, as neededXx_NEWLINE_xXIs expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXHave had prior enzalutamide, ARN-509, or galeterone therapyXx_NEWLINE_xXHave received any anti-pancreatic cancer therapy (symptomatic therapies are allowed)Xx_NEWLINE_xXPatients may not have received more than 3 prior regimens, where the regimen intent was to induce remissionXx_NEWLINE_xXUse of hormonal therapy or androgen deprivation therapy, including enzalutamide, except in the following setting:Xx_NEWLINE_xXPatients can be on androgen deprivation therapyXx_NEWLINE_xXPatients with brain metastasis will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning MK-3475 therapyXx_NEWLINE_xXPrior induction therapy with decitabine, clofarabine, idarubicin (DAC) + cytarabine (CIA)Xx_NEWLINE_xXPatients must have documentation of a defined initial progression free interval (PFI 1) of greater than 6 months following front-line therapyXx_NEWLINE_xXConcurrent administration of any other antitumor therapy.Xx_NEWLINE_xXPatient has newly diagnosed disease with no prior therapyXx_NEWLINE_xXPatients whose primary therapy was changed due to suboptimal response or toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCTXx_NEWLINE_xXPatients must have had at least one prior therapy to be eligible for either phase I or II, unless they are either not candidates for or refuse cisplatin-based therapyXx_NEWLINE_xXPatients with previously treated B-cell ALL (relapsed and/or refractory after prior therapy)Xx_NEWLINE_xXSystemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy; for patients receiving ALL maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs; for patients on oral targeted therapies (such as imatinib, dasatinib, ponatinib), - these agents should be discontinued at least 48 hours prior to start of study drugsXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatients must have histologically or cytologically confirmed diagnosis of stage IIIB or stage IV of non-small cell lung cancer and have received at least two lines of Food and Drug Administration (FDA)-approved or National Comprehensive Cancer Network (NCCN) accepted systemic therapy and progressed through, or not tolerated, such therapy; all subjects which harbor specific mutations, such as endothelial growth factor receptor (EGFR) deletion mutation of anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements, for which an acceptable targeted therapy exists, at least one of the lines of therapy must be such targeted therapy, unless the subject is not a candidate for the targeted therapy or unable to tolerate that therapy as determined by the treating physician\r\n* Subjects whose tumors harbor an exon 19 deletion or exon 21L858R EGFR mutation must have progressed on or had intolerance to EGFR tyrosine kinase inhibitor\r\n* Subjects whose tumors harbor an AKL translocation must have progressed on or had intolerance to crizotinib (or any FDA approved ALK inhibitor) ORXx_NEWLINE_xXBeen treated with appropriate maximal medical therapy for heart failureXx_NEWLINE_xXPatients must previously have received at least one prior line of therapy for their diseaseXx_NEWLINE_xXUse of any of the following after transplantation and prior to starting study therapy:Xx_NEWLINE_xXChemotherapeutic agents for therapy of AML (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for GVHD)Xx_NEWLINE_xXARM 1 SALVAGE COHORT: Patients with AML or biphenotypic or bilineage leukemia who have failed prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy will be eligible for Arm 1;Xx_NEWLINE_xXARM 1 AND 2 FRONT LINE OLDER COHORT: Patients age 65 years and above with previously untreated AML (>= 20% blasts) who are unfit for or decline standard induction therapy; prior therapy with hydroxyurea, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed; patients may have received one dose of cytarabine (up to 2 g/m2 administered at presentation for control) of hyperleucocytosis; the frontline cohort of vidaza+nivolumab+ipilimumab and vidaza+nivolumab will be open simultaneously and we will enroll alternately to these two frontline protocols with close monitoring for futility and as specified in the predefined statistical futility and toxicity stopping rulesXx_NEWLINE_xXIn the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of 5-azacytidine and nivolumab will be at least 2 weeks OR at least 5 half-lives for cytotoxic/noncytotoxic agents; the half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure’s, or drug-administration manuals) and will be documented in the protocol eligibility document; since the effect of both nivolumab and 5-azacytidine may be delayed; use of one dose of cytarabine (up to 2 g/m2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and during the study treatment; concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permittedXx_NEWLINE_xXPrior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapyXx_NEWLINE_xXSubject’s current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXPrior systemic therapy is allowed, although appropriate washout is required for patients who have been on BRAF inhibitors (at least 7 days)Xx_NEWLINE_xXFor subjects currently on active systemic cancer therapy, the treating medical oncologist should be consulted to ensure proper washout (if appropriate) periods prior to SRSXx_NEWLINE_xXPatients must not have received prior therapy with dasatinib and temsirolimus for any indicationXx_NEWLINE_xXPatients must meet one of the following criteria:\r\n* The presence of refractory or progressive disease (PD) prior to or following completion of standard therapy for MIBG avid tumors\r\n* For patients with neuroblastoma, the presence of mixed response (MR), or no response (NR) following the completion of A3973 or equivalent induction therapy, or the presence of a partial response (PR) with high Curie score (> 2) following induction therapy \r\n* Patients with de novo high risk neuroblastoma who have completed standard induction therapy and do not achieve a complete response (CR), very good partial response (VGPR), or PR with low Curie score post induction are eligible; for patients with neuroblastoma the revised International Neuroblastoma Response Criteria (INRC) shall be used to assess pre-treatment disease statusXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapy; any significant organ impairment should be discussed with the study chair prior to patient entryXx_NEWLINE_xXPatients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBGXx_NEWLINE_xXPrior anthracycline therapy does not exceed 200 mg/m^2 total cumulative doseXx_NEWLINE_xXRelapsed/refractory disease that has failed conventional therapy and other therapies of higher priorityXx_NEWLINE_xXPatients must have relapsed (recurrence after complete response or presented progression after partial response) after last rituximab-containing therapy (other previous treatment lines after rituximab are allowed). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy is allowed for patients who responded to single-agent rituximab); at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible.Xx_NEWLINE_xXProgression of disease must be documented prior to study entryXx_NEWLINE_xXCutaneous T-cell lymphomas (mycosis fungoides, Sezary syndrome)\r\n* >= stage III\r\n* Disease progression >= 2 prior regimens, including at least one systemic therapyXx_NEWLINE_xXPatient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.Xx_NEWLINE_xXPatients may not have had prior SGT-53. Patient who have received prior topotecan, cyclophosphamide, or both are eligible.Xx_NEWLINE_xXPatient deemed eligible for complete androgen blockade, and androgen deprivation therapy by treating physician (this includes consideration of baseline liver function prior to initiation of therapy, if necessary at physician’s discretion); for patients not eligible for anti-testosterone therapy, hormone therapy with gonadotrophin releasing hormone (LHRH) agonist alone will be permitted on case by case by study principal investigator; AS can be any LHRH agonists, LHRG antagonists or anti-androgens that are approved for androgen suppression for the treatment of prostate cancerXx_NEWLINE_xXThere must be no plans for the patient to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, 2nd generation anti-androgen therapy (i.e. enzalutamide, abiraterone, etc.), or chemotherapy given as part of the treatment of prostate cancerXx_NEWLINE_xXPatients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollmentXx_NEWLINE_xXAny systemic anti-cancer therapy within 3 weeks prior to course 1 day 1 (C1D1) of study therapy\r\n* Exception is made for patients with EGFR or ALK re-arrangements who must have stopped TKI therapy at least 7 days prior to C1D1Xx_NEWLINE_xXPrior therapy with >= 1 prior systemic therapy over a period of at least 2 months (eg, at least two 4-week cycles of a regimen such as gemcitabine and nab-paclitaxel; or at least four 2-week cycles of a regimen such as fluorouracil/leucovorin calcium/oxaliplatin [FOLFOX], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin [FOLFIRINOX], or folinic acid-fluorouracil-irinotecan [FOLFIRI])Xx_NEWLINE_xXPatients who have received a vaccine for HIV-1 or any prior gene modified cell product, at any timeXx_NEWLINE_xXStudy specific limitations on prior therapy:\r\n* Patients who have received poly-ICLC are eligible for this trial if all acute poly-ICLC -related toxicity has resolved\r\n* Patients must not have received pegylated interferon previouslyXx_NEWLINE_xXDisease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.Xx_NEWLINE_xXPrior treatment of B-NHL with radiation therapy, non-standard systemic therapy, or antibiotics (in cases of MZL) within 21 days of the first dose of ixazomibXx_NEWLINE_xXMore than 2 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimusXx_NEWLINE_xXPatients who have received more than one prior line of EGFR TKI therapy1 (applies only to Group 1)Xx_NEWLINE_xXPatients who have received prior everolimus or ceritinibXx_NEWLINE_xXPrior systemic therapyXx_NEWLINE_xXProgressive disease or sites of new metastasis after definitive therapy for oligometastatic diseaseXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXNo prior genetically modified cell therapy that is still detectable or prior virotherapyXx_NEWLINE_xXInclusion:\n\n          1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a\n             candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.\n\n          2. Patients may have received one prior treatment regimen with crizotinib (all other ALK\n             inhibitors are excluded).\n\n          3. Patients may have received prior chemotherapy, biologic therapy, or other\n             investigational agents. ALK inhibitors other than crizotinib are excluded.\n\n          4. Patient has a World Health Organization (WHO) performance status 0-2.\n\n        Exclusion:\n\n          1. Prior treatment with an ALK inhibitor other than crizotinib.\n\n          2. History of carcinomatous meningitis.\n\n          3. Presence or history of a malignant disease other than an ALK-positive advanced tumor\n             that has been diagnosed and/or required therapy within the past 3 years.\n\n        5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6\n        months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis,\n        including clinically significant radiation pneumonitis (i.e., affecting activities of daily\n        living or requiring therapeutic intervention).\n\n        7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently\n        receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative\n        anticoagulants.Xx_NEWLINE_xXPatients with EGFR mutations or ALK rearrangements must have disease progression on appropriate Food and Drug Administration (FDA)-approved therapy for these genomic aberrations prior to enrollmentXx_NEWLINE_xXHormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registrationXx_NEWLINE_xXPrior therapy with ceritinibXx_NEWLINE_xXPrior local therapy, such as surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment; local therapy must have been completed at least 4 weeks prior to the baseline scanXx_NEWLINE_xXNo concurrent herbal or unconventional therapy (e.g., St. John's wort)Xx_NEWLINE_xXPreviously treated for advanced cancer with no additional therapy options available known to prolong survivalXx_NEWLINE_xXAny history of systemic anti-cancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpointsXx_NEWLINE_xXUnresolved immune-related adverse events following prior biological therapyXx_NEWLINE_xXSubjects with any acute infection or severe or uncontrolled that requires systematic antibiotic therapy; acute therapy must have been completed at least seven days prior to study enrollmentXx_NEWLINE_xXPersistent or recurrent adenovirus infection or disease despite at least 7 days of standard therapy or failure of therapy as described below or if unable to tolerate standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function. i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by polymerase chain reaction (PCR) or culture from ONE site, such as stool or blood or urine or nasopharynx. ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, Direct fluorescent assay (DFA) or culture from two or more sites such as stool or blood or urine or nasopharynx. iii. Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR (or any other quantitative assay) after 7 days of antiviral therapy.Xx_NEWLINE_xXPatients who have received prior FGFR targeted therapyXx_NEWLINE_xXChronic corticosteroid dependence (except replacement therapy)Xx_NEWLINE_xXIn the phase I portion of the study all patients with relapsed or refractory AML are eligible; for the Phase II portion of the study, patients must have AML progressing from prior MPN (MPN-BP) or have myelodysplastic syndrome (MDS)/MPN with more than 20% blasts; temporary prior measures to control blood counts, such as apheresis or Hydrea are allowed; patients with newly diagnosed or previously treated disease are eligible as long as prior therapy does not include hypomethylating agents; prior therapy for ruxolitinib for MPN is allowedXx_NEWLINE_xXPatients with brain metastasis will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning ipilimumab therapyXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)Xx_NEWLINE_xXTherapy with CPI-613 prior to participating in this trialXx_NEWLINE_xXPrior BRAF or mitogen-activated protein kinase kinase (MEK) directed therapy; patients who have received prior interferon are eligibleXx_NEWLINE_xXPatients with another active malignancy; asymptomatic sites of disease are not considered active; treated or untreated sites of disease may be considered inactive if they are stable for at least 2 months and are not expected to require therapy for 4 monthsXx_NEWLINE_xXArms 1E: previously treated with and progressed on gemcitabine-containing therapyXx_NEWLINE_xXHad eculizumab therapy within three months prior to screeningXx_NEWLINE_xXNewly-diagnosed chemo-naive or recurrent after curative-intent surgery\r\n* >= 6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy)\r\n* No prior treatment with any targeted agent\r\n* Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening\r\n** These patients will be required to meet ‘next cycle’ parameters for eligibility before commencing treatment on trial rather than being required to meet parameters as indicated below which is for previously untreated metastatic/recurrent patientsXx_NEWLINE_xXPatients can have had prior treatment for RCC including prior surgery, radiation therapy, immunotherapy with interleukin (IL)-2 or interferon (but not anti-programmed cell death [PD]1 or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), target therapy with receptor tyrosine kinase (RTK) inhibitors/mammalian target of rapamycin (mTOR) inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus, and temsirolimus (but not bevacizumab) or chemotherapyXx_NEWLINE_xXPatients must not have received prior anticancer therapy with bevacizumab, anti-CLTA-4, or anti-PD1 for renal cell carcinoma; patients receiving any concomitant systemic therapy for renal cell cancer are excludedXx_NEWLINE_xXPersistent CMV infection despite optimum anti-viral therapy\r\n* Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates; OR \r\n* Failure of antiviral therapy: defined as the continued presence of deoxyribonucleic acid (DNA)emia (defined as >= 137 copies/ml by polymerase chain reaction [PCR]) for at least 2 weeks of CMV antiviral therapy; OR \r\n** Optimum therapy is defined as at least 14 days of therapy with ganciclovir, foscarnet, cidofovir, or valganciclovir for patients with disease or CMV viremia\r\n** Relapse while on CMV antiviral therapy defined as recurrence of DNAemia while being on at least 2 weeks of antiviral therapy OR\r\n* Patients who cannot tolerate standard anti-viral therapy and cannot continue anti-viral treatment due to side effect profile will be eligible independent of anti-viral therapy durationXx_NEWLINE_xXPrior systemic therapy for pancreatic cancerXx_NEWLINE_xXPatients must be anticipated to complete 2 cycles of therapy in the opinion of the treating physicianXx_NEWLINE_xXCandidate for neoadjuvant endocrine therapyXx_NEWLINE_xXPrior therapy with neural stem cellsXx_NEWLINE_xXUnwilling to undergo anti-endocrine therapyXx_NEWLINE_xXRefractory disease (i.e. less than a partial response to frontline therapy)Xx_NEWLINE_xXPrior therapy with fenretinide and/or fenretinide + ketoconazole is allowed if no DLT's were experienced. Prior therapy with other retinoidsXx_NEWLINE_xXPatients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollmentXx_NEWLINE_xXPatients on bisphosphonates, denosumab, and/or endocrine therapy are eligibleXx_NEWLINE_xXDocumentation of recurrence/progression/residual disease following prior therapyXx_NEWLINE_xXCurrent use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study; (note: megestrol [Megace] if used as an appetite stimulant is allowed; thyroid-stimulating hormone [TSH] suppressive therapy is also allowed; palliative radiation therapy to non-target lesions is also allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)Xx_NEWLINE_xXInability to tolerate first-line treatment with sorafenib (e.g., unacceptable toxicity), tumor progression on sorafenib, patient preference to stop sorafenib and for alternative therapy/trial, or patient preference to forgo sorafenib for alternative therapy/trial\r\n* Note:\r\n** Unacceptable toxicities due to sorafenib include, but are not limited to, the following drug-induced adverse events including: hepatitis, skin rash (grade 3 or higher), hypertension (grade 3 or higher), hand-foot skin reaction (grade 3 or higher), QT prolongation (grade 3 or higher), and/or diarrhea (grade 3 or higher)\r\n** Patient preference to stop sorafenib for alternative therapy/trial will include the following indications: the aforementioned adverse events at lesser grades for which the patient is unwilling to continue therapy, as well as situations in which the patient deems the side effects to be intolerable with their quality of life; examples include, but are not limited to, intolerable nausea, vomiting, abdominal pain, fatigue, loss of appetite, and weight loss\r\n** Patient preference to forgo sorafenib for alternative therapy/trial is based upon the patients' right for autonomy; this allows them to refuse or choose their treatment; the practitioner will always act in the best interest of the patient and recommend that the patient start with known life-prolonging therapies before enrolling in a clinical trial of an investigational agent that has not been determined to be safe and effective in patients with liver cancerXx_NEWLINE_xXAble to start the protocol therapy (1st dose of rituximab) between day 28-60 post-transplantXx_NEWLINE_xXFirst episode of recurrent disease following completion of aggressive multi-drug frontline therapy.Xx_NEWLINE_xXFirst episode of progressive disease during aggressive multi-drug frontline therapy.Xx_NEWLINE_xXCurrent disease state must be one for which there is currently no known curative therapy or no additional therapies proven to prolong survival with an acceptable quality of life.Xx_NEWLINE_xXIf newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours prior to start of study therapy is allowedXx_NEWLINE_xXExpected to require any other form of antineoplastic therapy while on studyXx_NEWLINE_xXReceipt of no, or of >1, prior systemic drug therapies for HCC.Xx_NEWLINE_xXPrior allograft or prior autograftXx_NEWLINE_xXWillingness to forego additional therapy until evidence of disease progressionXx_NEWLINE_xXFor frontline cohort: no prior potentially curative therapy for leukemia; prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, tretinoin (ATRA), or a total dose of cytarabine up to 2 g (for emergency use for stabilization) is allowedXx_NEWLINE_xXPatients may be previously untreated or have received up to 3 prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use in the adjuvant or metastatic disease settings is permitted (in this trial interferon is mainly used to enhance or initiate immune responses to MK-3475); vaccine therapy will not be counted as systemic therapy; all prior therapies must have been discontinued for at least 4 weeks; a 2 week washout for kinase inhibitors is acceptableXx_NEWLINE_xXPatient is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXCytoreduction therapy with plasmapheresis or hydroxyurea acceptableXx_NEWLINE_xXMore than 2 cycles of prior induction therapy for AMLXx_NEWLINE_xXAdenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy; standard therapy is defined as antiviral therapy with cidofovir^13 or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function\r\n* Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx\r\n* Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, direct fluorescent antibody (DFA) or culture from two or more sites such as stool or blood or urine or nasopharynx\r\n* Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapyXx_NEWLINE_xXPatients who received more than one full course of prior hypomethylating agents azacitidine or decitabineXx_NEWLINE_xXPatients progressing on LHRH agonist plus an anti-androgen as first line therapy must be off anti-androgen for 4 weeks prior to first treatment with testosteroneXx_NEWLINE_xXPrior seizures while on enzalutamide therapyXx_NEWLINE_xXPHASE II -- Patients aged 60 and older with newly diagnosed primary or secondary AML according to WHO classification, without any prior therapy for AML with the exception of (a) emergency leukapheresis and (b) emergency treatment for hyperleukocytosis with hydroxyurea that is allowed until 24 hours before start of the trial treatment; Note: prior therapy for preexisting hematological condition e.g. MDS or myeloproliferative disease (MPD), including but not limited to hypomethylating agents is allowed until at least 2 weeks have elapsed from completion of that agent before the first dose of MEK 162; patients with relapsed AML, and relapsed MDS and CMML, after prior hypomethylating therapy are also eligible to participateXx_NEWLINE_xXInclusion Criteria\n\n        -Male or female patients ?18 years of age who present with one of the following:\n\n        LGH447 monotherapy arm\n\n          -  Refractory/Relapsed AML following no more than 2 prior therapies, or in previously\n             untreated AML patients who are not candidates for standard therapy.\n\n          -  High and very high risk MDS according to the revised International Prognostic Scoring\n             System (rIPSS) who have failed prior therapies, such as azacitidine and decitabine\n\n          -  Patients with rIPSS score of > 4.5\n\n        LGH447 and midostaurin combination arm\n\n          -  Refractory/Relapsed AML following no more than 2 prior therapies, or in previously\n             untreated AML patients who are not candidates for standard therapy. AML patients may\n             have either FLT3 wild type or FLT3-ITD/TKD mutant disease, and FLT3 mutation status\n             needs to be defined at study entry.\n\n               -  For AML patients, peripheral blast counts < 50,000 blasts/mm3\n\n               -  For MDS patients;\n\n          -  Platelet count > 25,000/mm3\n\n          -  Neutrophils > 500/mm3\n\n          -  Blood transfusions are allowed to maintain clinically adequate hemoglobin and\n             hematocrit levels\n\n               -  Patients with active central nervous system (CNS) disease are eligible to\n                  participate and may be treated concurrently with intrathecal (or intra Ommaya)\n                  chemotherapy\n\n               -  Patients who are maintained on prophylactic antibiotics are eligible to\n                  participate as long as agents comply with the list of approved concomitant\n                  medications\n\n               -  Performance status ? 2\n\n               -  Meet other lab criteria\n\n        Exclusion Criteria\n\n          -  Systemic antineoplastic therapy (including unconjugated therapeutic antibodies and\n             toxin immunoconjugates) or any experimental therapy within 7 days or 5 half-lives,\n             whichever is longer, before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Radiotherapy with a wide field of radiation within 28 days or radiotherapy with a\n             limited field of radiation for palliation within 7 days of the first dose of LGH447\n             monotherapy or LGH447 in combination with midostaurin\n\n          -  Patients who received CNS irradiation for meningeal leukemia, except if radiotherapy\n             occurred > 3 months previously\n\n          -  Major surgery within 4 weeks before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Ongoing therapy with corticosteroids greater than 10 mg of prednisone or its\n             equivalent per day. Inhaled and topical steroids are permitted\n\n          -  Patients who are currently receiving hydroxyurea to control peripheral blood leukemic\n             blasts and cannot be discontinued for at least 48 hours prior to obtaining PD\n             biomarkers at screening/baseline and during the study\n\n          -  Patients who are currently receiving treatment with prohibited medication and that\n             cannot be discontinued at least one week prior to the start of treatment with LGH447\n             monotherapy or LGH447 in combination with midostaurin\n\n          -  Active infection requiring systemic therapy or other severe infection, including\n             pneumonia, within 2 weeks before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Known human immunodeficiency virus (HIV) positive\n\n          -  Corrected QT interval (QTc) of > 450 milliseconds (ms) in males and > 470 milliseconds\n             (ms) in females on baseline electrocardiogram (ECG) (using corrected QT interval using\n             Fridericia [QTcF] or local standards).\n\n          -  Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias,\n             congestive heart failure, angina, or myocardial infarction within the past 6 months\n\n          -  Pregnant or nursingXx_NEWLINE_xXPatients who received hormone therapy before prostatectomyXx_NEWLINE_xXReceipt of Gliadel therapyXx_NEWLINE_xXFollicular lymphoma, previously identified as CD19+\r\n* At least 2 prior chemotherapy or immunochemotherapy regimens (not including single agent monoclonal antibody therapy)\r\n* Patients who progress within 2 years after second or higher line of therapy will be eligible; for instance, patients who have progression of lymphoma < 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible; patients may have progression, stable disease or responding disease at the time of enrollment\r\n* Patients with a history of large cell transformation are eligibleXx_NEWLINE_xXAny relapse after prior autologous SCT will make patient eligible regardless of other prior therapyXx_NEWLINE_xXPatients who have a history of listeriosis prior ADXS11-001 therapyXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXPatient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic diseaseXx_NEWLINE_xXIn the phase II portion, patients must be newly diagnosed or treatment naive, or have been off adjuvant imatinib therapy for at least 3 months; patients with newly diagnosed GIST and who had been on imatinib for up to 4 weeks prior to signing the consent are allowed to enroll in order to expedite accrualXx_NEWLINE_xXIn the phase II portion of the study, patients that have been previously treated with any systemic therapy for GIST are not permitted to enroll, with the exception of adjuvant imatinib systemic therapy or exposure to imatinib within 4 weeks of signing consentXx_NEWLINE_xXCurrent anticoagulant therapy; (acetylsalicylic acid [ASA] =< 325 mg per day is allowed)Xx_NEWLINE_xXPatient is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXHas had prior systemic cancer therapy within the past four weeks or v-raf murine sarcoma viral oncogene homolog B (B-RAF) or mitogen-activated protein kinase (MEK) inhibitors within 7 days at the time of the start of the lymphodepletion regimen (Turnstile II)Xx_NEWLINE_xXMore than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)Xx_NEWLINE_xXIf prior therapy with gamma knife or other focal high-dose radiation, must have subsequent histologic documentation of local relapse, or relapse with new lesion outside the irradiated fieldXx_NEWLINE_xXHistologically or cytologically documented MDS of any risk group that has failed previous therapy (therapy failure is defined as patients who have been sufficiently treated with previous agents without response in the opinion of the treating physician, or whose disease has progressed or relapsed while on a hypomethylating agent)Xx_NEWLINE_xXDIAGNOSIS REQUIREMENT FOR PHASE I PATIENTS: Refractory AML without complete remission (CR) after induction therapy (primary induction failure) or relapsed AML after obtaining a CR ORXx_NEWLINE_xXPatients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]) are eligible; tamoxifen therapy or other SERMs should be discontinued at least 1 week before the patient is enrolled on this studyXx_NEWLINE_xXPatients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)Xx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowedXx_NEWLINE_xXFor Phase I Only: Refractory or relapsed disease defined as follows: Patients with MDS or CMML should have failed prior therapy (e.g., with a hypomethylating agent, clofarabine, and/or with lenalidomide); Patients with AML should have failed any prior induction therapy or have relapsed after prior therapy; Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML; Patients with any of the eligible diagnoses who have received no prior therapy are eligible if not candidates to receive standard intensive therapy (ie, high-dose cytarabine-based chemotherapy).Xx_NEWLINE_xXFor Phase II Only: Patients with MDS, CMML or AML who are either: Age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of WBC is acceptable.; Age 18 years or older and with refractory or relapse disease who have received no more than one prior treatment regimen and will be receiving first salvage. For this purposes, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in CR (or CRp or CRi) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies).;Xx_NEWLINE_xXFor Phase II only: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AMLXx_NEWLINE_xXFor Phase I and II: Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the toxic effects of that therapy to at least grade 1. Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. The additional days of Hydrea after 28 is permitted as clinically indicated, on case by case basis after discussion with the PI. Other agents given transiently with the intention to control rapid proliferation such as 1-2 doses of single agent ara-C or few doses of sorafenib are also allowed.Xx_NEWLINE_xXRelapsed/refractory MCL: Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficultyXx_NEWLINE_xXNewly diagnosed MCL: Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity in tissue\r\nbiopsy; patients must have never received any prior therapy for their diseaseXx_NEWLINE_xXPatients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligibleXx_NEWLINE_xXINCLUSIONS FOR CAR-T CELL THERAPYXx_NEWLINE_xXPatients with:\r\n* CLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody or who were not eligible for such therapy; patients with CLL for whom ibrutinib is now standard first line therapy, must have progressed on ibrutinib; patients with fludarabine refractory disease are eligible; patients may be treated following allogeneic hematopoietic cell transplant (HCT); for the concurrent ibrutinib cohort, patients must agree to continue on or be restarted on ibrutinib and must not have had prior intolerance to ibrutinib that would prevent this; patients managed with prior dose reductions for toxicity will continue at the reduced dose for the remainder of this study\r\n* Indolent NHL or mantle cell NHL who are beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy; patients who have relapsed following autologous or allogeneic HCT are eligible\r\n* Aggressive NHL such as diffuse large B-cell lymphoma (DLBCL), who have relapsed or have residual disease following treatment with curative intent; patients should have relapsed following, or not be eligible for high-dose therapy and autologous HCT; patients with chemotherapy refractory disease or marrow involvement or comorbidities precluding successful autologous HCT are eligible; patients may be treated following allogeneic HCT\r\n* Patients with CD19 expressing, relapsed or refractory ALL\r\n* Patients with one of the above diagnoses whose disease state does not qualify but who have prognostic indicators that suggest a high risk of progression of disease may be screened and undergo leukapheresis; enrollment for T cell therapy would require meeting the full disease state eligibilityXx_NEWLINE_xXEXCLUSIONS FOR CAR-T CELL THERAPYXx_NEWLINE_xXCytokine therapy (e.g. filgrastim [G-CSF], sargramostim [GM-CSF], interleukin [IL]-6, IL-2): must be discontinued a minimum of 24 hours prior to MIBG therapyXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapyXx_NEWLINE_xXPrior exposure to thiazolidinedione (TZD) therapy in the past 12 monthsXx_NEWLINE_xXPatients on chronic nitrate therapy or alpha-blockersXx_NEWLINE_xXPrior gene therapyXx_NEWLINE_xXPrevious therapy:\r\n* It is expected that patients will have received upfront standard of care therapy for their respected disease\r\n* Patients who relapse after either single or tandem autologous BMT are eligible (> 6 months must have elapsed from start of last BMT)\r\n* Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMTXx_NEWLINE_xXCohort B: patients who have received prior fludarabine , clofarabine or drugs known to target T cells not permitted; but prior standard induction with anthracyclines and cytarabine ALLOWED including after demethylating agentsXx_NEWLINE_xXSubjects must not have received medical therapy for any cancer within ONE year prior to registrationXx_NEWLINE_xXPatients must have previously received standard initial therapy, including attempted gross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non- metastatic tumors and at least microscopic residual disease) involved field fractionated radiation therapy (RT); patients may have received re-irradiation but not to the index lesion within 4 weeksXx_NEWLINE_xXTetanus vaccine during therapy or within 1 week prior to enrollmentXx_NEWLINE_xXPatients who have received prior immunotherapyXx_NEWLINE_xXPatients with previously untreated AML (by the World Health Organization [WHO] criteria, i.e. >= 20% blasts); prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine; patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease; hydroxyurea, and a single dose of cytarabine up to 3 g/m^2, is permitted for control of counts prior to treatmentXx_NEWLINE_xXPrior therapy with rituximab is permitted, even in the setting of rituximab-refractory diseaseXx_NEWLINE_xXRelapsed or refractory to the most recently received therapy; refractory disease is defined as =< 25% response or progression during therapy or within 60 days after completionXx_NEWLINE_xXPatients must be on continuous TKI therapy for management of their CML. Any commercially available and FDA- approved TKI can be used, i.e., imatinib mesylate (IM), nilotinib (NIL) or dasatinib (DAS). Patients may be receiving TKI at entry in the frontline or salvage setting, including patients currently on imatinib after alpha-interferon failure or on dasatinib or nilotinib after failure to prior therapy including imatinib.Xx_NEWLINE_xXStage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)Xx_NEWLINE_xXStage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)Xx_NEWLINE_xXPatients must be willing to stay within 2 hours drive of MD Anderson Cancer Center whilst receiving Ipilimumab therapy. Patient must also agree to present to MD Anderson emergency center while on Ipilimumab therapy.Xx_NEWLINE_xXConcomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses).Xx_NEWLINE_xXPatients having received alemtuzumab (anti-CD52) therapy ? 6 months prior to the first study dose.Xx_NEWLINE_xXFor cohort of patients that are already on ruxolitinib therapy: on therapy with ruxolitinib for at least for 6 months, and on stable dose for last 2 months, before starting therapy with sotaterceptXx_NEWLINE_xXReceived systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generation of the two cell therapies in this protocolXx_NEWLINE_xXPrior therapy with any hypoxic cytotoxin (hypoxia-targeting drugs).Xx_NEWLINE_xXSuitability for concurrent chemoradiation therapy per treating physician's assessmentXx_NEWLINE_xXBisphosphonates, hormone modification therapy, and trastuzumab are permitted without restrictionXx_NEWLINE_xXPatients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologistXx_NEWLINE_xXPatients who received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, analgesics, and other drugs to treat symptoms or prevent complicationsXx_NEWLINE_xXAny hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration (study enrollment); continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian or breast cancer are not exclusionaryXx_NEWLINE_xXAny number of prior therapies is allowedXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXDermatology evaluation with excision of any suspicious lesions prior to initiation of therapyXx_NEWLINE_xXPatients with previously untreated AML or high risk myelodysplastic syndrome (MDS) (>= 10 % blasts or International Prognostic Scoring System [IPSS] >= intermediate-2); prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, all-trans retinoic acid (ATRA), or an isolated dose of cytarabine up to 2 g is allowed; patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AMLXx_NEWLINE_xXPrior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabineXx_NEWLINE_xXPatients are eligible whether they have received or not prior tyrosine kinase inhibitor (TKI) therapy; for the phase I portion of the study, patients who had received prior therapy with dasatinib should have been able to tolerate the dose equivalent to the starting dose of dasatinib in the dose level at which the patient is being entered; patients who previously received dasatinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3-4 toxicity not responding to optimal managementXx_NEWLINE_xXPatients must have been off all prior therapy for CML for 2 weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, and bosutinib) which should be discontinued >= 24 hours prior to the start of therapy; patients who are receiving dasatinib prior to enrollment do not have to discontinue this agent prior to start of study therapyXx_NEWLINE_xXPrior therapy with pomalidomideXx_NEWLINE_xXPrior therapies:\r\n* For patients stratified to the untreated arm:\r\n** Untreated patients should have received zero prior therapies for metastatic disease\r\n** They may have received prior adjuvant chemotherapy and/or radiation therapy, but not within 6 months prior to treatment\r\n** They may have received prior palliative radiation therapy for unresectable disease, but without any systemic chemotherapy, even as a radiosensitizer\r\n* For patients in the previously treated arm:\r\n** Previously treated patients may have received any number of prior therapies\r\n** Patients who received prior adjuvant chemotherapy and/or radiation therapy within 6 months of treatment will be considered previously treated\r\n*** Patients may have received any prior therapies EXCEPT prior therapy with a PARP inhibitor\r\n** Timing of prior therapies:\r\n*** At least 14 days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy\r\n*** However, at least 28 days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n*** Additionally, at least 28 days must have passed since any prior investigational agent\r\n*** All patients must have completely recovered from all transient side effects related to prior therapies\r\n**** However, any side effects that are expected to be more durable or even permanent (e.g., neurotoxicity or ototoxicity) must have resolved to at least grade 1Xx_NEWLINE_xXPatient should not be getting any other experimental therapy for aGvHDXx_NEWLINE_xXHodgkin lymphoma that is: \r\n* PIF (primary induction failure): did not enter complete remission with first line of therapy; Note: a patient with PIF who responds to salvage therapy with a PR or CR is also eligible (and would be considered PIF-sensitive)\r\n* Early 1st relapse: initial CR of > 3 months and < 12 months after 1st line chemotherapy\r\n* 1st relapsed HL in a patient who is not in CR after 2 cycles of salvage therapy\r\n* In 2nd or subsequent relapse (RL) whether in CR or not after salvage therapyXx_NEWLINE_xXNo more than 2 prior chemotherapies and 1 relapse; prior bevacizumab therapy is allowedXx_NEWLINE_xXPHASE I: Patients may have had treatment for any number of prior relapses; relapse is defined as progression following initial therapy (i.e. surgery and radiation +/- chemotherapy [chemo] if that was used as initial therapy)Xx_NEWLINE_xXPHASE II: Patients may have had treatment for no more than 1 prior relapse (i.e. failed 2 lines of treatment-initial therapy and therapy for first relapse) at 2nd relapse, treatment per BTTC09-01 is an option; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy); the intent therefore is that patients had no more than 2 prior therapies (initial and treatment for 1 relapse); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse; for patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapseXx_NEWLINE_xXRapidly progressive disease that in the estimation of the treating physician would compromise ability to complete study therapyXx_NEWLINE_xX1) Subject has [follicular lymphoma that has progressed within 24 months of first diagnosis and treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP) OR Progression of iNHL within 6 months of completion of second or later line therapy containing both an anti-CD20 antibody and alkylating agent OR Progression of iNHL at any point following autologous transplantation. 2) Subject has [measurable disease]. 3) Subject has no known presence or history of CNS involvement by lymphoma. 4) If subject is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, subject is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis. 5) Subject has ECOG performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function 6) Subject is not pregnant or breastfeeding (female subjects only) and is willing to use birth control from the time of consent through 6 months following CAR T cell infusion (both male and female subjects).B24Xx_NEWLINE_xXOngoing androgen deprivation therapy (ADT) using a luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performedXx_NEWLINE_xXPatients must not have received prior whole brain radiation therapy; previous SRS/SRT done at least 3 weeks from the planned start of IPdR therapy is acceptable; SRS/SRT/fractionated boosts or neurosurgery can be performed once the dose limiting toxicity (DLT) assessment has been completed, if felt clinically necessaryXx_NEWLINE_xXOngoing therapy with LHRH analog or bilateral orchiectomy.Xx_NEWLINE_xXRadiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).Xx_NEWLINE_xXParticipant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy.)Xx_NEWLINE_xXParticipant has received prior therapy with a BH3 mimetic.Xx_NEWLINE_xXTherapy-related MDS (t-MDS)Xx_NEWLINE_xXSubjects with AML previously treated with initial induction therapy using a standard intensive chemotherapy regimen, including cytarabine and an anthracycline, and who are refractory to initial induction (primary refractory) or in relapse after such initial induction with or without prior HCT.Xx_NEWLINE_xXPrior hypomethylating agent (HMA) therapy is allowed, however this study excludes: (1) patients whose relapse occurred on HMA-based therapy immediately prior to this study and (2) patients who experience disease progression (see definition below) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study; disease progression is defined as either: (1) patients with MDS who have evidence of initial progression to AML (defined by the presence of >= 20% blasts in peripheral blood or bone marrow) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study; OR (2) patients with AML who have evidence of progressive disease according to European Leukemia Net (ELN) 2017 criteria (e.g. > 50% increase in marrow blasts over baseline or > 50% increase in peripheral blasts to > 25 x10^9/L [> 25,000/uL] [in absence of differentiation syndrome]) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study\r\n* (Note: Patients who relapse post-transplant who received HMA treatment prior to transplant are eligible for study)Xx_NEWLINE_xXPrevious systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 3 weeks prior to treatment; for the dose expansion phase, in progressing subjects, a 2 week washout may be allowed after discussion with Memorial Sloan-Kettering (MSK) principal investigatorXx_NEWLINE_xXFor the romidepsin arm of the study, prior therapy with romidepsin if discontinued due to toxicityXx_NEWLINE_xXHas been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomizationXx_NEWLINE_xXPatients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.Xx_NEWLINE_xXPhase II IMT naive cohorts: Patients have not received systemic cytotoxic or immune-based therapy for advanced melanoma. BRAF and/or MEK inhibition therapy is acceptable before immunotherapy where clinically indicated. Other systemic cytotoxic or targeted therapy in the advanced setting is not permitted in this subsetXx_NEWLINE_xXPhase Ib: no restriction on prior therapyXx_NEWLINE_xXReceived more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).Xx_NEWLINE_xXReceived antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.Xx_NEWLINE_xXRAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 24 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigatorXx_NEWLINE_xX131I therapy =< 6 months prior to registration; Note: 131I administered solely for diagnostic purposes is not considered 131I therapyXx_NEWLINE_xX(Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or progressive disease, specifically: (a) Solid tumors: Following at least 1 prior systemic therapy, and no further standard therapy is available for the patient's advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at least 2 prior systemic therapies in patients who are not candidates for autologous stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL: Following at least 1 prior systemic therapy; patients must have also received intensive salvage therapy unless they refused or were deemed ineligible; or (d) Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option existsXx_NEWLINE_xXFor HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.Xx_NEWLINE_xXFor NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.Xx_NEWLINE_xXPrior therapy with romidepsinXx_NEWLINE_xXPrior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)Xx_NEWLINE_xXPrior hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist with or without antiandrogen) up to 8 weeks is permittedXx_NEWLINE_xXPatients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early)Xx_NEWLINE_xXAny patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied; patients treated on this protocol will be without morphological evidence of disease, or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemo-responsiveXx_NEWLINE_xXPatients with previously untreated ALL of pre-B, Philadelphia chromosome (Ph-) negative ALL; minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowedXx_NEWLINE_xXPrevious systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed; the lesion must however have shown criteria of progression based on RECIST; local therapy must be completed at least 4 weeks prior to the baseline scan; this is to create a safer treatment environment and to help determine the effect of treatment by SBRT alone; patients will be allowed to go onto appropriate systemic therapy, as determined by their medical oncologist, 2 weeks following delivery of SBRTXx_NEWLINE_xXPatients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or United States (US) Food and Drug Administration–approved first- or second-line systemic therapy regimensXx_NEWLINE_xXPrior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or bilateral orchiectomyXx_NEWLINE_xXPatient must either have recurrence of ICGCT or should be refractory to initial therapyXx_NEWLINE_xXCorticosteroid therapy and endocrine replacement therapy (L-thyroxine, testosterone, estrogen, desmopressin acetate [DDAVP]) are permissible; any patient already receiving human growth replacement therapy should discontinue this prior to commencing chemotherapy, and should not restart until 3 years from diagnosisXx_NEWLINE_xXAllogeneic SCT recipient requiring additional cellular therapyXx_NEWLINE_xXPatients on Strata C and D must have recovered from the toxic effects of prior therapy to grade 1 or better; patients must be at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy, at least 1 week from the last dose of non-myelosuppressive biologic therapy and at least 6 months from placement of bis-chloroethylnitrosourea (BCNU) wafers; any questions related to the definition of non-cytotoxic agents should be directed to the principal investigatorXx_NEWLINE_xXPatients who have received prior immunotherapyXx_NEWLINE_xXDISEASE CHARACTERISTICS:\n\n          -  Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma\n\n               -  Stage IA or IIA disease\n\n        PATIENT CHARACTERISTICS:\n\n          -  Not specified\n\n        PRIOR CONCURRENT THERAPY:\n\n          -  No prior therapyXx_NEWLINE_xXA prior course of hormone therapy (androgen deprivation) of greater than 3 months durationXx_NEWLINE_xXPatients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapyXx_NEWLINE_xXWaldenstrom's macroglobulinemia: must have failed 2 courses of therapyXx_NEWLINE_xXDuring phase I: all patients with relapsed disease will be eligible if they have received at least 1 prior standard CLL therapy and no more than 4 prior therapies (one of which must be a purine analog and/or an alkylating agent)Xx_NEWLINE_xXDuring phase II: all patients with relapsed disease will be eligible if they have received a minimum of 1 prior standard therapy and a maximum of 2 prior treatments (one of which must be a purine analog and/or an alkylating agent) for B-CLL and have developed relapse disease\r\n* Note: patients who have refractory disease (defined as – progressive disease on last treatment, or less than 6 months of clinical response to the last treatment) will not be eligibleXx_NEWLINE_xXAndrogen suppression therapy within past year; defined as: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or androgen blocker, not 5-alpha reductase inhibitorXx_NEWLINE_xXUp to one cycle of prior induction therapy will be permitted to include patients in whom presence of \good-risk\ cytogenetics was initially missed; if the patient is in remission from induction therapy, he/she will receive post-remission therapy; if the patient is not in remission then he/she will receive induction therapyXx_NEWLINE_xXHodgkin disease: Must have received and failed frontline therapyXx_NEWLINE_xXPSA Doubling time < 10 months after local therapy in patients who have not had any previous hormone therapyXx_NEWLINE_xXPatients may have received prior hormonal therapy; the hormonal treatment must have been discontinued for > 6 months prior to study entryXx_NEWLINE_xXAdvanced non-Hodgkin lymphoma (NHL): A) low-grade NHL (Working Formulation A, B, C) following progression after initial therapy if asymptomatic at diagnosis (>= CR2, >= PR2; response duration < 1 year from last therapy) or if no CR was achieved (> PR1); at least one prior therapy of intermediate intensity (e.g. cyclophosphamide, doxorubicin, vincristine, prednisone [CHOP]); B) mantle zone lymphoma after any progression following initial therapy (> CR1, > PR1); at least one prior therapy of intermediate intensity (e.g. CHOP); C) intermediate grade lymphoma (> PR2); response duration < 1 year from prior therapy; D) high-grade NHL (IWF H, I, J) after initial therapy if >= stage III at diagnosis; after any progression even if localized (stage I, II) at diagnosis with prior response duration < 1 year; E) recent chemotherapy responsiveness after treatment with >= 3 intermediate intensity regimensXx_NEWLINE_xXA histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agentsXx_NEWLINE_xXHaving received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDSXx_NEWLINE_xXSee Disease Characteristics PRIOR CONCURRENT THERAPY:Xx_NEWLINE_xXPatients with relapsed disease are eligible if they have had no more than one prior therapyXx_NEWLINE_xXHas had prior B-RAF or mitogen-activated protein kinase kinase (MEK) targeted therapy within 7 days prior to the start of lymphodepletion regimen (Cohort A and Cohort B)Xx_NEWLINE_xXRequire steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 30 days, or have used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion; Exception: patients on physiologic dose of steroid (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)Xx_NEWLINE_xXPrevious Therapies\r\n* Patients who are currently being treated with intrathecal (IT) IL-2 for LMD are eligible; no wash out period is required\r\n* Patients who have been previously treated with other IT therapies are eligible, as long as there is at least a 2 week wash out period\r\n* Patients who have previously received therapy with systemic TIL therapy are eligible\r\n* Patients with ventriculo-peritoneal (VP) shunts must have VP shunts with on/off valves and must be expected to tolerate VP shunt valve off for more than 6 hours; patients who have received CNS irradiation, including whole brain radiation or stereotactic radiosurgery, are eligible, if they are at least 1 weeks post CNS-irradiation (Cohort D); patients who are currently being treated with IT IL-2 for LMD are eligible; no wash out period is required. (Cohort D)Xx_NEWLINE_xXExtensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiationXx_NEWLINE_xXPatients who have received Y-90 ibritumomab (zevalin) or I-131 tostumomab (bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplantXx_NEWLINE_xXNo prior systemic therapy or iodine I 131 (I131) or chemoembolization treatment after surgeryXx_NEWLINE_xXInclusion Criteria (main):\n\n          -  Patients with advanced and/or metastatic cancer who have no available standard therapy\n             or who are not candidates for available standard therapy, and for whom, in the opinion\n             of the investigator, experimental therapy with GEN1029 may be beneficial.\n\n          -  Patient must be ? 18 years of age\n\n          -  Patients must have measurable disease according to Response Evaluation Criteria In\n             Solid Tumors (RECIST) version 1.1\n\n          -  Have an acceptable hematological status\n\n          -  Have an acceptable renal function\n\n          -  Have an acceptable liver function\n\n          -  Have an Eastern Cooperative Oncology Group performance status of 0 or 1\n\n          -  Body weight ? 40kg\n\n          -  Patients both females and males, of childbearing or reproductive potential must agree\n             to use adequate contraception from screening visit until six months after last\n             infusion of GEN1029\n\n        Exclusion Criteria (main):\n\n          -  Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for\n             at least 8 weeks prior to first GEN1029 administration\n\n          -  Have clinically significant cardiac disease\n\n          -  Uncontrolled hypertension defined as systolic blood pressure ?160 mmHg and/or\n             diastolic blood pressure ?100 mmHg, despite optimal medical management\n\n          -  Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new\n             (younger than 6 months) or progressive brain metastases or stroke\n\n          -  History of organ allograft (except for corneal transplant) or autologous or allogeneic\n             bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of\n             Investigational Medicinal Product (IMP)\n\n          -  Have received a cumulative dose of corticosteroid ? 150 mg prednisone (or equivalent\n             doses of corticosteroids) within two weeks before the first GEN1029 administration\n\n          -  History of ? grade 3 allergic reactions to monoclonal antibody therapy as well as\n             known or suspected allergy or intolerance to any agent given in the course of this\n             trial\n\n          -  Radiotherapy within 14 days prior to first GEN1029 administration\n\n          -  Any prior therapy with a compound targeting DR4 or DR5\n\n          -  History of chronic liver disease or evidence of hepatic cirrhosisXx_NEWLINE_xXdocumented progression on the most recent line of therapyXx_NEWLINE_xXPrior treatment with a Mucin 16 (MUC16)-targeted therapyXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;Xx_NEWLINE_xXRefractory to or intolerant of existing therapy(ies) known to provide clinical benefit.Xx_NEWLINE_xXHistory of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapyXx_NEWLINE_xXPrior systemic therapy: (a) Phase 1b: Any number of lines of prior therapy; (b) Phase 2: Progressed after 1 or 2 lines of prior chemotherapyXx_NEWLINE_xXTherapeutic options: Participant's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.Xx_NEWLINE_xXCellular therapy: ?42 days after the completion of any type of cellular therapy (eg, modified T-cells, natural killer cells, dendritic cells, etc)Xx_NEWLINE_xXRadiopharmaceutical therapy (eg, radiolabeled antibody, 131I-metaiodobenzylguanidine): ?42 days after systemically administered radiopharmaceutical therapy.Xx_NEWLINE_xXReceived prior therapy with eribulin mesylateXx_NEWLINE_xXHave documented evidence of progressive disease (PD) on or after their last regimen as defined by IMWG criteria. All participants must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a treatment plan for MM [eg, a single-agent or combination therapy or a sequence of planned treatments such as induction therapy followed by autologous stem cell transplant (SCT) and then consolidation and/or maintenance therapy]).Xx_NEWLINE_xXHave achieved a response (partial response (PR) or better) to at least 1 prior therapy.Xx_NEWLINE_xXHave received prior ixazomib at any time or daratumumab or other anti-CD38 therapies, except as part of initial therapy if this was stopped to move on to SCT and the participants did not progress on anti-CD38 treatment.Xx_NEWLINE_xXAre refractory to bortezomib or carfilzomib at the last exposure before this study (defined as participants having PD while receiving bortezomib or carfilzomib therapy or within 60 days after ending bortezomib or carfilzomib therapy).Xx_NEWLINE_xXCandidate for further therapy and able to wait 7 days prior to start of next systemic therapyXx_NEWLINE_xXMust have previously received at least 1, but no more than 2, lines of novel androgen receptor (AR)-targeted therapy (for example, abiraterone acetate with prednisone, enzalutamide, apalutamide) for prostate cancer. Participants must have had at least 4 weeks of AR-targeted therapyXx_NEWLINE_xXBiopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted > 6 months; refractory is no response or relapse within 6 months; previous biopsies < 6 months prior to treatment on this protocol will be acceptable\r\n* NOTE: Arms A/B – relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\r\n* NOTE: Arm C patients include relapsed lymphoma patients of any type, other than those eligible for Arms A/B, for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed double-hit high grade lymphoma patients and relapsed Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without respondingXx_NEWLINE_xXAny therapy =< 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretionXx_NEWLINE_xXNo prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])Xx_NEWLINE_xXMore than two prior lines of systemic anti-cancer therapy for urothelial carcinomaXx_NEWLINE_xXPatients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.Xx_NEWLINE_xXPatients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.Xx_NEWLINE_xXSerious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permittedXx_NEWLINE_xXPatients must have histologically confirmed disease that is unresectable and not amenable to curative intent therapy: \r\n* Cohort A: salivary gland cancers (mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology) originating in salivary glands \r\n* Cohort B: thyroid cancer, radioactive iodine (RAI)-refractory and after failure, intolerance to or refusal of anti-antiangiogenic therapy, or with evidence of dedifferentiated or anaplastic histologyXx_NEWLINE_xXFirst or later relapse AND has received at least 2 prior therapies (one of which can be frontline therapy) orXx_NEWLINE_xXChronic use of high-dose oral corticosteroid therapy .Xx_NEWLINE_xXFirst autologous or allogeneic HCT and hematologic disease in remission on initiation of antiviral therapy for hepatitis C infectionXx_NEWLINE_xXInclusion Criteria:\n\n        - Patients must be ? 1 and ?25 years of age.\n\n        Diagnosis:\n\n        - Patients with AML must have ? 5% blasts (by morphology) in the bone marrow\n\n          -  Patients may have CNS or other sites of extramedullary disease. No cranial irradiation\n             is allowed during the protocol therapy.\n\n          -  Patients with secondary AML are eligible\n\n          -  Patients with Down syndrome and DNA fragility syndromes (such as Fanconi anemia, Bloom\n             syndrome) are excluded.\n\n        Performance Level:\n\n        - Karnofsky >50% for patients >16 years of age and Lansky > 50% for patients ? 16 years of\n        age (See Appendix II for Performance Scales)\n\n        Prior therapy\n\n        - Patients must have fully recovered from the acute toxic effects of all prior\n        chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n          1. Phase 1\n\n             - Any patient with AML in 1st or greater relapse, OR\n\n             - Patients with AML failed to go into remission after first or greater relapse, OR\n\n             - Patients with AML failed to go into remission from original diagnosis after two or\n             more induction attempts.\n\n          2. Cytoreduction with hydroxyurea - Hydroxyurea can be initiated and continued for up to\n             24 hours prior to the start of decitabine/vorinostat. It is recommended to use\n             hydroxyurea in patients with significant leukocytosis (WBC >50,000/L) to control blast\n             count before initiation of systemic protocol therapy.\n\n          3. Patients who relapsed while they are receiving cytotoxic therapy\n\n             - At least 14 days must have elapsed since the completion of the cytotoxic\n             therapy,except Intrathecal chemotherapy.\n\n             Hematopoietic stem cell transplant (HSCT):\n\n             - Patients who have experienced their relapse after a HSCT are eligible, provided they\n             have no evidence of acute or chronic Graft-versus-Host Disease (GVHD).\n\n             Hematopoietic growth factors:\n\n             - It must have been at least 7 days since the completion of therapy with GCSF or other\n             growth factors at the time of enrollment. It must have been at least 14 days since the\n             completion of therapy with pegfilgrastim (Neulasta ®)\n\n             Biologic (anti-neoplastic agent):\n\n             -At least 7 days after the last dose of a biologic agent. For agents that have known\n             adverse events occurring beyond 7 days after administration, this period must be\n             extended beyond the time during which adverse events are known to occur. The duration\n             of this interval must be discussed with the study chair.\n\n             Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after\n             the last dose of monoclonal antibody (i.e. Gemtuzumab = 36 days)\n\n             Immunotherapy: At least 42 days after the completion of any time of immunotherapy,\n             e.g. tumor vaccines or CAR T-cell therapy.\n\n             XRT: Cranio or craniospinal XRT is prohibited during protocol therapy. No washout\n             period is necessary for radiation given to non-CNS chloromas; >90 days must have\n             elapsed if prior TBI, cranio or craniospinal XRT.\n\n             Prior Demethylating and/or HDAC Inhibitor Therapy: Patients who have received prior\n             DNMTi (e.g. decitabine) and/or HDACi (e.g. vorinostat) therapy are eligible to\n             participate in this Phase 1 study. At least 7 days must have passed from prior DNMTi\n             or HDACi as a washout period.\n\n             Renal and hepatic function: Patients must have adequate renal and hepatic functions as\n             indicated by the following laboratory values:\n\n             A. Adequate renal function defined as: Patient must have a calculated creatinine\n             clearance or radioisotope GFR ? 70ml/min/1.73m2 OR a normal serum creatinine based on\n             age/gender.\n\n             B. Adequate Liver Function Defined as: Direct bilirubin < 1.5 x upper limit of normal\n             (ULN) for age or normal, AND alanine transaminase (ALT) < 5 x ULN for age. The hepatic\n             requirements are waived for patients with known or suspected liver involvement by\n             leukemia. This must be reviewed by and approved by the study chair or vice chair.\n\n             Adequate Cardiac Function Defined as: Shortening fraction of ? 27% by echocardiogram,\n             OR ejection fraction of ? 50% by radionuclide angiogram (MUGA).\n\n             Reproductive Function A. Female patients of childbearing potential must have a\n             negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n\n             B. Female patients with infants must agree not to breastfeed their infants while on\n             this study.\n\n             C. Male and female patients of child-bearing potential must agree to use an effective\n             method of contraception approved by the investigator during the study and for a\n             minimum of 6 months after study treatment.\n\n             Exclusion Criteria:\n\n             -No NG or G-Tube administration of Vorinostat is allowed. Capsule must be swallowed\n             whole or given as oral suspension.\n\n             -They are currently receiving other investigational drugs.\n\n             -There is a plan to administer non-protocol chemotherapy, radiation therapy, or\n             immunotherapy during the study period.\n\n             -They have significant concurrent disease, illness, psychiatric disorder or social\n             issue that would compromise patient safety or compliance, interfere with consent,\n             study participation, follow up, or interpretation of study results.\n\n             -They have a known allergy to any of the drugs used in the study.\n\n             -Patients with Down syndrome are excluded.\n\n               -  Patients with DNA fragility syndromes are excluded (e.g. Fanconi Anemia, Bloom\n                  Syndrome)\n\n               -  They are receiving valproic acid (VPA) therapy.\n\n               -  Patients with Acute Promyelocytic Leukemia (APL, APML) are excluded\n\n               -  Patients with documented active and uncontrolled infection at the time of study\n                  entry are not eligibleXx_NEWLINE_xXOral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial.Xx_NEWLINE_xXProphylactic anti-infective therapy, which is given without clinical symptoms is allowed.Xx_NEWLINE_xXConcurrent NSAID therapy; washout period of 7 daysXx_NEWLINE_xXPatients who have received prior immunotherapiesXx_NEWLINE_xXPatients with genomic tumor aberrations should have received prior treatment with an FDA-approved targeted therapy (if available)Xx_NEWLINE_xXPatients whose tumors harbor an ALK rearrangement must have demonstrated progression on or intolerance to an FDA-approved first-line TKI; if the first-line TKI was crizotinib, then they also must have demonstrated progression on or intolerance to an FDA-approved second-line TKI; patients who received alectinib or ceritinib as first-line therapy and have demonstrated progression or intolerance will be eligible for this trialXx_NEWLINE_xXCriteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy, see Appendix E for guidance)Xx_NEWLINE_xXCriteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)Xx_NEWLINE_xXCriteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatmentXx_NEWLINE_xXSubjects who have received prior immunotherapy may be eligibleXx_NEWLINE_xXTissue Procurement Inclusion Criteria:\n\n        Subjects will be eligible for tissue procurement for the Vigil manufacturing process, if\n        they meet all of the following criteria:\n\n          1. Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous, clear\n             cell, or endometrioid ovarian, fallopian tube or primary peritoneal carcinoma\n\n          2. Age ? 18 years.\n\n          3. Estimated survival ? 6 months.\n\n          4. ECOG Performance Status ? 1\n\n          5. Metastatic disease\n\n          6. Planned standard of care surgical procedure (e.g., tumor biopsy or palliative\n             resection or thoracentesis) and expected availability of a cumulative soft-tissue mass\n             of ~10-30 grams tissue (\grape\ to \golf-ball\ size) or ascites fluid estimated volume\n             ? 500mL (from a primary or secondary paracentesis, yielding in a high volume of tumor\n             cells) for immunotherapy manufacture.\n\n          7. Tumor intended for immunotherapy manufacture is not embedded in bone and does not\n             contain luminal tissue (e.g. bowel, ureter, bile duct).\n\n          8. Presence of at least one additional site of disease that is RECIST 1.1\n             evaluable/measurable.\n\n          9. Ability to understand and the willingness to sign a written informed protocol specific\n             consent for tissue harvest or a parental/guardian informed consent and pediatric\n             assent when appropriate.\n\n        Tissue Procurement Exclusion Criteria:\n\n        Subjects meeting any of the following criteria are not eligible for tissue procurement for\n        the Vigil manufacturing:\n\n          1. Medical condition requiring any form of chronic systemic immunosuppressive therapy\n             (steroid or other) except physiologic replacement doses of hydrocortisone or\n             equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily)\n             for < 30 days duration.\n\n          2. Known history of other malignancy unless having undergone curative intent therapy\n             without evidence of that disease for ? 3 years except cutaneous squamous cell and\n             basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other\n             in situ cancers are allowed if definitively resected.\n\n          3. Brain metastases unless treated with curative intent (gamma knife or surgical\n             resection) and without evidence of progression for ? 2 months.\n\n          4. Any documented history of autoimmune disease with exception of Type 1 diabetes on\n             stable insulin regimen, hypothyroidism on stable dose of replacement thyroid\n             medication, vitiligo, or asthma not requiring systemic steroids.\n\n          5. Known HIV or chronic Hepatitis B or C infection.\n\n          6. Known history of allergies or sensitivities to gentamicin.\n\n          7. History of or current evidence of any condition (including medical, psychiatric or\n             substance abuse disorder), therapy, or laboratory abnormality that might confound the\n             results of the study, interfere with the patient's participation for the full duration\n             of the study, or is not in the best interest of the patient to participate, in the\n             opinion of the treating Investigator.\n\n        Study Enrollment Inclusion Criteria:\n\n        Subjects will be eligible for registration into the trial if they meet all of the following\n        inclusion criteria:\n\n          1. Successful manufacturing of at least 4 vials of Vigil.\n\n          2. One of the following:\n\n               1. Failure to meet the eligibililty criteria for Protocol CL-PTL-119 due to i)\n                  histology of ovarian cancer and failure to achieve a complete clinical response\n                  following primary debulking surgery and standard paclitaxel/carboplatin therapy\n                  OR, ii) a histologic diagnosis of another gynecologic malignancy which is not\n                  ovarian cancer.\n\n               2. Recurrent ovarian cancer.\n\n               3. Randomized on Protocol CL-PTL-119 and were subsequently unblinded at recurrence\n                  and were assigned to the placebo arm.\n\n          3. ECOG performance status (PS) ? 1\n\n          4. Estimated survival ? 6 months.\n\n          5. Measureable or evaluable disease.\n\n          6. Adequate organ and bone marrow function as defined below:\n\n               1. Absolute neutrophil count (ANC) ? 1.5 × 10e9/L (1500 per mm^3)\n\n               2. Platelets >100 × 10e9/L (100,000 per mm^3)\n\n               3. Hemoglobin ?9.0 g/dL (5.59 mmol/L)\n\n               4. Creatinine clearance (CrCL) >50 mL/min by the Cockcroft-Gault formula or by\n                  24-hour urine collection for determination of creatinine clearance:\n\n                  Females:\n\n                  CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL)\n\n               5. Serum bilirubin ?1.5 × upper limit of normal (ULN). This will not apply to\n                  patients with confirmed Gilbert's syndrome (persistent or recurrent\n                  hyperbilirubinemia that is predominantly unconjugated in the absence of evidence\n                  of hemolysis or hepatic pathology) who will be allowed in consultation with their\n                  physician.\n\n               6. AST and ALT ?2.5 × ULN in patients with no liver metastasis\n\n               7. AST or ALT ?5 × ULN in patients with liver metastasis\n\n               8. TSH within institutional limits. If TSH is greater or less than institutional\n                  limits patients may participate if their T4 is within normal limits (WNL);\n                  patients may be on a stable dose of replacement thyroid medication; dose\n                  adjustments are allowed if needed\n\n          7. Subject has recovered to CTCAE Grade 1 or better from all adverse events associated\n             with prior therapy or surgery\n\n          8. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to\n             CTCAE Grade 2 or better\n\n          9. Patients with irreversible toxicity that is not reasonably expected to be exacerbated\n             by the IPs may be included (e.g., hearing loss) after consultation with the Principal\n             Investigator\n\n         10. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,\n             endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal\n             antibodies, other investigational agent) prior to tissue procurement and at least 21\n             days prior to the first dose of study drug (at least 21 days prior to the first dose\n             of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib\n             and crizotinib] and within 6 weeks for nitrosourea or mitomycin C).\n\n         11. Subjects who are not rendered surgically sterile as a result of surgery for ovarian\n             cancer, must have, negative urine or serum pregnancy test. If the urine test is\n             positive or cannot be confirmed as negative, a negative serum test will be required\n             for study entry.\n\n         12. Ability to understand and the willingness to sign a written informed protocol specific\n             consent.\n\n         13. Willing and able to comply with the protocol for the duration of the study including\n             undergoing treatment and scheduled visits and examinations including follow up.\n\n        Study Enrollment Exclusion Criteria:\n\n        Subjects will NOT be eligible for study registration and enrollment if meeting any of the\n        following criteria:\n\n          1. Have received more than two additional chemotherapy regimens for recurrent ovarian\n             cancer, after their initial treatment with paclitaxel/carboplatin, OR have received\n             more than two additional chemotherapy regimens for the treatment of another\n             gynecologic malignancy\n\n               1. Patients must have fully recovered from chemotherapy associated toxicities prior\n                  to starting treatment on this protocol.\n\n               2. Palliative radiotherapy is permitted provided:\n\n             i. More than 3 weeks have elapsed between the end of radiotherapy and the first dose\n             of study therapy, AND ii. The lung is not in the radiation field, AND iii. The\n             irradiated lesion(s) cannot be used as target lesions.\n\n          2. Participation in another clinical study with an investigational product within the\n             last 3 weeks prior to study start.\n\n          3. Patients with autoimmune diseases are excluded from enrollment with the exception of\n             patients with hypothyroidism on stable thyroxine replacement, and patients with T1DM\n             on stable insulin replacement.\n\n          4. Receipt of steroid therapy within the 2 weeks of the first dose of study therapy.\n\n          5. Live vaccine used for the prevention of infectious disease administered < 30 days\n             prior to the start of study therapy. NOTE: Subjects, if enrolled, should not receive\n             live vaccine during the study and for 5 months after the last dose of atezolizumab.\n\n          6. Post-surgery complication that in the opinion of the treating investigator would\n             interfere with the subject's study participation or make it not in the best interest\n             of the subject to participate.\n\n          7. Mean QT interval corrected for heart rate (QTc) ?470 ms calculated from 3\n             electrocardiograms (ECGs) using Frediricia's Correction.\n\n          8. Female subjects who are pregnant, breast-feeding or of reproductive potential who are\n             not employing an effective method of birth control defined in the protocol. Effective\n             contraception is required for women receiving atezolizumab for 5 months after the last\n             dose.\n\n          9. Any condition that, in the opinion of the investigator, would interfere with\n             evaluation of study treatment or interpretation of patient safety or study results.Xx_NEWLINE_xXthienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;Xx_NEWLINE_xXpatients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;Xx_NEWLINE_xXare in relapse following an initial response and no more than 1 prior salvage therapyXx_NEWLINE_xXfailed primary induction therapy with no complete remission and for whom no other approved therapy is available, and no more than 1 prior salvage therapyXx_NEWLINE_xXNo more than 4 prior lines of anti leukemia therapy (not including ibrutinib)Xx_NEWLINE_xXNo more than 4 prior lines of anti leukemia therapy (not including ibrutinib)Xx_NEWLINE_xXSubjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.Xx_NEWLINE_xXOestrogens, including hormone replacement therapy;Xx_NEWLINE_xXIndication to initiate androgen deprivation therapy (ADT)Xx_NEWLINE_xXUnresolved immune-related adverse events following prior biological therapy. Subjects with asymptomatic endocrinopathy may enroll.Xx_NEWLINE_xXRefractory to and disease progression within 6 months from the last dose of at least 2 lines of prior therapyXx_NEWLINE_xXSubject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.Xx_NEWLINE_xXHistologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival existsXx_NEWLINE_xXArm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapiesXx_NEWLINE_xXArm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.Xx_NEWLINE_xXInclusion Criteria:\n\n        Note: No waivers of the study inclusion or exclusion criteria will be granted.\n\n          1. Diagnosis of a solid tumor for which the accepted standard of care includesa licensed\n             anti-EGFR therapy;\n\n          2. Tumor progression in patients with RAS wild type metastatic colorectal cancer\n             irrespective of their exposure to licensed anti-EGFR therapy including anti-EGFR\n             antibodies; OR Tumor progression in patients with metastatic colorectal cancer\n             refractory to cetuximab or panitumumab or other anti-EGFR antibodies OR Tumor\n             progression in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have\n             refused therapy.\n\n             OR Tumor progression or recurrence in patients with squamous cell carcinoma of the\n             head and neck irrespective of their exposure to licensed anti-EGFR therapy including\n             anti-EGFR antibodies.\n\n             OR Patients with locally advanced or metastatic colorectal carcinoma who have\n\n               1. relapsed after standard of care treatment,\n\n               2. proved refractory to standard of care treatment\n\n               3. refused standard of care treatment\n\n               4. been found to be medically unsuitable for standard of care treatment\n\n          3. Completion of written informed consent procedure;\n\n          4. Male or female subjects over 17 years of age\n\n          5. Life expectancy of at least 3 months;\n\n          6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;\n\n          7. At least one measureable non-irradiated site of disease according to Response\n             Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n\n          8. Adequate bone marrow function, with absolute neutrophil count (ANC) >1,500/mm3,\n             platelet count >100,000/mm3, and hemoglobin > 10 g/mm3;\n\n          9. Adequate liver function, with bilirubin <1.5 x the upper limit of the normal range\n             (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x the\n             ULN;\n\n         10. Adequate renal function, with serum creatinine <1.5 mg/dL;\n\n         11. Adequate cardiac function, with left ventricular ejection fraction (LVEF) ?50%, normal\n             electrocardiogram, and absence of significant cardiac disease;\n\n         12. In women of childbearing potential (defined as women of reproductive capacity who are\n             pre-menopausal or within 12 months of cessation of menses): negative serum pregnancy\n             test and use of an acceptable non-hormonal method of contraception;\n\n         13. Ability to communicate with the investigator, and understand and comply with the\n             requirements of the protocol;\n\n         14. Agrees to notify the investigator when deviating from the protocol requirements with\n             regard to concomitant medications;\n\n         15. Agrees to stay in contact with the study site for the duration of the study and to\n             provide updated contact information as necessary, and has no current plans to move\n             from the study area for the duration of the study.\n\n        Exclusion Criteria:\n\n          1. Participation in a study of an investigational agent or use of an investigational\n             device at the time of screening or within 4 weeks of enrollment;\n\n          2. Receipt of treatment with a monoclonal antibody (mAb) within 4 weeks of enrollment or\n             not recovered from an adverse event (i.e., event is >Grade 1 or subject has not\n             returned to baseline) due to treatment with a mAb administered >4 weeks before\n             enrollment;\n\n          3. Receipt of chemotherapy, targeted small molecule therapy, or radiation therapy within\n             2 weeks prior to enrollment, or not recovered from an adverse event (i.e., event is\n             >Grade 1 or subject has not returned to baseline) due to a previously-administered\n             agent;\n\n          4. Major surgical procedure or significant traumatic injury within 4 weeks prior to\n             screening;\n\n          5. Diagnosis of an additional malignancy that is progressing and requires treatment;\n             exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\n             skin, and in situ cervical cancer that has undergone potentially curative therapy;\n\n          6. Active autoimmune disease requiring systemic treatment within the past 3 months, or a\n             documented history of severe autoimmune disease, or a syndrome that requires systemic\n             steroids or immunosuppressive agents (subjects with vitiligo or resolved childhood\n             asthma/atopy are allowed);\n\n          7. Diagnosis of an immune deficiency;\n\n          8. Receipt of systemic steroids or any form of immunosuppressive therapy within 7 days\n             prior to enrollment, with the following exceptions:\n\n               1. Stable doses of topical, ocular, intranasal or inhaled corticosteroids\n\n               2. Doses of systemic steroids that, in the opinion of the investigator, are\n                  pysiologic replacement doses\n\n               3. Systemic steroids as prophylactic treatment for subjects with allergy to contrast\n                  media\n\n               4. Non-absorbed intra-articular steroid injections\n\n               5. Systemic corticosteroids required for control of infusion reactions or AEs if\n                  doses have been tapered to <10 mg prednisone or equivalent for 2 weeks prior to\n                  the first study treatment\n\n          9. Evidence of interstitial lung disease or active, non-infectious pneumonitis;\n\n         10. Active infection requiring systemic therapy;\n\n         11. History of cerebrovascular accident, transient ischemic attack, or subarachnoid\n             hemorrhage within 6 months prior to screening;\n\n         12. Active hepatitis B (i.e., hepatitis B surface antigen [HBsAg] positive) or hepatitis C\n             (i.e., hepatitis C virus [HCV] ribonucleic acid [RNA; qualitative] is detected);\n\n         13. Serious non-healing wound, ulcer, or bone fracture;\n\n         14. Any severe or uncontrolled medical condition or other condition that could affect\n             participation in the study;\n\n         15. Any current medical, psychiatric, occupational, or substance abuse problems that, in\n             the opinion of the investigator, will make it unlikely that the subject will comply\n             with the protocol.Xx_NEWLINE_xXRadiographic demonstration of disease progression following prior therapyXx_NEWLINE_xXAny condition that prevents compliance with the protocol or adherence to therapy.Xx_NEWLINE_xXPatients must have discontinued systemic antineoplastic therapy (including endocrine and biological agents, as well as systemic corticosteroids) at least three (3) to four (4) weeks prior to enrollment. Toxicities from previous therapies must be grade 1 or less.Xx_NEWLINE_xXSubjects must have been treated with at least 2 prior therapies including a proteasome inhibitor and a cereblon-binding agent\r\n* Subjects who are refractory to carfilzomib may enroll throughout the trial; carfilzomib refractory status is defined by IMWG criteria: disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course\r\n* In the twice weekly dosing cohort of the study, enrollment will be limited to patients meeting carfilzomib refractory status\r\n* In the weekly dosing cohort, it will be required that one of the expansion cohorts (20 subjects) enrolls carfilzomib refractory subjects and the other (20 subjects) enrolls carfilzomib/proteasome inhibitor (PI) naive/sensitive subjectsXx_NEWLINE_xXPrior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollmentXx_NEWLINE_xXCurrent progestin-based hormone replacement therapy.Xx_NEWLINE_xXPatients with MF/SS must have failed at least 1 prior topical therapy (including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam); there is no upper limit for prior therapiesXx_NEWLINE_xXNon-MF/SS patients who are candidates for topical therapy must be refractory or intolerant to at least 1 prior topical therapyXx_NEWLINE_xXPatients who have received topical therapy, systemic chemotherapy, or biological therapy within 4 weeks prior to registration are NOT eligible for participationXx_NEWLINE_xXPatient currently requires systemic therapy.Xx_NEWLINE_xXPrior TCN-PM therapyXx_NEWLINE_xXPatients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.Xx_NEWLINE_xXPatients must have documented radiological disease progression either during or after the first-line therapy.Xx_NEWLINE_xXKey inclusion criteria:\n\n          1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or\n             gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of\n             the lower esophagus acceptable with radiographic or endoscopic documentation of\n             gastroesophageal-junction or proximal-stomach involvement.)\n\n          2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable\n             disease\n\n          3. ECOG performance status 0 or 1\n\n          4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a\n             fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant\n             chemotherapy acceptable provided 6 months elapsed between the end of this therapy and\n             the start of first-line therapy.)\n\n          5. Disease progression after the start of the 1 prior regimen based on computed\n             tomography\n\n          6. Adequate bone marrow, hepatic, and renal function\n\n          7. Ability to swallow an oral solid-dosage form of medication\n\n        Key exclusion criteria:\n\n          1. Squamous cell gastric carcinoma\n\n          2. Bone-only metastatic disease\n\n          3. History or presence of brain metastasis or leptomeningeal disease\n\n          4. Operable gastric or gastroesophageal-junction cancer\n\n          5. HER2-positive disease if the patient has not previously been treated with an anti-HER2\n             agent\n\n          6. Uncontrolled diarrhea, nausea, or vomiting\n\n          7. Known malabsorptive disorder\n\n          8. Significant medical disease other than gastric cancer\n\n          9. Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria)\n\n         10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted\n             agent (indibulin, eribulin, etc.)\n\n         11. Prior radiation therapy to more than 25% of the bone marrow\n\n         12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer\n             of the CYP3A pathway\n\n         13. Pregnancy or lactationXx_NEWLINE_xXNo non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXPrior gene therapy.Xx_NEWLINE_xXPrior cytotoxic therapies are NOT allowed; the only exception is prior corticosteroid therapy (prednisone up to 1 mg/kg for =< 3 months) which must be stopped at least 1 week prior to study enrollmentXx_NEWLINE_xXPatient refractory to dacarbazine defined as patient presenting a disease progression after 3 months of dacarbazine therapy.Xx_NEWLINE_xXPatients must have failed prior therapy with either a hypomethylating agent (e.g., azacytidine, decitabine) alone or in combination with other agents. Patients with abnormalities in chromosome 5q, should have failed either a hypomethylating agent or lenalidomide.Xx_NEWLINE_xXOngoing systemic immunosuppressive therapy after haploidentical HCTXx_NEWLINE_xXPatients who never achieved at least minor response (MR) to at least one prior line of therapyXx_NEWLINE_xXReceived prior systemic anti-cancer therapy for NSCLCXx_NEWLINE_xXCompleted autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entryXx_NEWLINE_xXPrevious cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor. Subjects who received Gliadel wafers will be excluded.Xx_NEWLINE_xXPrior AQ4N therapy.Xx_NEWLINE_xXFailed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not existXx_NEWLINE_xXInclusion Criteria:\n\n        2.3.1 Inclusion Criteria for the Biology (KIR2DL1 Polymorphisms/ALL MRD), Comparative\n        Outcomes, and Cost Effectiveness Trial\n\n          1. Any patient with ALL, AML, or MDS who is deemed eligible for and undergoes HCT at\n             participating centers who provides consent for the KIR2DL1 polymorphisms, comparative\n             outcomes and cost-effectiveness portion of the trial.\n\n          2. Any ALL patient undergoing allogeneic HCT at participating centers is eligible for the\n             ALL deep sequence MRD portion of the trial.\n\n          3. Patients ineligible for the KIR-favorable haploidentical phase II trial who require\n             T-cell depletion may be treated using TCR ??+CD3+/CD19+ cell depletion. These patients\n             will be followed descriptively on this portion of the trial. Preparative regimen will\n             be at the discretion of the transplant center, but the options associated with this\n             protocol are recommended.\n\n        2.3.2 Inclusion Criteria for the KIR-favorable Haploidentical Phase II trial:\n\n          1. Age < 22 years\n\n          2. Disease and disease status:\n\n               -  ALL high-risk in first remission (<5% blasts by morphology pre-transplant)\n                  meeting criteria for transplant. Example CR1 indications: induction failure (>5%\n                  blasts by morphology on post-induction BM), minimal residual disease greater than\n                  or equal to 1% marrow blasts by morphology after induction, minimal residual\n                  disease by flow cytometry >0.01% after consolidation, hypodiploidy (<44\n                  chromosomes), persistent or recurrent cytogenetic or molecular evidence of\n                  disease during therapy requiring additional therapy after induction to achieve\n                  remission (e.g. persistent molecular BCR-ABL positivity).\n\n               -  ALL in second remission: B-cell; early (less than or equal to 36 months from\n                  initiation of therapy) BM relapse, late BM relapse with MRD >0.1% by flow\n                  cytometry after first induction therapy; T-cell or Ph+ with BM relapse at any\n                  time; very early (less than 18 months from initiation of therapy) isolated\n                  extramedullary relapse (T or B-cell)\n\n               -  Myelodysplastic syndrome (MDS): Any 2001 WHO classification subtype (Appendix I).\n                  RAEB-2 patients may proceed directly to transplant, but may also receive\n                  induction chemotherapy before transplant. Patients with ?20% morphologic marrow\n                  blasts will require induction therapy to reduce morphologic marrow blasts below\n                  5% before transplant.\n\n               -  High-risk AML defined as monosomy 5, del 5q, monosomy 7, M6, M7, t(6;9),\n                  FLT3-ITD, or patients who have greater than or equal to 25% blasts by morphology\n                  after induction, or who do not achieve CR after 2 courses of therapy. Also,\n                  patients with ? 0.1% MRD or evidence of progressive extramedullary disease after\n                  induction chemotherapy.\n\n               -  AML in second or subsequent morphologic remission.\n\n          3. Has not received a prior allogeneic hematopoietic stem cell transplant.\n\n          4. Does not have a suitable HLA-matched sibling donor available for stem cell donation.\n\n          5. Does not have a suitable matched or single antigen mismatched related or unrelated\n             donor available at any time (noted by search), or it is in the patient's best interest\n             as judged by the attending to move forward with stem cell transplantation rather than\n             wait for an unrelated donor to become available (refer to subsection 2.5.1 for further\n             details).\n\n          6. Has a suitable HLA KIR favorable haploidentical matched family member available for\n             stem cell donation.\n\n          7. Karnofsky Index or Lansky Play-Performance Scale ? 60 % on pre-transplant evaluation.\n             Karnofsky scores must be used for patients > 16 years of age and Lansky scores for\n             patients < 16 years of age.\n\n          8. Able to give informed consent if > 18 years, or with a legal guardian capable of\n             giving informed consent if < 18 years.\n\n          9. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined\n             as:\n\n               -  Pulmonary: FEV1, FVC, and corrected DLCO must all be ? 50% of predicted by\n                  pulmonary function tests (PFTs). For children who are unable to perform for PFTs\n                  due to age, the criteria are: no evidence of dyspnea at rest and no need for\n                  supplemental oxygen.\n\n               -  Renal: Creatinine clearance or radioisotope GFR ³ 70 mL/min/1.73 m2 or a serum\n                  creatinine based on age/gender as follows:\n\n        Age Maximum Serum Creatinine (mg/dL) Male Female 1 to < 2 years 0.6 0.6 2 to < 6 years 0.8\n        0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4\n\n        ? 16 years 1.7 1.4 The threshold creatinine values in this Table were derived from the\n        Schwartz formula for estimating GFR utilizing child length and stature data published by\n        the CDC.45\n\n          -  Cardiac: Shortening fraction of ? 27% by echocardiogram or radionuclide scan (MUGA) or\n             ejection fraction of ? 50% by echocardiogram or radionuclide scan (MUGA), choice of\n             test according to local standard of care.\n\n          -  Hepatic: \\SGOT (AST) or SGPT (ALT) < 5 x upper limit of normal (ULN) for age.\n             Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.\n\n        Exclusion Criteria:\n\n          1. Pregnant or lactating females are ineligible as many of the medications used in this\n             protocol could be harmful to unborn children and infants.\n\n          2. Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded.\n             Patients with history of fungal disease during induction therapy may proceed if they\n             have a significant response to antifungal therapy with no or minimal evidence of\n             disease remaining by CT evaluation.\n\n          3. Patients with active CNS leukemia or any other active site of extramedullary disease\n             at the time of enrollment are not permitted. Note: Those with prior history of CNS or\n             extramedullary disease, but with no active disease at the time of pre-transplant\n             workup, are eligible.\n\n          4. Patients with genetic disorders (generally marrow failure syndromes) prone to\n             secondary AML/ALL with known poor outcome are not eligible (Fanconi Anemia, Kostmann\n             Syndrome, Dyskeratosis Congenita, etc).Xx_NEWLINE_xXTherapy related MDS.Xx_NEWLINE_xXSubjects who have received prior taxane therapy in the metastatic settingXx_NEWLINE_xXPatients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery (Day 0)Xx_NEWLINE_xX202 Prior anti-cancer therapy as specified below: At least 3 half-lives from first dose of AMG 562 must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Other targeted anti-cancer therapy (chemotherapy, antibody therapy,molecular targeted therapy, steroids) within 14 days or 5 half lives (which ever is longer) prior to first dose of AMG 562. Patients requiring continued treatment due to aggressive disease may only be included if there is agreement by both the investigator and the Amgen Medical Monitor. Radiation therapy completed within 28 days prior to first dose of AMG 562. Autologous HSCT within six weeks prior to start of AMG 562 treatment.Xx_NEWLINE_xX203 Prior anti-CD19-directed therapies.Xx_NEWLINE_xX207 Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Patient may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 562 at a low likelihood of relapse AND if there is agreement by both the investigator and the Amgen Medical Monitor.Xx_NEWLINE_xXInclusion Criteria:\n\n          1. Male or female patients age ? 18 years of age at the time of informed consent\n\n          2. HLA-A*0201 positive, confirmed by central laboratory\n\n          3. NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central laboratory\n\n          4. Arm 1: Patients must be refractory to or intolerant to all existing therapies known to\n             provide clinical benefit for their condition.\n\n          5. Arm 2: Subjects will have received the following previous therapies:\n\n               1. NSCLC — PD-1/PD-L1 inhibitor\n\n               2. Patients with NSCLC and an EGFR or ALK genomic tumor aberration must have disease\n                  progression after treatment with Health Authority-approved agents for these\n                  aberrations\n\n               3. Urothelial cancer — PD-1/PD-L1 inhibitor\n\n               4. Synovial sarcoma — at least one prior chemotherapy regimen\n\n          6. Arm 1 only: Histologically confirmed diagnosis of advanced NSCLC, melanoma, urothelial\n             carcinoma, or synovial sarcoma\n\n          7. Arm 2 only: Histologically confirmed diagnosis of advanced NSCLC, urothelial\n             carcinoma, or synovial sarcoma\n\n          8. Arm 2 only: Disease amenable to biopsy\n\n          9. Arm 2 only: Measurable disease to RECIST v.1.1 criteria\n\n        Exclusion Criteria:\n\n        Impaired baseline organ function as evaluated by out-of-range laboratory values 2. History\n        of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or\n        monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac\n        function 4. Presence of symptomatic or untreated central nervous system (CNS) metastases 5.\n        Active infection requiring systemic antibiotic therapy 6. Known history of human\n        immunodeficiency virus infection (HIV) 7. Active hepatitis B virus (HBV) or hepatitis C\n        virus (HCV) infection 8. Malignant disease, other than that being treated in this study 9.\n        Patients receiving systemic steroid therapy or any other systemic immunosuppressive\n        medication. Local steroid therapies are acceptable 10. Systemic anti-cancer therapy within\n        2 weeks of the first dose of study drug.\n\n        11. Major surgery within 2 weeks of the first dose of study drug 12. Radiotherapy within 2\n        weeks of the first dose of study drug, with the exception of palliative radiotherapy to a\n        limited field 13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF,\n        GM-CSF, M-CSF) ? 2 weeks prior to start of study drug 14. Pregnant, likely to become\n        pregnant, or lactating womenXx_NEWLINE_xXPatients must have disease that is recurrent or refractory to standard therapy; patients must have failed front-line therapy and declined or are not candidates for autologous stem cell transplant (ASCT) or have failed prior ASCTXx_NEWLINE_xXPatients must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease; unlimited prior hormonal therapy, targeted therapy or antiangiogenic therapy will be permittedXx_NEWLINE_xXAny local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ? 4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intra-arterial chemotherapy, without lipiodol or embolizing agents are not eligible.Xx_NEWLINE_xXPrior systemic therapy for HCC; prior exposure to regorafenib.Xx_NEWLINE_xXHistory of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapyXx_NEWLINE_xXSubjects with proven or suspected persistent bacteremia despite 72 hours of both systemic antibiotic therapy and lock therapy to which the infecting organism is susceptible;Xx_NEWLINE_xXCarcinoma patients in Arm A or Arm B must have received at least 1 prior regimen of standard of care systemic antitumor therapy for their metastatic disease and experienced tumor progression within 3 months after the last prior administration of the therapy or experienced unacceptable toxicity to these treatments.Xx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Any medical contraindications or previous therapy that would preclude treatment with either nivolumab, IRX-2, the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriatelyXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Any medical contraindications or previous therapy that would preclude treatment with either nivolumab or IRX-2 or the surgery, reconstruction or adjuvant therapy required to treat the oropharynx tumor appropriatelyXx_NEWLINE_xXPer PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy.Xx_NEWLINE_xXCancer-directed therapy within 2 weeks prior to starting treatment, with the exception of hydroxyurea, which is allowed to control white blood cell count. Hydroxyurea will be weaned as soon as clinically feasible.Xx_NEWLINE_xXHas FLT3-ITD mutant (> 3% FLT3-ITD/total FLT3) AML (primary AML or secondary to myelodysplastic syndrome [MDS]) that have failed any prior induction therapy regimen or have relapsed after prior induction/consolidation therapy, have not received more than one salvage therapy, and have not received more than one FLT3 inhibitor during prior AML treatment(s)Xx_NEWLINE_xXMicrosatellite instability-high (MSI-H) / mismatch repair-deficient (dMMR) tumors must have received prior therapy with pembrolizumab or nivolumab (where approved in the country) and must have progressed on that therapy.Xx_NEWLINE_xXNo more than 6 calendar months from last dose of previous anti-EGFR mAb treatment to date of consent for this trial (regardless of the line of therapy in which it was used)Xx_NEWLINE_xXSkin rash > Grade 1 from prior anti-EGFR therapy at the time of randomization.Xx_NEWLINE_xXHave been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy according to the IMWG criteria.Xx_NEWLINE_xXSubjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.Xx_NEWLINE_xXHas received at least 2 prior lines of therapy as described in the protocol.Xx_NEWLINE_xXHas had documented disease progression on or within 60 days after completion of the last therapy.Xx_NEWLINE_xXHistory of grade IV anaphylactic reaction to monoclonal antibody therapyXx_NEWLINE_xXFailed at least 1 prior systemic therapyXx_NEWLINE_xXSubjects have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide containing systemic anti-cancer therapy regimenXx_NEWLINE_xXMust have documentation of no evidence of disease progression of the tumor during or after completion of first line systemic anti-cancer therapyXx_NEWLINE_xXHave received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy >28 days prior to day 1Xx_NEWLINE_xXHave received prior NY-ESO-1 therapyXx_NEWLINE_xXHave received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamideXx_NEWLINE_xXSymptomatic metastatic brain or meningeal tumors unless the patient is >6 months from definitive therapy, has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study treatment. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).Xx_NEWLINE_xXIs expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma\n             using AJCC edition 8\n\n          -  Previously treated for unresectable or metastatic melanoma. Subjects must have at\n             least received the following treatments:\n\n               -  V600BRAF wild-type patients: must have received anti-PD-1/PD-L1 single-agent, or\n                  in combination with anti-CTLA-4 therapy\n\n               -  V600BRAF mutant patients: must have received prior anti-PD-1/PD-L1 single-agent,\n                  or in combination with anti-CTLA-4 therapy. In addition, subjects must have\n                  received prior V600BRAF inhibitor therapy, either single-agent or in combination\n                  with a MEK inhibitor\n\n          -  ECOG performance status 0-2\n\n          -  At least one measurable lesion per RECIST v1.1\n\n          -  At least one lesion, suitable for sequential mandatory tumor biopsies (screening and\n             on-treatment) in accordance with the biopsy guidelines specified in protocol. The same\n             lesion must be biopsied sequentially.\n\n          -  Screening tumor biopsy must fulfill the tissue quality criteria outlined in the\n             protocol, as assessed by a local pathologist\n\n        Key exclusion criteria common to all combination arms:\n\n          -  Subjects with uveal or mucosal melanoma\n\n          -  Presence of clinically active or unstable brain metastasis. Note: Subjects with\n             unstable brain lesions who have been definitively treated with stereotactic radiation\n             therapy, surgery or gamma knife therapy are eligible.\n\n             - Subjects with brain lesions who are untreated (i.e. newly discovered brain lesions\n             during screening) or received whole brain radiation must have documented stable\n             disease as assessed by two consecutive assessments ? 4 weeks apart and have not\n             required steroids for at least ? 4 weeks prior to enrollment.\n\n          -  Use of any live vaccines against infectious diseases within 4 weeks of initiation of\n             study treatment.\n\n          -  Active infection requiring systemic antibiotic therapy.\n\n          -  Systemic chronic steroid therapy (? 10mg/day prednisone or equivalent) or any other\n             immunosuppressive therapy 7 days prior to planned date of first dose of study\n             treatment. Note: Local steroids such as topical, inhaled, nasal and ophthalmic\n             steroids are allowed.\n\n          -  Active, known or suspected autoimmune disease or a documented history of autoimmune\n             disease. Note: Subjects with vitiligo, controlled type I diabetes mellitus on stable\n             insulin dose, residual autoimmune-related hypothyroidism only requiring hormone\n             replacement or psoriasis not requiring systemic treatment are permitted.\n\n          -  Prior allogenic bone marrow or solid organ transplant\n\n          -  History of known hypersensitivity to any of the investigational drugs used in this\n             studyXx_NEWLINE_xXPathologically-documented diagnosis of multiple myeloma that has relapsed after prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy. ?Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study.Xx_NEWLINE_xXreceived immunosuppressive therapy < 3 months prior to study Day 1Xx_NEWLINE_xXOngoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapyXx_NEWLINE_xXPathologically confirmed diagnosis of stage IIIB/IV recurrent squamous cell NSCLC defined as not amenable to local curative therapy (surgery, radiation, or chemoradiation), and refractory to systemic therapy OR Pathologically or radiologically (fulfilling non-invasive criteria) confirmed diagnosis of HCC not amenable to resection (partial hepatectomy or liver transplantation) or local therapy with curative intent (e.g. radiofrequency ablation) and must not be a liver transplant candidate as defined according to Milan criteriaXx_NEWLINE_xXPatients must not have received any of the specified therapies as stated in the protocol in the time period prior to registrationXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapy.Xx_NEWLINE_xXPatients with a history of having to discontinue anti-GD2 antibody therapy due to toxicity are not eligible.Xx_NEWLINE_xXPrior anti-GD2 therapy is not otherwise an exclusionary criteria unless it was given in combination with therapeutic 131I-MIBG.Xx_NEWLINE_xXThe patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.Xx_NEWLINE_xXHas received prior therapy with IL-2 or other investigational systemic cytokine therapy signaling through a common gamma-chain cytokine receptor including IL-7, IL-15 or IL-21Xx_NEWLINE_xXPrior hysterectomyXx_NEWLINE_xXFludarabine based therapy within 6 months of enrollmentXx_NEWLINE_xXFailure to demonstrate adequate compliance with medical therapy and follow-upXx_NEWLINE_xXHydroxyurea may be used to control leukocytosis and can be taken until day 1 of therapy; patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as suchXx_NEWLINE_xXPatients who have received any therapy other than hydroxyurea with the purpose of treating their AML are not eligibleXx_NEWLINE_xXAppropriate for single agent study drug therapy as prescribed by this protocol;Xx_NEWLINE_xXSystemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;Xx_NEWLINE_xXPrior 131 I-MIBG therapy is excludedXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapyXx_NEWLINE_xXPatients who are not candidates for, or decline, intensive therapyXx_NEWLINE_xXPatients who have received chemo-, hormone-, radio or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 14 days prior to start of treatment or those who have not recovered from adverse events attributed to the agent to grade 1 or baseline\r\n* Exceptions for prior treatments are:\r\n** Hydroxyurea for increased blast count (no washout period required; it can be continued throughout the first cycle of therapy)\r\n** Leukapheresis for leukocytosis (no wash out period required; it can be continued during the study)\r\n*** Note: If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration; please see assigned quality assurance monitor (QAM) with questionsXx_NEWLINE_xXHistory of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary disease requiring systemic steroid therapy, oxygen, or hospitalizationXx_NEWLINE_xXHistological confirmation of WM for which the patient has received at least one prior treatment; patients may have relapsed or refractory disease;(definition: relapse; patients who have received prior treatment for WM and now have disease recurrence; refractory; patients who have received anti-WM therapy and are noted to have progressive disease while on therapy, or those patients who demonstrated disease progression within 6 months of the last anti-WM treatment)Xx_NEWLINE_xXConcurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)Xx_NEWLINE_xXRequires hospitalization for IV empiric antibiotic therapyXx_NEWLINE_xXExpected requirement for hemodialysis while on study therapyXx_NEWLINE_xXReceived > 24 hours of systemic antibacterial therapy within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection; antibiotic prophylaxis is allowed; prophylactic use of antiviral or antifungal medication is permittedXx_NEWLINE_xXRequirement for any non-study potentially effective concomitant systemic antibacterial therapyXx_NEWLINE_xXProgression on at least two prior lines of therapy for unresectable metastatic colorectal adenocarcinoma\r\n* Administration of bevacizumab previously does not impact study inclusionXx_NEWLINE_xXPatients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapyXx_NEWLINE_xXPatients with tumors having actionable genomic alterations should have received prior therapy with Food and Drug Administration (FDA) approved agents targeting these aberrations (ie EGFR, ALK, ROS1, BRAF V600E)Xx_NEWLINE_xXPrior oncology vaccine therapyXx_NEWLINE_xXSteroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.Xx_NEWLINE_xXHas received prior therapy with an anti-IDO-1 agentXx_NEWLINE_xXPRE-REGISTRATION: Patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life.Xx_NEWLINE_xXPatients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.Xx_NEWLINE_xXStable on, or responding to 1st line therapy for metastatic disease \r\n* At least 8 and not more than 16 weeks after initiating 1st line therapy for metastatic disease\r\n* Tumor stability/response on 1st line therapy will be determined as per RECIST 1.1Xx_NEWLINE_xXFailed >= 2 prior systemic therapiesXx_NEWLINE_xXAny skin-directed therapy within 14 days prior to day 1 of protocol therapyXx_NEWLINE_xXActive infection; any systemic antimicrobial therapy must be completed >= 5 days prior to initiation of protocol therapyXx_NEWLINE_xXPathologically confirmed diagnosis of MDS by World Health Organization (WHO) criteria (including secondary and therapy-related disease) who have failed standard therapy, who are intolerant of prior therapy, or who refuse standard therapy; any prior therapy, including ibrutinib and/or lenalidomide (unless intolerant of one or both of these medications), is permitted\r\n* Hypomethylating agent failure is defined as disease progression or stable disease as best response to an adequate course of treatment (at least four cycles) with an injectable hypomethylating agent (azacitidine or decitabine)Xx_NEWLINE_xXPrior treatment with ARN-509 or enzalutamide (there is a grace period for men who wish to enroll and who have recently started enzalutamide for the first time but have taken less than 15 days of therapy)\r\n* Concurrent use of androgen deprivation therapy aside from LHRH agonist or antagonist (i.e. bicalutamide, flutamide, nilutamide, abiraterone, ketoconazole, estrogen); there will be a 2 week wash-out period from the last dose of any of these agents until the first dose of enzalutamide on study; patients who have just started enzalutamide for fewer than 5 doses prior to enrollment in the trial are still considered eligible and not subject to wash-outXx_NEWLINE_xXHepatocellular carcinoma cohort specific criteria:\r\n* Patients must have a histologically proven diagnosis of hepatocellular carcinoma that is not amenable to curative surgical therapeutic options\r\n* Patients must not be good candidates for locoregional therapy as determined by the investigator (ie diffuse multifocal disease, vascular involvement, etc)\r\n* Patients must have had evidence of radiologic progression on sorafenib or have had intolerance to sorafenib as defined by the recurrence of clinically significant toxicities despite a minimum of one dose reduction and appropriate supportive care; patients who refuse sorafenib are eligible with documentation of refusal by the treating physician\r\n* Patients may have received other treatment for HCC such as embolization, chemoembolization, intra-arterial chemotherapy, ethanol injection, ablative therapy, cryosurgery, or other locoregional or targeted therapy\r\n* Patients must have a Child Pugh score of 7 points or less \r\n* International normalized ratio (INR) =< 2.3 or prothrombin time =< 6 seconds above control\r\n* Patients with hepatitis B infection must be on appropriate anti-viral therapyXx_NEWLINE_xXPatients must have never received any prior systemic therapy for their disease.Xx_NEWLINE_xXFOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Patients must have relapsed/progressed after any therapy for MCL.Xx_NEWLINE_xXFOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): The patient condition remains suitable for the selected therapy. If the patient receives prior therapy with a given agent (X) and progressed, but the testing in Part 1 found this agent to be effective in a combination, the patient remains eligible for this combination that includes agent X.Xx_NEWLINE_xXPatient has any prior use of anti-androgen therapies.Xx_NEWLINE_xXUse of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal hormone therapy [HT] or contraceptives)Xx_NEWLINE_xXAnti-CD20 mAb-naive or anti CD20 mAb-sensitive (defined as progression of FL >= 6 months following prior anti-CD20 mAb containing therapy).Xx_NEWLINE_xXProgression during or within 6 months after fluoropyrimidine, irinotecan, and oxaliplatin; for oxaliplatin-based therapy, failure of therapy will also include patients who progressed within 12 months of adjuvant therapy and patients who had oxaliplatin discontinued secondary to toxicity or allergic reaction; patients with a known history of Gilbert’s disease who cannot receive irinotecan or patients who are intolerant of irinotecan or fluoropyrimidine are eligibleXx_NEWLINE_xXPrevious retreatment with cetuximab following progression on initial course of cetuximab therapyXx_NEWLINE_xXNo other therapy with demonstrated clinical benefit in relapsed/refractory B-cell NHL available to the patientXx_NEWLINE_xXPatients who received most recent therapy =< 4 weeks prior to registration; NOTE: use of systemic steroid therapy is allowed pretreatmentXx_NEWLINE_xXBeen treated with appropriate maximal medical therapy for heart failureXx_NEWLINE_xXPatients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvestXx_NEWLINE_xXSubjects must have received at least one line of chemotherapy prior to receiving adoptive T cell therapy and should have exhausted standard of care systemic therapy options; the decision to implement the T cell therapy will be at the discretion of the treating physician; the timing and total exposure to chemotherapy will depend on the tumor type in question (more systemic options for breast cancer; fewer for gastric cancer, for example); due to the heterogeneity of tumors being treated in this protocol, the discretion of the treating physician in terms of timing of immunotherapy will be criticalXx_NEWLINE_xXSteroids are not permitted 3 days prior to T cell infusion and concurrently during therapyXx_NEWLINE_xXPatients who are taking or anticipate taking any maintenance therapy while actively being treated on protocol or while being followed on protocol will be excluded; an example of this would be maintenance therapy with a Poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor such as olaparibXx_NEWLINE_xXSubjects with recurrence must have a documented complete response upon completion of initial definitive therapyXx_NEWLINE_xXPatients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: \r\n* Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy\r\n* Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)Xx_NEWLINE_xXPatients must have relapsed/refractory disease; patients with secondary AML (including those progressing from MDS or myeloproliferative neoplasm [MPN], and those with AML secondary to chemotherapy or radiotherapy for other malignancies) are eligible whether they have received prior therapy for AML or notXx_NEWLINE_xXNo prior targeted treatment (tx) or anti-angiogenic therapy; patients may have received one line of prior therapy with octreotide, locoregional therapy; continuation of concurrent octreotide is allowed; patients will be maintained on octreotide (sandostatin) for the duration of their treatmentXx_NEWLINE_xXPatients who have received bevacizumab, Gliadel, or are on active therapy with Optune are not eligibleXx_NEWLINE_xXPrevious therapy:\r\n* Patients must have progressed after standard therapy for metastatic/recurrent disease; this must have included irinotecan and oxaliplatin-containing regimens for patients with colorectal cancer (CRC) and platinum-containing regimens for patients with head and neck squamous cell carcinoma (H&NSCC)\r\n* Patients may have received cetuximab or panitumumab previouslyXx_NEWLINE_xXRelapsed and/or refractory AML from any duration of complete remission (CR); any number of prior therapies allowedXx_NEWLINE_xXAny number of prior endocrine therapies is allowed and must be discontinued prior to randomizationXx_NEWLINE_xXAny number of prior lines of therapyXx_NEWLINE_xXSubjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.Xx_NEWLINE_xXNo prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m^2 per day for one week or less for hyperleukocytosis), andXx_NEWLINE_xXPrior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as stated above; the patient must have recovered from all acute toxicities from any previous therapyXx_NEWLINE_xXPathologically confirmed advanced, unresectable, or metastatic colon or rectal cancer who have had intolerance to or progression after a fluoropyrimidine, oxaliplatin, irinotecan, and cetuximab or panitumumab in the event of wild-type RAS/BRAF tumors\r\n* Of note, prior bevacizumab or regorafenib exposure is not mandated as some patients are deemed poor candidates for anti-angiogenesis therapy and never receive these agentsXx_NEWLINE_xXPrior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptableXx_NEWLINE_xXPart 1 patients may have an unlimited number of prior therapy regimensXx_NEWLINE_xXParticipant has received more than one prior systemic therapy regimen for SCLC.Xx_NEWLINE_xXPatients with disease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXProgressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castrationXx_NEWLINE_xXSigns of leukostasis requiring urgent therapyXx_NEWLINE_xXPatients with non-melanoma skin cancers (NMSC) must have advanced or refractory tumors\r\n* Advanced/unresectable is defined by at least 1 of the following criteria: tumors 2 cm or more, tumors considered unresectable, tumors invading deep tissues such as muscle, cartilage or bone, tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes and/or distant sites\r\n* Refractory is defined by persistent or recurrent tumor despite prior therapy consisting of at least 1 of the following: surgery, radiation therapy, intralesional therapy, topical therapy, or systemic therapyXx_NEWLINE_xXPrevious treatment with talimogene laherparepvec or other herpes virus based therapy; (prior therapy with checkpoint inhibitors and/or other immunotherapy is allowed)Xx_NEWLINE_xXFor stratum B, patients must have disseminated recurrent disease (defined as multifocal disease, positive spine MRI including leptomeningeal disease and/or positive cytology within 21 days prior to study registration) and have adequate cerebrospinal fluid (CSF) flow based on spine MRI with no evidence of bulky disease or if bulky disease is present based on a CSF flow study per institutional guidelines; children must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapyXx_NEWLINE_xXPatients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin for NET and for GEP-NECXx_NEWLINE_xXSystemic antineoplastic therapyXx_NEWLINE_xXFor the dose escalation cohort, patients may have received any number of prior therapiesXx_NEWLINE_xXPatients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapyXx_NEWLINE_xXPrior gene transfer therapy or prior therapy with a cytolytic virus of any typeXx_NEWLINE_xXHas received prior therapy with an anti-CTLA4 agentXx_NEWLINE_xXPrior therapy with elotuzumabXx_NEWLINE_xXHistological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO ClassificationXx_NEWLINE_xXReceived hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatmentXx_NEWLINE_xXReceived hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatmentXx_NEWLINE_xXSubjects with one to three lines of therapy for their disease with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this periodXx_NEWLINE_xXSubjects must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes:\r\n* Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy, or investigational agent) at least 21 days prior to cycle 1 day 1 (C1D1) AMG 232 + KRd\r\n* Corticosteroids at least 3 weeks prior to starting AMG-232 + KRd, except for a dose equivalent to dexamethasone of =< 4 mg/day\r\n* Autologous stem cell transplantation at least 12 weeks prior to starting AMG-232 + KRd\r\n* Allogeneic stem cell transplantation at least 24 weeks prior to starting AMG-232 + KRd, and these subjects must also NOT have moderate to severe active acute or chronic graft versus host disease (GVHD)Xx_NEWLINE_xXSubjects who have received radiation therapy targeting > 10% of the bone marrow space must have completed this at least 2 weeks prior to starting therapy with AMG-232 + KRdXx_NEWLINE_xXSubjects with myeloma that is relapsed and/or refractory to KRd when used in combination defined as progression of disease while on therapy or within 60 days of completing therapyXx_NEWLINE_xXAll patients must have received, and be relapsed/refractory to at least one line of systemic therapy\r\n* NOTE: This does not include surgery or radiation alone; patients may have received any number of systemic therapies\r\n* NOTE: For patients with aggressive lymphoma, there should be no other standard therapies that would confer survival benefitXx_NEWLINE_xXPatients who have received prior anti-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigenXx_NEWLINE_xXIdiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to step 1 registrationXx_NEWLINE_xXPatients may have received previous NY ESO 1 vaccine therapy; patients who received bevacizumab or other experimental therapies are eligible for enrollment provided they have discontinued therapy (at least 4 weeks) prior to randomization and recovered from toxicities to less than grade 2Xx_NEWLINE_xXSubjects who have received prior therapy with hypomethylating agents (5-azacytidine, decitabine, SGI-110)Xx_NEWLINE_xXAny patient requiring supplemental oxygen therapyXx_NEWLINE_xXPatients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)Xx_NEWLINE_xXPrevious therapy with pazopanibXx_NEWLINE_xXRelapsed after achieving remission with a prior therapyXx_NEWLINE_xXDiagnosis of relapsed or refractory AML and not candidate for standard consolidation treatment after daunorubicin and cytosine arabinoside OR diagnosis of APL relapsed after tretinoin (ATRA) and arsenic trioxide therapy or APL with persisting or rising blasts, and no other comparable or satisfactory alternative therapy available (including patients not eligible for, or who have access to, investigational therapies via a clinical trial)Xx_NEWLINE_xXPatients must have prior chemotherapy for advanced CRC and have previously received both an oxaliplatin and an irinotecan based regimen; patients who are not appropriate for second line therapy because of their KRAS gene mutational status or because they cannot tolerate second line therapy, will be included even after only one prior therapy regimenXx_NEWLINE_xXPatients must have received < 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen)Xx_NEWLINE_xXSubjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least 1 month (30 days) prior to receiving the first dose of randomized therapyXx_NEWLINE_xXDOSE ESCALATION COHORT: Prior treatment with at least one line of systemic therapyXx_NEWLINE_xXDOSE EXPANSION COHORT: Prior treatment with at least one line of systemic therapyXx_NEWLINE_xXPrior therapy with axitinibXx_NEWLINE_xXAll subjects must have documented disease progression during or after their last antimyeloma therapyXx_NEWLINE_xXIntolerance to previous trastuzumab or pertuzumab therapyXx_NEWLINE_xXFor phase II part of the trial: =< 3 prior lines of treatment in the metastatic setting for the current breast cancer; however, there is no limit on number of prior line of therapy in phase I part of the trialXx_NEWLINE_xXPatients who have received any tumor-directed therapy prior to biopsy are not eligible; concurrent treatment with corticosteroids is allowedXx_NEWLINE_xXSubjects must not have had prior androgen deprivation therapy in the past 6 monthsXx_NEWLINE_xXHistory of androgen deprivation therapy within the past 6 monthsXx_NEWLINE_xXPatients requiring concomitant therapy with phenytoin, phenobarbital, carbamazepine, or valproic acidXx_NEWLINE_xXAnti-arrhythmic therapy other than beta blockers or digoxinXx_NEWLINE_xXConcomitant chemotherapy, radiation therapy\r\n* For patients with hyperleukocytosis with > 50,000 blasts/uL; leukapheresis or hydroxyurea may be used prior to study drug administration for cytoreduction at the discretion of the treating physician; hydroxyurea must be stopped 24 hours prior to initiation of protocol defined therapyXx_NEWLINE_xXTo be eligible for the dose-finding phase: (the dose-finding phase completed in 12/2016) \r\n* Relapsed patients\r\n** Patients must be in first relapse, and\r\n** Patients must not have received prior re-induction therapy\r\n* Refractory patients\r\n** Patients must not have received more than one attempt at remission induction, which may consist of up to two different therapy courses; Children Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is an example\r\n* Treatment-related AML (t-AML)\r\n** Patients must be previously untreated for secondary AMLXx_NEWLINE_xXTo be eligible for the phase 2 efficacy phase:\r\n* Relapse patients:\r\n** Patients must be in first marrow relapse, and \r\n** Patients must not have received prior re-induction therapy; donor lymphocyte infusion (DLI) is considered a re-induction attemptXx_NEWLINE_xXReceived anticoagulation therapy with warfarin, or equivalent vitamin K antagonists, within the last 28 days prior to day 1 of ibrutinib; patients with familial coagulopathic diseases (e.g. hemophilia, von Willebrand disease) are also excluded; if applicable, subjects must discontinue fish oil and vitamin E supplements within 7 days prior to initiating ibrutinib therapyXx_NEWLINE_xXProgressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapyXx_NEWLINE_xXPrior history of up to 8 weeks of androgen deprivation therapy defined as luteinizing-hormone releasing hormone (LHRH) or other medical castration therapy prior to registration is acceptable; this will be in addition to the 6 months of ADT on studyXx_NEWLINE_xXPatients must have recovered from the acute effects of prior liver-directed therapy (e.g. RT, radiofrequency ablation [RFA], or transarterial chemoembolization [TACE]), and a minimum of 4 weeks must have passed since the last procedure and protocol therapyXx_NEWLINE_xXFor melanoma patients, patients must have received prior programmed cell death protein 1 (PD-1) therapy and have progressed immune-related progressive disease (irPD) by immune-related Response Criteria (irRC)Xx_NEWLINE_xXPatients with secondary AML or therapy related disease (t-AML) are eligibleXx_NEWLINE_xXPatients already using topical sirolimus therapyXx_NEWLINE_xXAt least one prior systematic therapy in the metastatic settingXx_NEWLINE_xXPatients may have received prior interferon alpha (IFN-alpha), but must not have received IFN-alpha in the 4-week period prior to enrollment on the trial; patients who have not received prior adjuvant therapy should be informed of the potential therapeutic benefit of IFN-alpha; previous radiation therapy, including after the surgical resection, is allowed as long as 14 days have elapsed between the radiation and initiation of first vaccination with NeoVaxXx_NEWLINE_xXPrior investigational melanoma-directed cancer vaccine therapyXx_NEWLINE_xXUse of a non-oncology vaccine therapy for prevention of infectious diseases during the 4 week period prior to first dose of NeoVax administration; patients may not receive any non-oncology vaccine therapy during the period of NeoVax administration and until at least 8 weeks after the last dose of study therapyXx_NEWLINE_xXReceived more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, the dose counts against the total dose limit.Xx_NEWLINE_xXNo other experimental therapy is permitted while on studyXx_NEWLINE_xXPatients must have received at least one prior systemic therapy for lymphoma; a washout period of at least 3 weeks is required from the most recent prior therapyXx_NEWLINE_xXPatients must have at least ONE of the following:\r\n* Recurrent/progressive disease at any time prior to enrollment - regardless of response to frontline therapy\r\n* Refractory disease: persistent sites of disease (after less than a partial response to frontline therapy, following a minimum of 4 cycles of induction therapy) AND patient has never had a relapse/progression\r\n* Persistent disease: persistent disease after achieving at least a partial response to frontline therapy after a minimum of 4 cycles of induction therapy and patient has never had a relapse/progressionXx_NEWLINE_xXPatients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study\r\n* Myelosuppressive chemotherapy: must have received last dose at least 2 weeks prior to protocol therapy; this includes cytotoxic agents given on a low dose metronomic regimen\r\n* Biologic (anti-neoplastic agent) (includes retinoids): must have received last dose at least 7 days prior to protocol therapy\r\n* Monoclonal antibodies: must have received last dose at least 7 days or 3 half-lives, whichever is longer, prior to protocol therapyXx_NEWLINE_xXA minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapyXx_NEWLINE_xXPrior anti-disialoganglioside (GD2) antibody, isotretinoin, or lenalidomide therapy:\r\n* Patients who have received prior anti-GD2 antibody therapy are eligible if they did not have tumor relapse/progression while receiving this therapy\r\n* Patients who have received either isotretinoin or lenalidomide are eligible, but not if they have received the two agents concomitantlyXx_NEWLINE_xXPrior exposure to PLD or anthracycline therapy.Xx_NEWLINE_xXPrior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab).Xx_NEWLINE_xXPrior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.Xx_NEWLINE_xXSubject meets institutional requirements for IL-2 therapyXx_NEWLINE_xXThere is no limit to number of prior therapiesXx_NEWLINE_xXBe willing to undergo a second core or excisional biopsy of a bone metastasis on therapy (approximately after 8 weeks of study therapy or after 2 doses of radium-223 if delays have occurred)Xx_NEWLINE_xXPatients with AML, relapsed or refractory to standard therapy or elderly patients with AML (age 65 or over). Patients who have AML and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. Patients with de novo or treated MDS or chronic myelomonocytic leukemia (CMML) INT-1 or above are eligible. Patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; a caveat to this is in the case of rapidly progressive disease. Hydroxyurea is permitted for control of elevated white blood cell (WBC) prior to treatment and can be continued for the first 4 weeks of therapy. Erythropoiesis stimulating agents (ESAs) and granulocyte colony stimulating factor (GCSF) are allowed before therapy. ESAs, GCSF or other growth factors are permitted on therapy.Xx_NEWLINE_xXImmunosuppressive therapy within 30 days prior to initiation of protocol therapyXx_NEWLINE_xXPatients who are initially rendered NED or have MRD following standard therapy but exhibit disease progression prior to initiation of vaccinationXx_NEWLINE_xXInclusion Criteria:\n\n          1. Patients having histologically confirmed unresectable (Stage III) or metastatic\n             (Stage IV) malignant melanoma with a positive BRAF mutation result determined by\n             Roche CoDx or local CLIA-certified analysis\n\n          2. Patients naïve to a selective BRAF inhibitor therapy or must have progressed after\n             therapy on a selective BRAF inhibitor. For patients entering the protocol progressing\n             on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.\n\n          3. Tumor biopsies are optional in this study except for patients entering the mandatory\n             biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients\n             with accessible tumors for biopsy to include the collection of formalin-fixed,\n             paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker\n             sections of the protocol. Willingness of patient to give consent of biopsy, should be\n             ascertained\n\n          4. Patients of ? 18 years of age\n\n          5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1\n\n          6. Patients with measurable disease per 'Response Evaluation Criteria In Solid Tumors'\n             (RECIST version 1.1)\n\n          7. Patients must have normal organ and adequate marrow function\n\n          8. Patients with ability to swallow and retain oral medication\n\n          9. Women of childbearing potential and men willing to agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to\n             study entry, during the duration of study participation and for at least 4 weeks\n             after withdrawal from the study, unless they are surgically sterilized.\n\n         10. Negative serum pregnancy test within 10 days prior to commencement of therapy dosing\n             in premenopausal women. Women of non-childbearing potential may be included if they\n             are either surgically sterile or have been postmenopausal for ?1 year.\n\n         11. Ability to understand and the willingness to offer a written Informed Consent\n             document prior to the screening procedures for participation into the study\n\n               -  For Extension phase-\n\n               -  For patients entering the protocol progressing on vemurafenib therapy, they must\n                  be tolerant of the vemurafenib dose selected for the extension phase\n\n        Exclusion Criteria:\n\n          1. Prior malignancy (within the last 2 years) except for adequately treated basal cell\n             or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ\n             prostate cancer or any other cancer for which the patient has been disease-free for\n             at least 2 years\n\n          2. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted\n             anti-cancer therapy (one week  for BRAF inhibitor for melanoma) or surgery within 4\n             weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any\n             radio-or toxin-immunoconjugates) before Day 1 of Investigational product\n             administration and have not recovered (to < Grade 1) from the toxic effects from any\n             prior therapy\n\n          3. Patients having received any other investigational agents within 4 weeks prior to Day\n             1 of Investigational product administration and have not recovered completely (to <\n             Grade 1) from the side effects of the earlier investigational agent\n\n          4. Anticipated administration of any anti-cancer therapies (chemotherapy, radiation\n             therapy, immunotherapy, biological therapy, hormonal therapy, surgery, and/or tumor\n             embolisation) other than those administered in this study such as BRAF inhibitor\n\n          5. Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal\n             cord compression [patients with previous brain metastases will be allowed to enter\n             the trial if metastases have been surgically removed or all known sites of metastases\n             have been treated with stereotactic high dose radiosurgery. Patients must be off\n             corticosteroids for at least one month and have a stable lesion with verification by\n             imaging (CT/MRI) within 28 days prior to Day 1 of Investigational product\n             administration]\n\n          6. Patients with clinically significant medical condition of malabsorption, inflammatory\n             bowel disease, chronic diarrheal condition, refractory nausea, vomiting or any other\n             condition that will interfere significantly with the absorption of study drugs\n\n          7. Patients with mean QTc interval >480 msec at screening\n\n          8. Treatment with drugs with potential to cause dysrhythmias including but notXx_NEWLINE_xXInclusion Criteria:\n\n          1. Patients having histologically confirmed unresectable (Stage III) or metastatic\n             (Stage IV) malignant melanoma with a positive BRAF mutation result determined by\n             Roche CoDx or local CLIA-certified analysis\n\n          2. Patients naïve to a selective BRAF inhibitor therapy or must have progressed after\n             therapy on a selective BRAF inhibitor. For patients entering the protocol progressing\n             on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.\n\n          3. Tumor biopsies are optional in this study except for patients entering the mandatory\n             biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients\n             with accessible tumors for biopsy to include the collection of formalin-fixed,\n             paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker\n             sections of the protocol. Willingness of patient to give consent of biopsy, should be\n             ascertained\n\n          4. Patients of ? 18 years of age\n\n          5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1\n\n          6. Patients with measurable disease per 'Response Evaluation Criteria In Solid Tumors'\n             (RECIST version 1.1)\n\n          7. Patients must have normal organ and adequate marrow function\n\n          8. Patients with ability to swallow and retain oral medication\n\n          9. Women of childbearing potential and men willing to agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to\n             study entry, during the duration of study participation and for at least 4 weeks\n             after withdrawal from the study, unless they are surgically sterilized.\n\n         10. Negative serum pregnancy test within 10 days prior to commencement of therapy dosing\n             in premenopausal women. Women of non-childbearing potential may be included if they\n             are either surgically sterile or have been postmenopausal for ?1 year.\n\n         11. Ability to understand and the willingness to offer a written Informed Consent\n             document prior to the screening procedures for participation into the study\n\n               -  For Extension phase-\n\n               -  For patients entering the protocol progressing on vemurafenib therapy, they must\n                  be tolerant of the vemurafenib dose selected for the extension phase\n\n        Exclusion Criteria:\n\n          1. Prior malignancy (within the last 2 years) except for adequately treated basal cell\n             or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ\n             prostate cancer or any other cancer for which the patient has been disease-free for\n             at least 2 years\n\n          2. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted\n             anti-cancer therapy (one week  for BRAF inhibitor for melanoma) or surgery within 4\n             weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any\n             radio-or toxin-immunoconjugates) before Day 1 of Investigational product\n             administration and have not recovered (to < Grade 1) from the toxic effects from any\n             prior therapy\n\n          3. Patients having received any other investigational agents within 4 weeks prior to Day\n             1 of Investigational product administration and have not recovered completely (to <\n             Grade 1) from the side effects of the earlier investigational agent\n\n          4. Anticipated administration of any anti-cancer therapies (chemotherapy, radiation\n             therapy, immunotherapy, biological therapy, hormonal therapy, surgery, and/or tumor\n             embolisation) other than those administered in this study such as BRAF inhibitor\n\n          5. Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal\n             cord compression [patients with previous brain metastases will be allowed to enter\n             the trial if metastases have been surgically removed or all known sites of metastases\n             have been treated with stereotactic high dose radiosurgery. Patients must be off\n             corticosteroids for at least one month and have a stable lesion with verification by\n             imaging (CT/MRI) within 28 days prior to Day 1 of Investigational product\n             administration]\n\n          6. Patients with clinically significant medical condition of malabsorption, inflammatory\n             bowel disease, chronic diarrheal condition, refractory nausea, vomiting or any other\n             condition that will interfere significantly with the absorption of study drugs\n\n          7. Patients with mean QTc interval >480 msec at screening\n\n          8. Treatment with drugs with potential to cause dysrhythmias including but notXx_NEWLINE_xXInclusion Criteria:\n\n          -  Patients having histologically and/or cytologically confirmed non-haematological\n             malignancy that is metastatic or unresectable and for which standard\n             curative/palliative treatment does not exist or is no longer effective or is not\n             tolerated by patient.\n\n          -  Patients of either sex, of all races and ethnic groups, and more than 18 years of\n             age.\n\n          -  ECOG (Eastern Cooperative Oncology Group) performance status less than 2.\n\n          -  Patients with life expectancy of at least 4 months.\n\n          -  Patients with measurable or evaluable disease per Response Evaluation Criteria In\n             Solid Tumors (RECIST) version 1.1.\n\n          -  Patients must have adequate organ and marrow function as defined below:\n\n          -  Absolute neutrophil count more than equal to 1500/cmm\n\n          -  Platelets more than equal 100,000/cmm\n\n          -  Total bilirubin within normal limits of the institution.\n\n          -  AST/ALT less than equal 2.5 X institutional upper limit of normal (ULN) or less than\n             equal 5 X institutional upper limit of normal (ULN) in the presence of liver\n             metastases\n\n          -  Creatinine less than equal 1.5 X institutional upper limit of normal (ULN)\n\n          -  Women of childbearing potential and men willing to agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to\n             study entry, during the duration of study participation and for at least 4 weeks\n             after withdrawal from the study, unless they are surgically sterilised.\n\n          -  Ability to understand and the willingness to provide a written informed consent\n             document.\n\n        Exclusion Criteria:\n\n          1. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted\n             anti-cancer therapy or surgery within 4 weeks (3 months for monoclonal antibodies,\n             radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before\n             study drug administration and have not recovered (to < Grade 1) from the toxic\n             effects from any prior therapy.\n\n          2. Patients having received any other investigational agents within 4 weeks prior to the\n             date of enrolment and have not recovered completely (to < Grade 1) from the side\n             effects of the earlier investigational agent.\n\n          3. Patients with known brain metastases (except for patients who have previously-treated\n             CNS metastases, are asymptomatic, and have had no requirement for steroids or\n             anti-seizure medication for two months prior to first dose of study drug.)\n\n          4. Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction\n             during the previous 6 months.\n\n          5. Patients with diabetes mellitus requiring insulin therapy at screening or patients\n             with clinically significant diabetic complications, such as neuropathy, retinopathy,\n             peripheral vascular disease or nephropathy.\n\n          6. Clinically significant medical condition of malabsorption, inflammatory bowel\n             disease, or chronic diarrheal condition that might affect the absorption of the\n             investigational agent.\n\n          7. Patients on chronic anticoagulation treatment. Prophylactic anticoagulation with\n             low-molecular heparin is allowed.\n\n          8. Patients with inter-current illness including, but not limited to ongoing or\n             clinically significant active infection, symptomatic congestive heart failure,\n             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social\n             situations that would limit compliance with study requirements.\n\n          9. Patients with a known history of allergic reaction to any other medication considered\n             to be clinically significant by the investigator.\n\n         10. Women who are pregnant or nursing.\n\n         11. Patients with immune deficiency and at increased risk of lethal infections, for\n             example, known h/o HIV, HBV or HCV.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Patients having histologically and/or cytologically confirmed non-haematological\n             malignancy that is metastatic or unresectable and for which standard\n             curative/palliative treatment does not exist or is no longer effective or is not\n             tolerated by patient.\n\n          -  Patients of either sex, of all races and ethnic groups, and more than 18 years of\n             age.\n\n          -  ECOG (Eastern Cooperative Oncology Group) performance status less than 2.\n\n          -  Patients with life expectancy of at least 4 months.\n\n          -  Patients with measurable or evaluable disease per Response Evaluation Criteria In\n             Solid Tumors (RECIST) version 1.1.\n\n          -  Patients must have adequate organ and marrow function as defined below:\n\n          -  Absolute neutrophil count more than equal to 1500/cmm\n\n          -  Platelets more than equal 100,000/cmm\n\n          -  Total bilirubin within normal limits of the institution.\n\n          -  AST/ALT less than equal 2.5 X institutional upper limit of normal (ULN) or less than\n             equal 5 X institutional upper limit of normal (ULN) in the presence of liver\n             metastases\n\n          -  Creatinine less than equal 1.5 X institutional upper limit of normal (ULN)\n\n          -  Women of childbearing potential and men willing to agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to\n             study entry, during the duration of study participation and for at least 4 weeks\n             after withdrawal from the study, unless they are surgically sterilised.\n\n          -  Ability to understand and the willingness to provide a written informed consent\n             document.\n\n        Exclusion Criteria:\n\n          1. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted\n             anti-cancer therapy or surgery within 4 weeks (3 months for monoclonal antibodies,\n             radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before\n             study drug administration and have not recovered (to < Grade 1) from the toxic\n             effects from any prior therapy.\n\n          2. Patients having received any other investigational agents within 4 weeks prior to the\n             date of enrolment and have not recovered completely (to < Grade 1) from the side\n             effects of the earlier investigational agent.\n\n          3. Patients with known brain metastases (except for patients who have previously-treated\n             CNS metastases, are asymptomatic, and have had no requirement for steroids or\n             anti-seizure medication for two months prior to first dose of study drug.)\n\n          4. Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction\n             during the previous 6 months.\n\n          5. Patients with diabetes mellitus requiring insulin therapy at screening or patients\n             with clinically significant diabetic complications, such as neuropathy, retinopathy,\n             peripheral vascular disease or nephropathy.\n\n          6. Clinically significant medical condition of malabsorption, inflammatory bowel\n             disease, or chronic diarrheal condition that might affect the absorption of the\n             investigational agent.\n\n          7. Patients on chronic anticoagulation treatment. Prophylactic anticoagulation with\n             low-molecular heparin is allowed.\n\n          8. Patients with inter-current illness including, but not limited to ongoing or\n             clinically significant active infection, symptomatic congestive heart failure,\n             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social\n             situations that would limit compliance with study requirements.\n\n          9. Patients with a known history of allergic reaction to any other medication considered\n             to be clinically significant by the investigator.\n\n         10. Women who are pregnant or nursing.\n\n         11. Patients with immune deficiency and at increased risk of lethal infections, for\n             example, known h/o HIV, HBV or HCV.Xx_NEWLINE_xXPrior exposure to another anti-angiogenic therapy (eg, bevacizumab, sunitinib)Xx_NEWLINE_xXPrior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapyXx_NEWLINE_xXNo ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 daysXx_NEWLINE_xXPrior therapy for the treatment of solitary plasmacytoma is permitted, but > 7 days should have elapsed from the last day of radiation\r\n* NOTE: Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate, or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigatorXx_NEWLINE_xXPrior therapy requirements:\r\n* At least one prior therapy using an agent with the potential for prolonged remission (generally includes interleukin-2, checkpoint-blocking antibodies, or adoptive cell therapy)\r\n* At least 4 weeks from last dose of prior chemotherapy or immunomodulator therapy with resolution of the acute toxicities; for patients coming off molecularly-targeted therapy, at least 2 weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria\r\n* At least 2 weeks from completion of prior radiation therapy with no residual radiation toxicities\r\n* At least 4 weeks from last dose of prior investigational therapy with recovery to meet baseline eligibility criteria\r\n* Not receiving any current anticancer therapy\r\n* Note: any patient whose tumors carry a B-Raf proto-oncogene, serine/threonine kinase (BRAF) v600 mutation should either be excluded, or may be included after experiencing progression following treatment with BRAF inhibitor regimen or if they consent and agree to forgo Food and Drug Administration (FDA)-approved therapies that increase median survivalXx_NEWLINE_xXPatients with thyroid disease should be excluded unless euthyroid on suppressive or replacement therapyXx_NEWLINE_xXChronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapyXx_NEWLINE_xXImmunosuppressive therapy within 30 days prior to initiation of protocol therapyXx_NEWLINE_xXArm 2 patients may have an unlimited number of prior therapy regimens but may not have received prior antiangiogenesis therapy except for bevacizumab (patients may not have received aflibercept, ramucirumab, cediranib, cabozantinib, or XL184)Xx_NEWLINE_xXLiver-directed therapy (chemoembolization, radioembolization, bland embolization, ablative therapy) within 4 weeks of DEB-TACEXx_NEWLINE_xXHepatic encephalopathy refractory to medical therapyXx_NEWLINE_xXAll patients must have previously received trastuzumab and a taxane, separately or in combination and have received prior therapy for metastatic diseaseXx_NEWLINE_xXMyelodysplastic syndrome of all subtypes including refractory anemia (RA) or all International Prognostic Scoring Systems (IPSS) categories if severe pancytopenia, transfusion requirements not responsive to therapy, or high risk cytogenetics; blasts must be less than 5%; if >= 5% requires therapy (induction or hypomethylating agents) pre-transplant to decrease disease burdenXx_NEWLINE_xXPhase I: Pathologically confirmed relapsed or refractory B cell lymphoma; must have relapsed after initial therapy; no restriction in number of prior lines of therapyXx_NEWLINE_xXPhase II: Pathologically confirmed relapsed or refractory HL; no restriction in number of prior lines of therapyXx_NEWLINE_xXPrevious history of intravesical therapy allowedXx_NEWLINE_xXSubjects must not have had prior pazopanib therapyXx_NEWLINE_xXCytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, low dose cytarabine, and intrathecal chemotherapy which is permitted up to 24 hours prior to the start of protocol therapy; for patients with aggressive disease that is in the peripheral blood and rising, this 14 day washout period may be omittedXx_NEWLINE_xXPatients may not have undergone any prior therapy for their AML other than hydroxyurea; however, if patients had an antecedent myelodysplastic syndrome (MDS), prior treatment with a hypomethylating agent or any other therapy (with the exception of allogeneic stem cell transplant) used to treat their MDS is allowedXx_NEWLINE_xXMust have received prior anthracyline and taxane compound therapy unless clinically contraindicatedXx_NEWLINE_xXNo limitations to number of prior chemotherapies for metastatic disease; treatment with prior taxanes (except nab-paclitaxel) is allowed as long as it has been 6 months or more since exposure to prior taxane; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatmentXx_NEWLINE_xXSubjects should be > 2 weeks from prior systemic chemotherapy for breast cancer AND should have recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy prior to study entry; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatmentXx_NEWLINE_xXSubjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)Xx_NEWLINE_xXAny prior treatment for prostate cancer \r\n* Radical prostatectomy \r\n* Radiation therapy (external beam or brachytherapy) \r\n* Cryotherapy \r\n* High intensity focused ultrasound treatment \r\n* Photodynamic therapy \r\n* Androgen deprivation therapyXx_NEWLINE_xXAML has relapsed after, or is refractory to, first-line therapy, with or without additional subsequent therapyXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPatients who have received prior therapy with eribulin mesylate are not eligibleXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXFor stage 1 (all patients) and dose expansion (stage 2) endometrial and ovarian cancer cohorts, participants are allowed following unlimited prior therapy; for stage 2 GBM participants, no more than 2 prior relapses are allowed; for these patients, relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or a subsequent therapy; the intent therefore is that GBM patients enrolling onto stage 2 had no more than 3 prior therapies (initial and treatment for 2 relapses); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute 1 relapse\r\n* NOTE: for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of glioblastoma will be considered the first relapse; therefore, these participants may have had more than 3 prior therapiesXx_NEWLINE_xXHave progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting; trastuzumab emtansine (T-DM1) would count as a line of therapy and patients previously treated with T-DM1 are eligibleXx_NEWLINE_xXTherapeutic options: patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPrevious treatment with genetically engineered GD2-CAR T cells; previous vaccine therapy, anti-GD2 mAb therapy or therapy with other genetically engineered T cells is not an exclusion criteriaXx_NEWLINE_xXPatients who require systemic corticosteroid or other immunosuppressive therapy; immunosuppressive therapy must be stopped at least 14 days prior to cell infusionXx_NEWLINE_xXNo requirement for supplemental oxygen therapyXx_NEWLINE_xXPatient may have had any prior topical or systemic therapy except for total electron beam irradiation; patients must be a minimum of 2 weeks from topical therapy and 3 weeks from systemic therapies, phototherapy, or local radiation therapy before initiating protocol specific therapy except for HDACI if they are in Arm B; patients are allowed to take weak potency topical corticosteroids if patient has been on a stable dose for more than a monthXx_NEWLINE_xXPatients who have received one prior regimen must have a GOG performance status of 0, 1 or 2; patients who have received two or more prior regimens must have GOG performance status of 0 or 1Xx_NEWLINE_xXThere is no limit to the number of prior therapiesXx_NEWLINE_xXPatient has had prior therapy with neural stem cellsXx_NEWLINE_xXPrevious therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2 targeted therapies for any malignancyXx_NEWLINE_xXAny sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (these patients are eligible if this therapy is discontinued prior to randomization)Xx_NEWLINE_xXPatients may have had prior systemic therapy without constraint on the number of prior treatment regimens except:\r\n* Patients may not have had > 450 mg/m^2 doxorubicin \r\n* Patients may not have had > 3000 centigray (cGy) to fields encompassing the entire pelvisXx_NEWLINE_xXNo recent treatment for thyroid cancer as defined as:\r\n* No radioactive iodine therapy is allowed if given < 3 months prior to initiation of this protocol therapy; a diagnostic study using < 10 mCi of radioactive iodine (RAI) is not considered radioactive iodine therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapyXx_NEWLINE_xXPatients MAY HAVE received non-cytotoxic (biologic or targeted) agent(s) as part of initial treatment and/or for management of recurrent or persistent disease, with the below stated exceptions (see NOTE below); prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration\r\n* NOTE: Prior therapy with PI3K inhibitors, AKT inhibitors and/or mammalian target of rapamycin (mTor) inhibitors (e.g., everolimus, temsirolimus) is NOT allowed; prior therapy with MEK inhibitors (e.g., AZD6244 or selumetinib) is NOT allowedXx_NEWLINE_xXPatients should be newly diagnosed HNSCC, with no prior therapy for this diseaseXx_NEWLINE_xXPatients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:\r\n* An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden\r\n* Any maintenance therapy used after an Induction should be considered part of that Induction regimen\r\n* Use of any agent or combination of agents more than once during the patient’s disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)\r\n* In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimenXx_NEWLINE_xXPatient must have been eligible for and initially randomized to Arm 1 (low dose carfilzomib), begun cycle 2 of treatment, and progressed prior to completing 12 cycles of protocol therapyXx_NEWLINE_xXRelapsed or refractory after at least 1 front-line therapyXx_NEWLINE_xXNo systemic steroid use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowedXx_NEWLINE_xXAbsence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodiesXx_NEWLINE_xXPatients may have received prior bortezomib therapy.Xx_NEWLINE_xXPatients may have received any number of prior systemic treatment regimens for distant metastatic disease or advanced regional disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon-alpha, interleukin-2, GM-CSF, ipilimumab, anti-PD1, cancer vaccines, or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin, or paclitaxel alone or in combination\r\n* Targeted therapy with temsirolimus, bevacizumab, or sorafenibXx_NEWLINE_xXA requirement for systemic immunosuppressive therapy for any reasonXx_NEWLINE_xXPatient who has received previous chemotherapy or radiation therapy in the previous 3 months, except for empiric initial intrathecal administration at diagnosis; rituximab or steroid administration is not an exclusion criterionXx_NEWLINE_xXPatient who has received any prior anthracyclinesXx_NEWLINE_xXPrior therapy with a tyrosine kinase inhibitors (TKI) other than nilotinib is allowable, however, nilotinib must be the current therapy; all patients must be under the care of a Moffitt Cancer Center physician, and enrollment is expected to be complete within six monthsXx_NEWLINE_xXThe target population of this study are patients who have a suboptimal response to steroids as their first line of treatment for acute GVHD (ie steroid refractory); this protocol is designed to provide second line therapy, and is not for patients (pts) in whom additional, alternate immunosuppressive agents have already been addedXx_NEWLINE_xXSystemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximabXx_NEWLINE_xXPatients are allowed to have up to 3 prior treatmentsXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXPlatelet count < 50,000/uL, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)Xx_NEWLINE_xXPrior therapy with other human or humanized monoclonal antibodies, unless HAHA tested\n             and negativeXx_NEWLINE_xXPrior use of pazopanib (prior use of other kinase inhibitors allowed)Xx_NEWLINE_xXPatients that have received prior radioimmunotherapyXx_NEWLINE_xXWomen diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapyXx_NEWLINE_xXPatients must have received prior trastuzumab for > 2 month period before disease recurrence or recurrence or progression while on trastuzumab-based therapyXx_NEWLINE_xXPatients must have received and completed first line therapyXx_NEWLINE_xXCurrent corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapyXx_NEWLINE_xXPatients must have had progressive disease after at least one line of endocrine therapy for metastatic disease (includes relapse while receiving endocrine therapy); there should be at least 1 week interval between the last endocrine treatment for an aromatase inhibitor and at least 2 weeks for tamoxifen or fulvestrantXx_NEWLINE_xXENTRY CRITERIA:\n\n        DISEASE CHARATERISTICS:\n\n          -  Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis,\n             and urethra\n\n          -  Histologically or cytologically confirmed with a clinical plan that would potentially\n             include cisplatin* plus gemcitabine systemic therapy or with disease refractory to a\n             first-line platinum-based therapy (as defined in the protocol).\n\n             * Does not apply to patients screened for Phase II expansion\n\n          -  Surgically incurable\n\n        PRIOR/CONCURRENT THERAPY:\n\n          -  No concurrent radiotherapy, other chemotherapy, or other immunotherapy\n\n          -  Must have recovered from side effects of prior treatments\n\n          -  If prior Proleukin® treatment, must have had a clinical benefit\n\n          -  No use of other investigational agents within 30 days of start or concurrently\n\n        PATIENT CHARACTERISTICS:\n\n        Age\n\n          -  ? 18 years\n\n        Performance Status\n\n          -  ECOG 0 or 1\n\n        Bone Marrow Reserve\n\n          -  Absolute neutrophil count (AGC/ANC) ? 1,500/uL\n\n          -  Platelets ? 100,000/uL\n\n          -  Hemoglobin ? 10g/dL\n\n        Renal Function\n\n          -  Glomerular Filtration Rate (GFR):\n\n               -  ? 50mL/min/1.73m^2 for cisplatin-containing regimen\n\n               -  ? 40mL/min/1.73m^2 for non-cisplatin-containing regimen\n\n        Hepatic Function\n\n          -  Total bilirubin ? 1.5 X ULN\n\n          -  AST, ALT, ALP ? 2.5 X ULN, or ? 5.0 X ULN (if liver metastases exists)\n\n          -  PT INR ? 1.5 X ULN\n\n        Cardiovascular\n\n          -  No congestive heart failure < 6 months\n\n          -  No unstable angina pectoris < 6 months\n\n          -  No myocardial infarction < 6 months\n\n          -  No history of ventricular arrhythmias\n\n          -  No NYHA Class > II CHF\n\n          -  Normal cardiac stress test required for subjects who are ? 50 years old, or have a\n             history of EKG abnormalities, or have symptoms of cardiac ischemia or arrhythmia\n\n          -  No uncontrolled hypertension\n\n        Pulmonary\n\n          -  Not receiving chronic medication for asthma\n\n          -  Normal clinical assessment of pulmonary function\n\n        Hematologic\n\n          -  No evidence of bleeding diathesis or coagulopathy\n\n        Other\n\n          -  Negative serum pregnancy test if female and of childbearing potential\n\n          -  No women who are pregnant or nursing\n\n          -  Subjects, both females and males, with reproductive potential must agree to use\n             effective contraceptive measures for the duration of the study\n\n          -  No known autoimmune disease other than corrected hypothyroidism\n\n          -  No known prior organ allograft or allogeneic transplantation\n\n          -  Not HIV positive\n\n          -  No active systemic infection requiring parenteral antibiotic therapy\n\n          -  No ongoing systemic steroid therapy required\n\n          -  No history or evidence of CNS disease (Controlled brain metastases treated with\n             radiation therapy or surgery where the disease has been clinically stable for a\n             period of a least 3 months before screening is allowed)\n\n          -  No psychiatric illness/social situation\n\n          -  No other illness that in the opinion of the investigator would exclude the subject\n             from participating in the study\n\n          -  Must provide informed consent and HIPAA authorization and agree to comply with all\n             protocol-specified procedures and follow-up evaluationsXx_NEWLINE_xXENTRY CRITERIA:\n\n        DISEASE CHARATERISTICS:\n\n          -  Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis,\n             and urethra\n\n          -  Histologically or cytologically confirmed with a clinical plan that would potentially\n             include cisplatin* plus gemcitabine systemic therapy or with disease refractory to a\n             first-line platinum-based therapy (as defined in the protocol).\n\n             * Does not apply to patients screened for Phase II expansion\n\n          -  Surgically incurable\n\n        PRIOR/CONCURRENT THERAPY:\n\n          -  No concurrent radiotherapy, other chemotherapy, or other immunotherapy\n\n          -  Must have recovered from side effects of prior treatments\n\n          -  If prior Proleukin® treatment, must have had a clinical benefit\n\n          -  No use of other investigational agents within 30 days of start or concurrently\n\n        PATIENT CHARACTERISTICS:\n\n        Age\n\n          -  ? 18 years\n\n        Performance Status\n\n          -  ECOG 0 or 1\n\n        Bone Marrow Reserve\n\n          -  Absolute neutrophil count (AGC/ANC) ? 1,500/uL\n\n          -  Platelets ? 100,000/uL\n\n          -  Hemoglobin ? 10g/dL\n\n        Renal Function\n\n          -  Glomerular Filtration Rate (GFR):\n\n               -  ? 50mL/min/1.73m^2 for cisplatin-containing regimen\n\n               -  ? 40mL/min/1.73m^2 for non-cisplatin-containing regimen\n\n        Hepatic Function\n\n          -  Total bilirubin ? 1.5 X ULN\n\n          -  AST, ALT, ALP ? 2.5 X ULN, or ? 5.0 X ULN (if liver metastases exists)\n\n          -  PT INR ? 1.5 X ULN\n\n        Cardiovascular\n\n          -  No congestive heart failure < 6 months\n\n          -  No unstable angina pectoris < 6 months\n\n          -  No myocardial infarction < 6 months\n\n          -  No history of ventricular arrhythmias\n\n          -  No NYHA Class > II CHF\n\n          -  Normal cardiac stress test required for subjects who are ? 50 years old, or have a\n             history of EKG abnormalities, or have symptoms of cardiac ischemia or arrhythmia\n\n          -  No uncontrolled hypertension\n\n        Pulmonary\n\n          -  Not receiving chronic medication for asthma\n\n          -  Normal clinical assessment of pulmonary function\n\n        Hematologic\n\n          -  No evidence of bleeding diathesis or coagulopathy\n\n        Other\n\n          -  Negative serum pregnancy test if female and of childbearing potential\n\n          -  No women who are pregnant or nursing\n\n          -  Subjects, both females and males, with reproductive potential must agree to use\n             effective contraceptive measures for the duration of the study\n\n          -  No known autoimmune disease other than corrected hypothyroidism\n\n          -  No known prior organ allograft or allogeneic transplantation\n\n          -  Not HIV positive\n\n          -  No active systemic infection requiring parenteral antibiotic therapy\n\n          -  No ongoing systemic steroid therapy required\n\n          -  No history or evidence of CNS disease (Controlled brain metastases treated with\n             radiation therapy or surgery where the disease has been clinically stable for a\n             period of a least 3 months before screening is allowed)\n\n          -  No psychiatric illness/social situation\n\n          -  No other illness that in the opinion of the investigator would exclude the subject\n             from participating in the study\n\n          -  Must provide informed consent and HIPAA authorization and agree to comply with all\n             protocol-specified procedures and follow-up evaluationsXx_NEWLINE_xXUnlimited prior therapies are permitted for patients enrolled in the dose escalation phase of the study; patients in the expansion cohort of the study may not have any prior therapy with riluzole or sorafenib and must have biopsiable tumorXx_NEWLINE_xXAll previous immunologic or molecularly targeted therapy must be completed at least 2 weeks prior to study entry; any prior non-hematologic toxicity of any previous therapy must have resolved to grade 1 or less, unless specified elsewhere, or except breakpoint cluster region/tyrosine-protein kinase ABL1 (BCR-ABL) tyrosine kinase in patients who have Philadelphia chromosome positive (Ph+) ALL, where there will be no washout periodXx_NEWLINE_xXPrior therapy with trastuzumabXx_NEWLINE_xXPlease note: prior intensive induction therapy for acute leukemia is allowed only in the phase I portion of this study\r\n* PHASE I PORTION ONLY: Patients of any age who have received no more than one prior attempt at induction chemotherapy (and may have received treatment consolidation), must have recovered from acute toxicities of therapy and be >= 4 weeks from last dose of cytotoxic treatment; patients who have received prior autologous or allogeneic stem cell transplantation are not eligible; patients may have received 1 or 2 cycles of cytarabine-based therapy as attempted inductionXx_NEWLINE_xXPhase II portion: Patients must have not received any prior intensive induction therapy for AML\r\n* Intensive induction includes standard induction chemotherapy such as 7 & 3, high dose cytarabine, mitoxantrone-etoposide, low-dose subcutaneous cytarabine\r\n* Allowed \non-intensive\ prior treatments for pre-existing hematologic conditions (i.e., MDS, chronic myelomonocytic leukemia [CMML]) will include: hydroxyurea, thalidomide, hematopoietic growth factors, Zarnestra, Lenalidomide, arsenic, Imatinib, and corticosteroids, suberoylanilide hydroxamic acid [SAHA] inhibitors; hydroxyurea is allowed up to 24 hours before initiating treatment and to control blood counts during the first cycle of chemotherapy after azacitidine has completed; a minimum of 4 weeks must have elapsed since the administration of thalidomide, Zarnestra, Revlimid, arsenic, SAHA inhibitors, or any investigational medication; a minimum of five days must have elapsed since the administration of growth factorsXx_NEWLINE_xXPrior resection permitted, no prior systemic, ablative or infusion therapy permittedXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy:\r\n* Myelosuppressive chemotherapy:\r\n** Solid tumors: Patients with solid tumors must not have received chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n** Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse; for patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy; Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of PF-02341066Xx_NEWLINE_xXPatients must not have received prior therapy with PF-02341066Xx_NEWLINE_xXPrior therapy with LMB-2Xx_NEWLINE_xXSystemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximabXx_NEWLINE_xXNeoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed only if the onset of androgen ablation is =< 90 days prior to the date of registrationXx_NEWLINE_xXPatients who have received prior pelvic irradiation are not eligibleXx_NEWLINE_xXPatients with histologically proven HL will be eligible for transplantation after failing prior therapyXx_NEWLINE_xXRefractory to first-line AML therapy is defined as:Xx_NEWLINE_xXSubject is in second or later hematologic relapse or has received salvage therapy for refractory diseaseXx_NEWLINE_xXSubject has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib and midostaurin used in first-line therapy regimen as part of induction, consolidation, and/or maintenance).Xx_NEWLINE_xXPatient has not received prior anti-angiogenic therapy, systemic targeted agents or systemic chemotherapy\r\n* Prior surgical resection, chemoembolization or other local therapy prior to transplant is permittedXx_NEWLINE_xXHas completed a prior therapy (ies) according to the criteria below:Xx_NEWLINE_xXAchieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed less than or equal to 6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.Xx_NEWLINE_xXCohort A (asymptomatic patients): At least 1 measurable brain metastasis ? 0.5 cm in and ? 3 cm in longest diameter that has not been previously irradiated. No clinical requirement for local intervention (surgery, radiosurgery, corticosteroid therapy) or other systemic therapy Cohort B (symptomatic patients): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligibile. Subjects must have at least 1 measurable brain metastasis ? 0.5 cm in and ? 3 cm in longest diameter that has not been previously irradiated. No immediate requirement (within 3 weeks prior to first treatment) for local intervention (surgery, radiosurgery, corticosteroid therapy). Steroid use is permitted as defined in the protocol.Xx_NEWLINE_xXAllowable prior therapy:Xx_NEWLINE_xXBrain lesion size > 3cm 3. Medical History and Concurrent Diseases a) History of whole brain irradiation b) Subjects with an active, known or suspected autoimmune disease c) Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled d) Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. For any prior invasive malignancy, at least 5 years must have elapsed since curative therapy and patients must have no residual sequelae of prior therapy e) Cohort A (asymptomatic): The use of corticosteroids is not allowed within 10 days prior to first treatment (based upon 5 times the expected half life of dexamethasone) except patients who are taking steroids for physiological replacement. If alternative corticosteroid therapy has been used, consultation with the sponsor Medical Monitor is required to determine the washout period prior to initiating study treatment Cohort B (symptomatic): Subjects with neurologic sign and symptoms related to brain metastases who are being treated with a total daily dose of higher than 4 mg dexamethasone or equivalent within 10 prior to the start of treatment with study drug are excluded.Xx_NEWLINE_xXThere are two patient populations eligible for the study: those who have not started any therapy with LHRH agonist or antagonist (or orchiectomy) (Early Induction Group) and those who have already started therapy with LHRH agonist or antagonist (or orchiectomy) within the 30 days prior to registration (Late Induction Group); patients must be registered within 30 days of first injection of the LHRH agonist or antagonist (or orchiectomy)Xx_NEWLINE_xXPatients who have not yet started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) and will not have an LHRH agonist injection until after randomization (early induction group) must have radiographic assessments of all disease including bone scan (or positron emission tomography [PET] scan) within 42 days prior to registration; patients who have started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) prior to registration (late induction group) must have radiographic assessments including bone scan (or PET scan) within 42 days prior to start of androgen deprivation therapy (if scans have not been obtained prior to LHRH agonist/antagonist or orchiectomy they must be done within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment Form; NOTE: Androgen deprivation therapy does not include treatment with anti-androgens such as bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or dutasterideXx_NEWLINE_xXPatients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or abiraterone acetate, or enzalutamide (MDV3100); concurrent megestrol for hot flashes is allowedXx_NEWLINE_xXIn first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.Xx_NEWLINE_xXPrior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permittedXx_NEWLINE_xXPrior/Concomitant TherapyXx_NEWLINE_xXLast dose of any prior therapy administered by the following time intervals before the first dose of study drug:Xx_NEWLINE_xXAnti-angiogenic therapy within the last monthXx_NEWLINE_xXHas had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib, prior to the start of study drug.Xx_NEWLINE_xXHas received locoregional therapy to liver (transcatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug.Xx_NEWLINE_xXRelapsed, refractory, or progressive disease following at least 2 prior systemic therapiesXx_NEWLINE_xXSubjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study.Xx_NEWLINE_xXMust have received 1 or 2 prior anti-angiogenic therapies.Xx_NEWLINE_xXDisease progression despite Androgen Deprivation TherapyXx_NEWLINE_xXPrior therapy with any anti CD137 monoclonal antibody.Xx_NEWLINE_xXFor Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)Xx_NEWLINE_xXFor Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.Xx_NEWLINE_xXPrior therapy:\r\n* No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to =< grade 1 or baseline; for lapatinib and intravenous (IV) trastuzumab and/or pertuzumab, no washout is required\r\n* Patients with prior whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) are eligible, provided that there are new lesions not previously treated by SRS and >= 4 weeks have passed since radiation\r\n* Patients with prior cranial surgery are eligible, provided that there is evidence of residual disease and/or progression of disease and >= 4 weeks have passed since surgery\r\n* Prior hormonal therapy for locally advanced or metastatic disease is allowed and can be continued, if everolimus is used in a combination with hormonal therapy, then, everolimus must be discontinued but hormonal therapy can be continued\r\n* Continuation of intravenous (IV) trastuzumab is allowed for those patients already on IV trastuzumab therapy, patients previously treated with intrathecal (IT) trastuzumab are allowed if there is evidence of progression as determined by treating physician and last dose administered is >= 4 weeks\r\n* Prior capecitabine therapy is allowed, provided >= 6 months have passed since the last dose of capecitabineXx_NEWLINE_xXPrior systemic therapy requirements.Xx_NEWLINE_xXSubjects must have received prior antiangiogenic therapy.Xx_NEWLINE_xXSubjects may have received no more than 2 lines of prior therapy for advanced disease.Xx_NEWLINE_xXSubjects may have received no more than 2 lines of prior therapy for advanced disease.Xx_NEWLINE_xXSubjects may have received no more than 2 lines of prior therapy for the advanced diseaseXx_NEWLINE_xXPrevious treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.Xx_NEWLINE_xXPrior therapy with PARP inhibitors.Xx_NEWLINE_xXPrior taxane therapy for metastatic breast cancer is allowed if the patient received ? 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to C1D-2.Xx_NEWLINE_xXPatients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.Xx_NEWLINE_xXThey have had previous I-131 MIBG therapyXx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapy.Xx_NEWLINE_xXPart 1: Progression of disease following up to three lines of prior therapy, including at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant therapy is permitted as one line of prior therapy.Xx_NEWLINE_xXPatients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomyXx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intent.Xx_NEWLINE_xXPatients unlikely to be available for evaluation at the transplant center on Day 28 and 56 of therapy.Xx_NEWLINE_xXHas received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)Xx_NEWLINE_xXpreviously received:Xx_NEWLINE_xXmay have received any endocrine therapy (excluding fulvestrant)Xx_NEWLINE_xXPrior therapy with any antibody or drug targeting T-cell coregulatory proteinsXx_NEWLINE_xXPatient must have histologically or cytologically confirmed solid tumor, including glioma, with documented IDH1 and/or IDH2 gene-mutation. Patients in the dose escalation phase must have disease that has recurred or progressed following standard therapy and/or therapy with an inhibitor of mutant IDH1 and/or IDH2, or that has not responded to this therapy. Patients in the expansion phase may have previously untreated diseaseXx_NEWLINE_xXPrior treatment with gene therapy productXx_NEWLINE_xXTreatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapyXx_NEWLINE_xXReceived prior sorafenib.Xx_NEWLINE_xXIf the subject has DLBCL, there is no curative option with conventional therapy and the prior treatment included ? 1 prior combination chemoimmunotherapy regimen.Xx_NEWLINE_xXInclusion Criteria:\n\n          1. Written informed consent and any locally-required authorization (eg, Health Insurance\n             Portability and Accountability Act in the US, EU Data Privacy Directive in the EU)\n             obtained from the patient prior to performing any protocol-related procedures,\n             including pre-screening and screening evaluations\n\n          2. Age ?18 years at time of study entry\n\n          3. Histological or cytological confirmation of locally advanced (stage IIIB) or\n             metastatic (stage IV) solid tumours refractory to standard therapy or for which no\n             standard therapy exists\n\n          4. World Health Organisation Eastern Cooperative Oncology Group (ECOG) performance status\n             0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12\n             weeks\n\n          5. At least 1 lesion, not previously irradiated, that can be accurately measured at\n             baseline as ?10 mm in the longest diameter (except lymph nodes which must have short\n             axis ?15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and\n             which is suitable for accurate repeated assessment as per Response Evaluation Criteria\n             in Solid Tumours (RECIST criteria v1.1)\n\n          6. Female patients and males with partners of childbearing potential should be using\n             highly effective contraceptive measures. Females should not be breastfeeding and must\n             have a negative pregnancy test prior to start of dosing if of childbearing potential\n             or must have evidence of non-childbearing potential by fulfilling 1 of the criteria\n             below at screening.\n\n               -  Postmenopausal defined as aged more than 50 years and amenorrhoeic for at least\n                  12 months following cessation of all exogenous hormonal treatments\n\n               -  Women <50 years old would be considered postmenopausal if they have been\n                  amenorrheic for the past 12 months or more following cessation of exogenous\n                  hormonal treatments. The levels of luteinising hormone (LH) and follicle\n                  stimulating hormone (FSH) must also be in the postmenopausal range (as per the\n                  institution)\n\n               -  Documentation of irreversible surgical sterilisation by hysterectomy and / or\n                  bilateral oophorectomy and/or bilateral salpingectomy but not tubal ligation\n\n          7. Male patients should be willing to use barrier contraception ie, condoms plus\n             spermicide\n\n          8. Mandatory provision of tumour tissue sample available at study entry for exploratory\n             biomarker research. Cytology samples for this exploratory biomarker research will not\n             be acceptable\n\n          9. Patients must have mCRC and, if MSI status is known, non-high MSI status. MSI status\n             will be evaluated based on previous results of local MSI testing, if available.\n             Patients with known MSI-high status will be excluded; patients with MSS, MSI-low, or\n             unknown MSI status may be enrolled\n\n        Exclusion Criteria:\n\n        Patients must not enter the study if any of the following exclusion criteria are fulfilled\n\n          1. Previous enrolment in the present study\n\n          2. Treatment with any of the following:\n\n               -  Cytotoxic chemotherapy or other anticancer drugs within 28 days of the 1st dose\n                  of study treatment or any investigational agents within 5 half-lives of the\n                  product\n\n               -  MEDI4736 or selumetinib in the present study (ie, dosing with MEDI4736 or\n                  selumetinib previously initiated in this study)\n\n               -  Major surgical procedure, (excluding placement of vascular access) or significant\n                  traumatic injury within 4 weeks of the 1st dose of study treatment, or have an\n                  anticipated need for major surgery during the study\n\n               -  Palliative radiotherapy with a wide field of radiation within 4 weeks or\n                  radiotherapy with a limited field of radiation for palliation within 2 weeks of\n                  the 1st dose of study treatment\n\n               -  Prior exposure to immune-mediated therapy, including, but not limited to, other\n                  anti-CTLA- 4 (Cytotoxic T-lymphocyte antigen-4), anti-PD-1 (Programmed cell death\n                  1), anti-PD-L1 (Programmed cell death ligand 1), or anti-PD-L2 (Programmed cell\n                  death ligand 2) antibodies, including therapeutic anticancer vaccines\n\n               -  Receipt of live attenuated vaccine within 30 days prior to the first dose of IP\n\n               -  Concurrent enrolment in another clinical study, unless it is an observational\n                  (non-interventional) clinical study or during the follow-up period of an\n                  interventional study\n\n          3. Any unresolved toxicity NCI CTCAE (National Cancer Institute Common Terminology\n             Criteria for Adverse Events) Grade ?2 from previous anticancer therapy with the\n             exception of alopecia, vitiligo, and the laboratory values defined in the inclusion\n             criteria\n\n               -  Patients with Grade ?2 neuropathy will be evaluated on a case-by-case basis and\n                  may be included after consultation with the medical monitor\n\n               -  Patients with irreversible toxicity not reasonably expected to be exacerbated by\n                  treatment with selumetinib, MEDI4736 or tremelimumab may be included after\n                  consultation with the medical monitor\n\n          4. History of leptomeningeal carcinomatosis and brain metastases or spinal cord\n             compression. Patients with suspected brain metastases at screening should have a CT /\n             MRI of the brain prior to study entry\n\n          5. Active or prior documented autoimmune or inflammatory disorders (including\n             inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the\n             exception of diverticulosis], celiac disease, irritable bowel disease, or other\n             serious GI (Gastrointestinal) chronic conditions associated with diarrhoea, systemic\n             lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [eg, granulomatosis\n             with polyangiitis, Graves' disease; rheumatoid arthritis, hypophysitis, uveitis])\n             within the past 3 years prior to the start of treatment. The following are exceptions\n             to this criterion:\n\n               -  Patients with vitiligo or alopecia\n\n               -  Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone\n                  replacement or psoriasis not requiring systemic treatment\n\n          6. History of active primary immunodeficiency\n\n          7. Current or prior use of immunosuppressive medication within 14 days before the 1st\n             dose of MEDI4736. The following are exceptions to this criterion:\n\n               -  Intranasal, inhaled, topical steroids, or local steroid injections (eg,\n                  intra-articular injection)\n\n               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of\n                  prednisone or its equivalent\n\n               -  Steroids as premedication for hypersensitivity reactions (eg, CT scan\n                  premedication)\n\n          8. As judged by the investigator, any evidence of severe or uncontrolled systemic\n             diseases, including uncontrolled hypertension, renal transplant, active bleeding\n             diatheses, which in the investigator's opinion makes it undesirable for the patient to\n             participate in the study or which would jeopardise compliance with the protocol or\n             active infection including hepatitis B surface antigen (HBsAg), hepatitis C virus\n             (HCV) antibody or human immunodeficiency virus (HIV) or known history of clinical\n             diagnosis of tuberculosis\n\n          9. Screening for chronic conditions is not required\n\n         10. Any of the following cardiac criteria:\n\n               -  Any factors that increase the risk of QT(ECG interval measured from the onset of\n                  the QRS complex to the end of the T wave) interval corrected for heart rate (QTc)\n                  prolongation or risk of arrhythmic events (eg, heart failure, hypokalaemia,\n                  congenital long QT syndrome, family history of long QT syndrome or unexplained\n                  sudden death under 40 years of age) or mean QTc >470 msec\n\n               -  Uncontrolled hypertension (eg, BP ?150/95 mmHg despite medical therapy)\n\n               -  Acute coronary syndrome within 6 months prior to starting treatment\n\n               -  Angina Canadian Cardiovascular Society Grade II-IV (despite medical therapy)\n\n               -  Symptomatic heart failure (New York Heart Association II-IV)\n\n               -  Prior or current cardiomyopathy\n\n               -  Baseline LVEF (Left ventricular ejection fraction) <55% measured by\n                  echocardiography or MUGA. Appropriate correction to be used if a MUGA is\n                  performed.\n\n               -  Atrial fibrillation with a ventricular rate >100 beats per minute at rest\n\n               -  Severe valvular heart disease\n\n         11. Any of the following ophthalmic criteria:\n\n               -  Current or past history of central serous retinopathy, detachment of retinal\n                  pigmented epithelium, or retinal vein occlusion\n\n               -  Intraocular pressure (IOP) >21 mmHg\n\n               -  Uncontrolled glaucoma (irrespective of IOP)\n\n         12. Inadequate bone marrow reserve or organ function as demonstrated by any of the\n             following laboratory values:\n\n               -  Absolute neutrophil count <1.5 x 109/L\n\n               -  Platelet count <100 x 109/L\n\n               -  Haemoglobin <90 g/L\n\n               -  Alanine aminotransferase >2.5 x ULN (upper limit of normal) if no demonstrable\n                  liver metastases or >5 times ULN in the presence of liver metastases\n\n               -  Aspartate aminotransferase >2.5 x ULN if no demonstrable liver metastases or >5\n                  times ULN in the presence of liver metastases\n\n               -  Serum bilirubin ?1.5 x ULN. This will not apply to patients with confirmed\n                  Gilbert's syndrome (persistent or recurrent hyperbilirubinaemia [predominantly\n                  unconjugated bilirubin] in the absence of evidence of haemolysis or hepatic\n                  pathology), who will be allowed in consultation with their physician\n\n               -  Creatinine clearance <50 mL/min (calculated by Cockcroft and Gault equation).\n                  Confirmation of creatinine clearance is only required when creatinine is >1.5\n                  times ULN\n\n         13. Refractory nausea and vomiting, chronic GI diseases, inability to swallow the\n             formulated product or previous significant bowel resection that would preclude\n             adequate absorption of selumetinib\n\n         14. History of hypersensitivity to active or inactive excipients of MEDI4736 or\n             selumetinib or drugs with a similar chemical structure or class to MEDI4736 or\n             selumetinib\n\n         15. Judgment by the investigator that the patient should not participate in the study if\n             the patient is unlikely to comply with study procedures, restrictions, and\n             requirements\n\n         16. Involvement in the planning and conduct of the study (applies to both AZ staff or\n             staff at the study site)\n\n         17. Previous allogeneic bone marrow transplant\n\n         18. Body weight <30 kgXx_NEWLINE_xXHas received previous therapy with pomalidomideXx_NEWLINE_xXPrior radio- or toxin-conjugated antibody therapy.Xx_NEWLINE_xXPrior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapyXx_NEWLINE_xXTreatment with any prior gene therapy productXx_NEWLINE_xXPatients on oral anticoagulation therapyXx_NEWLINE_xXPrior treatment with any adoptive T cell therapyXx_NEWLINE_xXPatient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane).Xx_NEWLINE_xXPatient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgmentXx_NEWLINE_xXExpected need for regular immunosuppressive therapyXx_NEWLINE_xXSubject has received zero to one prior cytotoxic chemotherapy regimen for metastatic disease, regardless of prior targeted therapy (eg. everolimus, palbociclib or lapatinib), biologic (eg. trastuzumab) or hormonal therapy treatment (eg. aromatase inhibitors, selective estrogen receptor modulators, or estrogen receptor down-regulators).Xx_NEWLINE_xXNo prior therapy for AML, except for hydroxyurea, in this setting is allowed.Xx_NEWLINE_xXSubjects with AML evolving from MDS may have received prior MDS therapy with demethylating agentsXx_NEWLINE_xXpreviously received at least 1 but no more than 4 lines of therapy, one therapy must have included a VEGF TKIXx_NEWLINE_xXpreviously received at least 1 but no more than 3 lines of therapy, one therapy must have included a fluoropyrimidine based regimenXx_NEWLINE_xXpreviously received at least 2 but no more than 4 lines of therapy, which must have included both an irinotecan and an oxaliplatin based regimenXx_NEWLINE_xXAny number of prior therapies is allowedXx_NEWLINE_xXMain Criteria for Inclusion:\n\n          1. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV) who\n             progressed following ? 1 lines of prior systemic therapy, including immune checkpoint\n             inhibitor (eg, anti-PD-1), and if BRAF mutation-positive, after BRAF inhibitor\n             systemic therapy. Patients must have no other therapy options that are expected to\n             have significant benefit in the opinion of the Investigator and must have:\n\n               -  At least 1 measurable target lesion, as defined by RECIST 1.1. Lesions in\n                  previously irradiated areas should not be selected as target lesion, unless\n                  treatment was ? 3 months prior, and there has been demonstrated disease\n                  progression in the lesion\n\n               -  At least 1 resectable target lesion to generate TIL of a minimum 1.5 cm in\n                  diameter post-resection; surgical removal with minimal morbidity (defined as any\n                  procedure for which expected hospitalization is ? 3 days)\n\n          2. Patients must be ?18 years and ?70 years of age at the time of consent. Enrollment of\n             patients >70 years of age may be allowed after consultation with the Medical Monitor\n\n          3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of\n             0 or 1 and an estimated life expectancy of ? 3 months\n\n          4. In the opinion of the Investigator, patient must be able to complete all\n             study-required procedures\n\n          5. Patients of childbearing potential or their partners of childbearing potential must be\n             willing to practice an approved method of birth control during treatment and for 12\n             months after receiving last protocol-related therapy\n\n             Approved methods of birth control are as follows:\n\n               -  Combined (estrogen and progestogen containing) hormonal birth control associated\n                  with inhibition of ovulation: oral; intravaginal; transdermal\n\n               -  Progestogen-only hormonal birth control associated with inhibition of ovulation:\n                  oral; injectable; implantable\n\n               -  Intrauterine device (IUD)\n\n               -  Intrauterine hormone-releasing system (IUS)\n\n               -  Bilateral tubal occlusion\n\n               -  Vasectomized partner\n\n               -  True sexual abstinence when this is in line with the preferred and usual\n                  lifestyle of the patient. Periodic abstinence (eg, calendar ovulation,\n                  symptothermal, post-ovulation methods) is not acceptable.\n\n          6. Patients must have the following hematologic parameters:\n\n               -  Absolute neutrophil count (ANC) ? 1000/mm3\n\n               -  Hemoglobin ? 9.0 g/dL\n\n               -  Platelet count ? 100,000/mm3\n\n          7. Patients must have adequate organ function:\n\n               -  Serum alanine transaminase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) and\n                  aspartate transaminase (AST)/serum glutamic oxaloacetic transaminase (SGOT) ? 3\n                  times the upper limit of normal [ULN]), patients with liver metastasis ? 5 times\n                  ULN\n\n               -  An estimated creatinine clearance (eClCr) ? 40 mL/min using the Cockcroft Gault\n                  formula at Screening\n\n               -  Total bilirubin ? 2 mg/dL: Patients with Gilbert's syndrome must have a total\n                  bilirubin ? 3 mg/dL\n\n          8. Patients must be seronegative for the human immunodeficiency virus (HIV) antibody,\n             hepatitis B antigens, and hepatitis C antibody or antigen\n\n          9. Patients must have recovered from all prior therapy-related adverse events (AEs) to ?\n             Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v4.03), except for\n             alopecia or vitiligo, prior to enrollment (tumor resection), with a washout period\n             from prior anticancer therapy(ies) to the start of planned NMA-LD of a minimum\n             duration detailed as follows:\n\n               -  Targeted therapy: prior targeted therapy with a MEK/BRAF or other-directed agent,\n                  is allowed provided the washout period is a ? 21 days or 5 half-lives, whichever\n                  is longer prior to the start of NMA-LD\n\n               -  Chemotherapy: adjuvant, neoadjuvant or definitive chemotherapy/ chemoradiation is\n                  allowed provided the washout period is ? 21 days or 5 half-lives, whichever is\n                  longer prior to the start of NMA-LD\n\n               -  Immunotherapy: prior checkpoint-targeted therapy with an anti-CTLA-4/anti-PD-1,\n                  other monoclonal antibody (mAb), or vaccine is allowed if disease progression is\n                  confirmed prior to or within the washout period of ? 21 days before the start of\n                  NMA-LD\n\n               -  Palliative radiation therapy is permitted between biopsy and NMA-LD if it does\n                  not involve lesions being selected as target or nontarget\n\n               -  Patients may undergo preplanned procedures if within 2 to 3 weeks prior to the\n                  start of NMA-LD\n\n         10. Patients with documented Grade 2 or higher diarrhea or colitis as a result of previous\n             treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least\n             6 months and/or had a normal colonoscopy post immune checkpoint inhibitor treatment by\n             visual assessment, prior to start of NMA-LD\n\n         11. Patients must have the ability to understand the requirements of the study, have\n             provided written informed consent, as evidenced by signature on an informed consent\n             form (ICF) approved by an Institutional Review Board/Independent Ethics Committee\n             (IRB/IEC), and agree to abide by the study restrictions and return to the site for the\n             required assessments\n\n         12. Patients have provided written authorization for use and disclosure of protected\n             health information\n\n        Criteria for Exclusion:\n\n          1. Patients with melanoma of uveal/ocular origin\n\n          2. Patients who have received an organ allograft or prior cell transfer therapy that\n             included a nonmyeloablative or myeloablative chemotherapy regimen (not applicable for\n             patients in the retreatment Cohort 3)\n\n          3. Patients with symptomatic and/or untreated brain metastases (of any size and any\n             number)\n\n               -  Patients with definitively treated brain metastases may be considered for\n                  enrollment after discussion with the Medical Monitor, and must be stable for ? 2\n                  weeks prior to the start of NMA-LD\n\n          4. Patients who are pregnant or breastfeeding\n\n          5. Patients who are on a systemic steroid therapy at a dose of > 10 mg of prednisone or\n             equivalent per day\n\n               -  A short course of higher-dose steroid therapy is allowed in cases of exacerbation\n                  of known disease or for treatments of new acute symptoms\n\n          6. Patients who have active medical illness(es) that in the opinion of the Investigator\n             would pose increased risk for study participation that may include active systemic\n             infections, such as syphilis, or any other infections requiring antibiotics,\n             coagulation disorders, or other active major medical illnesses of the cardiovascular,\n             respiratory, or immune system\n\n          7. Patients who have any form of primary immunodeficiency (such as severe combined\n             immunodeficiency disease [SCID] or acquired immunodeficiency syndrome [AIDS])\n\n          8. Patients who have a history of hypersensitivity to any component or excipient of the\n             TIL therapy and other study drugs:\n\n               -  NMA-LD (cyclophosphamide, mesna, and fludarabine)\n\n               -  IL-2\n\n               -  Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n\n               -  Any component of the TIL infusion product formulation including dimethyl\n                  sulfoxide [DMSO], human serum albumin [HSA], IL-2, and dextran-40\n\n          9. Patients who have a left ventricular ejection fraction (LVEF) < 45% or New York Heart\n             Association (NYHA) functional classification > Class 1 at Screening. All patients must\n             have echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) at Screening. For\n             patients ? 60 years or patients who have a history of ischemic heart disease, chest\n             pain, or clinically significant atrial and/or ventricular arrhythmias, a cardiac\n             stress tests must be performed showing LVEF ?45%, and if any wall movement\n             abnormalities, they must be reversible.\n\n         10. Patients who have obstructive or restrictive pulmonary disease and have a documented\n             FEV1 (forced expiratory volume in 1 second) of ? 60%\n\n         11. Patients who have had another primary malignancy within the previous 3 years (with the\n             exception of carcinoma in situ of the breast, cervix, or bladder, localized prostate\n             cancer and nonmelanoma skin cancer that has been adequately treated)\n\n         12. Patients who have been shown to be BRAF mutation positive (V600), but have not\n             received prior systemic therapy with a BRAF-directed kinase inhibitor\n\n         13. Patients who have received a live or attenuated vaccine within 28 days of the start of\n             NMA-LD\n\n         14. Patients whose cancer requires immediate attention or who would otherwise suffer a\n             disadvantage by participating in this trial\n\n         15. Patients protected by the following constraints:\n\n               -  Hospitalized persons without consent or persons deprived of liberty because of a\n                  judiciary or administrative decision\n\n               -  Adult persons with a legal protection measure or persons who cannot express their\n                  consent\n\n               -  Patients in emergency situations who cannot consent to participate in the trialXx_NEWLINE_xXRecovery from significant toxicities from previous therapies and sufficient time since last dose of previous therapyXx_NEWLINE_xXPhase II only: at least one line of prior therapy for incurable diseaseXx_NEWLINE_xXAny condition that would preclude the ability to deliver appropriate IP therapyXx_NEWLINE_xXMust be relapsed or refractory after 1 or 2 prior therapies. For this protocol, relapsed is defined as progressive disease (PD) documented more than 60 days after last dose; refractory is defined as documented absence of hematologic response or hematologic progression on or within 60 days after last dose of prior therapy.Xx_NEWLINE_xXPrior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapyXx_NEWLINE_xXPatients must have the potential for benefit from local therapy (at the discretion of the investigator)Xx_NEWLINE_xXConcurrent administration of any other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed)Xx_NEWLINE_xXPatients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA.Xx_NEWLINE_xXInclusion Criteria:\n\n        Eligibility is determined prior to leukapheresis. Subjects must satisfy the following\n        criteria to be enrolled in the study:\n\n          1. Subject is ? 18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Documented diagnosis of multiple myeloma\n\n               -  Must have received at least 3 prior MM treatment regimens. Note: induction with\n                  or without hematopoietic stem cell transplant and with or without maintenance\n                  therapy is considered a single regimen.\n\n               -  Must have undergone at least 2 consecutive cycles of treatment for each regimen,\n                  unless PD was the best response to the regimen.\n\n               -  Must have received a proteasome inhibitor, an immunomodulatory agent and an\n                  anti-CD38 antibody.\n\n               -  Must be refractory to the last treatment regimen.\n\n          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\n          4. Subjects must have measurable disease, including at least one of the criteria below:\n\n               -  Serum M-protein greater or equal to 1.0 g/dL\n\n               -  Urine M-protein greater or equal to 200 mg/24 h\n\n               -  Serum free light chain (FLC) assay: involved FLC level greater or equal to 10\n                  mg/dL (100 mg/L) provided serum FLC ratio is abnormal\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subjects with known central nervous system involvement with myeloma.\n\n          2. History or presence of clinically relevant central nervous system (CNS) pathology.\n\n          3. Subjects with active or history of plasma cell leukemia.\n\n          4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence\n             of measurable disease\n\n          5. Inadequate organ function\n\n          6. Ongoing treatment with chronic immunosuppressants\n\n          7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment\n             with any gene therapy-based therapeutic for cancer or investigational cellular therapy\n             for cancer or BCMA targeted therapy\n\n          8. Evidence of human immunodeficiency virus (HIV) infection.\n\n          9. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV)\n\n         10. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV) and Hepatitis C virus (HCV)\n\n         11. Subjects with a history of class III or IV congestive heart failure (CHF) or severe\n             non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial\n             infarction, or ventricular arrhythmia within the previous 6 months.\n\n         12. Subjects with second malignancies in addition to myeloma if the second malignancy has\n             required therapy in the last 3 years or is not in complete remission\n\n         13. Pregnant or lactating women.\n\n         14. Subject with known hypersensitivity to any component of bb2121 productThe presence of\n             any of the following will exclude a subject from enrollment:\n\n        1. Subjects with known central nervous system involvement with myeloma. 2. History or\n        presence of clinically relevant central nervous system (CNS) pathology.\n\n        3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary\n        plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5.\n        Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous\n        history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene\n        therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA\n        targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9.\n        Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)\n        and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart\n        failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina,\n        myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects\n        with second malignancies in addition to myeloma if the second malignancy has required\n        therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating\n        women. 13 Subject with known hypersensitivity to any component of bb2121 product,\n        cyclophosphamide, fludarabine, or tocilizumab.Xx_NEWLINE_xXPrior immune-oncology therapyXx_NEWLINE_xX< 6 months between completion of prior RT and initiation of reirradiation using proton therapyXx_NEWLINE_xXAll patients must have received at least one prior therapy - 1 cycle of cytarabine containing regimen or 2 cycles of hypomethylating agent - before determination of refractory status (defined as response duration less than 3 months or no response)Xx_NEWLINE_xXMust have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)Xx_NEWLINE_xXPrior treatment with an immune-therapy.Xx_NEWLINE_xXSubject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:Xx_NEWLINE_xXReceived prior treatment with at least 1, but no more than 3, prior lines of therapy for MM.Xx_NEWLINE_xXPrior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field.Xx_NEWLINE_xXAbnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.Xx_NEWLINE_xXAny prostate related investigational therapy within 6 months of Visit 1Xx_NEWLINE_xXhave had documented radiographic or symptomatic progression during or after sorafenib therapy; ORXx_NEWLINE_xXThree or more prior lines of systemic therapy for GBM.Xx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while on study.Xx_NEWLINE_xXHas previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following criteria to be eligible for the study:\n\n          1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid\n             tumors that have exhausted standard of care therapy or either refuse or are not\n             considered to be candidates for any remaining standard therapy.\n\n          2. Age ?18 years\n\n          3. ECOG performance status 0 or 1 (see Appendix B)\n\n          4. Must have evaluable disease per RECIST 1.1. (see Appendix C)\n\n          5. Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either\n             archived or fresh core or punch needle biopsied at study entry (two fresh\n             cores/punches preferred whenever possible).\n\n          6. Must have received their last anti-cancer therapy, including radiotherapy,\n             chemotherapy, biologic therapy, or herbal therapy at least 3 weeks or 5 half-lives\n             (for systemic agents), whichever is shorter, from initiation of study treatment.\n\n          7. Platelets >100,000/mL without transfusions in the past 7 days\n\n          8. Total bilirubin within 1.5x institutional upper limit of normal (ULN)\n\n               -  AST (SGOT) and ALT (SGPT) <3 X institutional ULN\n\n               -  Patients with documented liver metastases: AST (SGOT) and/or ALT (SGPT) ? 5 × ULN\n\n               -  Albumin ? 3.0 g/dL\n\n               -  Creatinine <1.5 X institutional ULN OR\n\n               -  Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above\n                  institutional normal\n\n        Exclusion Criteria:\n\n        Subjects who meet any of the following criteria will not be eligible for participation in\n        the study:\n\n          1. Currently receiving any therapeutic treatment for their malignancy including other\n             investigational agents\n\n          2. Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement\n             except for individuals who have previously treated CNS metastases, are asymptomatic,\n             and have no requirement for a corticosteroid dose (indicated to reduce brain edema)\n             that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure\n             medication for at least 4 weeks prior to first dose of study drug.\n\n          3. History of a Grade 3 or 4 allergic reaction attributed to humanized or human\n             monoclonal antibody therapy\n\n          4. Significant intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\n             study requirements\n\n          5. Pregnant women or nursing women\n\n          6. Subjects with congestive heart failure with New York Heart Association Classification\n             III, or IV (see Appendix D)\n\n          7. Known clinically significant gastrointestinal disease including, but not limited to,\n             inflammatory bowel diseaseXx_NEWLINE_xXTreatment with any prior gene therapy productXx_NEWLINE_xXHas had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapyXx_NEWLINE_xXComorbidity that would interfere with therapyXx_NEWLINE_xXHave received prior treatment with therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab) if enrolling in the Phase 2 portion of the study. This criterion does not apply to patients enrolling in the Phase 1b portion of the study.Xx_NEWLINE_xXThere is no limitation in the number of prior lines of therapyXx_NEWLINE_xXPrior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs.Xx_NEWLINE_xXConcurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumourXx_NEWLINE_xXPrevious therapy with:Xx_NEWLINE_xXInclusion Criteria for Phase 1b:\n\n          1. Patients must have histologically or cytologically confirmed advanced solid tumors\n             with a histology and/or molecular alteration of interest as defined in Section 4,\n             detected by a CLIA-certified or equivalently accredited diagnostic laboratory\n\n             • Squamous NSCLC and Non-squamous NSCLC (no known RET alterations or BRAF V600E\n             mutations) patients must have archival tissue available for analysis by Ignyta; all\n             other patients must send tissue to Ignyta, if tissue is available\n\n          2. Prior Treatment:\n\n               -  Patients with BRAF V600E mutations must be TKI-naïve; any number of other prior\n                  therapies are allowed\n\n               -  NSCLC patients with RET alterations who have had a prior RET inhibitor or are RET\n                  inhibitor-naïve will be enrolled; (any number of other prior therapies are\n                  allowed); all other histologies with RET alterations must be RET inhibitor-naïve\n\n               -  Patients with Squamous NSCLC and Non-squamous NSCLC (no known RET alterations or\n                  BRAF V600E mutations) may have had prior TKIs and any number of other prior\n                  therapies\n\n          3. Measurable disease according to RECIST v1.1 for all patients except patients with RET\n             altered tumors; patients with RET altered tumors must have evaluable disease, but are\n             not required to have measurable disease\n\n          4. Patients with treated, stable CNS metastases, including leptomeningeal carcinomatosis\n             are allowed. The use of seizure prophylaxis is allowed. Patients requiring steroids\n             must be at a stable or decreasing dose for at least 2 weeks prior to the start of\n             RXDX-105 treatment.\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status ? 2\n\n          6. Able to ingest oral medication\n\n          7. Other inclusion criteria apply\n\n        Exclusion Criteria for Phase 1b:\n\n          1. Treated with systemic anticancer therapy or an investigational agent within 2 weeks or\n             5 half-lives, whichever is shorter, prior to start of study drug treatment (4 weeks\n             for antibody therapy and immunotherapy, and 2 weeks for bevacizumab in colon cancer\n             patients)\n\n          2. Major surgery 21 days or less prior to starting study drug or has not recovered from\n             adverse effects of such therapy\n\n          3. Radiotherapy within 2 weeks prior to start of study drug treatment (palliative\n             radiation or stereotactic radiosurgery within 7 days prior to start of study\n             treatment). Patients must have recovered from all radiotherapy-related toxicities\n\n          4. History of non-pharmacologically induced prolonged QTc interval (e.g., repeated\n             demonstration of a QTc interval > 500 milliseconds from ECGs performed at least 24\n             hours apart)\n\n          5. Major active infection requiring parenteral antibiotics\n\n          6. Severe or unstable medical condition, such as congestive heart failure (New York Heart\n             Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled\n             hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an\n             uncontrolled cardiac arrhythmia requiring medication (? Grade 2, according to NCI\n             CTCAE v4.03), myocardial infarction within 6 months prior to starting study treatment,\n             or any other significant or unstable concurrent medical illness that in the opinion of\n             the Investigator would preclude protocol therapy\n\n          7. History of other previous cancer that would interfere with the determination of safety\n             or efficacy of RXDX-105 with respect to the qualifying solid tumor malignancy\n\n          8. Known infection with human immunodeficiency virus (HIV) and active hepatitis B or\n             hepatitis C\n\n          9. Current participation in another clinical study of an investigational agent, vaccine,\n             or device. Concomitant participation in observational studies is acceptable\n\n         10. Presence of a significant gastrointestinal disorder that, in the opinion of the\n             Investigator or Sponsor, could interfere with absorption of RXDX-105 (e.g.,\n             malabsorption syndrome, gastrointestinal surgery)\n\n         11. Known hypersensitivity to any of the components of RXDX-105Xx_NEWLINE_xXHad more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapyXx_NEWLINE_xXOngoing immunosuppressive therapyXx_NEWLINE_xXFirst Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)Xx_NEWLINE_xXHave achieved CR/CRi following therapy with hypomethylating agentsXx_NEWLINE_xXTime required between the last dose of the latest therapy and the first dose of study drug:Xx_NEWLINE_xXHas received no prior systemic therapy for advanced RCC.Xx_NEWLINE_xXAML secondary to exposure to potentially leukemogenic therapies or agents (eg, radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years.Xx_NEWLINE_xXPrior use of targeted therapy agents (eg, FLT3 inhibitors, other kinase inhibitors).Xx_NEWLINE_xXOngoing AE attributed to ibrutinib therapyXx_NEWLINE_xXHas received previous therapy with pomalidomide and did not achieve at least a stable diseaseXx_NEWLINE_xXOccurrence or progression of BM while receiving first line therapy (either erlotinib, afatinib, or gefitinib) for at least 14 days. Patients may have received osimertinib (or other agents inhibiting the T790M EGFR mutation) as second line therapy. If BM progression occurs after osimertinib, patient will be eligible.Xx_NEWLINE_xXDisease is suitable for local therapy administered with curative intentXx_NEWLINE_xXInclusion Criteria:\n\n        Phase 1a\n\n          -  Aged 18 years or older\n\n          -  Histologically or cytologically confirmed solid tumor or hematologic malignancy\n\n          -  Life expectancy of 12 weeks or longer\n\n          -  Must have received ? 1 prior treatment regimen\n\n          -  Must not be a candidate for potentially curative or standard of care approved therapy\n\n        Phase 1b\n\n          -  Aged 18 years or older\n\n          -  Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma,\n             triple-negative breast cancer, urothelial cancer with at least 1 measurable or\n             evaluable target lesion\n\n          -  Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and\n             measureable/evaluable disease\n\n          -  Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome\n\n          -  Cohort H: Individuals diagnosed with lymphoma\n\n          -  Prior therapy:\n\n               -  Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic\n                  disease (not including neoadjuvant and/or adjuvant therapy)\n\n               -  Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ? 2\n                  prior treatment regimens\n\n               -  Cohort F: May have received any number of prior treatment regimens or be\n                  treatment-naïve\n\n               -  Cohort H: Must have relapsed from or have been refractory to available treatments\n\n        Phase 2\n\n          -  Aged 18 years or older\n\n          -  Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic\n             syndrome\n\n          -  Prior therapy:\n\n               -  Cohorts I and J: Must have failed prior therapy with a hypomethylating agent\n                  (HMA)\n\n        Exclusion Criteria:\n\n          -  Prior receipt of a JAK1 inhibitor (Phase 1a only)\n\n          -  Known active central nervous system metastases and/or carcinomatous meningitis\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status > 2\n\n          -  Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone,\n             carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3K? inhibitor\n             (Phase 1b and Phase 2 only, as appropriate to treatment cohort)\n\n          -  Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV)\n             or hepatitis C virus (HCV) infection or risk of reactivationXx_NEWLINE_xXSubjects must have received at least one line of hormonal therapy in the metastatic settingXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXSubject has received no prior systemic therapyXx_NEWLINE_xXSubject is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXProgressive disease on androgen deprivation therapy at enrollment;Xx_NEWLINE_xXPatients are ineligible if they have a history of prior treatment with ipilimumab, bevacizumab, or prior tumor CD137 agonist or CTLA-4 inhibitor or agonist; patients may be treatment naive or have had one prior systemic therapy for metastatic disease as outlined in the eligibility criteria; patients may have received PD-1 or PD-L1 as per current protocol eligibility, although they are not currently commercially approved in the front line settingXx_NEWLINE_xXPatients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXInclusion Criteria:\n\n        Phase 1a portion\n\n          -  Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with\n             evidence of either locally recurrent disease not amenable to resection or radiation\n             therapy with curative intent, or metastatic disease, both progressing after at least 6\n             months of hormonal therapy for estrogen receptor (ER) positive breast cancer\n\n          -  ER-positive, human epidermal growth factor 2 (HER2) negative\n\n          -  At least 2 months must have elapsed from the use of tamoxifen\n\n          -  At least 6 months must have elapsed from the use of fulvestrant\n\n          -  At least 2 weeks must have elapsed from the use of any other anticancer hormonal\n             therapy\n\n          -  At least 3 weeks must have elapsed from the use of any chemotherapy\n\n          -  Postmenopausal status\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n\n          -  Adequate organ function\n\n        Phase Ib portion\n\n          -  All above inclusion criteria, except:\n\n          -  Postmenopausal status, pre- and peri-menopausal participants will also be included\n\n          -  ECOG performance status less than 2\n\n          -  At least 2 months must have elapsed from the use of tamoxifen not applicable\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Documented sensitivity to prior hormonal therapy\n\n          -  Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent\n             kinase (CDK) 4/6 inhibitor\n\n        Phase IIa portion\n\n          -  All above inclusion criteria for Phase Ia, except:\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of\n             measurable disease as per RECIST v1.1 or evaluable bone disease\n\n          -  Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from\n             the use of tamoxifen\n\n          -  Cohort A2 only: prior fulvestrant allowed\n\n          -  Cohort B only: disease progression following no more than 1 prior treatment with an\n             aromatase inhibitor in the advanced/metastatic setting\n\n          -  Cohort B1 only: no prior fulvestrant allowed\n\n          -  Cohort B2 only: prior fulvestrant allowed\n\n        Exclusion Criteria:\n\n        Phase 1a portion\n\n          -  Untreated or symptomatic central nervous system (CNS) metastases\n\n          -  Endometrial disorders\n\n          -  More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant\n             chemotherapy is allowed so long as it occurred greater than or equal to 12 months\n             prior to enrollment)\n\n          -  Current treatment with any systemic anticancer therapies for advanced disease\n\n          -  Any significant cardiac dysfunction within 12 months prior to enrollment\n\n          -  Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper\n             gastrointestinal surgery including gastric resection\n\n          -  Known human immunodeficiency virus (HIV) infection\n\n          -  Known clinically significant history of liver disease\n\n          -  Major surgery within 4 weeks prior to enrollment\n\n          -  Radiation therapy within 2 weeks prior to enrollment\n\n        Phase Ib portion - all above exclusion criteria, plus:\n\n          -  Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event\n             requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to\n             enrollment\n\n        Phase IIa portion - all above exclusion criteria, plus:\n\n          -  Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the\n             advanced/metastatic setting\n\n          -  Cohort B1 only: prior chemotherapy in the advanced/metastatic settingXx_NEWLINE_xXReceipt of prior immunomodulatory agents, including programmed death-1 or PD-L1 targeted therapy or cytotoxic T-lymphocyte-associated antigen 4 targeted therapy including ipilimumab (this exclusion criterion does not apply to participants enrolled in Expansion Cohort A)Xx_NEWLINE_xXDiagnosis of one of the following: Part 1 Only: NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by IHC and/or detection of NUT gene translocation as determined by FISH. Subjects may be treatment naïve or have had prior therapy; SCLC, CRC, NB, TNBC, ER positive BC, CRPC, NSCLC and any other solid tumor which has been confirmed by clinical testing to be MYCN amplified (defined as a MYCN gene copy number gain of >=5). Subjects should have tumor progression after receiving at least one prior standard/approved chemotherapy, or where there is no approved therapy, or where standard therapy is refused. Part 2 only: NUT Midline Carcinoma as diagnosed by the Central Laboratory. Subjects may be treatment naïve or have had prior therapy. SCLC, CRPC, TNBC and ER+BC .Xx_NEWLINE_xXSpecific eligibility criteria for Part 2 CRPC expansion cohort: Persistent disease with evidence of disease progression following standard therapy(ies) including prior treatment with androgen/androgen receptor directed therapy, including enzalutamide and/or abirateroneXx_NEWLINE_xXPrimary refractory patients will be eligible if, on day 14 of their previous chemotherapy regimen, they have significant residual disease; patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for purposes of this study and are not eligibleXx_NEWLINE_xXPatients must be registered to Consolidation therapy within 60 days of beginning Induction therapy (with day 1 being the start of Induction)Xx_NEWLINE_xXRecovery from the effects of previous chemotherapy, with a minimum of 21 days from initiation of last therapy; hydroxyurea or anagrelide may be used to manage elevated cell counts in patients up to the time they begin therapy under this protocolXx_NEWLINE_xXPrior anti-CD19 therapiesXx_NEWLINE_xXPrior therapy(ies), if applicable, must be completed according to the criteria below prior to first dose of tazemetostat:Xx_NEWLINE_xXFor RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.Xx_NEWLINE_xXDocumented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.Xx_NEWLINE_xXPrior therapy containing MMAEXx_NEWLINE_xXHas a disease that is suitable for therapy administered with curative intent.Xx_NEWLINE_xXPreviously received any prior TKI, including ALK-targeted TKIs.Xx_NEWLINE_xXSubjects must not be on home oxygen therapy (intermittent or continuous).Xx_NEWLINE_xXPatients taking herbal remedies (e.g., St. John's Wort [Hypericum perforatum]) who cannot interrupt therapy from the time the C-13 consent is signed through 30 days after the last dose of study therapy.Xx_NEWLINE_xXPatients must be suitable for and willing to undergo a radical prostatectomy at the completion of study therapyXx_NEWLINE_xXKEY INCLUSION CRITERIA\n\n          -  Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or\n             refractory disease who, for the lead-in phase, either have had a prior autologous or\n             allogeneic HSCT or are not eligible for HSCT, and , for the expansion phase, have had\n             a prior allogeneic HSCT. In the expansion phase there must be a documented CD3+ donor\n             chimerism of ?20%.\n\n          -  Patients must be off previous cHL therapy for at least 28 days prior to randomization\n             in the lead-in phase/first dose of study treatment in the expansion phase.\n\n          -  At least 1 fluorodeoxyglucose (FDG) PET avid (Deauville 4/5) measurable lesion >1.5 cm\n             on PET-CT scan as defined by the Response Criteria for Malignant Lymphoma (for the\n             lead-in phase) and the Lugano Classification (for the expansion phase) that has not\n             previously been irradiated.\n\n          -  Expansion phase: Required \de novo\ or \archival\ tumor biopsy, as well as required on\n             treatment biopsy\n\n          -  Estern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n\n        KEY EXCLUSION CRITERIA\n\n          -  Patients with prior allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) who\n             have had:\n\n               1. Lead-in phase: allo HSCT performed <12 months prior to randomization. Expansion\n                  phase: allo-HSCT performed ?4 months prior to the first dose of study treatment.\n                  NOTE: Patients who have had allo-HSCT performed >4 months prior to the first dose\n                  of study treatment must have discontinued all immunosuppressive therapy, and must\n                  have no clinical evidence of GVHD; or\n\n               2. Immunosuppressive treatment for acute or chronic GVHD within 3 months prior to\n                  randomization for the lead-in phase or prior to the first dose of study treatment\n                  for the expansion phase (with the exception of those patients who required 15\n                  mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral\n                  prednisone or equivalent must have discontinued it within 7 days prior to first\n                  dose of study treatment; or\n\n               3. Acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified\n                  Seattle Glucksberg criteria (Consensus Conference on Acute GVHD Grading\n                  Criteria); or\n\n               4. Prior chronic GVHD (as defined by the NIH Consensus Development Project) that\n                  persisted for >6 months and required systemic immunosuppression (with the\n                  exception of those patients who required 15 mg/day oral prednisone or\n                  equivalent). Patients who required 15 mg/day oral prednisone or equivalent must\n                  have discontinued it within 7 days prior to the first dose of study treatment; or\n\n               5. A donor lymphocyte infusion (DLI) within 3 months prior to randomization for the\n                  lead-in phase or first dose of study treatment for the expansion phase.\n\n          -  Prior therapy with an anti PD 1 or anti PD L1 mAb.\n\n               1. Lead-in Phase: May be enrolled if patient stopped prior anti PD1 or anti-PD-L1\n                  therapy more than one year prior to randomization and had a documented prior\n                  response.\n\n               2. Expansion Phase: Prior therapy with an anti-PD-1 or anti-PD-L1 agent following\n                  allo-HSCT is prohibited unless the therapy was stopped more than one year prior\n                  to the first dose of study treatment, and the patient had a documented prior\n                  response. NOTE: Prior therapy with an anti-PD-1 or anti-PD-L1 agent prior to\n                  allo-HSCT is permitted with no time limits and irrespective of a documented\n                  response.\n\n               3. Patients with a history of ?Grade 3 anti-PD-1 or anti-PD-L1-related immune\n                  toxicity are not eligible.Xx_NEWLINE_xXInvestigational treatment within 4 weeks prior to leukapheresis; experimental anti-cancer vaccine within 2 months prior to leukapheresis in the absence of response or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months prior to leukapheresis; any prior gene therapy using an integrating vector.Xx_NEWLINE_xXNo concurrent herbal or unconventional therapyXx_NEWLINE_xXNo prior therapy with IL-15 or IL-15 analogXx_NEWLINE_xXNo prior exposure to immune-mediated therapy,Xx_NEWLINE_xXPrior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);Xx_NEWLINE_xXInclusion Criteria:\n\n        For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not\n        count as a prior line of therapy.\n\n        For Cohorts A and C:\n\n          -  At least one systemic treatment for metastatic breast cancer\n\n          -  Documented disease progression on or after the most recent therapy\n\n          -  Prior treatment must include an anthracycline and a taxane in the neoadjuvant,\n             adjuvant, or metastatic setting\n\n        For Cohort B:\n\n          -  No prior systemic treatment for metastatic breast cancer\n\n          -  Programmed cell death-ligand 1 (PD-L1)-positive mTNBC.\n\n        For Cohort C:\n\n        - PD-L1 strong positive mTNBC\n\n        For all cohorts:\n\n          -  mTNBC confirmed by a central laboratory\n\n          -  For biomarker analysis, adequate newly obtained core or excisional biopsy of a\n             not-previously-irradiated metastatic tumor lesion (mandatory)\n\n          -  Measurable metastatic disease\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          -  Female participants of childbearing potential should be willing to use 2 methods of\n             birth control or be surgically sterile, or abstain from heterosexual activity for the\n             course of the study through 120 days after the last dose of study treatment\n\n          -  Male participants should agree to use an adequate method of contraception starting\n             with the first dose of study treatment through 120 days after the last dose of study\n             treatment\n\n          -  Adequate organ function\n\n        Exclusion Criteria:\n\n          -  Currently participating and receiving study treatment, or has participated in a study\n             of an investigational agent and received study therapy or used an investigational\n             device within 4 weeks prior to study Day 1\n\n          -  Prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic\n             treatment within 4 weeks prior to study Day 1\n\n          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within at\n             least 2 weeks prior to study Day 1\n\n          -  Not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to agents\n             administered within at least 2 weeks prior to study Day 1\n\n          -  Active autoimmune disease requiring systemic treatment in past 2 years\n\n          -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form\n             of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n\n          -  Known additional malignancy that progressed or required active treatment within the\n             last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell\n             carcinoma of the skin that has undergone potentially curative therapy, or in situ\n             cervical cancer\n\n          -  Radiographically-detectable central nervous system (CNS) metastases and/or\n             carcinomatous meningitis\n\n          -  History of (non-infectious) pneumonitis that required steroids or current pneumonitis\n             or a history of interstitial lung disease\n\n          -  Active infection requiring systemic therapy\n\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\n             with the requirements of the study\n\n          -  Pregnant, breastfeeding, or expecting to conceive or father children within the\n             projected duration of the study, starting with the screening visit through 120 days\n             after the last dose of study treatment\n\n          -  Prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1,\n             anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor\n             (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137) or has\n             participated in Merck MK-3475 (pembrolizumab) study\n\n          -  Known history of human immunodeficiency virus (HIV)\n\n          -  Known active Hepatitis B or C\n\n          -  Received a live vaccine within 30 days of planned start of study treatmentXx_NEWLINE_xXHas histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapyXx_NEWLINE_xXHas histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapyXx_NEWLINE_xXHas received ?3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ?4 lines for NSCLC or urothelial cancer.Xx_NEWLINE_xXPrior therapy with pomalidomide with best response of PD or SD.Xx_NEWLINE_xXHepatic artery embolization or ablation of hepatic metastasis within 3 months of enrollment, prior peptide receptor radionuclide therapy (PRRT) within 4 months or any other cancer therapy within 4 weeks (as long as all toxicities are resolved)Xx_NEWLINE_xXreceived at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapyXx_NEWLINE_xXPatients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCTXx_NEWLINE_xXbe able and willing to receive adequate prophylaxis and/or therapy for thromboembolic eventsXx_NEWLINE_xXwere previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)Xx_NEWLINE_xXCRLX101 or with any topoisomerase I therapy;Xx_NEWLINE_xXConcurrent hormone replacement therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Cohort A:\n\n          1. Subjects with newly diagnosed, untreated, unmethylated MGMT GBM who are eligible for\n             standard radiation therapy.\n\n             Cohorts B, B2, B3 and C:\n\n          2. First or second recurrence of GBM by diagnostic biopsy or contrast enhanced MRI per\n             modified RANO criteria (122), with last baseline MRI confirmation within 14 days prior\n             to Study Day 1.\n\n             NOTE: Recurrence is defined as progression following therapy (i.e., chemotherapy;\n             radiation). If the subject had a surgical resection for relapsed disease and no\n             anti-tumor therapy was administered for up to 12 weeks, and the subject has further\n             evidence of tumor growth or undergoes another resection, this will be considered as\n             one episode of recurrence.\n\n          3. On Study Day 1, at least 12 weeks from prior radiotherapy (unless progressive disease\n             outside of the radiation field or histopathologic confirmation of unequivocal tumor).\n\n          4. Cohort B, B2, B3: No prior VEGF/VEGFR targeted therapy; Cohort C: No more than one\n             prior bevacizumab regimen.\n\n          5. Recovery from any prior treatment clinically significant, related adverse events to\n             grade ? 1 or pretreatment baseline with the exception of alopecia and laboratory\n             values listed per inclusion criteria.\n\n             Cohorts A, B, B2, B3 and C:\n\n          6. Subjects with measurable or non-measurable disease.\n\n          7. Histopathologic confirmation of glioblastoma.\n\n          8. At the time of Study Day 1, subjects must be at least 4 weeks since major surgical\n             procedure, open biopsy, or significant traumatic injury; there should be no\n             anticipation of need for major surgical procedure during the course of the study.\n\n             There should be no core biopsy or other minor surgical procedure, excluding placement\n             of a vascular access device, within 7 days prior to Study Day 1.\n\n          9. Subjects who have previously been treated with the Optune device are eligible for the\n             study as long as toxicity related to the treatment has resolved to ? Grade 1 or\n             baseline.\n\n         10. ECOG ? 1 or Karnofsky performance status of ? 70.\n\n         11. Adequate hematologic, renal and hepatic function, as defined below:\n\n               -  Absolute Neutrophil Count ? 1000/mm3\n\n               -  Platelet count ? 100,000/mm3\n\n               -  Total bilirubin ? 1.5 x ULN; or if subject has Gilbert syndrome, then total\n                  bilirubin ? 3 x ULN\n\n               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.0 x ULN\n\n               -  Creatinine ? 1.5x ULN or creatinine clearance (CrCl) ? 50 mL/min (using the\n                  Cockcroft-Gault formula):\n\n                    -  Female CrCl = (140 - age in years) x weight in kg x 0.85 /72 x serum\n                       creatinine in mg/dL\n\n                    -  Male CrCl = (140 - age in years) x weight in kg x 1.00/72 x serum creatinine\n                       in mg/dL Cohorts B2, B3 and C\n\n               -  Urinary protein quantitative value of ? 30 mg/dL in urinalysis or ?1+ on\n                  dipstick, unless quantitative protein is < 1000 mg in a 24 hour urine sample.\n\n         12. Age must be greater than or equal to 18 years at date of consent.\n\n         13. Written informed consent and any locally required authorization (e.g., Health\n             Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the\n             subject/legal representative prior to performing any protocol-related procedures,\n             including screening evaluations.\n\n        Exclusion Criteria:\n\n        All Cohorts\n\n          1. Primary tumors localized to the brainstem or spinal cord.\n\n          2. Locally directed therapies including but not limited to stereotactic radiosurgery,\n             re-irradiation, Gliadel, and therapeutics administered by direct injection or\n             convection-enhanced delivery within 6 months of start of study treatment.\n\n          3. Prior exposure to MEDI4736 or other anti-PD-1, anti-PD-L1, anti-CTLA4 antibodies.\n\n          4. Presence of diffuse leptomeningeal disease or extracranial disease.\n\n          5. Active, suspected or prior documented autoimmune disease (including inflammatory bowel\n             disease, celiac disease, irritable bowel syndrome, Wegner's granulomatosis and\n             Hashimoto's thyroiditis). Subjects with vitiligo, type I diabetes mellitus, residual\n             hypothyroidism due to autoimmune condition only requiring hormone replacement,\n             psoriasis not requiring systemic treatment, or conditions not expected to recur in the\n             absence of an external trigger are permitted to enroll.\n\n          6. Known primary immunodeficiency or active HIV.\n\n          7. Known active or chronic viral hepatitis or history of any type of hepatitis within the\n             last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or\n             hepatitis C virus ribonucleic acid (HCV antibody).\n\n          8. History of organ transplant requiring use of immunosuppressive medication.\n\n          9. History of active tuberculosis.\n\n         10. Significant active systemic illness including infections requiring intravenous\n             antibiotics.\n\n         11. Current pneumonitis or interstitial lung disease.\n\n         12. Other invasive malignancy within 2 years prior to entry into the study, except for\n             those treated with surgical therapy only.\n\n         13. History of severe allergic reactions to any unknown allergens or any components of the\n             study drugs.\n\n         14. Any prior Grade ? 3 immune-related adverse event (irAE) or any prior\n             corticosteroid-refractory irAE.\n\n         15. Mental impairment that may compromise the ability to give informed consent and comply\n             with the requirements of the study.\n\n         16. Lack of availability for follow-up assessments.\n\n         17. Lack of availability for Post Study Follow-up contacts to determine relapse and\n             survival.\n\n         18. Women who are breast-feeding or pregnant as evidenced by positive serum pregnancy test\n             (minimum sensitivity 25 IU/L or equivalent units of HCG).\n\n         19. Women of childbearing potential not using a medically acceptable means of\n             contraception for the duration of the study and unsterilized males not willing to\n             abide by requirements for contraception as stated in Section 5.4.\n\n         20. If a subject previously received another investigational treatment, the last dose of\n             investigational treatment was administered within 4 weeks of Day 1 of the study.\n\n         21. Any condition that, in the clinical judgment of the treating physician, is likely to\n             prevent the subject from complying with any aspect of the protocol or that may put the\n             subject at unacceptable risk.\n\n         22. Cohorts B2, B3 and C:\n\n               -  Evidence of hemorrhage on the baseline MRI or CT scan other than those that are ?\n                  grade 1 and either post-operative or stable on at least two consecutive scans\n\n               -  Current use of warfarin sodium or any other Coumadin-derivative anticoagulant.\n                  Participant must be off Coumadin-derivative anticoagulants for at least seven\n                  days prior to starting study drug. Low molecular weight heparin and Factor Xa\n                  antagonists are allowed\n\n               -  History of clinically significant bleeding within 6 months of enrollment\n\n               -  History of arterial thromboembolism within 12 months prior to enrollment\n\n               -  Inadequately controlled hypertension (defined as systolic blood pressure 150\n                  and/or diastolic blood pressure > 90 mmHg on antihypertensive medications)\n\n               -  Any prior history of hypertensive crisis or hypertensive encephalopathy\n\n               -  Clinically significant cardiovascular disease within 12 months prior to\n                  enrollment (or randomization), including myocardial infarction, unstable angina,\n                  grade 2 or greater peripheral vascular disease, cerebrovascular accident,\n                  transient ischemic attack, congestive heart failure, or arrhythmias not\n                  controlled by outpatient medication, percutaneous transluminal coronary\n                  angioplasty/stent\n\n               -  Evidence of bleeding diathesis or coagulopathy\n\n               -  History of abdominal fistula, gastrointestinal perforation, or intra abdominal\n                  abscess within 6 months prior to study enrollment\n\n               -  Serious, non healing wound, ulcer, or bone fractureXx_NEWLINE_xXCo-medication that may interfere with study results, e.g., immuno-suppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the Investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to first dose of MRZ.)Xx_NEWLINE_xXHistory of a significant allergic reaction attributed to humanized or human monoclonal antibody therapyXx_NEWLINE_xXAll forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the local-regional therapy has shown an increase of ? 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.Xx_NEWLINE_xXPatients enrolling onto Arm A (Gemcitabine and nab-Paclitaxel) or Arm B (mFOLFIRINOX) are allowed to have up to two prior lines of systemic therapy, with adjuvant therapy counted as one line of therapy as long as disease recurrence occurred > 6 months of last dose of therapy. Prior systemic therapy in the metastatic setting is allowed for as long as the therapy contained BBI608 in combination with either Gemcitabine and nab-Paclitaxel or mFOLFIRINOX. Toxicities related to prior therapy must have completely resolved (except for alopecia and anemia), or be deemed irreversible.Xx_NEWLINE_xXPatients enrolling onto Arm C (FOLFIRI) or Arm D (MM-398 with 5-FU and leucovorin) must have failed one prior line of gemcitabine-based therapy with or without BBI608 in the metastatic setting. No additional lines of therapy in the metastatic setting are allowed. Prior adjuvant therapy with gemcitabine is allowed as long as disease recurrence occurred > 6 months of last dose of therapy. Toxicities related to prior therapy must have completely resolved (except for alopecia and anemia), or be deemed irreversible. Prior treatment with radiotherapy is allowed.Xx_NEWLINE_xXSubjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.Xx_NEWLINE_xXInclusion Criteria: (For all patients unless otherwise specified)\n\n          -  Histologically or cytologically confirmed locally advanced (stage IIIB not amenable to\n             definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR\n             mutant NSCLC.\n\n          -  Patients with controlled brain metastases\n\n          -  ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1\n\n          -  Presence of at least one measurable lesion according to RECIST 1.1\n\n          -  Patients who are either HBsAg positive or HBV-DNA positive must be willing and able to\n             take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on\n             antiviral therapy for at least 4 weeks after the last dose of EGF816\n\n          -  Patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but\n             undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible\n             for the study.\n\n          -  For Phase I: patients must have failed no more than 3 lines of any systemic\n             antineoplastic therapy for advanced NSCLC, including EGFR-TKI\n\n          -  For Phase II: patients must be naïve from any systemic antineoplastic therapy in the\n             advanced setting. Patients who have failed no more than 1 cycle of systemic\n             antineoplastic therapy in the advanced setting are allowed.\n\n        Exclusion criteria: (Applies to all patients unless otherwise specified)\n\n          -  Patients with a history or presence of ILD or interstitial pneumonitis, including\n             clinically significant radiation pneumonitis (i.e. affecting activities of daily\n             living or requiring therapeutic intervention)\n\n          -  Presence or history of another malignancy\n\n          -  Undergone a bone marrow or solid organ transplant\n\n          -  Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not\n             mandatory)\n\n          -  Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use\n             at the time of study entry except for control of brain metastases, topical\n             applications, inhaled sprays, eye drops or local injections\n\n          -  Patients with clinically significant, uncontrolled heart disease\n\n          -  Any prior therapies ? 4 weeks prior to the first dose of study treatment\n\n          -  Patients who are receiving treatment with medications that are known to be strong\n             inhibitors or inducers of CYP3A4/5 and cannot be discontinued 1 week prior to the\n             start of EGF816 treatment and for the duration of the study.\n\n          -  Patients who have impairment of GI function or GI disease that may significantly alter\n             the absorption of EGF816 (e.g., ulcerative diseases, uncontrolled nausea, vomiting,\n             diarrhea, or malabsorption syndrome)\n\n          -  Patients who are receiving treatment with any enzyme-inducing anticonvulsant that\n             cannot be discontinued at least 1 week before first dose of study treatment, and for\n             the duration of the study\n\n          -  Women of child-bearing potential, defined as all women physiologically capable of\n             becoming pregnant, unless they are using highly effective methods of contraception\n\n          -  Sexually active males unless they use a condom during intercourse while taking drug\n             and for 3 months after stopping treatment Other protocol-defined inclusion and\n             exclusion criteria may apply.Xx_NEWLINE_xXFor all other malignancies, the subject is eligible if they have undergone potentially curative therapy and they have been considered disease free for at least 5 years prior to Screening.Xx_NEWLINE_xXRelapsed or refractory de novo or transformed DLBCL disease following at least one prior systemic therapy (for DLBCL)Xx_NEWLINE_xXExpected to require any other form of antineoplastic therapy while on studyXx_NEWLINE_xXFor AML patients, no more than 1 prior salvage therapy.Xx_NEWLINE_xXOther ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to patient registration.Xx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXPatients whose insurance will not cover proton therapy will still be eligible for the studyXx_NEWLINE_xXGroup 3 - Patients must have disease progression while on or within one month after CDK4/6 inhibitor based therapy (except those patients who received prior LEE011 based therapy).Xx_NEWLINE_xXPatients who have had prior therapy that specifically and directly targets the EGFR/HER2 pathway.Xx_NEWLINE_xXPatients must have been treated with 1-2 courses of therapy as first therapy for AML, commonly described as remission induction; examples include, but are not limited to:\r\n* Anthracycline containing regimens\r\n* Nucleoside analogs as monotherapy or in combination\r\n* Deoxyribonucleic acid (DNA) methyltransferase inhibitorsXx_NEWLINE_xXPatients must be in morphologic complete response (CR), complete response with incomplete hematologic recovery (CRi), partial response (PR) by international working group criteria post induction therapy, or patients refractory to induction therapy provided they have < 1000 peripheral blasts/mm^3 and white blood cells (WBC) =< 10 x 10^9/L; patients in PR and/or those who are refractory and who have undergone only one course of induction therapy will be eligible only if one or more of the following criteria are met:\r\n* Patient preference to forgo further induction therapy in favor of low or intermediate-intensity therapy\r\n* Patients are deemed unlikely to benefit from anthracycline cytarabine induction therapies for any of the following reasons:\r\n** Therapy-related AML\r\n** Prior myelodysplastic syndrome or myeloproliferative neoplasm\r\n** The presence of cytogenetic or molecular genetic features place patient in the Intermediate-I, Intermediate-II or adverse genetic group as defined by the European LeukemiaNet\r\n* Patients who have experienced one or more Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3-4 treatment related non-hematologic toxicity within 30 days of beginning the first course of induction therapyXx_NEWLINE_xXPatients in CRi must have evidence of hematologic recovery after prior therapy to at least: absolute neutrophils >= 0.8 x 10^9/LXx_NEWLINE_xXPatients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML.Xx_NEWLINE_xXLimited prior therapy, including systemic glucocorticoids for 1 week or less, 1 dose of vincristine, emergency radiation therapy to the mediastinum, and 1 dose of IT chemotherapy; other circumstances must be cleared by principal investigator (PI) or co-PIXx_NEWLINE_xXStable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the 96 hours prior to initiation of therapy.Xx_NEWLINE_xXProgression of disease after last therapy demonstrated by RANO criteriaXx_NEWLINE_xXNo prior therapy with AvastinXx_NEWLINE_xXPatients must have received at least 2 prior therapies.Xx_NEWLINE_xXWith the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932\r\n* Patients receiving prior steroid therapy may be eligible for AALL0932Xx_NEWLINE_xXUrothelial carcinoma that is suitable for local therapy with curative intent.Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXBe considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.Xx_NEWLINE_xXDisease that is suitable for local therapy administered with curative intent.Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXAndrogen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration; \r\n* Note: The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to prostatectomy is acceptableXx_NEWLINE_xXMust not have received any prior systemic therapy for their mRCC.Xx_NEWLINE_xXUse of protocol-defined prior/concomitant therapy.Xx_NEWLINE_xXPeritoneal mesothelioma basket \r\n* Refractory or intolerant to platinum and pemetrexed systemic therapy\r\n* Any number of prior therapiesXx_NEWLINE_xXPleural mesothelioma basket\r\n* Metastatic or locally recurrent disease not amenable to curative intent treatment\r\n* Refractory to platinum and pemetrexed systemic therapy\r\n* Any number of prior therapiesXx_NEWLINE_xXPatients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowedXx_NEWLINE_xXPatients must have progressed on or within 60 days after end of previous therapy before to study entry, i.e., refractory to the last line of treatment.Xx_NEWLINE_xXPrior therapy with pomalidomide.Xx_NEWLINE_xXPatients who have disease progression prior to completion of intended frontline therapy, including patients demonstrating disease progression after interval cytoreductionXx_NEWLINE_xXParticipant must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. A line of therapy consists of greater than or equal to 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens.Xx_NEWLINE_xXhave experienced any Grade 3 or 4 venous thromboembolic event that is considered by the investigator to be life threatening or that is symptomatic and not adequately treated by anticoagulation therapy, within 6 months prior to enrollmentXx_NEWLINE_xXRadiologic evidence of progressive disease (according to [RECIST Version 1.1) either during or within 6 months after stopping their most recent systemic therapy for RCC before enrollment into this study.Xx_NEWLINE_xXAt least 1, prior line of VEGF-targeted therapy, but not more than 4 total prior lines of systemic therapy. Exposure to more than 1 line of VEGF-targeted therapy is acceptable. Participants may also have received prior therapies with interferon, interleukin 2 (IL-2), anti-PD1 antibodies, cabozantinib or other experimental agents, but not prior therapy with any agent that targets phosphoinositide 3-kinase (PI3K), serine/ threonine-specific protein kinase (AKT), or mechanistic (or mammalian) target of rapamycin (mTOR).Xx_NEWLINE_xXFor Cohort 1: had prior systemic therapy for HCC other than sorafenib, or intercurrent local therapy to the liver tumor between sorafenib and study drugXx_NEWLINE_xXFor Cohort 2: had prior systemic therapy in the advanced disease settingXx_NEWLINE_xXFor patients with GIST, patients will have progressed on at least one prior tyrosine kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or PDGFRA-D842V GIST, no prior therapy is required for study entry. Other patients with KIT positive cancers will have progressed on at least one prior therapy.Xx_NEWLINE_xXmust have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)Xx_NEWLINE_xXAny medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriatelyXx_NEWLINE_xXRelapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.Xx_NEWLINE_xXGroup A at least one prior regimen of therapyXx_NEWLINE_xXEARLY INDUCTION GROUP: Subjects who have started androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an anti-androgen agent) a maximum of 28 days before registration and who otherwise meet all the eligibility criteria.Xx_NEWLINE_xXLATE INDUCTION GROUP: Subjects who have NOT started any androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an antiandrogen agent).Xx_NEWLINE_xXAnti-androgen receptor antagonist therapy must be bicalutamide. Subjects already started on other anti-androgens must be willing to switch over to bicalutamide.Xx_NEWLINE_xXPrior concomitant therapy with ketoconazole, aminoglutethimide or abiraterone acetate or enzalutamide (MDV3100) or intent to treat with the above. Concurrent megestrol for hot flashes is allowed.Xx_NEWLINE_xXHave received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting)Xx_NEWLINE_xXHas received prior therapy with vorinostat or other epigenetic agentXx_NEWLINE_xXPrior treatment with less than or equal to (>=) 2 treatment lines of anti-myeloma therapy. Prior lines of therapy must include a proteasome inhibitor (PI) (eg, bortezomib, carfilzomib) and an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide) in any order during the course of treatment. Each prior line of therapy may consist of one or more agents and may include induction, hematopoietic stem cell transplantation, and/or maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of steroids is not considered a prior line of therapyXx_NEWLINE_xXPatients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapyXx_NEWLINE_xXPatients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer; they must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment; patients are allowed to have received, but are not required to have received, one to two cytotoxic regimens for management of recurrent or persistent disease; (for the purposes of this study poly adenosine diphosphate [ADP] ribose polymerase [PARP] inhibitors given for recurrent or progressive disease will be considered cytotoxic; PARP inhibitors given as maintenance therapy in continuation with management of primary disease will not be considered as a separate cytotoxic regimen); if two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agentXx_NEWLINE_xXConcurrent, malignant disease for which patient is on active therapyXx_NEWLINE_xXCandidate for first-line therapy with sunitinib initiated 5-8 weeks after nephrectomyXx_NEWLINE_xXPrior systemic antitumour therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumour is allowedXx_NEWLINE_xXPatient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.Xx_NEWLINE_xXNo prior history of immune checkpoint modulator therapyXx_NEWLINE_xXPatients must have started androgen deprivation therapy (bilateral orchiectomy versus luteinizing hormone-releasing hormone [LHRH] agonist, and with or without androgen antagonist) at least one month (4 weeks) prior to enrollment and no more than six months (24 weeks) prior to enrollment; patients must continue the androgen deprivation therapy throughout the study period, and patients are not permitted to change the type of androgen deprivation therapy (e.g. by adding an androgen antagonist) during the course of investigational therapyXx_NEWLINE_xXPatients with AML or biphenotypic or bilineage leukemia who have failed at least one prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapyXx_NEWLINE_xXPatients should not be eligible or able to receive approved therapy of confirmed clinical benefit in this patient populationXx_NEWLINE_xXIn the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of 5-azacytidine and lirilumab will be at least 2 weeks OR at least 5 half-lives for cytotoxic/noncytotoxic agents; use of one dose of cytarabine (up to 2 g/m^2) is allowed prior to the start of study therapy or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and while the patient is on active study treatment, as needed, for clinical benefit and after discussion with the principal investigator (PI); concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permittedXx_NEWLINE_xXPatients must have received at least two or more prior courses of intravesical therapy per recommended schedules. BCG must have been one of the prior therapies administered.Xx_NEWLINE_xXPatients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The first standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG therapy must include at least two weekly treatments.Xx_NEWLINE_xXdisease recurrence either must occur within 12 months of the most recent intravesical therapy of any kind, ORXx_NEWLINE_xXImmunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.Xx_NEWLINE_xXHistory of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) within the last yearXx_NEWLINE_xXPart A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapyXx_NEWLINE_xXPart D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitorXx_NEWLINE_xXPhase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic) only: patients must harbor an EGFR activating mutation and must be naïve from any line of systemic antineoplastic therapy in the advanced setting.Xx_NEWLINE_xXPatients who have received more than three prior lines of antineoplastic therapies (including EGFR TKI) in advanced setting.Xx_NEWLINE_xXMore than 3 prior lines of systemic antineoplastic therapies (including EGFR TKI) in the advanced settingXx_NEWLINE_xXPrevious treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Patients who received only one cycle of antineoplastic therapy in the advanced setting are allowed).Xx_NEWLINE_xXMore than 2 prior lines of systemic antineoplastic therapies in the advanced settingXx_NEWLINE_xXPatients with secondary AML or therapy related disease (t-AML) are eligible; patients who received decitabine or 5-azacytidine as prior treatment for myelodysplastic syndrome (MDS) remain eligibleXx_NEWLINE_xXUse of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapyXx_NEWLINE_xXNo prior systemic anti-cancer therapy for advanced ER+ diseaseXx_NEWLINE_xXAnti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cellsXx_NEWLINE_xXFor phase II, any receipt of cytotoxic, biologic, or immune therapy aimed to treat GIST except for adjuvant imatinib systemic therapy that concluded at least 90 days prior to registration; for phase I, patients are eligible regardless of prior therapyXx_NEWLINE_xXPatients who have previously received hormonal therapy for endometrial cancer.Xx_NEWLINE_xXPatients must have been off therapy for MDS for 2 weeks prior to entering this study, and must have recovered from the toxic effects of that therapy to at least grade 1, unless there is evidence of rapidly progressive disease; use of hydroxyurea (any dose) or cytarabine (ara-C) (up to 1 g/m^2 x 2 doses) for patients with rapidly proliferative disease is allowed before the start of study therapy; these should be stopped for 24 hours prior to the initiation of azacitidine and sorafenibXx_NEWLINE_xXPrevious therapy with Akt, PI3K, and/or mTOR inhibitorsXx_NEWLINE_xXPatients requiring supplemental oxygen therapyXx_NEWLINE_xXPrior therapy with gene modified cellsXx_NEWLINE_xXPrevious experimental therapy with SS1 moiety, murine or chimeric antibodies (human and humanized antibodies are allowed)Xx_NEWLINE_xXExpected to require any other form of systemic or localized antineoplastic therapy during the studyXx_NEWLINE_xXIs refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomibXx_NEWLINE_xXENTRY CRITERIA:\n\n        DISEASE CHARACTERISTICS:\n\n          -  Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at\n             least two different previous regimens.\n\n               -  Refractory disease is defined as progressive disease while on therapy or\n                  progression within 60 days of therapy.\n\n               -  Progressive disease is defined by a 25% increase from the lowest response value\n                  in specified tests.\n\n          -  Measurable disease as defined by at least one of the following:\n\n               -  Serum M-protein ? 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)\n\n               -  Urine M-protein ? 200mg/24hours\n\n               -  Serum free light chains ? 10 mg/dL and abnormal kappa/lambda ratio\n\n        PRIOR/CONCURRENT THERAPY:\n\n          -  No anti-myeloma treatments within 14 days before the start of study treatment.\n\n          -  Must have recovered from side effects of prior treatments.\n\n        PATIENT CHARACTERISTICS:\n\n        Performance Status\n\n        • ECOG 0, 1, or 2\n\n        Bone Marrow Reserve\n\n          -  Absolute neutrophil count (AGC/ANC) ? 1000/uL\n\n          -  Platelets ? 30,000/uL\n\n          -  Hemoglobin ? 8g/dL\n\n          -  Absolute lymphocytes ? 800/uL\n\n          -  Leukocytes ? 3,000/uL\n\n        Renal Function\n\n        • Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ? 1.5 X ULN\n\n        Hepatic Function\n\n          -  Total bilirubin ? 2.0 X ULN\n\n          -  AST, ALT, ALP ? 3.0 X ULN, or ? 5.0 X ULN (if liver metastases exist)\n\n          -  No positive Hep C serology or active Hep B infection\n\n        Cardiovascular\n\n          -  No congestive heart failure < 6 months\n\n          -  No unstable angina pectoris < 6 months\n\n          -  No myocardial infarction < 6 months\n\n          -  No history of ventricular arrhythmias\n\n          -  No history of supraventricular arrhythmias\n\n          -  No NYHA Class > II CHF\n\n          -  No marked baseline prolongation of QT/QTc interval\n\n        Pulmonary\n\n        • Normal clinical assessment of pulmonary function\n\n        Other\n\n          -  Negative serum pregnancy test if female and of childbearing potential\n\n          -  Women who are not pregnant or nursing\n\n          -  Subjects, both females and males, with reproductive potential must agree to use\n             effective contraceptive measures for the duration of the study\n\n          -  No known autoimmune disease other than corrected hypothyroidism\n\n          -  No known prior organ allograft or allogeneic transplantation\n\n          -  Not HIV positive\n\n          -  No history or evidence of uncontrollable CNS disease\n\n          -  No psychiatric illness/social situation\n\n          -  No other illness that in the opinion of the investigator would exclude the subject\n             from participating in the study\n\n          -  Must provide informed consent and HIPPA authorization and agree to comply with all\n             protocol-specified procedures and follow-up evaluations\n\n          -  No active systemic infection requiring parenteral antibiotic therapy\n\n          -  No on-going chronic systemic corticosteroid (>10 mg daily prednisone equivalent) use\n             or other immunosuppressive therapy (a history of mild asthma not requiring therapy is\n             eligible). Inhaled or topical steroids, and adrenal replacement steroid doses ? 10 mg\n             daily prednisone equivalent, are permitted in the absence of active autoimmune\n             disease.Xx_NEWLINE_xXMEL subjects may be treatment naïve or may have received prior lines of therapy for metastatic disease (Parts 1A and 1B)Xx_NEWLINE_xXEach subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapyXx_NEWLINE_xXExperimental therapies when given as separate regimen are considered as separate line of therapyXx_NEWLINE_xXPrior anthracycline therapyXx_NEWLINE_xXPrior therapy for NHLXx_NEWLINE_xXHistory of adrenal insufficiency (including subjects using replacement therapy)Xx_NEWLINE_xXInclusion Criteria:\n\n        Patients enrolled in Part A must receive the 99mTc- etarfolatide scan but they do not need\n        to have FR-positive target lesions.\n\n        Parts A and B:\n\n        To qualify for enrollment, the following criteria must be met:\n\n          1. Patient must have the ability to understand and sign an approved informed consent form\n             (ICF).\n\n          2. Patient must be ? 18 years of age.\n\n          3. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0\n             or 1.\n\n          4. Patient must have a life expectancy of > 3 months.\n\n          5. Patient must have at least one measurable lesion per RECIST v1.1 Criteria as assessed\n             on baseline radiologic evaluation obtained no more than 28 days prior to beginning\n             study therapy.\n\n          6. Patients with central nervous system (CNS) metastases that are symptomatic must have\n             received therapy (e.g., surgery, XRT, gamma knife, etc.) and be neurologically stable\n             and off of steroids. The patient should be off steroids at least 14 days before\n             registration. Patients with asymptomatic CNS metastatic disease without associated\n             edema, shift, and a requirement for steroids or anti-seizure medications may be\n             eligible after discussion with the sponsor medical monitor.\n\n          7. Patients must have formalin fixed tissue (biopsy or FNA) available.\n\n          8. Patient must have recovered (to baseline/stabilization) from prior chemo or radio\n             therapy and associated acute toxicities must have resolved to a NCI CTCAE V4 Grade 1\n             or less, with the exception of alopecia.\n\n          9. Patients treated with prior radiation therapy may be eligible if:\n\n               1. Radiotherapy was completed at least 2 weeks before first dose of EC1456 and\n\n               2. Patient has recovered from acute radiation toxicity.\n\n         10. Patients must have adequate organ function:\n\n               1. Bone marrow reserve: Absolute neutrophil count (ANC) ? 1.5 x 109/L; Platelets ?\n                  100 x 109/L; Hemoglobin ? 9 g/dL.\n\n               2. Cardiac:\n\n             i. QTcFridericia (QTcF) < 450 msec on at least 2 of 3 screening ECG's. On site\n             determination of QTcF may be used for screening purposes.\n\n             ii. Left ventricular ejection fraction (LVEF) equal to or greater than the\n             institutional lower limit of normal. LVEF must be evaluated within 28 days prior to\n             C1D1.\n\n             iii. Cardiac Troponin I or T within normal limit. (whichever troponin is done for\n             screening will need to be done throughout the rest of the study).\n\n             c. Hepatic: Total bilirubin ? 1.5 x the upper limit of normal (ULN); Alanine\n             aminotransferase (ALT), aspartate aminotransferase (AST) ? 3.0 x ULN OR ? 5.0 x ULN\n             for patients with liver metastases.\n\n             d. Renal: Serum creatinine ? 1.5 x ULN or for patients with serum creatinine > 1.5\n             ULN, creatinine clearance ? 50 mL/min.\n\n             Patients of childbearing potential:\n\n         11. All women of childbearing potential MUST have a negative urine or serum pregnancy test\n             within 1 week prior to the 99mTc-etarfolatide imaging procedure and within 1 week\n             prior to treatment with EC1456.\n\n         12. Women of child bearing potential must practice an effective method of birth control\n             (i.e., oral, transdermal or injectable contraceptives, intrauterine device [IUD], or\n             double-barrier contraception, such as diaphragm and spermicidal jelly) for the\n             duration of their participation in the trial through 90 days following the last dose\n             of EC1456.\n\n         13. Male patients who are sexually active must practice an effective method of birth\n             control (e.g., condom and spermicidal jelly) for the duration of their participation\n             in the trial through 90 days following the last dose of EC1456.\n\n             Patient and Disease Specific Inclusion Criteria: Part A\n\n             EC1456 dose escalation cohorts (Treatments 1, 2, 3, and 4):\n\n         14. Patients must have pathologically confirmed metastatic or locally advanced solid\n             cancer (preferably TNBC, NSCLC, ovarian, or endometrial cancers due to frequent high\n             FR expression in these cancers) that has failed to respond to standard therapy, is not\n             amenable to standard therapy, or for which standard therapy does not exist.\n\n         15. TNBC and ovarian patients must agree to submit results of BRCA 1/2 status (i.e.,\n             deleterious mutation present, mutation of unknown significance, no mutation detected)\n             if known. BRCA testing is not required for study inclusion.\n\n         16. Patients must have received ? 4 prior lines of systemic anti-cancer therapy (including\n             but not limited to cytotoxic agents, targeted inhibitors, and monoclonal antibodies).\n             Hormonal therapies are not included toward this criterion.\n\n         17. Patients must undergo a 99mTc-etarfolatide SPECT imaging procedure in compliance with\n             the Investigator's Imaging Operations Manual (IIOM). FR expression on 99mTc\n             -etarfolatide SPECT is not required for inclusion in Treatments 1, 2, 3, and 4.\n\n             (Patients who underwent a 99mTc-etarfolatide SPECT/CT imaging procedure as a subject\n             on Endocyte study EC20.12 will not be required to have a repeat scan for participation\n             in study EC1456-01 if the scan was obtained within 4 weeks of cycle 1 day 1 of EC1456\n             administration and has been deemed acceptable by Endocyte Imaging.)\n\n             Part B Only:\n\n             Patient and Disease Specific Inclusion Criteria: Part B\n\n             Patients with FR-positive NSCLC (all subtypes): (Treatments 5, 6, and 7)\n\n         18. Patients with NSCLC (all subtypes) must have received one prior platinum based therapy\n             for advanced or metastatic disease. No additional cytotoxic therapy for advanced or\n             metastatic disease is allowed. Any number of prior targeted therapies (e.g.,\n             inhibitors of ALK, EGFR, and PD-1 or PD-L1) are allowed. Patients with known relevant\n             genomic tumor aberrations (i.e., EGFR, ALK, ROS-1, etc) must have received and\n             progressed on approved therapy for these aberrations. This information must be\n             documented prior to study entry.\n\n         19. Patients must undergo a 99mTc-etarfolatide SPECT imaging procedure in compliance with\n             the Investigator's Imaging Operations Manual (IIOM) and be FR-positive.\n\n        Exclusion Criteria:\n\n        Parts A and B:\n\n        The presence of any of the following will exclude patients from the study:\n\n          1. Systemic anti-cancer treatment, except hormonal treatment, within 28 days prior to\n             EC1456 administration unless there are no remaining or ongoing uncontrolled\n             toxicities. Please contact the medical monitor to discuss requests for less than 28\n             day washout period.\n\n          2. Known hypersensitivity to the components of the study therapy or its analogs.\n\n          3. Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases.\n\n          4. Malignancies that are expected to alter life expectancy or may interfere with disease\n             assessment. Patients with adequately treated non-melanoma skin cancer, carcinoma in\n             situ of the cervix, or low-grade (Gleason score ? 6) localized prostate cancer, ductal\n             carcinoma in situ (DCIS), and patients with prior history of malignancy who have been\n             disease free for more than 3 years are eligible.\n\n          5. Serious cardiac illness or medical conditions such as unstable angina, pulmonary\n             embolism, or uncontrolled hypertension.\n\n          6. Patients considered at risk for life-threatening QTc prolongation (i.e., personal or\n             family history of Long QT syndrome, presence of implantable pacemaker or implantable\n             cardioverter defibrillator, etc.).\n\n          7. Use of the following medications within 6 months prior to EC1456 administration:\n             amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine,\n             or sotalol.\n\n          8. Need for concurrent anti-folate therapy such as methotrexate for rheumatoid arthritis.\n\n          9. Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational\n             therapy.\n\n         10. Pregnant or lactating women.\n\n         11. Active uncontrolled infections.\n\n         12. Known active Hepatitis B or C infection.\n\n         13. Unable or unwilling to have a pretreatment scan performed with 99mTc-etarfolatide for\n             any reason (such as claustrophobia, an inability to lie supine on an imaging table\n             because of pain or cardiopulmonary disease, etc.).Xx_NEWLINE_xXDocumented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be Rituximab-refractory.Xx_NEWLINE_xXSystemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximabXx_NEWLINE_xXPrior treatment with nintedanib or any other prior line of therapyXx_NEWLINE_xXExpected to require any other form of systemic or localized antineoplastic therapy while on trialXx_NEWLINE_xXOther investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable)Xx_NEWLINE_xXPatients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (e.g. AML)Xx_NEWLINE_xXPrior treatment with systemic steroids within 4 weeks prior to lymphodepletion (except for physiologic replacement doses for adrenal insufficiency, premedication for contrast allergies for scans, and for drug fever related to targeted therapy)Xx_NEWLINE_xXSubjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligibleXx_NEWLINE_xXPrior gene therapy treatments or prior therapy with cytolytic virus of any typeXx_NEWLINE_xXNo prior systemic anti-cancer therapy for advanced ER+ disease.Xx_NEWLINE_xXPhase 2: Clinically active cerebral melanoma metastases. Subjects with up to 3 cerebral metastases, and neurological performance status of 0 may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or Gamma knife therapy, with no evidence of progression, and have not required steroids, for at least 2 months prior to enrollment.Xx_NEWLINE_xXPatients may have received one or more lines of prior chemotherapy with/without rituximab (including high dose therapy plus stem cell transplant which is counted as one regimen); prior bortezomib is allowed; patients must not have received bortezomib in the past 6 monthsXx_NEWLINE_xXHistory of limb perfusion therapyXx_NEWLINE_xXOral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy.Xx_NEWLINE_xXHowever, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.Xx_NEWLINE_xXSubjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.Xx_NEWLINE_xXDuring the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.Xx_NEWLINE_xXConcurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be continued if distant metastases are non-responsive (i.e. no complete response [CR] or partial response [PR]) on that regimen for >= 8 weeks as assessed by the investigatorXx_NEWLINE_xXPatients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within 4 weeks prior to first dosing of study agentXx_NEWLINE_xXWho have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose; mobilization therapy is not considered initial therapyXx_NEWLINE_xXPrior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed; hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy; patients who have previously received any other chemotherapy, radiation therapy or any other antileukemic therapy are not eligible for this protocolXx_NEWLINE_xXFor subjects who have discontinued anti-androgen therapy, PSA rise as defined above must be documented:\r\n* Within two weeks after discontinuation if used following surgical or medical castration (second line therapy)\r\n* After four weeks discontinuation if used as first line therapyXx_NEWLINE_xXPrior anti-androgen therapy: first line of therapy (started simultaneously with LHRH) initiated at least eight weeks prior to screening; second line, anytime before start of study treatmentXx_NEWLINE_xXPatients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (eg, radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser]) are not eligibleXx_NEWLINE_xXReceived systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generate of the two cell therapies in this protocolXx_NEWLINE_xXPatients must not have received any prior chemotherapy, radiation therapy, biologic therapy, or bone marrow transplant; surgery and dexamethasone are permitted prior to study entry; in patients who require anticonvulsants prior to study entry, it is permissible to start VPA, but trough VPA concentration must be repeated within 48 hours of study entryXx_NEWLINE_xXPrior curative-intent surgery at least 3 months prior to the nodal recurrence.Xx_NEWLINE_xXHave no curative therapy available.Xx_NEWLINE_xXPrior therapy with thalidomide in combination with ruxolitinibXx_NEWLINE_xXPrior anti-HER2 targeting therapyXx_NEWLINE_xXAny prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteriaXx_NEWLINE_xXExperienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy for castration-resistant diseaseXx_NEWLINE_xXRelapse or refractory disease after at least 1 systemic therapyXx_NEWLINE_xXPrior therapy with ruxolitinibXx_NEWLINE_xXTestosterone or testosterone-like agents (methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, dehydroepiandrosterone, androstenedione) other androgenic compounds or anti-androgens within 30 days prior to day 1 of protocol therapyXx_NEWLINE_xXA patient with non-squamous NSCLC must have been tested for relevant EGFR mutations, ALK translocation or other genomic aberrations (e.g. ROS rearrangement, BRAF V600E mutation) for which FDA-approved targeted therapy is available and, if positive, the patient should have received such therapy prior to study entry.Xx_NEWLINE_xXA patient with a tumor with an EGFR mutation, ALK translocation, ROS rearrangement, or BRAF V600E mutation may have received appropriate inhibitors of EGFR, ALK, ROS or BRAF in addition to 3 prior lines of therapy for metastatic disease.Xx_NEWLINE_xXThe patient must have received no more than 1 prior line of therapy for extensive disease.Xx_NEWLINE_xXIf considered for combination therapy:Xx_NEWLINE_xXThe patient requires statin therapy. Patients who are taking a statin and are considered appropriate to discontinue treatment, must discontinue the statin at least 5 days prior to starting study therapy.Xx_NEWLINE_xXReceived therapy with any immunotherapeutic agents including, but not limited to, any anti-PD1 or anti-PDL1 antibody therapy, with these exceptions: Melanoma patients having received and progressed on anti-CTLA4 (cyctotoxic T lymphocyte-associated antigen 4) may participate in the trial; Bladder cancer patients having received intra-vesical BCG may participate in the trial.Xx_NEWLINE_xXAt least three prior lines of therapy for advanced ovarian cancer as defined in the protocolXx_NEWLINE_xXTreatment naive patients in first-line or pre-treated patients with no more than 2 lines of prior therapyXx_NEWLINE_xXSubject has received previous therapy for AML, with the exception of the following:Xx_NEWLINE_xXPatients must have fully recovered from the acute effects of all prior therapy and must meet the following criteria:\r\n* At least 14 days must have elapsed since the completion of myelosuppressive therapy\r\n* At least 24 hours must have elapsed since the completion of low-dose chemotherapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day)\r\n* For patients who have received prior HSCT, there can be no evidence of graft-versus-host disease (GVHD) and greater than 60 days must have elapsed since the HSCT; patients cannot be receiving therapy, including steroids, for the treatment or prevention of GVHD; all such medications must be discontinued at least 24 hours prior to enrollmentXx_NEWLINE_xXDose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapyXx_NEWLINE_xXRelapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporal photochemotherapy (ECP) will be considered a systemic therapy. Local radiation and topical agents are not systemic therapies.Xx_NEWLINE_xXPatients who have received prior therapy with a TLR agonist, excluding topical agents. Patients who have received experimental vaccines or other investigational immune therapies should be discussed with the Medical Monitor to confirm eligibility.Xx_NEWLINE_xXRelapsed or refractory disease after first or later salvage therapyXx_NEWLINE_xXPrior medication:Xx_NEWLINE_xXPrior CD19 directed therapy, including CAR+ T cell, BiTE, and antibody drug conjugate (ADC), with the exception of subjects who received KTE-C19 in this study and are eligible for re-treatmentXx_NEWLINE_xXPatients in Phase 2 expansion cohort B will have experienced disease progression with 1 or 2 prior lines of therapy, including up to 1 prior line of liver-directed therapyXx_NEWLINE_xXInclusion Criteria:\n\n        For patients participating in any part of the trial:\n\n          -  has an advanced solid tumor previously treated with, or inability to tolerate,\n             standard therapy for the disease, or for which a standard therapy does not exist, and\n             as such is considered a candidate for Phase 1 treatment\n\n          -  has adequate organ function: Hgb ?9 g/dL; absolute neutrophil count (ANC) ? 1.5x109/L;\n             plt ? 100,000/?L; AST and ALT < 2.5x ULN (< 5x ULN in patients with liver metastases);\n             total bilirubin < 2.0 mg/dL; serum creatinine ? 1.5x ULN\n\n          -  ECOG performance score 0-2\n\n        For patients participating in any expansion group:\n\n          -  has measurable disease based on RECIST 1.1 as determined by the treating investigator.\n             Tumor lesions in a previously irradiated area are considered measurable if progression\n             has been demonstrated in such lesions\n\n          -  willing to consent for biopsy is strongly recommended but not mandatory\n\n          -  recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v\n             4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant\n             and/or stable on supportive therapy.\n\n        For patients participating in specific expansion groups:\n\n        Cutaneous Melanoma:\n\n          -  unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous\n             malignant melanoma\n\n          -  relapsed or progressive disease after or unable to tolerate at least one prior\n             systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1,\n             anti-PD-L1, or anti-CTLA-4)\n\n          -  in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at\n             least one prior systemic anticancer regimen for metastic disease involving a BRAF\n             inhibitor\n\n        Uveal Melanoma:\n\n          -  uveal melanoma at metastic stage\n\n        Small Cell Lung Cancer:\n\n          -  extensive disease previously treated with, or inability to tolerate, platinum-based\n             chemotherapy\n\n        Exclusion Criteria:\n\n          -  has primary CNS malignancy\n\n          -  history of untreated brain mets or leptomeningeal disease or spinal cord compression\n\n          -  effects of prior anticancer therapy recovered to grade < 2\n\n          -  known HIV\n\n          -  active infection\n\n          -  major surgery within 2 weeks\n\n          -  history of another malignancy within 2 years priorXx_NEWLINE_xXB-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survivalXx_NEWLINE_xXNSCLC that has progressed during or following 1 - 5 prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard cancer therapy. For squamous cell carcinoma, or adenocarcinoma without known activating mutation: the prior systemic therapy is at least one platinum analogue. For adenocarcinoma with known activating driver mutation: the prior systemic therapy is at least TKI directedXx_NEWLINE_xXUrothelial cancer arising in the bladder, renal pelvis, ureter or urethra that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease (includes anti-PD-L1,anti-PD-1, but excludes other experimental therapies). Patients must have received at least one platinum-containing regimen (e.g., gemcitabine/cisplatin [GC], dose-dense methotrexate/vinblastine/doxorubicin/cisplatin [DDMVAC], or carboplatinum/gemcitabine). No more than 5 prior systemic regimens allowed.Xx_NEWLINE_xXNo more than 1 line of anthracycline-containing chemotherapy prior to ASCT, and no more than 3 lines of therapy total prior to ASCT for arms A and B; no more than 1 line of therapy prior to ASCT for arm CXx_NEWLINE_xXNo plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy [chemo], biologic, vaccine therapy or surgery) while on this protocol except at disease progressionXx_NEWLINE_xXLimited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy to the mediastinum and one dose of intrathecal chemotherapy; other circumstances must be cleared by principal investigator (PI) or co-PIXx_NEWLINE_xXParticipants with prior therapy, other than therapy including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy to the mediastinum and one dose of intrathecal chemotherapyXx_NEWLINE_xXPatients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:\r\n* After initial therapy in either first complete or partial remission or no objective response\r\n* After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial responseXx_NEWLINE_xXSubjects must have completed or had disease progression on at least one prior line of disease-appropriate therapy or not be candidates for therapy of proven efficacy for their diseaseXx_NEWLINE_xXPrior therapy with Laser-Induced Thermal Therapy (LITT) is allowed but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence.Xx_NEWLINE_xXAny non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab doseXx_NEWLINE_xXPatients who have received prior capecitabine therapy are not eligibleXx_NEWLINE_xXAnti-cluster of differentiation(CD)38 therapy, including daratumumabXx_NEWLINE_xXPrior treatment with >= 4 cycles of a hypomethylating agent (decitabine or azacitidine) without response OR documented disease progression on or after hypomethylating agent therapyXx_NEWLINE_xXPatients with chronic myeloid leukemia (CML) in chronic phase who have resistance and/or intolerance to frontline TKI therapy; resistance is defined as lack (lack defined as response not achieved or lost by the given dates mentioned hereafter) of CHR (complete hematologic response) within 3 months, lack of major cytogenetic response (MCyR) within 6 months, and lack of CCyR within 12 months of therapy with frontline TKIs; in addition, loss of MCyR, CCyR or MMR at any time during the course of therapy is also considered resistance to therapy; intolerance is defined as persistent or severe toxicity that is unacceptable to the patientXx_NEWLINE_xXOther concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational; prior therapy with bisphosphonate is allowed; prior therapy for smoldering myeloma MM may not be an exclusion criterion, discussion with principal investigator must occur before enrolling patients with prior treatments; prior radiation therapy to a solitary plasmacytoma is allowed; patients who received prior therapy due to being incorrectly diagnosed as having overt multiple myeloma may not be excluded after discussion with the overall PIXx_NEWLINE_xXHistory of severe infusion reactions to monoclonal antibody therapyXx_NEWLINE_xXReceived 1 or 2 prior lines of therapy.Xx_NEWLINE_xXPrevious therapy with bevacizumab is allowed, but patient who experienced serious dose-limiting toxicities while on prior bevacizumab therapy are excludedXx_NEWLINE_xXPatients must have primary refractory ALL based on failure to achieve a hematologic or molecular remission after induction therapy with dasatinib and steroids or dasatinib and chemotherapy, or have relapsed after treatment with a tyrosine kinase inhibitor with or without chemotherapy\r\n* Note: Prior course of dasatinib and steroid induction therapy should have included dasatinib 140mg PO daily on days 1-84 and prednisone 60mg/m^2 (capped at 120mg, or equivalent steroid dose) on days 1-28; if patients were unable to tolerate full steroid dose during induction therapy they will still be eligible\r\n* Note: Patients with refractory or relapsed disease in the central nervous system will be eligibleXx_NEWLINE_xXHas participated in a previous trial and received pembrolizumab therapyXx_NEWLINE_xXRelapsed or progressed following endocrine therapy.Xx_NEWLINE_xXSubjects who are resistant to conventional chemotherapy or have declined conventional therapy for TNBC; patients having received any prior line of systemic therapy for inoperable/recurrent or metastatic disease are eligibleXx_NEWLINE_xXHas chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHDXx_NEWLINE_xXPersistent, recurrent or progressive disease following at least one prior line of systemic therapy and there is no available therapy likely to improve survivalXx_NEWLINE_xXMore than three prior lines of cytotoxic therapy.Xx_NEWLINE_xXMust have received at least 2 prior approved therapiesXx_NEWLINE_xXMore than 1 previous systemic anti-cancer therapy lineXx_NEWLINE_xXPrior systemic therapy for WMXx_NEWLINE_xXInclusion:\n\n          1. Signed and dated written informed consent prior to any mandatory study specific\n             procedures, sampling and analyses.\n\n          2. Signed and dated written informed consent for tumour biopsies. If the tumour is found\n             not to be safely accessible the biopsy will not be taken. Accessible lesions are\n             defined as those which are biopsiable and amenable to repeat biopsy, unless clinically\n             contraindicated. In this case the patient will remain in the study and there will be\n             no penalty or loss of benefit to the patient and they will not be excluded from other\n             aspects of the study.\n\n          3. Postmenopausal women aged ? 18 years\n\n          4. Negative pregnancy test prior to dosing and willing to use a highly effective method\n             of contraception for the duration of the study and for 90 days after the last dose of\n             IP if they are under 50 unless they have medically confirmed irreversible premature\n             ovarian failure, bilateral oophorectomy, bilateral salpinectomy, or complete or\n             partial hysterectomy.\n\n             Highly effective methods of contraception are:\n\n             • Use of oral, injected or implanted hormonal methods of contraception which inhibit\n             ovulation, either estrogen and progestogen containing intravaginal, transdermal) or\n             only progesterone containing (oral, injectable, implantable)\n\n             • Placement of an intrauterine device (IUD or intrauterine system (IUS)\n\n             • True abstinence\n\n             • Bilateral tubal ligation\n\n             • Vasectomised partner\n\n          5. World Health Organisation/Eastern Cooperative Oncology Group (ECOG) performance status\n             of patient is 0-1 with no deterioration over the previous 2 weeks and minimum life\n             expectancy of 12 weeks.\n\n          6. Histologically or cytologically proven diagnosis of breast cancer with evidence of\n             locally advanced or metastatic disease, not amenable to resection or radiation therapy\n             with curative intent.\n\n          7. Documentation of estrogen receptor positive (ER+) breast cancer based on most recent\n             tumour biopsy (unless bone-only disease).\n\n          8. Documented human epidermal growth factor receptor 2 negative (HER2-) tumor on most\n             recent tumor biopsy.\n\n          9. Where regionally permitted, all patients must agree to provide if available a\n             formalin-fixed paraffin embedded (FFPE) tissue biopsy sample taken at the time of\n             presentation with recurrent or metastatic disease.\n\n         10. At least one lesion (measurable and/or non measurable) that can be accurately assessed\n             at baseline with computerised tomography (CT) or magnetic resonance imaging (MRI)\n             which is suitable for accurate repeated measurements.\n\n         11. Meet the following study part specific criteria related to previous therapy for breast\n             cancer:\n\n        For Part A: Postmenopausal patient suitable for fulvestrant. Patient is allowed to have a\n        maximum of 3 prior lines of chemotherapy. Previous treatment with CDK4/6 inhibitors is\n        allowed\n\n        For Part B: Postmenopausal patient with locally advanced or metastatic ER+ve breast cancer\n        and refractory to AIs defined as:\n\n          -  Disease recurrence while on, or within 12 months of end of adjuvant treatment with\n             letrozole, anastrozole, or exemestane, or\n\n          -  Disease progression while on, or within one month of end of letrozole, anastrozole or\n             exemestane treatment for locally advanced or metastatic breast cancer\n\n               -  Letrozole or anastrozole do not have to be the last treatment prior to\n                  randomization.\n\n               -  Patients who received one prior chemotherapy line for advanced/metastatic breast\n                  cancer are allowed.\n\n        Previous treatment with fulvestrant (or letrozole) is allowed. Other prior anticancer\n        therapy (e.g. tamoxifen) are also allowed.\n\n        For Part C: Postmenopausal patient with locally advanced or metastatic ER+ve breast cancer\n        and refractory to AIs defined as:\n\n          -  Disease recurrence while on, or within 12 months of end of adjuvant treatment with\n             letrozole, anastrozole, or exemestane, ot\n\n          -  Disease progression while on, or within one month of end of letrozole, anastrozole or\n             exemestane treatment for locally advanced or metastatic breast cancer\n\n               -  Letrozole or anastrozole do not have to be the last treatment prior to\n                  randomization.\n\n               -  Patients who received one prior chemotherapy line for advanced/metastatic breast\n                  cancer are allowed.\n\n        Previous treatment with CDK4/6 inhibitors is allowed. Other prior anticancer therapy (e.g.\n        tamoxifen) are also allowed.\n\n        For inclusion in the optional research component:\n\n          1. Genetic research: Provision of signed and dated written consent for genetic research\n             sampling and analyses. If a patient declines to participate in genetic component of\n             the study, there will be no penalty or loss of benefit to the patient. The patient\n             will not be excluded from other aspects of the study described in this Clinical Study\n             Protocol, so long as they consent to the main study.\n\n        Exclusion:\n\n          1. Prior chemotherapy, biological therapy, radiation therapy, or immunotherapy,\n             androgens, thalidomide, other anticancer agents, investigational drug or\n             corticosteroids within 14 days. Patients who received prior radiotherapy to >= 25% of\n             bone marrow are not eligible independent of when it was received. Patients is not\n             eligible if there are unresolved toxicities from prior therapy > CTCAE grade 1 at the\n             start of study treatment with the exception of alopecia.\n\n          2. Exposure to potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) or BCRP\n             within stated washout periods.\n\n          3. Exposure to sensitive or narrow therapeutic range substrates of drug transporters\n             OATP1B1, OATP1B3, MATE1 and MATE2K within wash-out period (5 x elimination half-life).\n\n        4 Exposure to proton pump inhibitors within wash-out period (5 x elimination half-life).\n\n        5. Previous AZD2014, AZD8055 or other dual mTORC1/2 inhibitor\n\n          -  In Part B only: Prior treatment with CDK4/6, or everolimus or any PI3K-mTOR pathway\n\n          -  In Part C only: Prior treatment with fulvestrant, or with everolimus, or any agent\n             whose mechanism of action is to inhibit the PI3K-mTOR pathway\n\n             6. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis,\n             or leptomeningeal disease. Patients with a history of CNS metastases or cord\n             compression are eligible if definitively treated and clinically stable and off\n             anticonvulsants and steroids for at least 4 weeks. Patients are not eligible if there\n             is spinal cord compression and/or brain metastases, unless asymptomatic or treated and\n             stable and off steroids for at least 4 weeks.\n\n             7. Evidence of severe or uncontrolled systemic diseases such as:\n\n             • Severe hepatic impairment\n\n               -  Interstitial lung disease (bilateral, diffuse, parenchymal lung disease)\n\n               -  Current unstable or uncompensated respiratory or cardiac conditions\n\n               -  Uncontrolled hypertension\n\n               -  Active bleeding diatheses\n\n               -  Any active infection\n\n                  8. Other malignancy within 3 years, except adequately treated basal cell or\n                  squamous cell skin cancer, or carcinoma in situ of the cervix\n\n                  9. Experienced any of the following currently or in the last 12 months:\n\n               -  Coronary/peripheral artery bypass graft\n\n               -  Angioplasty\n\n               -  Vascular stent\n\n               -  Myocardial infarction\n\n               -  Angina pectoris\n\n               -  Congestive heart failure NYHA Grade ? 2\n\n               -  Ventricular arrhythmias requiring continuous therapy\n\n               -  Supraventricular arrhythmias including atrial fibrillation of any grade\n\n               -  Symptomatic pulmonary embolism\n\n               -  Haemorrhagic or thrombotic stroke\n\n                  10. Abnormal ECHO or MUGA at baseline (LVEF <50%).\n\n                  11. Mean resting QTc >470 msec, family or personal history of long or short QT\n                  syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de\n                  Pointes within 12 months.\n\n                  12. Clinically important abnormalities in rhythm, conduction or morphology of\n                  resting ECG.\n\n                  13. Hepatitis B (HBV), Hepatitis C (HCV) or Human Immunodeficiency virus (HIV).\n\n                  14. Concomitant medications known to predispose to Torsade de Pointes, or factors\n                  that increase the risk of QT prolongation or risk of arrhythmic events such as:\n\n               -  Heart failure\n\n               -  Hypokalaemia\n\n               -  Congenital long QT syndrome\n\n               -  Family history of long QT syndrome\n\n               -  Family history of unexplained sudden death under 40 years-of-age\n\n                  15. Inadequate bone marrow reserve or organ function as demonstrated by:\n\n               -  ANC <1.5 x 10^9/L.\n\n               -  In Part A only - Cohorts of patients with specific baseline ANC range to be\n                  enrolled defined as follows: I) Low ANC patients: between 1.5 x 10^9/L and 3.0 x\n                  10^9/L; ii) High ANC patients > 3.0 x 10^9/L.\n\n               -  Platelets <100 x 10^9/L\n\n               -  Haemoglobin <90 g/L\n\n               -  ALT >2.5 x ULN or > 5 x ULN in the presence of liver mets.\n\n               -  AST >2.5 x ULN or > 5 x ULN in the presence of liver mets.\n\n               -  Total bilirubin >1.5 x ULN. Total bilirubin >3 x ULN in patients with documented\n                  Gilbert's Syndrome.\n\n               -  Serum creatinine >1.5 x ULN concurrent with creatinine clearance ?50 mL/min.\n\n                  16. Pre-existing renal disease including glomerulonephritis, nephritic syndrome,\n                  Fanconi Syndrome or Renal tubular acidosis.\n\n                  17. Refractory nausea/vomiting, chronic GI diseases, inability to swallow the\n                  product or previous significant bowel resection.\n\n                  18. Hypersensitivity to excipients of AZD2014, Palbociclib or Fulvestrant or\n                  drugs with a similar structure.\n\n                  19. Diabetes Type I or uncontrolled Type II, as defined in WHO 2006 (fasting\n                  serum glucose of > 7.0 mmol/L [126 mg/dL]).\n\n                  20. Patient with advanced/metastatic, symptomatic, visceral spread, that are at\n                  risk of life-threatening complications in the short term including patients with\n                  massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary\n                  lymphangitis, and over 50% of liver involvement in metastases.\n\n                  21. Prior hematopoietic stem cell or bone marrow transplant.\n\n                  22. Regular coumadin therapy. Low-molecular-weight heparin therapy or oral Factor\n                  Xa antagonists are allowed.\n\n                  23. Known abnormalities in coagulation, e.g. bleeding diathesis.\n\n                  24. Hematopoietic growth factors (such as erythropoietin, granulocyte colony\n                  stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor\n                  [GM-CSF]) within 2 weeks prior. Primary prophylactic use of G-CSF is not\n                  permitted.\n\n                  25. Other severe acute or chronic psychiatric condition that may increase the\n                  risks associated with study participation.Xx_NEWLINE_xXPatients with MDS (up to 20% blasts) of any risk; patients with lower risk MDS (low and intermediate [int]-1 by International Prognostic Scoring System [IPSS]) could have received prior non-hypomethylating agent therapy (i.e. growth factors or lenalidomide); patients with higher risk MDS (int-2 or high by IPSS) should not have received prior therapy with a hypomethylating agentXx_NEWLINE_xXCurrent therapy with other systemic anti-neoplastic or anti-neoplastic investigational agentsXx_NEWLINE_xXPrior exposure to immune-mediated therapyXx_NEWLINE_xXCompleted any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)Xx_NEWLINE_xXPrior or concurrent therapy with somatostatin analogs is permitted for patients with secretory NETXx_NEWLINE_xXHas histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapyXx_NEWLINE_xXHas histopathologically or cytologically confirmed HCC, Child-Pugh Class A, with documented disease progression during or after discontinuation of sorafenib therapy, or intolerance of sorafenib therapy, and an ?-fetoprotein (AFP) ? 1.5x upper limit of normalXx_NEWLINE_xXHave received previous systemic therapy with ramucirumabXx_NEWLINE_xXAny number of prior therapies other than oxaliplatin is allowedXx_NEWLINE_xXNo prior therapy with the exception of prior radiation therapy and/or prednisone alone, at the discretion of the investigator based on current diagnosis and clinical condition; this prednisone treatment will not count toward the 6 cycles of treatment given in the studyXx_NEWLINE_xXPatients on immunosuppressive therapy including:Xx_NEWLINE_xXTarget lesion previously embolized, perfused, or irradiated without objective evidence of progression before start of therapy to be considered for response assessmentXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXSubject received prior systemic treatment for HCC with sorafenib or other anti-VEGF therapy and had confirmed disease progression or discontinued treatment due to a drug-related toxicity. Subject may have received 1 line of systemic therapy before or after sorafenib/anti-VEGF treatment.Xx_NEWLINE_xXFor all other malignancies, the subject is eligible if he/she has undergone potentially curative therapy and has been considered disease free for at least 3 years prior to Screening.Xx_NEWLINE_xXSubject had previous local therapy (e.g., surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 14 days prior to Day 1, has not recovered from toxicities from prior local therapy or may require major surgical procedure during the course of the study.Xx_NEWLINE_xXPatients must have failed at least one prior line of systemic immune suppressive therapy for management of chronic GVHDXx_NEWLINE_xXPrior systemic therapy directed at advanced RCC.Xx_NEWLINE_xXPrior therapy with axitinib as well as any prior therapies with other VEGF pathway inhibitors.Xx_NEWLINE_xXFailure of at least one prior line of systemic immune suppressive therapy for management of chronic GVHDXx_NEWLINE_xXMajor inclusion criteria:\n\n          1. A histologically or cytologically confirmed solid tumor that is locally advanced,\n             recurrent, or metastatic; for which curative resection is not currently possible; and\n             for which systemic treatment with one of the selected anti-cancer agents is a\n             reasonable therapeutic option.\n\n          2. Must be ? 18 years of age\n\n          3. Has disease such that progression or response to therapy can be evaluated objectively\n             while on protocol.\n\n          4. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          5. Male or female patients of childbearing potential must agree to use contraception or\n             avoidance of pregnancy measures during the study and for 30 days after the last dose.\n\n          6. Females of childbearing potential must have a negative serum pregnancy test.\n\n          7. Must have aspartate transaminase (AST) ? 2.5 × upper limit of normal (ULN) and alanine\n             transaminase (ALT) ? 2.5 × ULN. Patients who do not have hepatocellular carcinoma but\n             who have liver lesions or liver metastases may be eligible if AST ? 3.5 × ULN and AST\n             ? 3.5 × ULN if agreed upon by the investigator and medical monitor for the sponsor.\n\n          8. Hemoglobin (Hgb) ? 9 g/dl\n\n          9. Total bilirubin ? 1.5 × ULN. For patients with liver lesions, total bilirubin ? 2.0 ×\n             ULN may be enrolled if agreed upon by the investigator and medical monitor for the\n             sponsor\n\n         10. Creatinine ? 1.5 × ULN or creatinine clearance ? 60 mL/min/1.73 m^2 for patients with\n             creatinine levels above institutional upper limit of normal (using the Cockcroft-Gault\n             equation).\n\n         11. Absolute neutrophil count ? 1.5 × 10^9/L\n\n         12. Platelets ? 100 × 10^9/L\n\n         13. Life expectancy ? 3 months\n\n        Major exclusion criteria:\n\n          1. Received anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational\n             agents within 7 days of first dose of protocol therapy. Patients may begin protocol\n             therapy on a date determined by the investigator and medical monitor for the sponsor\n             after a minimum of 7 days since last receiving anti-cancer treatment, provided that\n             all adverse events related to that have resolved or have been deemed irreversible.\n\n          2. Major surgery within 4 weeks prior to first dose; major surgery is defined as a\n             procedure requiring any of the following: general anesthesia, intubation and\n             mechanical ventilation, or major incision (e.g., thoracotomy, laparotomy)\n\n          3. Any known, untreated, brain metastases. Patients with treated brain metastases must\n             have no clinical symptoms from the metastases, and must be either off steroids or on a\n             stable dose of steroids ? 10 mg prednisone or equivalent for at least 2 weeks prior to\n             protocol enrollment. Patients with known leptomeningeal metastases are excluded, even\n             if treated.\n\n          4. Pregnant or breastfeeding or expecting to conceive or father children within the\n             projected duration of the study.\n\n          5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n             Investigator, such as active inflammatory bowel disease, extensive gastric or small\n             intestinal resection (which has resulted in short-gut syndrome or the inability to\n             take oral medications).\n\n          6. Unable or unwilling to swallow either BBI503 daily or an oral selected anti-cancer\n             therapeutics; or, unwilling to receive intravenous injection of IV anti-cancer\n             therapeutics.\n\n          7. Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B Surface\n             Antigen [HBsAg] reactive), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid\n             (HCV RNA] (qualitative) is detected).\n\n          8. Uncontrolled concurrent illness including, but not limited to: ongoing or active\n             infection requiring therapy, clinically significant non-healing or healing wounds,\n             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,\n             significant pulmonary disease (shortness of breath at rest or on mild exertion),\n             uncontrolled infection or psychiatric illness/social situations that would limit\n             compliance with study requirements\n\n          9. Subjects with a history of another primary cancer with the exception of: a) curatively\n             resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ;\n             c) localized prostate cancer not requiring systematic therapy; and d) other primary\n             cancer with no known active disease present, and no treatment administered in the 2\n             years prior to enrollment.\n\n         10. For patients to be treated with a regimen containing capecitabine: a) Known\n             hypersensitivity to capecitabine, b) Known dihydropyrimidine dehydrogenase (DPD)\n             deficiency, c) Significant gastrointestinal disorder(s) that would, in the opinion of\n             the Investigator, prevent absorption of an orally available agent\n\n         11. For patients to be treated with a regimen containing sunitinib: a) Uncontrolled\n             hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg\n             despite optimal medical management), b) Evidence of bleeding diathesis or a clinically\n             significant coagulopathy (? CTCAE Grade 3) within 4 weeks prior to the start of study,\n             c) Recent hypoglycemia, d) Uncontrolled thyroid dysfunction despite optimal medical\n             therapy\n\n         12. For patients to be treated with a regimen containing doxorubicin: a) Known left\n             ventricular ejection fraction < 50%, b) Hypersensitivity to doxorubicin\n\n         13. A patient to be treated with a regimen containing nivolumab or pembrolizumab will be\n             excluded if the patient: a) Has an active autoimmune disease requiring\n             immunosuppression with the exception of subjects with isolated vitiligo, resolved\n             childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism,\n             and euthyroid patients with a history of Grave's disease, b) Has had a previous\n             life-threatening (CTCAE grade 4) immune-mediated adverse reaction; or, a previous\n             severe (CTCAE grade 3) immune mediated adverse reaction that required treatment with\n             corticosteroids (more than 10 mg/day prednisone or equivalent dose) for longer than 12\n             weeks, c) Has a transplanted organ, d) Has interstitial lung disease or active,\n             non-infectious pneumonitis, e) Has received a live vaccine within 30 days prior to\n             first dose, f) Previous severe hypersensitivity reaction to another monoclonal\n             antibody (mAb), g) Has been treated with another monoclonal antibody ? 4 weeks before\n             first dose.Xx_NEWLINE_xXAny hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.Xx_NEWLINE_xXChronic use of steroid therapy.Xx_NEWLINE_xXPatients who have received Gliadel wafers or alternating electrical field therapy are not eligible for this studyXx_NEWLINE_xXUnresolved toxicities from prior therapyXx_NEWLINE_xXFor stratum A, patients must not have received prior anthracycline-based therapy (prior treatment with non-anthracyclines is permitted)Xx_NEWLINE_xXFor stratum B patients must have received prior anthracycline-based therapy (or have a contraindication to receiving this treatment) and must not have received prior gemcitabine (gemcitabine hydrochloride)Xx_NEWLINE_xXFor stratum C, patients must have received prior anthracycline therapy anthracycline (or have a contraindication to anthracycline) or gemcitabine-based therapy (or have a contraindication to gemcitabine)Xx_NEWLINE_xXFor cohort 1: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least one prior systemic therapy that included rituximab (or other monoclonal CD20 antibody); patients should have rituximab-sensitive disease defined as a documented complete or partial response lasting at least 6 months after the last rituximab containing therapy or rituximab-refractory disease defined as stable or progressive disease within 6 months of the last rituximab-containing therapyXx_NEWLINE_xXFor cohort 2: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least two prior systemic therapies, one of which must include rituximab (or other monoclonal CD20 antibody) or histologic proof of DLBCL relapsing after at least two prior systemic therapies, one of which must include rituximab (or other monoclonal CD20 antibody) and are considered ineligible for high dose therapy/autologous stem cell transplantXx_NEWLINE_xXPatients must have no known curative therapy availableXx_NEWLINE_xXPrior history of any viral-based therapyXx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXPatients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (biologic/ targeted) or extended therapy administered after surgical or non-surgical assessment; if patients were treated initially with paclitaxel for their primary disease, this can have been given weekly or every 3 weeks; the most recent therapy and any therapies subsequent to initial therapy, however, cannot have contained weekly paclitaxel; if the immediate prior (most recent therapy) is the initial therapy, it may not have been with weekly paclitaxelXx_NEWLINE_xXPatients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their treatment for recurrent or persistent disease and/or as treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted) therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will NOT count as a prior regimenXx_NEWLINE_xXHave received at least one prior therapy for WMXx_NEWLINE_xXConcurrent anti-coagulation therapyXx_NEWLINE_xXRelapsed or refractory CLL patients must meet the following requirements:\r\n* Received at least 1 prior therapy\r\n* Require treatment in the opinion of the investigator\r\n* Relapsed patients must have developed progressive disease following a response to a prior therapy\r\n* Refractory patients must have failed to respond or relapsed within 6 months to the last prior therapyXx_NEWLINE_xXHistory of severe (defined as grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodiesXx_NEWLINE_xXPancreatic neuroendocrine patients must have had progression after prior therapy; patients with other foregut neuroendocrine tumors must have had progressive disease over the last 12 months, irrespective of prior therapy; patients with both functional (who may continue somatostatin analogues as required for control of related symptoms) and non-functional tumors are eligible; in patients who have previously received therapy, the number of prior lines of therapy should not be more than 2 lines of systemic therapy not including somatostatin analoguesXx_NEWLINE_xXImmunomodulatory therapy: greater than 28 days must have elapsed since last dose of an immune modulating agent, including vaccine therapyXx_NEWLINE_xXDisease progression within 60 days of discontinuation from most recent therapyXx_NEWLINE_xXDocumented response of at least partial response (PR) to 1 line of prior therapyXx_NEWLINE_xXELIGIBILITY FOR TREATMENT ON ARM 1: Patients must have received at least one line of therapy for NSCLC or mesothelioma or previously documented to have declined therapyXx_NEWLINE_xXFor patients in the sorafenib tosylate (sorafenib) cohort, no prior therapy with sorafenib is allowed and at least 1 line of prior therapy is required including prior: VEGF-targeting therapy (such as sunitinib, axitinib, tivozanib, bevacizumab), mTOR-targeting therapy (such as everolimus, temsirolimus), immunotherapy (such as anti-PD-1 or anti-PD-L1), cytokine therapy (such as interleukin-2, interferon-alpha [IFN-a]) or cytotoxic systemic chemotherapy allowedXx_NEWLINE_xXPatients that are considered candidates for ipilimumab therapyXx_NEWLINE_xXHas had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable).Xx_NEWLINE_xXThe patient has undergone potentially curative therapy for all prior malignancies,Xx_NEWLINE_xXThroughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);Xx_NEWLINE_xXFor patients who have received prior cryotherapy, radiofrequency ablation, radioembolization, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, at least 28 days must have elapsed since that therapy, and lesions that have not been treated with local therapy must be present and measurable.Xx_NEWLINE_xXPreviously treated with an anti-Dkk-1 therapy.Xx_NEWLINE_xXSubject agrees to refrain from blood donations during therapy on study and for 8 weeks after therapy is completedXx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXPatients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.Xx_NEWLINE_xXPrior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.Xx_NEWLINE_xXSymptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization; note: patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)Xx_NEWLINE_xXCandidate for intralesional therapyXx_NEWLINE_xXVisible uptake in at least one lesion on bone scanning prior to radium therapyXx_NEWLINE_xXPatients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.Xx_NEWLINE_xXDisease suitable for local therapy administered with curative intentXx_NEWLINE_xXPatients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollmentXx_NEWLINE_xXMust have progressed on, been intolerant to, or refused gemcitabine-based therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic\n        leukemia) according to WHO classification.\n\n        Performance status (ECOG) of 0-3. Adults with previously untreated AML except for\n        hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for\n        myelodysplastic syndrome (MDS) is allowed.\n\n        Not considered candidates for intensive remission induction chemotherapy at time of\n        enrollment based on EITHER:\n\n          1. ?75 years of age OR\n\n          2. <75 years of age with at least 1 of the following:\n\n        i. Poor performance status (ECOG) score of 2-3.\n\n        ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:\n\n          1. Left ventricular ejection fraction (LVEF) ?50%.\n\n          2. Lung diffusing capacity for carbon monoxide (DLCO) ?65% of expected.\n\n          3. Forced expiratory volume in 1 second (FEV1) ?65% of expected.\n\n          4. Chronic stable angina or congestive heart failure controlled with medication.\n\n        iii. Liver transaminases >3 × upper limit of normal (ULN).\n\n        iv. Other contraindication(s) to anthracycline therapy (must be documented).\n\n        v. Other comorbidity the investigator judges incompatible with intensive remission\n        induction chemotherapy, which must be documented and approved by the study medical monitor\n        before randomization.\n\n        Creatinine clearance as estimated by the Cockroft-Gault (C-G) or other medically acceptable\n        formulas ?30 mL/min.\n\n        Exclusion Criteria:\n\n        Candidate for intensive remission induction chemotherapy at the time of enrollment.\n\n        Candidate for best supportive care only, ie, not a candidate for any active therapy with\n        the TC comparators.\n\n        Known extramedullary central nervous system (CNS) AML.\n\n        Second malignancy currently requiring active therapy except breast or prostate cancer\n        stable on or responding to endocrine therapy.\n\n        Prior treatment with decitabine or azacitidine.\n\n        Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.\n\n        Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C\n        virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on\n        antivirals is allowed.\n\n        Known significant mental illness or other condition such as active alcohol or other\n        substance abuse or addiction that, in the opinion of the investigator, predisposes the\n        subject to high risk of noncompliance with the protocol.\n\n        Refractory congestive heart failure unresponsive to medical treatment; active infection\n        resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute\n        (LPM) oxygen.Xx_NEWLINE_xXPatients may have received but may not have progressed on prior anti-angiogenic therapy in the upfront settingXx_NEWLINE_xXDisease progression following therapy with erlotinib, afatinib, or gefitinibXx_NEWLINE_xXPrevious systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment and adverse effects must have resolved to =< grade 1 or baseline; in the phase IIa portion, in progressing subjects, a 2 week washout may be allowed after discussion with the Memorial Sloan-Kettering (MSK) principal investigatorXx_NEWLINE_xXPrior therapy with romidepsin if discontinued due to toxicityXx_NEWLINE_xXPrior therapy with carfilzomib if discontinued due to toxicityXx_NEWLINE_xXIneligible for cisplatin therapyXx_NEWLINE_xXDisease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXRelapsed refractory disease after at least 1 but not more than 4 lines of previous systemic therapyXx_NEWLINE_xXNo prior exposure to immune-mediated therapy;Xx_NEWLINE_xXPatients must have a histologically confirmed solid tumor malignancy at either original diagnosis or relapse for which no curative therapy exists, and which has either recurred or progressed after at least one prior systemic therapy; patients with primary brain tumors, or those with brain metastases at time of potential enrollment, are excluded; additionally, patients with gastrointestinal stomal tumors (GIST), alveolar soft part sarcoma, or dermatofibrosarcoma protuberans are excludedXx_NEWLINE_xXAt least one prior systemic therapy regimen for R/M HPV-related carcinomaXx_NEWLINE_xXAll patients need to have received at least one prior CNS directed therapy; there is no restriction on the number of recurrencesXx_NEWLINE_xXPatients with SCNSL actively receiving treatment for extra-CNS disease are excluded; patient should have complete resolution of their systemic disease not requiring additional systemic therapy (e.g. maintenance rituximab or Decadron)Xx_NEWLINE_xXConcurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)Xx_NEWLINE_xXPrevious failure of at least one fluoropyrimidine- and irinotecan-containing chemotherapy regimen for metastatic disease; Note: previous failure is defined as disease progression while receiving treatment or within 6 weeks after the last dose of irinotecan; failure for this assessment is defined as any enlargement of measurable or assessable lesion(s) or the development of any new lesion; a rising tumor marker alone is not sufficient to define failure; patients can have received irinotecan in any previous line of therapyXx_NEWLINE_xXFor Phase I part: o Patients who have not previously received at least one line of therapy for ALK-positive NSCLCXx_NEWLINE_xXPrior systemic chemotherapy allowed; it is anticipated and suggested that most patients enrolled on study will have received a minimum of approximately 2 months of systemic therapy according to routine institutional practices; the patient must also be felt by the treating medical oncologist and radiation oncologist to be a candidate for treatment with gemcitabine/nab-paclitaxel chemoradiotherapyXx_NEWLINE_xXAdditionally, patients will be required to meet the following criteria \r\n* Karnofsky performance status (KPS) >= 70\r\n* Prostate volume =< 60 cc (cytoreductive androgen deprivation therapy prior to brachytherapy of =< 6 months duration will be allowed to achieve this goal); for patients with a prostate volume between 50-60 ccs, hormone therapy will be at the discretion of the physician\r\n* International Prostate Symptom Score =< 15Xx_NEWLINE_xXReceiving hormone replacement therapy, tamoxifen, or raloxifene within 6 months of trial entry; patients on non-systemic hormone replacement therapy are eligibleXx_NEWLINE_xXPatient has been on TKI therapy for at least 3 yearsXx_NEWLINE_xXPatient has been compliant with therapy per treating physicianXx_NEWLINE_xXPatients who have been resistant to previous TKI therapy are not eligibleXx_NEWLINE_xXPatients must have previously treated relapsed and/or refractory MCL with at least 2 prior lines of therapy (prior carfilzomib, ibrutinib, bortezomib, anthracycline, rituximab or stem cell transplant are acceptable); there is no upper limit for prior lines of therapyXx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, ARN-509 and others), cytochrome P450, family 17 (CYP17) inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens, luteinizing hormone-releasing hormone (LHRH) agonist/antagonists; topical ketoconazole and other topical antifungal agents are allowed; prior therapy with 5alpha-reductase inhibitors is allowed; LHRH therapy allowed if begun within 4 weeks of day 1\r\n* Prior androgens are allowed if the patient had a testosterone within the normal range prior to starting androgens and the androgens have been stopped for at least 7 daysXx_NEWLINE_xXPrior therapy with all choices of active comparatorXx_NEWLINE_xXDisease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXNot recovered from AEs due to a previously administered therapyXx_NEWLINE_xX=< 3 prior chemotherapies in the metastatic setting; prior anthracycline, taxane, gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, TDM-1, etc.) are allowed; if patients received prior gemcitabine, it could not have been combined with pertuzumab; patients should have progression of disease on current therapyXx_NEWLINE_xXDisease is suitable for local therapy administered with curative intentXx_NEWLINE_xXInclusion Criteria: 1.Age ? 18 years the time of signing the Informed Consent Form (ICF).\n\n        2. Understand and voluntarily provide written informed consent prior to the conduct of any\n        study related assessments/procedures.\n\n        3. Able to adhere to the study visit schedule and other protocol requirements. 4.\n        Histologically or cytologically confirmed advanced NSCLC who will receive study therapy as\n        second- or third-line of treatment for advanced disease.\n\n        5. No other current active malignancy requiring anticancer therapy. 6. Radiographically\n        documented measurable disease (defined by the presence of ? 1 radiographically documented\n        measurable lesion).\n\n        7. One prior platinum-containing chemotherapy for metastatic or recurrent NSCLC unless\n        patients are ineligible to receive it. Patients may have received no more than one line of\n        chemotherapy; immunotherapy in prior line of treatment (first or second line) is allowed.\n        Absolute neutrophil count (ANC) ? 1500 cells/mm3.\n\n        8. Platelets ? 100,000 cells/mm3. 9. Hemoglobin (Hgb) ? 9 g/dL. 10. Aspartate transaminase\n        (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT/serum\n        glutamic pyruvic transaminase [SGPT]) ? 2.5 × upper limit of normal range (ULN) or ? 5.0 ×\n        ULN if liver metastases.\n\n        11. Total bilirubin ? 1.5 ULN (unless there is a known history of Gilberts Syndrome).\n\n        12. Serum creatinine ? 1.5 x ULN, or calculated creatinine clearance ? 60 mL/min (if renal\n        impairment is suspected 24-hour urine collection for measurement is required).\n\n        13. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 14. Eastern\n        Cooperative Oncology Group (ECOG) performance status 0 or 1. 15. Females of childbearing\n        potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the\n        surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both\n        ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months\n        (ie, has had menses at any time during the preceding 24 consecutive months)] must:\n\n          1. Have a negative pregnancy test (ß-hCG) as verified by the study doctor within 72 hours\n             prior to starting study therapy. She must agree to ongoing pregnancy testing during\n             the course of the study, and after end of study therapy. This applies even if the\n             subject practices true abstinence* from heterosexual contact.\n\n          2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on\n             a monthly basis) or agree to use, and be able to comply with, effective contraception\n             without interruption, 28 days prior to starting investigational product (IP), during\n             the study therapy (including dose interruptions), and for 3 months after\n             discontinuation of study therapy.\n\n        Male subjects must:\n\n          1. Practice true abstinence* or agree to use a condom during sexual contact with a\n             pregnant female or a female of childbearing potential while participating in the\n             study, during dose interruptions and for at least 6 months following IP\n             discontinuation, even if he has undergone a successful vasectomy.\n\n          2. Refrain from semen or sperm donation while taking durvalumab and for at least 3 months\n             after the last dose of durvalumab.\n\n             16. Females must abstain from breastfeeding during study participation and 3 months\n             after IP discontinuation.\n\n             Exclusion Criteria:\n\n               -  The presence of any of the following will exclude a subject from enrollment:\n\n                    1. Refractory to prior taxane therapy for advanced disease. Prior taxane used\n                       in the adjuvant setting does not exclude eligibility, provided there is no\n                       disease recurrence within 12 months upon completion of chemotherapy in that\n                       setting.\n\n                    2. Evidence of active brain metastases, including leptomeningeal involvement\n                       (prior evidence of brain metastasis are permitted only if asymptomatic and\n                       clinically stable for at least 8 weeks following completion of therapy). MRI\n                       of the brain (or CT scan w/contrast) is preferred.\n\n                    3. Only evidence of disease is non-measurable at study entry.\n\n                    4. Known activating EGFR mutations (such as exon 19 deletions or L858R).\n\n                    5. Known activating EML4-ALK mutations.\n\n                    6. Preexisting peripheral neuropathy of Grade > 2 (per NCI CTCAE v4.0).\n\n                    7. Any unresolved toxicity NCI CTCAE Grade ? 2 from previous anticancer therapy\n                       with the exception of alopecia, vitiligo, and the laboratory values defined\n                       in the inclusion criteria.\n\n                    8. Venous thromboembolism within 1 month prior to Cycle 1 Day 1.\n\n                    9. Current congestive heart failure (New York Heart Association Class II-IV).\n\n                   10. History of the following within 6 months prior to Cycle 1 Day 1: a\n                       myocardial infarction, severe/unstable angina pectoris, coronary/peripheral\n                       artery bypass graft, New York Heart Association (NYHA) Class III-IV heart\n                       failure, uncontrolled hypertension, clinically significant cardiac\n                       dysrhythmia or clinically significant electrocardiogram (ECG) abnormality,\n                       cerebrovascular accident, transient ischemic attack, or seizure disorder.\n\n                   11. Known hepatitis B or C virus (HBV/HCV) infection, known history of human\n                       immunodeficiency virus (HIV) infection, or receiving immunosuppressive or\n                       myelosuppressive medications that would in the opinion of the investigator,\n                       increase the risk of serious neutropenic complications, history of active\n                       primary immunodeficiency, active tuberculosis (clinical evaluation that\n                       includes clinical history, physical examination and radiographic findings,\n                       and TB testing in line with local practice).\n\n                   12. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring\n                       systemic therapy, defined as ongoing signs/symptoms related to the infection\n                       without improvement despite appropriate antibiotics, antiviral therapy,\n                       and/or other treatment.\n\n                   13. History of interstitial lung disease, history of slowly progressive dyspnea\n                       and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary\n                       fibrosis, or pulmonary hypersensitivity pneumonitis or multiple allergies.\n                       Any lung disease that may interfere with the detection or management of\n                       suspected drug-related pulmonary toxicity.\n\n                   14. Subject has a clinically significant malabsorption syndrome, persistent\n                       diarrhea, or known sub-acute bowel obstruction > NCI CTCAE Grade 2, despite\n                       medical management.\n\n                   15. Treatment with any chemotherapy, investigational product, biologic or\n                       hormonal therapy for cancer treatment within 28 days prior to signing the\n                       ICF. Concurrent use of hormonal therapy for non-cancer-related conditions\n                       (e.g. hormone replacement therapy) is acceptable.\n\n                   16. History of or suspected allergy to any IP or their excipients.\n\n                   17. Major surgical procedure (as defined by the Investigator) within 28 days\n                       prior to the first dose of IP. Note: Local surgery of isolated lesions for\n                       palliative intent is acceptable.\n\n                   18. Currently enrolled in any other clinical protocol or investigational trial\n                       that involves administration of experimental therapy and/or therapeutic\n                       devices.\n\n                   19. Any other clinically significant medical condition, psychiatric illness,\n                       and/or organ dysfunction that will interfere with the administration of the\n                       therapy according to this protocol or which, in the views of investigator,\n                       preclude combination chemotherapy.\n\n                   20. Any other malignancy within 5 years prior to randomization/treatment\n                       assignement, or advanced malignant hepatic tumors, with the exception of\n                       adequately treated squamous cell carcinoma of the skin, in-situ carcinoma of\n                       the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the\n                       breast, or incidental histological finding of prostate cancer (TNM\n                       Classification of Malignant Tumours (TNM) stage of T1a or T1b). (All\n                       treatment of which should have been completed 6 months prior to signing\n                       ICF).\n\n                   21. Radiotherapy ? 4 weeks or limited field radiation for palliation ? 2 weeks\n                       prior to starting IP, and/or from whom ? 30% of the bone marrow was\n                       irradiated. Prior radiation therapy to a target lesion is permitted only if\n                       there has been clear progression of the lesion since radiation was\n                       completed.\n\n                   22. Any condition including the presence of laboratory abnormalities, which\n                       places the subject at unacceptable risk if he/she were to participate in the\n                       study.\n\n                   23. Any medical condition that confounds the ability to interpret data from the\n                       study.\n\n                   24. Female patients who are pregnant or breastfeeding or female patients of\n                       reproductive potential who are not willing to employ effective birth control\n                       from screening to 90 days after the last dose of durvalumab.\n\n                   25. Male patients of reproductive potential who are not willing to employ\n                       effective birth control from screenin to 90 days after the last dose of\n                       durvalumab and from screening to 6 months after the last dose of of\n                       nab-paclitaxel.\n\n                   26. History of allogenic organ transplantation.\n\n                   27. Active or prior documented autoimmune or inflammatory disorders (including\n                       inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis\n                       [with the exception of diverticulosis], celiac disease, irritable bowel\n                       disease, or other serious gastrointestinal chronic conditions associated\n                       with diarrhea, systemic lupus erythematosus, sarcoidosis syndrome, or\n                       Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease,\n                       rheumatoid arthritis, hypophysitis, uveitis, etc]) within the past 3 years\n                       prior to the start of treatment. The following are exceptions to this\n                       criterion:\n\n               -  Patients with vitiligo or alopecia\n\n               -  Patients with hypothyroidism (eg, following Hashimoto's syndrome) stable on\n                  hormone replacement\n\n               -  Any chronic skin condition that does not require systemic therapy\n\n               -  Patients without active disease in the last 5 years may be included but only\n                  after consultation with the study physician 28. Current or prior use of\n                  immunosuppressive medication within 14 days before the first dose of durvalumab.\n                  The following are exceptions to this criterion:\n\n               -  Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra\n                  articular injection)\n\n               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of\n                  prednisone or its equivalent\n\n               -  Steroids as premedication for hypersensitivity reactions (eg, CT scan\n                  premedication) 29. Receipt of live attenuated vaccine within 30 days prior to the\n                  first dose of IP. Note: Patients, if enrolled, should not receive live vaccine\n                  during the study and up to 30 days after the last dose of IP.\n\n                  30. Prior enrollment and treatment in a previous durvalumab clinical study. 31.\n                  Patients who have received prior anti-PD-1 or anti PD-L1:\n\n               -  Must not have experienced a toxicity that led to permanent discontinuation of\n                  prior immunotherapy.\n\n               -  All AEs while receiving prior immunotherapy must have completely resolved or\n                  resolved to baseline prior to screening for this study.\n\n               -  Must not have experienced a ? Grade 3 immune related AE or an immune related\n                  neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE:\n                  Subjects with endocrine AE of ? Grade 2 are permitted to enroll if they are\n                  stably maintained on appropriate replacement therapy and are asymptomatic.\n\n               -  Must not have required the use of additional immunosuppression other than\n                  corticosteroids for the management of an AE, not have experienced recurrence of\n                  an AE if re-challenged, and not currently require maintenance doses of > 10 mg\n                  prednisone or equivalent per day.Xx_NEWLINE_xXPatient is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXNo prior systemic therapy for RCC with the following exception:Xx_NEWLINE_xXPrior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)Xx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy\n        or relapsed after prior therapy.\n\n        FDG PET-CT (disease) positive baseline scan with measurable disease.\n\n        The patient must have received prior therapy that included:\n\n          -  CD20-targeted therapy (for example, rituximab),\n\n          -  Alkylating agent (for example, cyclophosphomide), and\n\n          -  Steroid, unless the patient is steroid intolerant\n\n        Exposure to at least 1 or 2 (but no more than 3) prior systemic cytotoxic chemotherapeutic\n        regimens.\n\n        Note: Only those subjects who are not eligible for high-dose chemotherapy and autologous\n        stem cell transplant (HD-ASCT), or who refuse HD-ASCT, are eligible with exposure to only 1\n        prior cytotoxic chemotherapeutic regimen.\n\n        ECOG performance status of 0-1.\n\n        The patient must be a stable baseline with CTCAE grade ? 2 regarding any acute or chronic\n        toxicity associated with prior therapy, and have discontinued prior anti-cancer therapy for\n        ? 14 days prior to C1D1; mitomycin-C for at least 6 weeks prior to C1D1; SCT ? 2 months\n        prior to C1D1.\n\n        Note: Palliative steroids for control of disease-related symptoms are allowed and\n        maintenance hormone therapy is allowed.\n\n        Adequate organ function including:\n\n          -  Hematologic: ANC ? 0.5 x 10^9/L. and platelets ? 50 x 10^9/L.\n\n          -  Hepatic: Total Bilirubin ? 2 x ULN (patients with Gilbert's syndrome must have total\n             bilirubin ? 3 x ULN) and serum transaminase levels ? 2.5 x ULN. In the case of known\n             liver metastasis (i.e., radiological or biopsy documented), serum transaminase levels\n             must be ? 5 x ULN.\n\n          -  Renal: Serum creatinine ? 2 x ULN, or creatinine clearance ? 60 mL/min/1.73 m2 for\n             subjects with serum creatinine levels above 2 x ULN.\n\n        Willingness to: 1.) undergo pre-treatment biopsy to obtain adequate tissue for analysis\n        (e.g., core needle, excisional or incisional tumor biopsy) or 2.) provide archived tumor\n        (e.g., FFPE block) for analysis.\n\n        Exclusion Criteria:\n\n        Eligibility for high-dose chemotherapy (HDT) and stem cell transplant (SCT). Note: Subjects\n        who progressed ? 2 months after HDT/SCT are eligible\n\n        Concurrent malignancies requiring treatment.\n\n        Primary mediastinal (thymic) large B-cell lymphoma\n\n        Symptomatic CNS or leptomeningeal involvement of lymphoma.\n\n        Concurrent clinically significant illness, medical condition, surgical history, physical\n        finding, electrocardiogram or laboratory finding that, in the opinion of the investigator,\n        could adversely affect the safety of the patient or impair the assessment of the study\n        results.\n\n        Signs or symptoms of heart failure characterized as greater than NYHA Class II or other\n        significant cardiac abnormalities.\n\n        Pregnant or breast-feeding.\n\n        Prior exposure to PNT2258.\n\n        Life expectancy less than 3 months.Xx_NEWLINE_xXSubjects who have received prior therapy with regimens containing CTLA-4, PDL-1, or PD-1 antagonists are NOT permitted to enroll unless all of the following apply:Xx_NEWLINE_xXDocumented progressive (clinical and/or objective) disease after the most recent systemic therapy regimenXx_NEWLINE_xXPrior RRx-001 therapyXx_NEWLINE_xXNo prior exposure to immune-mediated therapyXx_NEWLINE_xXAny infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registrationXx_NEWLINE_xXPHASE II: GCSF is allowed during screening and therapy for all phase II patientsXx_NEWLINE_xXUnderwent standard of care induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial.Xx_NEWLINE_xXMust have not received post-ASCT consolidation therapy.Xx_NEWLINE_xXPatients must have received at least two prior lines of therapy and also must be refractory to lenalidomide (defined as progression while on active therapy or within 60 days of discontinuation); one prior line of therapy may consist of all predetermined components of induction followed by autologous stem cell transplantation and maintenanceXx_NEWLINE_xXDisease that is refractory to the last prior rituximab-containing therapy defined as eitherXx_NEWLINE_xXRelapse after the last rituximab-containing therapy <12 months since last dose of rituximab, ORXx_NEWLINE_xXRelapse after the last rituximab-containing therapy <12 months since last dose of rituximab, ORXx_NEWLINE_xXFailure to achieve at least a MR after the last rituximab-containing therapy.Xx_NEWLINE_xXHistologically confirmed metastatic and/or unresectable GIST; patients must demonstrate prior failure to at least imatinib, sunitinib and regorafenib (4th line and beyond); any number of previous therapies for GIST is allowed; failure of imatinib is defined as either prior intolerance to imatinib therapy or prior progression of disease on imatinib in the metastatic setting or progression during adjuvant imatinib, or within 3 months of completing adjuvant imatinib; failure of sunitinib and regorafenib is defined only as prior progression of disease on sunitinib or on regorafenib as assessed by the investigatorXx_NEWLINE_xXNo more than 2 prior courses of systemic therapy for metastatic melanomaXx_NEWLINE_xXNo systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowedXx_NEWLINE_xXPatients may have received unlimited lines of prior therapyXx_NEWLINE_xXPatients who are randomized to the control arm must not receive therapy based on prior molecular profilingXx_NEWLINE_xXPrior anti-VEGF directed therapy may be allowed only if approved by the principle investigator (PI)Xx_NEWLINE_xXSubject has refractory disease or developed recurrence after therapy with a BCR PIXx_NEWLINE_xXPrior treatment with systemic therapy for advanced RCCXx_NEWLINE_xXDyspnea at rest or other diseases that require continuous oxygen therapyXx_NEWLINE_xXPatients must have received a biologic therapy (interleukin 2 or ipilimumab) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for metastatic disease; if patient did not receive such agents, rationale for not treating the patients with the agent must be cleared study principal investigator (PI) (ie no V600e/k BRAF mutation or patient with autoimmunity, thus not eligible for biologic therapy)Xx_NEWLINE_xXPrior therapy with a combination regimen containing pomalidomide except the 2 drug combination of pomalidomide and dexamethasoneXx_NEWLINE_xXAt least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLCXx_NEWLINE_xXReceived more than 3 lines of prior conventional therapy for advanced diseaseXx_NEWLINE_xXIntraocular retinoblastoma not previously treated with systemic chemotherapy, radiation therapy, or IA therapy; local retinal therapy such as laser photocoagulation and cryotherapy will be permittedXx_NEWLINE_xXFor unilateral retinoblastoma\r\n* Group A eye that has failed local therapy\r\n* Group B eye that has failed local therapy\r\n* Group C eye that has failed local therapy\r\n* Group D eye\r\n* Group E eye that is not buphthalmic, is not planned for enucleation after first cycle of chemotherapy, and is in a child less than 1 year of ageXx_NEWLINE_xXPatients who have previously been treated with chemotherapy (with the exception of local retinal therapy such as laser photocoagulation and cryotherapy) radiation therapy, or intra-arterial therapyXx_NEWLINE_xXFor patients who have received prior cryotherapy, radiofrequency ablation, Therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measurable)Xx_NEWLINE_xXOther malignancies requiring active therapy or known to be associated with altered immune responseXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXPatients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as part of their first-line hormonal therapy must have shown progression of disease off the anti-androgen prior to enrollmentXx_NEWLINE_xXAt least 4 weeks must have elapsed from the use of androgen receptor antagonists (e.g., bicalutamide, flutamide, nilutamide); 5-alpha reductase inhibitors (e.g., dutasteride, finasteride, aminoglutethimide); estrogens; ketoconazole and other anti-cancer pharmacologic therapy prior to enrollmentXx_NEWLINE_xXAt least 6 weeks must have elapsed from the use of bicalutamide if used as part of an initial combined androgen blockage therapy for more than 6 months or if used as second line hormonal therapy and associated with a PSA response of at least 3 months durationXx_NEWLINE_xXIf not receiving myelofibrosis therapy, must remain off therapy for at least 2 weeks prior to screen date and through the screening periodXx_NEWLINE_xXPrior anthracycline therapyXx_NEWLINE_xXPrimary refractory patients (never responded to any therapy) are eligibleXx_NEWLINE_xXReceived any prior ALK-targeted TKI other than crizotinib.Xx_NEWLINE_xXPatients with secondary AML or therapy related disease (t?AML) are eligible; patients who received decitabine or 5?azacytidine as prior treatment for myelodysplastic syndrome (MDS) or AML remain eligible; however, none of these agents is permitted within 6 months of study entryXx_NEWLINE_xXOngoing androgen depletion therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration); for patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trialXx_NEWLINE_xXPatients who are receiving an anti-androgen as part of their first-line hormonal therapy must have shown progression of disease off the anti-androgen prior to enrollmentXx_NEWLINE_xXAt least 4 weeks must have elapsed from the use of androgen receptor antagonists (i.e., flutamide, nilutamide, bicalutamide, enzalutamide); 5-alpha (a) reductase inhibitors (i.e., finasteride, aminoglutethimide); abiraterone acetate; estrogens; nitrosoureas, mitomycin C, isotype therapy, ketoconazole, chemotherapy and other anti-cancer pharmacologic therapy prior to beginning protocol therapyXx_NEWLINE_xXPatients must have had at least 2 prior line of therapyXx_NEWLINE_xXPatient may be enrolled at any time from last line of therapyXx_NEWLINE_xXIf a participant has received subsequent anticancer therapy (salvage therapy), the participant must have a \wash-out period\ defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the planned start date of daratumumab monotherapy. The only exception is the emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapyXx_NEWLINE_xXIDH1 gene-mutated solid tumors refractory to conventional therapy or the subject does not tolerate the conventional therapyXx_NEWLINE_xXSubjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid dosing regimen 5 days prior to the screening MRI may be permitted to enroll with Medical Monitor approval.Xx_NEWLINE_xXPatients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib; prior treatment with liver directed, ablative or surgical therapies will be permitted as long as there is documented progression justifying the need for starting sorafenib therapyXx_NEWLINE_xXHistory of hormonal therapy for endometrial carcinoma for more than 3 months;Xx_NEWLINE_xXNo more than 4 prior lines of systemic anti-cancer therapy.Xx_NEWLINE_xXPatients may either be untreated for their newly diagnosed metastatic disease (preferred as much as possible) or have started androgen deprivation therapy; patients who have started androgen deprivation therapy for the treatment of their newly diagnosed metastatic disease are eligible as long as the duration of treatment is less than or equal to 2 weeks (14 days) prior to registration; the start date of androgen deprivation is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not the date when an oral antiandrogen startedXx_NEWLINE_xXPatients who have received androgen deprivation therapy for greater than 14 days (LHRH-agonist or antagonist) for the treatment of their newly diagnosed metastatic disease prior to enrollment are not eligible for this studyXx_NEWLINE_xXPatients may have received induction therapy prior to definitive therapy for the current head and neck cancerXx_NEWLINE_xXHistologically confirmed prostate adenocarcinoma with metastasis either starting or recently started on LHRH analogue therapy; (late induction permitted within 3 months of starting LHRH analogue therapy or antiandrogen); no minimum PSA requirement for patients with measurable diseaseXx_NEWLINE_xXPrevious enzalutamide therapyXx_NEWLINE_xX>= 30 days of antiandrogen therapy monotherapy without androgen deprivation therapyXx_NEWLINE_xXAbility to tolerate FCR based therapyXx_NEWLINE_xXPatients who have not recovered from toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment; all patients must have a two week washout period from prior chemotherapyXx_NEWLINE_xXPatients must have a one week washout period from prior hormonal therapy (e.g. testosterone, estrogen, progestin, gonadotropin-releasing hormone antagonist)Xx_NEWLINE_xXOvarian cancer patients who have received prior gemcitabine therapy are ineligible; (prior carboplatin therapy is allowed)Xx_NEWLINE_xXSubjects who received combined androgen blockade with an anti-androgen must have shown PSA(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.Xx_NEWLINE_xXPHASE II: Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as antineoplastic therapyXx_NEWLINE_xXParticipants must have demonstrated ability to tolerate adjuvant endocrine therapy, either tamoxifen or aromatase inhibitor (AI), by prior successful completion of at least 1 month of endocrine therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on endocrine therapy for at least a projected 2 year continuous duration; ongoing use of any AI, including letrozole, anastrozole, or exemestane, or tamoxifen is allowed; concurrent gonadotropin-releasing hormone (GNRH) agonist is allowable as well; patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapyXx_NEWLINE_xXPatients who have received previous systemic therapies including TKI inhibitors are eligible.Xx_NEWLINE_xXPatients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participationXx_NEWLINE_xXPatients with therapy-related AML or MDS should have not received prior cumulative anthracycline (daunorubicin equivalent) lifetime dose > 450 mg/m^2Xx_NEWLINE_xXSteroids are not permitted 3 days prior to T cell infusion and concurrently during therapyXx_NEWLINE_xXAny non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab doseXx_NEWLINE_xXAt least a 4 week interval from previous prostate cancer treatment other than LHRH agonist/antagonist therapy, bisphosphonates, denosumab to the start of protocol therapyXx_NEWLINE_xXPrior therapy with AAXx_NEWLINE_xXBilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphateXx_NEWLINE_xXMultiple myeloma (MM) in first relapse or refractory to first line therapy; the previous line of therapy should include either an immunomodulatory agent or a proteasome inhibitor\r\n* Refractory disease is defined as =< 25% response or progression during therapy or within 60 days after completion\r\n* The number of prior lines of anti-myeloma therapy will be determined as follows:\r\n** Induction chemotherapy for peripheral-blood stem cell harvest followed by planned mobilization and subsequent high-dose chemotherapy with autologous stem cell transplant (ASCT) is considered one therapy regardless of the induction regimen\r\n** Planned maintenance therapy after stem cell transplantation or other induction therapy is not considered a separate line of therapy, as long as there is no evidence of progression in the time between the induction or transplantation and the initiation of maintenance therapy\r\n** Two ASCTs within 6 months of each other is considered as one line unless different agents were used in the high-dose therapy-conditioning regimens\r\n** If the same regimen is repeated after a 6-month interval, they are considered to be two separate therapeutic lines\r\n** If cyclophosphamide is used for reasons other than planned stem cell mobilization, its use is considered to be a separate line of therapy\r\n** Dose modification of steroid and altering choices of steroid (i.e. from dexamethasone to prednisone) due to side effects, is not considered a line of therapy, as long as there is no evidence of progression\r\n** If a regimen was stopped for more than 2 months, its re-initiation is counted as another line of therapyXx_NEWLINE_xXCOHORT A: Concomitant therapy with any other experimental drugXx_NEWLINE_xXCOHORT A: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on studyXx_NEWLINE_xXCOHORT B: More than 3 cycles of intermittent hormones (for the treatment of biochemical recurrence or castration sensitive metastatic disease), with a cycle defined as a period of consistent androgen deprivation therapy (generally 3-12 months) followed by intentional cessation of androgen deprivation therapy (ADT) without reinitiation of ADT until PSA risesXx_NEWLINE_xXCOHORT B: Concomitant therapy with any other experimental drugXx_NEWLINE_xXCOHORT B: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on studyXx_NEWLINE_xXPatients who have not previously been treated with HMA therapy will be excludedXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXCurrently progressing, resistance to or with a suboptimal response to their most recent therapyXx_NEWLINE_xXFor participants with the 17p deletion, previously treated with 1-3 lines of therapy, including at least one prior standard chemotherapy-containing regimen or at least one prior alemtuzumab-containing therapyXx_NEWLINE_xXDisease progression on or within 60 days of completion of the last therapyXx_NEWLINE_xXPrior exposure to oprozomibXx_NEWLINE_xXProgressive disease on androgen deprivation therapyXx_NEWLINE_xXPatients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomyXx_NEWLINE_xXHistory of prior therapy with trastuzumab and a taxane, separately or in combination. For patients in dose escalation and MTD expansion cohorts, prior therapy with trastuzumab and a taxane must have been for metastatic disease. For patients in CNS disease expansion cohorts, trastuzumab and taxane (together or separately) may have been given at any time prior to study enrollment as part of neoadjuvant therapy, adjuvant therapy, or therapy for metastatic disease.Xx_NEWLINE_xXFor subjects who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the study.Xx_NEWLINE_xXSubject must have failed at least one course of androgen deprivation therapy (ADT), i.e., treatment with GnRH analogues.Xx_NEWLINE_xXOther investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable)Xx_NEWLINE_xXDisease that has relapsed or was refractory after prior chemo-immunotherapyXx_NEWLINE_xXPrevious therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancyXx_NEWLINE_xXPatients must have relapsed or relapsed and refractory disease after receiving 2 or more lines of therapy\r\n* Relapse is the occurrence of any of the following: 1) > 25% increase in in myeloma protein (M-protein) from the baseline levels; 2) reappearance of M-protein that had disappeared; or 3) definite increase in the size and number of lytic bone lesions recognized on radiographs (compression fractures per se do not constitute a relapse)\r\n* Subjects will be considered refractory to therapy, as defined by progression during treatment or within 60 days after the completion of salvage treatment; subjects with primary refractory disease, defined as disease that is non-responsive in patients that have never achieved a minor response or better with any therapy are excluded; this includes: 1) non-responding, non-progressing; patients who never achieve minor response (MR) or better in whom there is no significant change in M protein and no evidence of clinical progression; and 2) progressive; primary refractory, progressive disease where patients meet criteria for true progressive diseaseXx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXPatients may not have received prior interferon, either systemic or intra-cysticXx_NEWLINE_xXPrevious anti-androgen therapy and progression after withdrawal; patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>= 4 weeks since last flutamide, >= 6 weeks since last bicalutamide or nilutamide)Xx_NEWLINE_xXPrevious therapy with any HER2 TKI (such as trastuzumab, lapatinib, neratinib, etc.) for any malignancy.Xx_NEWLINE_xXPrior therapy restrictions:Xx_NEWLINE_xXNHL patients must have had prior treatment with an anti-CD20 antibody therapyXx_NEWLINE_xXSubject has received previous therapy for AML, with the exception of the following:Xx_NEWLINE_xXPatients must not have previously received hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist, antiandrogen, or both), with the exception of neoadjuvant or adjuvant hormones given in conjunction with prostatectomy; in such cases, hormone therapy must have been administered for =< 6 months, discontinued >= 6 months ago, and serum testosterone must be >= 150 ng/dLXx_NEWLINE_xXPrior therapy with ruxolitinib or other JAK inhibitorsXx_NEWLINE_xXInclusion Criteria:\n\n        In advanced esophagogastric malignancies:\n\n          -  Participants with histologically confirmed recurrent or metastatic esophageal or\n             gastro-esophageal junction squamous cell or adenocarcinoma or gastric adenocarcinoma\n             with Wnt Signaling Alterations\n\n          -  Participants must be refractory or intolerant to at least one prior therapy(ies) for\n             metastatic or locally advanced disease\n\n               -  If prior therapy consisted of palliative chemoradiation therapy, it will be\n                  considered one line of therapy\n\n               -  Prior treatment with paclitaxel as part of a definitive therapy regimen is\n                  acceptable. Patients who are unable to receive paclitaxel for any reason will be\n                  allowed to receive DKN-01 as a single agent.\n\n               -  Prior treatment anti- programmed death-1 (PD-1)/ anti-PD-ligand 1 (PD-L1)\n                  monoclonal antibody (mAb) is permitted in patients provided the patient's disease\n                  is primary refractory, and the patient is not intolerant of pembrolizumab.\n                  Patients who are not eligible to receive pembrolizumab will be allowed to receive\n                  single agent DKN-01\n\n          -  Tumor tissue for mandatory evaluation\n\n          -  Must have one or more tumors measurable on radiographic imaging as defined by the\n             Response Evaluation Criteria in Solid Tumors (RECIST). Patients with evaluable but not\n             measurable disease per RECIST criteria may be enrolled with the approval of the\n             medical monitor.\n\n          -  Must be ?18 years of age\n\n          -  Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. A\n             performance status of 2 on the ECOG scale may be entered upon the review and approval\n             of the medical monitor\n\n          -  Disease-free of active second/secondary or prior malignancies for equal to or over 2\n             years with the exception of currently treated basal cell, squamous cell carcinoma of\n             the skin, or carcinoma \in-situ\ of the cervix or breast\n\n          -  Acceptable liver, renal, hematologic and coagulation function\n\n          -  For men and women of child-producing potential, the use of effective contraceptive\n             methods during the study and for 6 months following the last dose of study drug\n\n        Exclusion Criteria:\n\n          -  New York Heart Association Class III or IV, cardiac disease, myocardial infarction\n             within the past 6 months, unstable arrhythmia\n\n          -  Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 (male), or\n             history of congenital long QT syndrome.\n\n          -  Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study\n             entry requiring systemic therapy\n\n          -  Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface\n             antigen (HBSAg), or hepatitis C antibodies (HCAb) unless HCV RNA is\n             undetected/negative.\n\n          -  Serious nonmalignant disease\n\n          -  Pregnant or nursing women\n\n          -  History of osteonecrosis of the hip or have evidence of structural bone abnormalities\n             in the proximal femur on MRI scan that are symptomatic and clinically significant.\n\n          -  Systemic central nervous system (CNS) malignancy or metastasis.\n\n          -  Clinically significant peripheral neuropathy at the time of study entry. Patients with\n             pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01\n\n          -  Known osteoblastic bony metastasis\n\n          -  History of known or suspected autoimmune disease with the specific exceptions of\n             vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.\n\n          -  Clinically-significant gastrointestinal disorders, such as perforation,\n             gastrointestinal bleeding, or diverticulitis.\n\n          -  Active autoimmune disease that has required systemic treatment in past 2 years (i.e.\n             with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n             Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement\n             therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of\n             systemic treatment.\n\n          -  Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days\n             for nitrosoureas or mitomycin C)\n\n          -  Treatment with low dose chemotherapy concurrent with radiation within 14 days prior to\n             study entry\n\n          -  Treatment with radiation therapy within 14 days prior to study entry\n\n          -  Treatment with any other investigational agent within 30 days prior to study entry\n\n          -  Previously treated with an anti-DKK-1 therapy\n\n          -  Participants who have a history of hypersensitivity reactions to TAXOL® or other drugs\n             formulated in Cremophor® EL (polyoxyethylated castor oil). Patients who exhibit these\n             hypersensitivities will be eligible to receive single agent DKN-01.\n\n          -  Significant allergy to a pharmaceutical therapy that, in the opinion of the\n             investigator, poses an increased risk to the participant\n\n          -  Treatment with corticosteroids (? 10 mg per day prednisone or equivalent) or other\n             immune suppressive drugs within the 14 days prior to study entry\n\n          -  Active substance abuse\n\n          -  Receipt of any live vaccines within 30 days before the first dose of study treatment\n             and while participating in the study\n\n          -  History of (non-infectious) pneumonitis that required steroids or current pneumonitis\n\n          -  History of interstitial lung disease\n\n          -  Intolerance or severe hypersensitivity (?Grade 3) to pembrolizumab and/or of its\n             excipientsXx_NEWLINE_xXPatient is expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXPatients who have previously provided samples at any time after trastuzumab resistance will be exempt from biopsy at the start of therapyXx_NEWLINE_xXPrevious therapy with daratumumab or other anti-CD38 monoclonal antibodies.Xx_NEWLINE_xXAndrogen deprivation therapy based on clinician judgment is permitted on studyXx_NEWLINE_xXNo prior systemic therapy for HCCXx_NEWLINE_xXFor phase Ib, any line of prior treatments is permitted including prior neratinib and capecitabineXx_NEWLINE_xXFor phase II, up to 4 prior chemotherapy-based treatments are allowed; patients must have had prior trastuzumab-based therapy; prior neratinib treatment is not permitted; prior capecitabine is allowed, if not combined with neratinibXx_NEWLINE_xXMust have been previously treated with 1 line of therapy including a fluoropyrimidine plus an oxaliplatin-based regimenXx_NEWLINE_xXAny prior therapy with irinotecanXx_NEWLINE_xXSubjects in the ibrutinib + JCAR017 combination therapy cohort must be either:Xx_NEWLINE_xXIf prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.Xx_NEWLINE_xXPrior treatment with any gene therapy productXx_NEWLINE_xXNo particle therapy such as but not limited to proton therapy is allowedXx_NEWLINE_xXDisease Status and Prior Therapy:Xx_NEWLINE_xXPrior therapy with ibrutinib or venetoclaxXx_NEWLINE_xXPrior TherapyXx_NEWLINE_xXCellular Therapy: ?42 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer cells, dendritic cells, etc)Xx_NEWLINE_xXRadiopharmaceutical therapy: ?42 days after systemically administered therapy.Xx_NEWLINE_xXOne or more prior lines of cytotoxic treatment for advanced disease (prior hormonal therapy is not considered to count as prior lines of therapy)Xx_NEWLINE_xXConcurrent therapy with protocol-defined excluded medicationsXx_NEWLINE_xXThe patient has received =< 5 lines of prior therapyXx_NEWLINE_xXPrior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)Xx_NEWLINE_xXFailure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapyXx_NEWLINE_xXReceived >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.Xx_NEWLINE_xXNo prior anti-androgen therapy (bicalutamide, flutamide or nilutamide) is permittedXx_NEWLINE_xXPatients on bisphosphonates and/or endocrine therapy are eligibleXx_NEWLINE_xXPrior therapy - prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DMI) are allowed; there is no limit on the number of prior lines of therapyXx_NEWLINE_xXHistologically confirmed, previously untreated CD30+ classical HL; (participants receiving limited emergent radiation therapy [RT] or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment)Xx_NEWLINE_xXPatients may have received up to 3 prior cycles of hypomethylator therapy (i.e. decitabine or azacitidine) prior to enrollment and may have received supportive care measures (growth factors, erythropoietin stimulating agents, transfusion, etc)Xx_NEWLINE_xXPrior treatment with four or more cycles of hypomethylator therapyXx_NEWLINE_xXThe target lesion(s) has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation)Xx_NEWLINE_xXPatients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible if the previously treated lesions have progressed or recurred can be identified as target lesions; local therapy must have been completed at least 4 weeks prior to the baseline scanXx_NEWLINE_xXPrior systemic therapy for the treatment of HCC, including sorafenibXx_NEWLINE_xXPatients must have completed at least 4 cycles of hypomethylating agent therapy (e.g azacitidine or decitabine) with failure to achieve at least a partial response, or with the presence of ongoing cytopenias per IWG (platelet count < 100x10^9/L, hemoglobin <11g/L or ANC <1x10^9/L). Patients with progressive disease on HMA-therapy prior to this time point are also eligible at the time of documented progression. Therapy with decitabine analogs (i.e. SGI-110) will be considered as decitabine for the purposes of this study.Xx_NEWLINE_xXPreviously untreated AML (>= 20% blasts); patients with high-risk MDS (defined as having >= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (CMML) (having >= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (PI); prior therapy with hydroxyurea, biological or targeted therapy (e.g. fms-related tyrosine kinase 3 [FLT3] inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed; patients may have received one dose of cytarabine (up to 2 g/m^2) administered at presentation for control of hyperleukocytosis; for patients with prior MDS or CMML who transformed to AML, therapy received for MDS is not considered as prior therapy for AMLXx_NEWLINE_xXMay include prior auto-SCT but not prior allo-SCT Patients who have failed second or third line therapy and beyond, such as DPACE, and who are experiencing a partial response rather than progressive disease are also eligible.Xx_NEWLINE_xXDuring dose escalation, patients must have received at least one prior therapy, need additional cytoreduction, and meet criteria for relapsed or refractory disease; relapsed disease is defined as a patient who previously achieved a CR or a PR, but after a period of six or more months demonstrates evidence of disease progression; refractory disease is defined as progression within six months of the last anti-leukemic therapy, or any response less than a CR or PR; patients who are previously untreated, and do not wish to receive chemotherapy or immunotherapy, are eligible for the dose expansion portion of the studyXx_NEWLINE_xXPrior treatment with enzalutamide, TOK-001, or ARN-509; prior therapy with abiraterone or orteronel is permitted, but must have been stopped a minimum of two weeks prior to study entry; prior and/or concurrent treatment with bone-targeted therapy such as bisphosphonates or denosumab is permittedXx_NEWLINE_xXPatients treated with hormonal therapy are eligible for the studyXx_NEWLINE_xXPrior therapy with mTOR inhibitors, including sirolimus, temsirolimus, deforolimus within 6 months prior to enrollmentXx_NEWLINE_xXPatients must agree to continue to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analogue/antagonist or bilateral orchiectomyXx_NEWLINE_xXSymptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 weeks of irinotecan initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to day 1 [D1] of treatment under this study)Xx_NEWLINE_xXPatients must have received at least one prior line of therapy for their advanced lung cancer but there is no restrictions on the maximum number of prior therapies allowedXx_NEWLINE_xXHistory of prior paclitaxel therapyXx_NEWLINE_xXPatients must have disease that is not amenable to potentially curative resection, transplantation or ablation; for Cohorts A and D patients must have progressed on, been intolerant to, or refused prior sorafenib therapy; Cohort E patients must have received at least one line of chemotherapy for BTCXx_NEWLINE_xXPatients who have progressed on initial therapy will not be considered for re-induction treatmentXx_NEWLINE_xXRecurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.Xx_NEWLINE_xXPatients treated with interferon or other anti-HCV therapy within 3 months prior to study entryXx_NEWLINE_xXPatients may have received therapy for other malignancies, as long as they have completed therapy at least 6 months prior to study entry and be deemed to have a life expectancy of at least 2 years with regard to that malignancyXx_NEWLINE_xXPatients with any intercurrent organ damage or medical problems that would prohibit therapy are NOT eligible for participationXx_NEWLINE_xXMore than two prior regimens for therapy of MMXx_NEWLINE_xXPatients may have been treated with locoregional liver directed therapies such as embolization, chemo-embolization including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded), radiation, radioactive microspheres, etc., provided that they either have a target lesion that has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of >= 25% in the size since last treatment; such therapy must be completed at least 4 weeks prior to treatment initiation; patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapyXx_NEWLINE_xXPatients must have one of the following disease characteristics:\r\n* Therapy-related myeloid neoplasm (t-MN) age >= 18 years\r\n** Patients must have received cytotoxic chemotherapy, radiation, or a drug known to affect the properties of deoxyribonucleic acid (DNA) or cell growth, prior to current diagnosis of t-MN; this broad definition is meant to include any prior therapy with chemicals that affect DNA replication, DNA integrity, or DNA structure, or chemicals that alter cell growth; this includes traditional cytotoxic chemotherapy, newer immunologic agents that have been shown to have cytotoxic activities in addition to immunosuppressive functions, and other chemicals; note that patients with primary AML could be diagnosed with a t-MN if morphology/cytogenetic analysis clearly indicated that the second process is not a relapse of the original disease\r\n* AML arising from an antecedent hematological disorder age >= 18 years\r\n* De novo AML in patients age >= 60 years\r\n* Relapsed and/or refractory AML >= 18 yearsXx_NEWLINE_xXPrior treatment with 5-azacytidine followed immediately by HiDAC and mitoxantrone as proposed in this study (NOTE: prior therapy with 5-azacytidine or decitabine or HiDAC or mitoxantrone would be allowed-in patients with relapsed/refractory disease- unless the prior therapy was identical to the schema/schedule proposed in this study)Xx_NEWLINE_xXKnown HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapyXx_NEWLINE_xXCurrent, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.Xx_NEWLINE_xXDisease which is amenable to curative local therapyXx_NEWLINE_xXPrior systemic anti-cancer therapy, unless administered for localized SCCHN and completed at least 6 months prior to disease recurrenceXx_NEWLINE_xXPatients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinibXx_NEWLINE_xXPatients who have had any prior line of systemic therapy including cytotoxic agents or molecularly targeted agents for advanced/unresectable disease; any number of prior regional therapies with transarterial chemoembolization (TACE), brachytherapy with yttrium-90 microsphere, intra-arterial chemotherapy, surgery, or ablative therapy are allowedXx_NEWLINE_xXHad at least a partial response to prior carfilzomib therapyXx_NEWLINE_xXWas not removed from carfilzomib therapy due to toxicity, unless approved by the medical monitorXx_NEWLINE_xXWas not removed from carfilzomib therapy for progressive disease nor experienced progressive disease within 6 months after any prior carfizolmib therapyXx_NEWLINE_xXPrior oprozomib exposureXx_NEWLINE_xXPatients may have been treated with up to 4 months of androgen deprivation therapyXx_NEWLINE_xXPatients who have received prior local therapy, including but not limited to embolization, chemoembolization, radiofrequency ablation, radiation therapy, are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of >= 20% in the size; prior local therapy must be completed at least 4 weeks prior to the baseline scanXx_NEWLINE_xXHaving received systemic immune suppressive therapy within 30 days prior to leukapheresisXx_NEWLINE_xXPatient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapyXx_NEWLINE_xXPatients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g. Saw Palmetto, PC-SPES), or agents such as abiraterone, TAK700, MDV3100 as well as any systemic corticosteroid use, must discontinue the agent for at least four weeks prior to study treatment. Progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist).Xx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201Xx_NEWLINE_xXPrior systemic fluoropyrimidine therapy; prior topical fluoropyrimidine use is allowed; prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency (DPD) deficiencyXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXFor 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease (for 1st line patients biopsy will be at time of diagnosis of advanced disease).Xx_NEWLINE_xXDiagnosis of multiple myeloma previously treated with at least 1 prior line of therapy (dose escalation only) or (safety expansion only) received treatment with a proteasome inhibitor or an IMiD(r) or immunomodulatory agent (e.g., thalidomide, lenalidomide). Induction therapy and following stem cell transplant are considered a single line of therapy.Xx_NEWLINE_xXPrior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6 months prior to randomizationXx_NEWLINE_xXNo prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapseXx_NEWLINE_xXConcurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)Xx_NEWLINE_xXPrior therapy\r\n* Patients with prior exposure to brentuximab vedotin are not eligible; NOTE: prior exposure to gemcitabine is NOT an exclusion criterion\r\n* Patients who have undergone prior autologous or allogeneic SCT are not eligible\r\n* Patients with HL who were stage IA or IIA at initial diagnosis and treated with either radiation alone or < 4 cycles of chemotherapy are not eligibleXx_NEWLINE_xXNo prior systemic regimens for HCCXx_NEWLINE_xXPatients with a prior history of liver directed therapy for their HCC (chemoembolization, radioembolization, bland embolization, radiation therapy, radiofrequency ablation, microwave ablation) can participate in the study if the liver-directed therapy was performed more than 4 weeks prior to their first dose of sorafenib and measurable lesions present outside of previously treated fieldXx_NEWLINE_xXHypercalcemia >2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin and/or bisphosphate therapy).Xx_NEWLINE_xXPermanent discontinuation of prior sorafenib therapy due to sorafenib related toxicity.Xx_NEWLINE_xXEvidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgeryXx_NEWLINE_xXProgressive disease during preoperative systemic therapyXx_NEWLINE_xXConcomitant therapy that precludes enrollment, as defined in the protocolXx_NEWLINE_xXRelapse or progression after at least 1 systemic therapyXx_NEWLINE_xXPrior therapy with romidepsin if discontinued due to toxicityXx_NEWLINE_xXMore than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex)\r\n* Note: patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocolXx_NEWLINE_xXFailure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapyXx_NEWLINE_xXReceived >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.Xx_NEWLINE_xXInclusion criteria:\n\n        Male or female patients age 18 years or older. Diagnosis of multiple myeloma and\n        documentation of at least 2 prior therapies (induction therapy, autologous stem cell\n        transplant, consolidation and maintenance therapy is considered one prior therapy); there\n        is no maximum number of prior regimens and prior bone marrow transplant is acceptable.\n\n        Confirmed evidence of disease progression from immediately prior MM therapy or refractory\n        to the immediately prior therapy.\n\n        Patients may have received prior immunomodulatory drugs (IMiDs®) (eg, lenalidomide or\n        thalidomide).\n\n        Patients with measurable disease. Patients with a Karnofsky ?60% performance status.\n        Females of childbearing potential (FCBP). Voluntary written informed consent before\n        performance of any study-related procedure not part of routine medical care with the\n        understanding that consent may be withdrawn by the subject at any time without prejudice to\n        future medical care.\n\n        Ability to understand the purpose and risks of the study and provide signed and dated\n        informed consent and authorization to use protected health information (in accordance with\n        national and local subject privacy regulations).\n\n        Able to take aspirin daily as prophylactic anti-coagulation therapy (patients intolerant to\n        aspirin may use warfarin, low molecular weight heparin or equivalent anti-platelet\n        therapy).\n\n        Adequate organ function.\n\n        Exclusion criteria:\n\n        Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the\n        exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the\n        skin, an in situ malignancy, or low risk prostate cancer after curative therapy.\n\n        Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy)\n        within 21 days except for alkylating agents (eg, melphalan) where 28 days will be required\n        or participated in another clinical trial during the past 30 days.\n\n        History of significant cardiovascular disease within the past 6 months, unless the disease\n        is well-controlled.\n\n        Prior autologous stem cell transplant within 12 weeks of the first dose of study treatment\n        and/or prior allogeneic transplant within 1 year or has evidence of active\n        graft-versus-host disease (GVHD) requiring >10 mg prednisone daily.\n\n        Daily requirement for corticosteroids (>10 mg prednisone qd for 7 consecutive days) (except\n        for inhalation corticosteroids and patients being treated for adrenal\n        insufficiency/replacement therapy).\n\n        Evidence of mucosal or internal bleeding. Prior radiation therapy or major surgical\n        procedure within 4 weeks of the first dose of study treatment.\n\n        Known active infection requiring parenteral or oral anti-infective treatment. Serious\n        psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse\n        follow-up evaluation.\n\n        Any medical conditions that, in the Investigator's opinion, would impose excessive risk to\n        the patient.\n\n        Hypersensitivity to any of the components of study therapy that is not amenable to\n        premedication with steroids and H2 blockers.\n\n        Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.\n\n        Neuropathy ? Grade 3 or painful neuropathy ? Grade 2. Gastro-intestinal abnormalities,\n        including bowel obstruction, inability to take oral medication, requirement for intravenous\n        (IV) alimentation, active peptic ulcer or prior surgical procedures or bowel resection\n        affecting absorption.\n\n        Pregnancy.\n\n        The above information is not intended to contain all considerations relevant to a patient's\n        potential participation in a clinical trial.Xx_NEWLINE_xXMore than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other ‘targeted’ agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapiesXx_NEWLINE_xXLess than 2 years between last therapy and progression (e.g. most recent progression free interval < 2 years)Xx_NEWLINE_xXAny relapse after prior autologous SCT will make patient eligible regardless of other prior therapyXx_NEWLINE_xXMinimum of 3 months of maintenance therapy prior to disease progressionXx_NEWLINE_xXRefractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule.Xx_NEWLINE_xXPrevious therapy with pomalidomide.Xx_NEWLINE_xXPatients must not have received prior therapy other than standard chemoradiation according to Stupp et al and GliadelXx_NEWLINE_xXSubjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapyXx_NEWLINE_xXSTEP 1 ENROLLMENT: three or less metastatic lesions (not sites); each lesion (including a satellite nodule) will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one; in addition, patients can receive treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy prior to randomization, but these lesions will be counted towards the total number after chemotherapy, and patients will only be eligible if there are remaining sites amenable to local therapy after up-front systemic therapyXx_NEWLINE_xXPatients must have disease that is refractory (unresponsive) to radioactive iodine (RAI) treatment as defined by one of the following: \r\n* One or more measurable lesions that do not demonstrate RAI uptake \r\n* One or more measurable lesions progressive by RECIST 1.1 within 12-months of prior RAI therapy and/or the appearance of one or more new lesion within 12 months of prior RAI therapy\r\n* Cumulative RAI dose of > 600 mCi\r\n* Measureable disease that is fludeoxyglucose (18F) positron emission tomography (PET) scan positiveXx_NEWLINE_xXPrior therapy allowed: \r\n* Patients may have been previously treated with up to three regimens of oral multikinase inhibitors, including sorafenib, sunitinib and pazopanib\r\n* Patients may have been previously treated with external beam radiation or cytotoxic chemotherapy therapyXx_NEWLINE_xXPreviously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.Xx_NEWLINE_xXPrior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.Xx_NEWLINE_xXPrior therapy with decitabine or azacitidineXx_NEWLINE_xXPatients whose primary therapy was changed due to suboptimal response of toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCTXx_NEWLINE_xXFor the expanded cohort only, patient must not have had prior therapy with an EGFR-specific monoclonal antibody or EGFR-specific tyrosine kinase inhibitor (TKI) for treatment of incurable HNSCC; prior therapy with an EGFR-specific monoclonal antibody as part of the definitive treatment of curable HNSCC is acceptable if this occurred more than 3 months prior to study enrollment; for the dose-finding cohorts, prior EGFR-specific therapy in the incurable setting is allowedXx_NEWLINE_xXHaving received rituximab within the prior 2 monthsXx_NEWLINE_xXPrior treatment with anti-cluster of differentiation (CD)20 monoclonal antibody or alemtuzumab within 2 months prior to start of therapyXx_NEWLINE_xXAny antibiotic therapy or evidence of infection within 1 week of registrationXx_NEWLINE_xXPrior taxane therapy for any indicationXx_NEWLINE_xXPrior chronic immune suppressive state (acquired immune deficiency syndrome [AIDS], immunosuppressive therapy)Xx_NEWLINE_xXTherapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated diseaseXx_NEWLINE_xXPrior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded.Xx_NEWLINE_xXSystemic immune suppression or systemic therapy for cGvHD started within preceding 4 weeks including extracorporeal photopheresisXx_NEWLINE_xXHave no contraindications to short-term metformin therapyXx_NEWLINE_xXPrior therapy with ipilimumab, other BRAF inhibitors, or mitogen-activated protein kinase (MEK) inhibitorsXx_NEWLINE_xXPrior treatment with anti-cluster of differentiation (CD)20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapyXx_NEWLINE_xXUncontrolled infectious complications not responsive to appropriate antimicrobial therapyXx_NEWLINE_xXConcurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)Xx_NEWLINE_xXAny number of prior regimens is allowed; prior investigational therapy is allowedXx_NEWLINE_xXIntolerance of prior treatment with bevacizumab, pazopanib, sorafenib, or sunitinib; Note: subjects who required a dose reduction of pazopanib, sorafenib, or sunitinib during prior therapy MAY be eligible if they tolerated the agent after dose level reduction (to a minimum of dose level -2 as defined in this protocol)Xx_NEWLINE_xXSystemic corticosteroid therapy (ongoing)Xx_NEWLINE_xXConfirmed primary AML relapsed or refractory after prior therapy, AML secondary to antecedent chemotherapy or radiation therapy, or AML due to prior myelodysplastic syndrome (MDS)/ myeloproliferative neoplasm (MPN) as defined by WHO criteria with presence of either FLT3 ITD and/or other FLT3 activating mutationsXx_NEWLINE_xXPatients with antecedent MDS/MPN, defined by WHO criteria, without any prior therapy for AML, regardless of the number of therapies for MDS/ MPNXx_NEWLINE_xXPatients with primary AML should have received no more than two (2) prior cytotoxic containing salvage regimens. Reinduction with the same regimen or stem cell transplant will not be considered a separate salvage regimen. Change of drugs will be considered a salvage regimen. Unlimited FLT3 TKI therapy (even in combination with cytotoxics/hypomethylating agents) is allowed for patients enrolled in cohort BXx_NEWLINE_xXSubjects should have received no anti-leukemic therapy (except hydroxyurea) prior to the first dose of crenolanib as follows: for 14 days for classical cytotoxic agents and for five times the t1/2 (half-life) for FLT3 inhibitors and antineoplastic agents that are neither cytotoxic nor FLT3 inhibitors (e.g. hypomethylating agent or MEK inhibitor)Xx_NEWLINE_xXPatient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment; patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemiaXx_NEWLINE_xXONLY APPLIES TO PATIENTS IN GROUP B (COMBINATION THERAPY)Xx_NEWLINE_xXPrior metformin treatment OR EGFR targeted therapyXx_NEWLINE_xXPatients on investigational therapy for graft-versus-host disease (GVHD)Xx_NEWLINE_xXPatients with uncontrolled acute or chronic GVHD or refractory disease not responding to conventional therapyXx_NEWLINE_xXSubjects who failed at least one prior therapy (BT062/Len/dex)Xx_NEWLINE_xXSubjects who failed at least two prior therapy (BT062/Pom/dex)Xx_NEWLINE_xXFor the phase I portion of the study patients should have failed any number of prior therapies, which should include at least the following: 1. Patients with MDS should have failed prior therapy with a hypomethylating agent and/or with lenalidomide. 2. Patients with AML should have failed any prior induction therapy or have relapsed after prior therapy. 3. Patients with MDS who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless of any prior therapy for AML. 4. Patients with any of the eligible diagnoses who have received no prior therapy are eligible if not candidates to receive standard therapy or if they refuse standard chemotherapy.Xx_NEWLINE_xXFor the phase II Portion of the study, only patients who are previously untreated for AML. 1. Patients with history of MDS who received therapy for MDS and progressed to AML are eligible at the time of diagnosis of AML. Only induction chemotherapy administered for AML will be considered for considerations of eligibility regarding prior therapy. Patients who received therapy for MDS before transforming to AML (e.g., with hypomethylating agents or lenalidomide) are eligible.Xx_NEWLINE_xXNewly diagnosed androgen-dependent prostate cancer; patients already on androgen-dependent therapy (ADT) are eligible as long as the time from initiation of luteinizing-hormone-releasing hormone (LHRH) analog or antagonist is not greater than 3 monthsXx_NEWLINE_xXPrior ADT is allowed if it was an adjunct to definite local therapy, was given for =< 1 year, and was completed at least 12 months before initiating therapy for metastatic diseaseXx_NEWLINE_xXPrior therapy with other tyrosine kinase inhibitors (TKI) inhibitors or any other type of investigational agent is allowed if it was an adjunct to definitive local therapy, was given for =< 6 months, and was completed at least 12 months before initiating therapy for metastatic diseaseXx_NEWLINE_xXPrior/concurrent therapy including:\r\n* Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months\r\n* Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months\r\n* Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months\r\n* Phytoestrogens or over-the-counter (OTC) medications with estrogenic or androgenic properties in the past 6 months\r\n* Any black cohosh preparation within the past 6 monthsXx_NEWLINE_xXMalignancy has failed curative therapy and has no reasonable expectation of cure with available alternative salvage therapyXx_NEWLINE_xXNewly diagnosed patients with no prior attempt at curative therapyXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXConcomitant therapy with bisphosphonates is allowedXx_NEWLINE_xXConfirmation of BRAF mutation-positive malignancy is required for selection of patients for vemurafenib therapyXx_NEWLINE_xXSubject had no response (i.e., stable disease only) to first-line therapy with R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen;Xx_NEWLINE_xXPrior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier); prior topical fluoropyrimidine use is allowed; prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil (fluorouracil) or known dihydropyrimidine dehydrogenase (DPD) deficiencyXx_NEWLINE_xXPatients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be requiredXx_NEWLINE_xXReceived at least 1 prior line of therapy for MM (Phase 1)Xx_NEWLINE_xXSecretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2).Xx_NEWLINE_xXPrior nitrosurea therapy (including lomustine or Gliadel)Xx_NEWLINE_xXAchieved at least a PR (and not progressed) after ABVD therapyXx_NEWLINE_xXParticipants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapyXx_NEWLINE_xXPeptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study.Xx_NEWLINE_xXPatients may have received any prior therapy deemed necessary for induction of remission except for patients whom have progressed while on sorafenib; patients who have responded to sorafenib previously are eligible for enrollment on the protocolXx_NEWLINE_xXPatients with active acute GVHD who have been initiated on therapy or had therapy escalation within 21 days are not eligibleXx_NEWLINE_xXPatients must discontinue antiandrogen therapy for at least 4 weeks (e.g. flutamide, bicalutamide, nilutamide) prior to registration with no evidence of a falling PSA after washout; patients on steroids are eligible as long as they will be switched to prednisoneXx_NEWLINE_xXPatients may continue on a daily multi-vitamin, calcium and vitamin D, but all other herbal, alternative and food supplements (i.e. PC-Spes, saw palmetto, St John’s wort, etc.) must be discontinued before registration; patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery, or radiation therapy during protocol treatment; hormonal-acting agents (including diethylstilbestrol/DES, aldosterone, and spironolactone) are forbidden during the trial and must be stopped prior to registration; no washout period will be required for any of these agents; patients on megestrol acetate for hot flashes are allowed to continue therapyXx_NEWLINE_xXPatients on stable doses of bisphosphonates or denosumab which have been started prior to registration may continue on this medication, patients who are not on bisphosphonates or denosumab are eligible as long as they initiate therapy prior to registrationXx_NEWLINE_xXProgressive disease as measured via RECIST 1.1 following EGFR-TKI therapy (with =< 5 sites of disease amenable to SRS or other locally-ablative treatment)Xx_NEWLINE_xXPatients who have received any systemic corticosteroid therapy within 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalentXx_NEWLINE_xXPrior therapies:Xx_NEWLINE_xXReceipt of an experimental vaccine within 2 months or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months, or has received any previous gene therapy using an integrating vectorXx_NEWLINE_xXWas refractory to lenalidomide or proteasome inhibitor-based therapy at any line. NOTE: Refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of a given therapy. Participants who progressed after 60 days from the last dose of a given therapy were considered relapsed and were eligible for inclusion in the study. Participants who were refractory to thalidomide-based therapy were eligible.Xx_NEWLINE_xXPatients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapyXx_NEWLINE_xXHigh-risk disease as defined by one of the following: \r\n* First relapse after CR within 12 months of initiation of front-line therapy \r\n* Less than CR to front-line therapy \r\n* Second-line Age-Adjusted International Prognostic Index (sAAIPI) of 2 or higher at the time of relapseXx_NEWLINE_xXReceipt of no more than three prior chemotherapy regimens; monoclonal antibody therapy alone and involved field radiotherapy are not included in this number; prior use of ofatumumab is allowed if there has been no disease progression following that therapy (i.e. ofatumumab-based salvage regimens are allowed)Xx_NEWLINE_xXProgression following prior ofatumumab-based therapyXx_NEWLINE_xXPatients must have a pilocytic astrocytoma or optic pathway glioma that has relapsed, progressed, or become refractory to conventional therapy; patients with neurofibromatosis (NF-1) are eligibleXx_NEWLINE_xXTherapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drugXx_NEWLINE_xXPhase Ib: Patients may have had any number of prior treatments, including 0, or prior pazopanibXx_NEWLINE_xXStable dose of glucocorticoids pre-therapy; if patients are receiving dexamethasone, the dose of dexamethasone should not increase during the 96 hours prior to initiation of therapyXx_NEWLINE_xXConcomitant therapy with any other experimental drugXx_NEWLINE_xXFor cohorts 1, 2, and 4 only: current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionaryXx_NEWLINE_xXPatients must have relapsed or progressed after at least one prior therapyXx_NEWLINE_xXNo prior treatment with bendamustine; prior therapy with gemcitabine is permittedXx_NEWLINE_xXPatients in cohort 2 being treated with concurrent HER2 therapy must have undergone treatment with the concurrent HER2 therapy selected by their attending physician for at least 3 weeks prior to initiation on this studyXx_NEWLINE_xXPatients on continuous steroid therapy for at least 72 hours (hrs) (or other continuous immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression; patients must have had 6 weeks of discontinuation of any continuous steroid therapy (taken for at least 72hrs duration) prior to enrollment (except steroids used for allergic reactions or as anti-emetics for systemic chemotherapy which are permitted)Xx_NEWLINE_xXPrior therapy with mammalian target of rapamycin (mTOR) inhibitors (e.g. sirolimus, temsirolimus)Xx_NEWLINE_xXThe patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visitXx_NEWLINE_xXAML that is considered to be therapy-relatedXx_NEWLINE_xXUse of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permittedXx_NEWLINE_xXPatients may have received prior systemic chemotherapy; such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapyXx_NEWLINE_xXResolution of prior therapy acute adverse events.Xx_NEWLINE_xXPrior systemic therapy for pancreas cancerXx_NEWLINE_xXSubjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screeningXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXPrior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier); prior topical fluoropyrimidine use is allowed; prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiencyXx_NEWLINE_xXAll patients may have had prior surgery, chemotherapy, and radiation therapy; prior biologic therapy is permitted only for bevacizumab-exposed patients (groups 2 and 4); prior treatment with Gliadel is permitted for all groupsXx_NEWLINE_xXPrevious treatment with SGN-35 or any other prior anti-cluster of differentiation (CD)30-based antibody therapyXx_NEWLINE_xXPrior systemic therapy for advanced pancreas cancer with gemcitabine is prohibited; prior gemcitabine with radiotherapy for localized pancreas cancer is allowed provided disease is present outside of the radiated field; prior gemcitabine as adjuvant therapy to surgical resection is allowed provided 3 months or greater has elapsed between the last dose of gemcitabine and the detection of recurrent diseaseXx_NEWLINE_xXAny non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)Xx_NEWLINE_xXSubjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions:Xx_NEWLINE_xXOnly prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowedXx_NEWLINE_xXFor dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and PazopanibXx_NEWLINE_xXSix weeks must have elapsed since any prior antibody therapy including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody therapy that could affect any anti-cancer immune response, at the time the patient receives the preparative regimen to allow antibody levels to decline; (NOTE: patients who have previously received ipililumab and have documented gastrointestinal [GI] toxicity must have a colonoscopy with normal colonic biopsies)Xx_NEWLINE_xXSubjects whose tumors overexpress ErbB2 are eligible provided that they have progressed following therapy which included trastuzumab and/or lapatinib:\r\n* Note for prior lapatinib: subjects must have completed therapy with lapatinib at least 7 days prior to the first dose of study drug\r\n* Note for prior trastuzumab: subjects who received thrice weekly (Q3 weekly), twice weekly (Q2 weekly) or once weekly (Q1 weekly) must have completed therapy with trastuzumab at least 3 weeks, 2 weeks or 1 week, respectively, prior to the first dose of study drugXx_NEWLINE_xXSubjects must have discontinued hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, United States Pharmacopeia [USP] or premarin), at least 28 days prior to receiving the first dose of randomized therapyXx_NEWLINE_xXAny prohibited concomitant medications for therapy with afatinib or gefitinibXx_NEWLINE_xXNo prior therapy with cabozantinibXx_NEWLINE_xXImaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.Xx_NEWLINE_xXDisease progression prior to randomizationXx_NEWLINE_xXRecurrent NSCLC, who relapse less than one year after completing curative intent therapyXx_NEWLINE_xXInclusion Criteria:\n\n          -  All subjects must be ? 18 years at the first screening examination / visit\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1\n\n          -  Life expectancy of at least 12 weeks\n\n          -  Histologically or cytologically documented invasive epithelial ovarian, primary\n             peritoneal, or fallopian tube cancer (tumors with pseudomyxomatous or mucinous\n             histology are excluded) or advanced predominantly epithelioid peritoneal mesothelioma.\n\n             -- Ovarian cancer must have relapsed >0 months and ? 12 months of the prior\n             platinum-based chemotherapy regimen (platinum resistant and partially platinum\n             sensitive).\n\n          -  All patients must provide the tumor tissue sample [Formalin Fixed Paraffin Embedded\n             (FFPE) slides] from archival tissue or fresh biopsy collected any time before the\n             general screening under the separate informed consent.\n\n          -  Mesothelin expression in the tumor tissue from archival or fresh biopsy samples\n             defined as the membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on at\n             least 30% of tumor cells.\n\n             -- Mesothelin expression must be determined by the validated Investigational Use Only\n             (IUO) assay for ovarian cancer or the prototype immunohistochemistry (IHC) assay for\n             mesothelioma at Ventana at any time before the general screening in patients who had\n             signed a separate informed consent for tumor tissue analysis for mesothelin\n             expression.\n\n          -  No more than 3 prior lines of systemic cytotoxic therapy for patients with advanced\n             peritoneal or pleural mesothelioma or\n\n          -  No more than 5 prior lines of systemic cytotoxic therapy for patients with ovarian\n             cancer\n\n          -  Possible intraperitoneal administration of cytotoxics during surgery will not count as\n             systemic cytotoxic therapy in either case.\n\n          -  Measurable disease with at least one lesion that can be accurately measured in at\n             least one dimension according to Response Evaluation Criteria In Solid Tumors (RECIST)\n             1.1.\n\n        exclusion Criteria:\n\n          -  More than 3 prior lines of systemic cytotoxic therapy for patients with advanced\n             peritoneal or pleural mesothelioma\n\n          -  More than 5 prior lines of systemic cytotoxic therapy for patients with ovarian cancer\n\n          -  Other systemic anticancer therapies (molecular-targeted, immunotherapy etc.) may be\n             acceptable after the consultation between the Investigator and the Bayer Medical\n             Expert.\n\n          -  Intraperitoneal administration of cytotoxic anticancer agents during tumor surgery\n             will not count as systemic cytotoxic therapy in this context.\n\n          -  Prior local radiotherapy is allowed if it is completed at least 4 weeks prior to the\n             first dose of study drug and the subject has evaluable lesions not previously\n             irradiated.\n\n          -  Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks\n             of start of first dose. Anticancer therapy is defined as any agent or combination of\n             agents with clinically proven anti tumor activity administered by any route with the\n             purpose of affecting the malignancy, either directly or indirectly, including\n             palliative and therapeutic endpoints.\n\n          -  Radiotherapy to the target lesions within 4 weeks prior to the first BAY94-9343\n             infusion, if the subject has evaluable tumor lesions not previously irradiated.\n\n          -  Use of strong inhibitors of P-glycoprotein (transporter) (P-gp) (e.g., ritonavir,\n             cyclosporine, verapamil, and dronedarone) is prohibited from Day -14 and for the\n             duration of the study.\n\n          -  Impaired cardiac function or clinically significant cardiac disease [i.e., congestive\n             heart failure (CHF) New York Heart Association (NYHA) Class III or IV].\n\n          -  Left ventriculat ejection fraction (LVEF) <50 % [as measured at screening by Multiple\n             Gated Acquisition scan (MUGA) or echocardiogram].\n\n          -  Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or\n             diastolic blood pressure > 90 mmHg, despite optimal medical management.\n\n          -  Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g.\n             diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at\n             the discretion of the ophthalmologist if deemed as no constituting a predisposition to\n             drug-induced corneal deposits and blurry vision.Xx_NEWLINE_xXPotentially curative therapy is availableXx_NEWLINE_xXPatients should be proteasome inhibitor naive (including bortezomib and carfilzomib) OR have received less than 6 cycles of therapy with a bortezomib or carfilzomib containing regimen and were not refractory to the bortezomib or carfilzomib based regimen (less than a PR or progression on or within 60 days of discontinuation)Xx_NEWLINE_xXParticipants may have received prior TKI therapy, however must be on a stable dose of their current TKI for at least one month prior to enrollmentXx_NEWLINE_xXPatient age > 50, or for patients < 50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplantsXx_NEWLINE_xXPart B: For Part B dose-expansion: once a MTD has been established in part A, additional dose escalation will occur with subsequent dose escalation of carfilzomib; during the dose escalation of part B, patient (pt) must have at least 1 line of prior therapy and no limitations on prior therapy; patients who had prior clinical benefit/response to ARRY-520 or carfilzomib with a stable disease (SD) or better may be eligible for dose expansion of part B; dose expansion of part B will be patients who are carfilzomib sensitiveXx_NEWLINE_xXAcute myeloid leukemia (AML) fitting within one of the following disease groups:\r\n* Primary induction failure (PIF): patients who have not achieved a complete remission (CR) after two induction cycles of cytotoxic therapy (i.e. 7+3, mitoxantrone, etoposide, and cytarabine [MEC], fludarabine, cytarabine, and granulocyte-colony stimulating factor [FLAG], etc.) and having =< 10,000 absolute circulating blasts measured at least 21 days from prior therapy; hydroxyurea may be used to control blasts count; demethylating agents do not count as induction therapy; however early re-induction therapy based on residual disease on a day 14 bone marrow (BM) will count as a 2nd cycle\r\n* Relapsed disease with low disease burden: AML with =< 10,000 absolute circulating blasts; hydroxyurea may be used to control blasts count: no re-induction attempts are required, but a maximum of 2 re-induction attempts is allowed to be eligible\r\n* CR3 or greater: this will include CRp defined as CR without platelet recovery to 100,000/mcL\r\n* CR1 or CR2 with high risk features: includes therapy induced, prior myelodysplastic syndromes (MDS) or myeloproliferative disease (MPD), high risk cytogenetic or molecular phenotype with no available donor (sibling or unrelated adult)Xx_NEWLINE_xXpc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone); pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least 3 monthsXx_NEWLINE_xXAll patients must be considered an eligible candidate for systemic therapy as determined by the investigator; to be eligible, LYP patients must be in need of systemic therapy i.e., have scarring or active lesions (>= 10 per month), or any number of active lesions on face, hands, or feetXx_NEWLINE_xXOne prior cytotoxic therapy for the treatment of metastatic disease is allowed. Unlimited regimens using biological agents (vaccines), immunotherapy, or targeted agents is permitted. For example, BRAF inhibitors and ipilimumab are permitted. Patients must have fully recovered from the acute toxicities related to any prior therapy. Prior therapy must be completed ?28 days before the first dose of cyclophosphamide.Xx_NEWLINE_xXPrior treatment with an luteinizing hormone-releasing hormone (LHRH) agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment; in this situation, patients must not have received more than 24 months of androgen deprivation treatment, and must not have been treated within 12 months prior to screening; other treatment with androgen deprivation therapy is prohibitedXx_NEWLINE_xXPatients must not have received prior Gliadel wafersXx_NEWLINE_xXPatients who have had prior therapy with chemokine receptor type 4 (CXCR4) inhibitorsXx_NEWLINE_xXCompleted cancer specific therapy at most 6 months prior to entryXx_NEWLINE_xXAdditional Exclusion Criteria for dabrafenib and trametinib combination therapy (Cohort B and C as well as subjects that crossover from monotherapy to combination therapy):Xx_NEWLINE_xXFor participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigatorXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXNonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.Xx_NEWLINE_xXReceived rituximab containing a multi-agent therapy for the treatment of NHL.Xx_NEWLINE_xXPrior therapy: patients with prior history of mediastinal radiation exposure will be ineligible; patients may not have received prior chemotherapy, or antibody therapy for esophageal or GE-junction adenocarcinomaXx_NEWLINE_xXPrior Navelbine allowed provided Navelbine therapy discontinued >= 12 months from day 1 of treatment under this protocolXx_NEWLINE_xXReceived other recent antitumor therapyXx_NEWLINE_xXProgression during or within 6 months following administration of a standard regimen for treatment of metastatic disease that included oxaliplatin with any of the following agents with or without bevacizumab:\r\n* 5-fluorouracil (5-FU) with or without leucovorin or levoleucovorin\r\n* Capecitabine\r\nNOTE: in patients receiving FOLFOX, oxaliplatin is sometimes discontinued due to toxicity or as part of maintenance therapy strategy; if such patients progress while on 5-FU alone, they are eligible for this trial; as an example, a patient who is begun on FOLFOX or CapeOx (with or without bevacizumab), whose oxaliplatin is held for neurotoxicity and who is switched to capecitabine monotherapy or capecitabine with bevacizumab, would be considered to have had ONE prior therapy OR patients who develop metastatic disease within 9 months of adjuvant FOLFOX for stage II or III colon cancerXx_NEWLINE_xXSymptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of FOLFIRI initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)Xx_NEWLINE_xXInclusion Criteria: Each patient MUST:\n\n          -  Have histologically confirmed cancer of the colon or rectum with radiologically\n             documented and measurable metastases (high CEA alone is insufficient for study entry).\n\n          -  Have received an oxaliplatin-based chemotherapy regimen in the metastatic setting or\n             relapsed within 6 months of completion of adjuvant therapy containing oxaliplatin.\n\n          -  Not have received prior FOLFIRI or irinotecan in the metastatic setting.\n\n          -  Have his/her tumor assessed for KRAS status and found to be mutation positive.\n\n          -  Have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy,\n             chemotherapy, or surgical procedures, i.e., all such effects must have been resolved.\n\n          -  Be at least 18 years of age.\n\n          -  Have an ECOG Performance Score of ? 2.\n\n          -  Have a life expectancy of at least 3 months.\n\n          -  Have baseline laboratory results as follows:\n\n               -  Absolute neutrophil count (ANC) ? 1.5 x 10^9 [SI unit 10^9/L]\n\n               -  Platelets ? 100 x10^9 [SI units 10^9/L] (without platelet transfusion)\n\n               -  Hemoglobin ? 9.0 g/dL [SI units gm/L] (with or without RBC transfusion)\n\n               -  Serum creatinine ? 1.5 x upper limit of normal (ULN)\n\n               -  Bilirubin ? ULN\n\n               -  AST/ALT ? 2.5 x ULN (? 5 x ULN if liver metastases)\n\n               -  Negative pregnancy test for females with childbearing potential.\n\n               -  Proteinuria < grade 2.\n\n          -  Have signed an informed consent indicating that the patient is aware of the neoplastic\n             nature of their disease and have been informed of the procedures of the protocol, the\n             experimental nature of the therapy, alternatives, potential benefits, side effects,\n             risks, and discomforts.\n\n          -  Be willing and able to comply with scheduled visits, the treatment plan, and\n             laboratory tests.\n\n          -  Be medically eligible to receive bevacizumab\n\n        Exclusion Criteria: No patient may:\n\n          -  Receive concurrent therapy with any other investigational anticancer agent while on\n             study.\n\n          -  Have previously received irinotecan or FOLFIRI in the metastatic setting (patient is\n             eligible if he/she had received irinotecan or FOLFIRI as adjuvant therapy more than 6\n             months before entry into the study)\n\n          -  Have brain metastases.\n\n          -  Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or\n             C.\n\n          -  Have received >20 Gy of radiation to the pelvis.\n\n          -  Have received chemotherapy, immunotherapy, hormonal therapy or had major surgery\n             within 28 days; or received radiotherapy within 14 days; or minor surgery within 7\n             days prior to receiving the study drug.\n\n          -  Be a pregnant or breast-feeding woman. Female patients of childbearing potential must\n             agree to use effective contraception, be surgically sterile, or be postmenopausal.\n             Male patients must agree to use effective contraception or be surgically sterile.\n             Barrier methods are a recommended form of contraception.\n\n          -  Have clinically significant cardiac disease (New York Heart Association, Class III or\n             IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial\n             infarction within 1 year prior to study entry, or Grade 2 or higher compromised left\n             ventricular ejection fraction.\n\n          -  Have dementia or altered mental status that would prohibit informed consent.\n\n          -  Have any other acute, or chronic medical or psychiatric condition or laboratory\n             abnormality that may increase the risk associated with study participation or study\n             drug administration or may interfere with the interpretation of study results and, in\n             the judgment of the Principal Investigator, would make the patient inappropriate for\n             this study.\n\n          -  Have uncontrolled hypertension, proteinuria, or recent major surgery (all clinical\n             parameters related to bevacizumab use). Any other clinical parameter considered\n             important should be discussed with the medical monitor.Xx_NEWLINE_xXPatient must have radioiodine refractory disease as defined by one or more of the following conditions:\r\n* All cases of medullary thyroid carcinoma\r\n* No iodine-uptake on a post-radioactive iodine treatment scan (in presence of low iodine diet and thyroid stimulating hormone [TSH] suppression) in an anatomically defined lesion that qualifies as target lesion by RECIST criteria, OR\r\n* If there is demonstrable iodine-uptake: the last radioiodine therapy of (>= 100 mCi) was given within the last 16 months OR if given more than 16 months before enrollment, there is evidence of disease progression after each of the last two radioiodine treatment performed within 16 months of each other (each dose should be >= 100mCi), OR\r\n* If the patient has received the maximum cumulative life time dose of radioactive iodine treatments of at least 600 mCi\r\n* If the patient declines or is intolerant of radioiodine therapy or if with progressive disease that is, in the opinion of the treating physician, likely to benefit from biologic therapy rather than further iodine therapy e.g. patient with heavy burden of diseaseXx_NEWLINE_xXAny hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Continuation of hormone replacement therapy is permittedXx_NEWLINE_xXPatients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for advanced, metastatic, or recurrent disease (e.g., bevacizumab)Xx_NEWLINE_xXPatients who have received prior therapy with ADXS11-001Xx_NEWLINE_xXPatient has a history of listeriosis or prior ADXS11-001 therapyXx_NEWLINE_xXHave been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trialXx_NEWLINE_xXPatients with castrate resistant prostate cancer (CRPC) must have no standard options for therapy; prior to registration on the study, patients with CRPC must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial)Xx_NEWLINE_xXFor patients who have been on anti-androgen therapy and had evidence of response to the addition of an anti-androgen (i.e., PSA reduction), patients must have discontinued anti-androgen therapy for at least six weeks (4 weeks for flutamide) without current evidence of an anti-androgen withdrawal responseXx_NEWLINE_xXConcurrent therapy with any excluded medications that cannot be safely discontinued prior to initiation of combination therapy; discontinuation prior to enrollment is not required, but discontinuation prior to combination therapy must be possibleXx_NEWLINE_xXBaseline studies must be performed 8 weeks prior to the start of systemic therapy, and must document the extent of disease in the breast; the specifics of this are at physician discretion, but must address clinical signs and symptoms; if pre-therapy scans were not performed, scans performed within the first 4 weeks of systemic therapy, but prior to registration, will be accepted; radiology reports documenting status of disease must be availableXx_NEWLINE_xXPatients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient’s age and menopausal status)\r\n* NOTE: The patient will be considered eligible if the last day of the treatment cycle meets the 16 weeks criteria\r\n* If systemic therapy is discontinued for toxicity, there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible; if systemic therapy is changed for reasons other than progression of disease (e.g. from chemotherapy to endocrine therapy), the patient remains eligibleXx_NEWLINE_xXDocumented progression from most recent line of therapyXx_NEWLINE_xX1-3 prior lines of therapyXx_NEWLINE_xXAll patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole and who are then randomized to ARM 2 must have sirolimus reduced according to the Standard Practice Antifungal Therapy GuidelinesXx_NEWLINE_xXPatients must not have received any prior pelvic irradiationXx_NEWLINE_xXOngoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomyXx_NEWLINE_xXSubjects must have active disease appropriate for therapyXx_NEWLINE_xXPrior everolimus or pazopanib therapy; other mammalian target of rapamycin (mTOR) inhibitors and tyrosine kinase inhibitors are allowedXx_NEWLINE_xXInitial therapy must have included total/near-total thyroidectomy and RAI ablation therapyXx_NEWLINE_xXInclusion Criteria\n\n        Subjects eligible for enrollment in the study must meet all of the following criteria:\n\n          1. Signed written informed consent. In Korea and Japan, subjects who are between >=18 and\n             <20 years of age must also have a legal representative sign the written informed\n             consent.\n\n          2. Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any\n             of the following:\n\n               -  Subjects at least 60 years of age.\n\n               -  Subjects under 60 years of age and amenorrhic for at least 12 consecutive months\n                  AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal\n                  range (utilizing ranges from the local laboratory facility).\n\n               -  Prior bilateral oophorectomy.\n\n               -  Prior radiation castration with amenorrhea for at least 6 months\n\n          3. Subjects must have a history of histologically confirmed breast cancer, with a\n             clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology\n             or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or\n             non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n\n          4. Tumors that are ER+ and/or PgR+ by local laboratory\n\n          5. Documentation of HER2 overexpression or gene amplification, in the invasive component\n             of either the primary tumor or metastatic disease site as defined as:\n\n               -  3+ by Immunohistochemistry (IHC) and/or\n\n               -  HER2/neu gene amplification by fluorescence, chromogenic or silver in situ\n                  hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH,\n                  CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ?2.0]\n\n          6. Subject must have received at least one prior regimen containing trastuzumab in\n             combination with chemotherapy for breast cancer:.\n\n               -  Subject has ONLY received prior trastuzumab in combination with chemotherapy as\n                  neoadjuvant and/or adjuvant treatment. OR\n\n               -  Subject has received ONE prior trastuzumab-containing regimen for metastatic\n                  disease (and has progressed), and may or may not have received prior trastuzumab\n                  in combination with chemotherapy as neoadjuvant and/or adjuvant treatment.\n\n          7. Subject must have received prior endocrine therapy (such as aromatase inhibitors or\n             selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6\n             months as assessed by the treating investigator\n\n        9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) ?50% measured by\n        echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an\n        ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE\n        (Version 4.0) ? Grade 1 at the time of randomization 12. Completion of screening\n        assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the\n        following criteria:\n\n          -  QTc <450msec or\n\n          -  QTc <480msec for subjects with bundle branch block The QTc is the QT interval\n             corrected for heart rate according to either Bazett's formula (QTcB) or to\n             Fridericia's formula (QTcF), machine or manual over read, for males and females. The\n             specific formula that will be used in a protocol should be determined prior to\n             initiation of the study, and the formula used to determine inclusion and\n             discontinuation should be the same throughout the study. The QTc should be based on\n             single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a\n             brief recording period\n\n        Exclusion criteria:\n\n          1. History of another malignancy. Exception: Subjects who have been disease-free for 5\n             years, or subjects with a history of completely resected non-melanoma skin cancer or\n             successfully treated in situ carcinoma are eligible.\n\n          2. Subjects with extensive symptomatic visceral disease including hepatic involvement and\n             pulmonary lymphangitic spread of tumor, or the disease is considered by the\n             investigator to be rapidly progressing or life threatening (subjects who are intended\n             for chemotherapy)\n\n          3. Serious cardiac illness or medical condition including but not confined to:\n\n               -  Uncontrolled arrhythmias\n\n               -  Uncontrolled or symptomatic angina\n\n               -  History of congestive heart failure (CHF)\n\n               -  Documented myocardial infarction <6 months from study entry\n\n          4. Known history of, or clinical evidence of, central nervous system (CNS) metastases or\n             leptomeningeal carcinomatosis\n\n          5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease\n             (with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones,\n             liver metastases or stable chronic liver disease per investigator assessment)\n\n          6. Have a concurrent disease or condition that may interfere with study participation, or\n             any serious medical disorder that would interfere with the subject's safety (for\n             example, active or uncontrolled infection or any psychiatric condition prohibiting\n             understanding or rendering of informed consent)\n\n          7. Have any clinically significant gastrointestinal abnormalities that may alter\n             absorption such as malabsorption syndrome or major resection of the stomach or bowels\n\n          8. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs\n             chemically related to any of the study agents or their excipients that, in the opinion\n             of the Investigator or GSK medical monitor, contraindicates their participation\n\n          9. Any prohibited medication.\n\n         10. Administration of an investigational drug within 30 days or 5 half-lives, whichever is\n             longer, preceding the first dose of study treatment.Xx_NEWLINE_xXPatients with CML must have demonstrated resistance and/or intolerance to therapy with at least 2 tyrosine kinase inhibitors (TKI)Xx_NEWLINE_xXGlioblastoma disease-specific concerns: Patients must have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, AED's, analgesics, and other drugs to treat symptoms or prevent complicationsXx_NEWLINE_xXSubject may have received prior investigational therapy (including immune therapy)Xx_NEWLINE_xXSubject may have received prior hormonal therapyXx_NEWLINE_xXSubject has any acute infection that requires specific therapy; acute therapy must have been completed within seven days prior to study enrollmentXx_NEWLINE_xXprior therapy specifically directed against ALKXx_NEWLINE_xXReceived at least one regimen of prior systemic therapy and then experienced documented radiographic progression or was not able to tolerate prior systemic therapy.Xx_NEWLINE_xXSubjects who received less than four weeks of therapy and were unable to continue therapy due to toxicity will be allowed to participateXx_NEWLINE_xXAbility to receive study drug therapy by enteral administrationXx_NEWLINE_xXFollicular lymphoma patients must have received at least 3 prior lines of therapy; patients are eligible regardless of whether they have received an autologous transplantXx_NEWLINE_xXThe participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).Xx_NEWLINE_xXInclusion Criteria:\n\n          1. Patients or their legal representatives must be able to provide written informed\n             consent.\n\n          2. Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).\n\n          3. Radiographic evidence of first recurrence or progression of GBM following primary\n             therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may\n             have undergone a second debulking surgery following initial recurrence or progression.\n             Patients whose tumors are O6 methyl guanyl-methyl-transferase (MGMT)\n             methylated-promoter negative need not have received chemotherapy in the past to be\n             eligible.\n\n          4. Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02.\n\n          5. Age ?18.\n\n          6. KPS score of ?60.\n\n          7. Serum creatinine value <2X the upper limit of normal (ULN) for the reference\n             laboratory.\n\n          8. Alanine aminotransferase/aspartate aminotransferase <3X the ULN and total bilirubin\n             <2× the ULN for the reference laboratory.\n\n          9. Patients must have recovered from the effect of all prior therapy to Grade 2 or less.\n\n         10. Patients must be at least 28 days from any major surgery, and any surgery incisions or\n             wounds must be completely healed.\n\n         11. Patients must be at least 12 weeks from the completion of prior radiation therapy (RT)\n             in order to discriminate pseudo progression of disease from progression.\n\n         12. Patients must be at least 4 weeks from the completion of prior systemic or\n             intracranial chemotherapy.\n\n         13. For patients who are not receiving therapeutic anticoagulation treatment, an\n             international normalized ratio (INR) and a PTT ? 1.5 × the ULN; patients who are\n             receiving anticoagulation treatment should be on a stable dose.\n\n        Exclusion Criteria:\n\n        Patients with any of the following will be excluded from the study:\n\n          1. Prior therapy with Bev.\n\n          2. Any anti-neoplastic therapy, including RT, for first relapse or recurrence.\n\n          3. Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of\n             metastatic disease extracranially.\n\n          4. Evidence of impending herniation on imaging.\n\n          5. Patients with infections that have required treatment with systemic antibiotics within\n             7 days of first dose of protocol therapy.\n\n          6. The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone\n             or in comparable doses with other glucocorticoids.\n\n          7. Treatment with any investigational agents within 5 half-lives of the agent in question\n             or, if the half life is unknown, within 28 days of enrollment.\n\n          8. Pregnant or lactating females.\n\n          9. Prior history of malignancy within 3 years of enrollment other than basal or squamous\n             cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of\n             the breast, or prostate cancer treated with surgery or RT with a prostate specific\n             antigen of <0.01 ng/mL.\n\n         10. Patients with active autoimmune diseases within 2 years of enrollment into the study\n             including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus,\n             systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis,\n             Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis\n             not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an\n             autoimmune condition has been clinically silent for 12 months or greater, the patient\n             may be eligible for enrollment.\n\n         11. Patients on immunosuppressive therapies; the use of topical, inhalational,\n             ophthalmologic or intra articular glucocorticoids, or the use of physiologic\n             replacement doses of glucocorticoids are permitted.\n\n         12. Patients with primary immunodeficiency diseases.\n\n         13. Patients with significant bleeding in the preceding 6 months or with known\n             coagulopathies.\n\n         14. History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in\n             the preceding 12 months.\n\n         15. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or\n             untreated hepatitis C; patients who have completed a course of anti-viral treatment\n             for hepatitis C are eligible.\n\n         16. Significant cardiovascular disease, including New York Hospital Association Class III\n             or IV congestive heart failure, myocardial infarction within 6 months of enrollment,\n             unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding\n             6 months.\n\n         17. Any other uncontrolled inter current medical condition, including systemic fungal,\n             bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or\n             chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the\n             preceding 12 months.\n\n         18. Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.Xx_NEWLINE_xXPrior endocrine therapy in the metastatic setting may include any aromatase inhibitor (AI) or tamoxifen, but may not include prior fulvestrant; in the metastatic setting, 1-2 prior lines of endocrine therapy are allowedXx_NEWLINE_xXParticipants who have discontinued prior palbociclib for toxicity, or have needed more than one dose or schedule reduction for toxicity from prior palbociclib therapy; if a participant required a single dose reduction during prior palbociclib therapy and tolerated it well, for example prior dosing at 100 mg qd 3 weeks on 1 week off schedule, than that dose may be selected for this trialXx_NEWLINE_xXPatients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within 6 months of the last dose of previous systemic therapyXx_NEWLINE_xXHas received prior systemic therapy for the treatment of SCLCXx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. (Prophylactic cranial irradiation will be possible for those participants with stable disease or better at the completion of the 4 cycles of chemotherapy with or without pembrolizumab.)Xx_NEWLINE_xXPatients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility. Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).Xx_NEWLINE_xXIndications B - LMS: Subjects previously treated with at least one prior line of approved therapy.Xx_NEWLINE_xXIndication C - SS: Subjects previously treated with at least one prior line of approved therapy, including first-line anthracycline containing regimen.Xx_NEWLINE_xXOngoing androgen depletion therapy with a gonadotropin-releasing hormone (GnRH) analog or inhibitor, or orchiectomy (i.e., surgical or medical castration). Note: patients who have not undergone orchiectomy must continue GnRH analog therapy for the duration of this protocol.Xx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXEndocrinopathies, unless on stable hormone replacement therapy;Xx_NEWLINE_xXFor Arm B, patients must be at first recurrence of GBM and must not have had prior anti-VEGF therapyXx_NEWLINE_xXPrior investigational therapy with an agent that is known or proposed to be active by action on any component of the EGFR tyrosine kinase, IGF1R, mTOR, or c-MET pathwaysXx_NEWLINE_xXPatients must not have received prior Gliadel wafersXx_NEWLINE_xXInclusion Criteria (Treatment Arm A)\n\n          1. Patients must have histologically-confirmed solid tumors that are advanced or\n             metastatic, and refractory after standard therapy, or for which there is no standard\n             therapy.\n\n          2. Patients must have measurable disease as defined by RECIST version 1.1.\n\n          3. Patients must have received prior anticancer therapy or not be eligible for any\n             established conventional therapy whether surgical or pharmacologic.\n\n          4. Patients must have recovered from all acute adverse effects (excluding alopecia) of\n             prior therapies to baseline or <=grade 1 prior to study entry.\n\n          5. Patients must have a performance status of 0, 1, or 2.\n\n          6. Patients must be men and women >=18 years of age.\n\n          7. Patients must have adequate bone marrow function, defined as an absolute neutrophil\n             count >=1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.\n\n          8. Patients must have adequate renal function, defined as serum creatinine <= 1.2 mg/dL\n             (if > 1.2 mg/dL, a calculated creatinine clearance [by the Cockcroft-Gault method]\n             must be >=60 mL/min/1.73 m^2).\n\n          9. Patients must have adequate hepatic function, defined as plasma total bilirubin <=1.5\n             mg, alanine transaminase (ALT) and aspartate transaminase (AST) <=2.5 X ULN. Patients\n             with Gilbert's disease outside these limits are judged to be ineligible.\n\n         10. Female patients of childbearing potential must have a negative serum or urine\n             pregnancy test result at time of pre-treatment screening.\n\n         11. Patients with reproductive potential must agree to use at least one form of barrier\n             contraception prior to study entry and for up to 30 days beyond the last\n             administration of study drug.\n\n         12. Patients must be judged to be capable by the Investigator of providing informed\n             consent and must be willing to provide written informed consent prior to the start of\n             any study specific procedures.\n\n         13. Patients should have a life expectancy of at least 12 weeks.\n\n        Exclusion Criteria (Treatment Arm A)\n\n          1. Patients may not have had prior chemotherapy, hormonal therapy, radiation therapy, or\n             biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C\n             or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients\n             who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days,\n             whichever is shorter) must have passed prior to enrollment in the study.\n\n          2. Patients may not have any concomitant condition that could compromise the objectives\n             of this study and the patients' compliance and ability to tolerate this therapy and\n             complete at least 2 cycles of therapy, including, but not limited to the following:\n\n               -  Congestive heart failure or uncontrolled angina pectoris, previous history of\n                  myocardial infarction within 1 year from study entry, uncontrolled hypertension,\n                  or dysrhythmias.\n\n               -  Active infection.\n\n               -  Unstable diabetes mellitus\n\n               -  Psychiatric disorder that may interfere with consent and/or protocol compliance.\n\n          3. Pregnant or breastfeeding women.\n\n          4. Patients with another malignancy in the past 3 years except: curatively treated\n             non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does\n             not require further treatment.\n\n          5. Patients with known HIV, HBV, or HCV infection.\n\n          6. Patients with an underlying diagnosis or disease state associated with an increased\n             risk of bleeding.\n\n          7. Patients with central nervous system metastases. Baseline CT or MRI scan of brain is\n             required only in the case of clinical suspicion of central nervous system metastases.\n             Patients with evidence of brain involvement, leptomeningeal disease, or seizure\n             disorder are also excluded.\n\n          8. Patients may not be treated with known CYP3A4 inhibitors or inducers.\n\n        Inclusion and Exclusion Criteria for Combination CTO Plus Temodar® (Treatment Arm B):\n        Inclusion Criteria (Treatment Arm B)\n\n        In addition to the inclusion criteria for adequate organ function as defined for the\n        patients with advanced or metastatic solid tumors, patients enrolled in Arm B (Combination\n        Therapy CTO Plus Temodar-R) must meet the following inclusion criteria:\n\n          1. Patients must have histologically proven malignant glioblastoma or other recurrent\n             malignant gliomas.\n\n          2. Measurable tumor must be present on gadolinium-enhanced MRI.\n\n          3. Patients must have a life expectancy of at least 8 weeks.\n\n          4. Patients must have a Performance Status of 0, 1, or 2 (ECOG scale).\n\n          5. Patients must be men and women >=18 years of age.\n\n          6. Patients must have recovered from all acute adverse effects (excluding alopecia) of\n             prior therapies to baseline or <=grade 1 prior to study entry.\n\n          7. Patients must have shown unequivocal radiographic evidence for tumor progression by\n             MRI scan to be performed within 14 days prior to registration and must be on a steroid\n             dose that has been stable for at least 5 days. If the steroid dose is increased\n             between the date of imaging and registration, a new baseline MRI scan is required.\n\n          8. Patients who have undergone recent resection for recurrent or progressive malignant\n             tumor will be eligible as long as all of the following conditions apply:\n\n               1. They have recovered from the effects of surgery\n\n               2. The extent of residual disease is assessed post-operatively, with an MRI scan\n                  done no later than 96 hours in the immediate post-operative period or at least 4\n                  weeks post-operatively, within 14 days prior to registration. If the 96-hour scan\n                  is more than 14 days before registration, the scan needs to be repeated.\n\n          9. Patients must have had prior radiation therapy with or without chemotherapy and must\n             have progressed following radiation therapy and must have an interval of >=12 weeks\n             from the completion of radiation therapy to registration date to minimize the\n             possibility of pseudo-progression.\n\n         10. Patients under treatment with anti-epileptic drugs which are not known CYP3A4\n             inhibitors or inducers must have been receiving a stable dose for at least 2 weeks\n             with no evidence of seizures at the time of registration.\n\n        Exclusion Criteria (Treatment Arm B)\n\n          1. Patients may not have had prior chemotherapy, hormonal therapy, or biologic therapy in\n             the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas,\n             for which patients must be 6 weeks from prior treatment. For patients who have been\n             treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is\n             shorter) must have passed prior to enrollment in the study. Additional exceptions: The\n             following specific drugs are permitted shorter recovery times: 14 days for\n             vincristine, 21 days for procarbazine, and 7 days for non-cytotoxic agents such as\n             interferon, tamoxifen, thalidomide, and cis-retinoic acid.\n\n          2. Patients may not have any concomitant condition that could compromise the objectives\n             of this study and the patients' compliance and ability to tolerate this therapy and\n             complete at least 2 cycles of therapy, including, but not limited to the following:\n\n               -  Congestive heart failure or uncontrolled angina pectoris, previous history of\n                  myocardial infarction within 1 year from study entry, uncontrolled hypertension,\n                  or dysrhythmias.\n\n               -  Active infection.\n\n               -  Unstable diabetes mellitus.\n\n               -  Psychiatric disorder that may interfere with consent and/or protocol compliance.\n\n          3. Pregnant or breastfeeding women.\n\n          4. Patients with another malignancy in the past 3 years except: curatively treated\n             non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does\n             not require further treatment.\n\n          5. Patients with known HIV, HBV, or HCV infection.\n\n          6. Patients with an underlying diagnosis or disease state associated with an increased\n             risk of bleeding.\n\n          7. Uncontrolled seizure activity.\n\n          8. Patients may not be treated with known CYP3A4 inhibitors or inducers.\n\n        Inclusion and Exclusion Criteria for Combination CTO and Temodar® in combination with\n        radiation therapy (Treatment Arm C):\n\n        Inclusion Criteria (Treatment Arm C)\n\n        In addition to the inclusion criteria for adequate organ function as defined for the\n        patients with advanced or metastatic solid tumors, patients enrolled in Arm C (Combination\n        Therapy CTO and Temodar® in combination with radiation therapy) must meet the following\n        inclusion criteria:\n\n          1. Patients must have histologically proven newly diagnosed glioblastoma or other\n             malignant gliomas. Note: Patients with anaplastic oligodendroglioma with 1p/19q\n             deletion or unknown 1p/19q status are not eligible\n\n          2. Patients must have a life expectancy of at least 8 weeks\n\n          3. Patients must have a Performance Status of 0, 1, or 2 (ECOG scale).\n\n          4. Patients must be men and women >=18 years of age.\n\n          5. Patients must have undergone an MRI scan performed within 14 days prior to\n             registration and must be on a steroid dose that has been stable for at least 5 days.\n             If the steroid dose is increased between the date of imaging and registration, a new\n             baseline MRI is required.\n\n          6. Patients under treatment with anti-epileptic drugs which are not known CYP3A4\n             inhibitors or inducers must have been receiving a stable dose for at least 2 weeks\n             with no evidence of seizures at the time of registration.\n\n        Exclusion Criteria (Treatment Arm C)\n\n          1. Patients may not have had any prior chemotherapy, hormonal therapy, or biologic\n             therapy for gliomas.\n\n          2. Patients may not have any concomitant condition that could compromise the objectives\n             of this study and the patients' compliance and ability to tolerate this therapy and\n             complete at least 2 cycles of therapy, including, but not limited to the following:\n\n               -  Congestive heart failure or uncontrolled angina pectoris, previous history of\n                  myocardial infarction within 1 year from study entry, uncontrolled hypertension,\n                  or dysrhythmias.\n\n               -  Active infection.\n\n               -  Unstable diabetes mellitus.\n\n               -  Psychiatric disorder that may interfere with consent and/or protocol compliance.\n\n          3. Pregnant or breastfeeding women.\n\n          4. Patients with another malignancy in the past 3 years except: curatively treated\n             non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does\n             not require further treatment.\n\n          5. Patients with known HIV, HBV, or HCV infection.\n\n          6. Patients with an underlying diagnosis or disease state associated with an increased\n             risk of bleeding.\n\n          7. Uncontrolled seizure activity.\n\n          8. Patients may not be treated with known CYP3A4 inhibitors or inducers.\n\n          9. Patients with anaplastic oligodendroglioma with 1p/19q deletion or unknown 1p/19q\n             status are excluded.Xx_NEWLINE_xXSuitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received < 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ? 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis).Xx_NEWLINE_xXPost ASCT or current therapy with other systemic anti-neoplastic or investigational agentsXx_NEWLINE_xXPatients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not progestins for management of anorexia while on protocol directed therapy.Xx_NEWLINE_xXPatients who have received prior therapy with any anti-VEGF drug, including bevacizumab.Xx_NEWLINE_xXPatients must not have received systemic chemotherapy or monoclonal antibody therapy within 2 weeks of study enrollment; patients who have previously received bolus nelarabine are still eligible; hydroxyurea or corticosteroids for control of blood counts is allowed, but must be discontinued 24 hours prior to initiating nelarabineXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXSubjects must have a pathologic diagnosis of advanced renal cell carcinoma (RCC), with histological or cytological confirmation of RCC and must have failed at least 1 prior line of anti-VEGF therapy (including but not limited to sunitinib, and/or sorafenib, and/or bevacizumab and/or pazopanib, and/or axitinib) and must not have received prior therapy with a TORC1 inhibitor (such as temsirolimus or everolimus); orXx_NEWLINE_xXPatients who have received more than two prior therapiesXx_NEWLINE_xXPatients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligibleXx_NEWLINE_xXPrior therapyXx_NEWLINE_xXArm D: Refractory to ? 1 regimen containing any anti-CD20-based therapy, including salvage regimens and maintenance rituximab. Refractory subjects are defined as any subject with less than a PR to any prior anti-CD20-based therapies or progressed within 6 months after completing therapy with any anti-CD20-based regimens, including maintenance rituximab. These subjects must not be eligible for hematopoietic SCT or BM transplantXx_NEWLINE_xXPrevious therapy directed against CD19, such as MAbs or MAb conjugatesXx_NEWLINE_xXNo therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 12 months prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids (replacement doses of steroids are allowed), PC-SPES, Saw Palmetto are not permitted at any time during the period that the PSA values are being collectedXx_NEWLINE_xXPrior therapy with anti-angiogenic agents is permittedXx_NEWLINE_xXPrevious use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan; (if the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)Xx_NEWLINE_xXPatients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy; otherwise systemic therapy should be given firstXx_NEWLINE_xXPatients may have received any number of prior therapies, including monotherapy with liposomal doxorubicin or bevacizumabXx_NEWLINE_xXHepatitis A, B and C status will be tested prior to therapy, but results will not exclude patients from participation (if positive, patients will be told they are at higher risk of adverse effects from allogeneic transplantation)Xx_NEWLINE_xXPatients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this studyXx_NEWLINE_xXCurrently taking corticosteroids for therapy of graft-versus-host disease (GVHD)Xx_NEWLINE_xXLow-grade NHL with < 6 month duration of CR between courses of conventional therapyXx_NEWLINE_xXWaldenstrom's macroglobulinemia must have failed 2 courses of therapyXx_NEWLINE_xXPatients who have received a prior allogeneic HCT must have no active GVHD requiring immunosuppressive therapy for at least 21 days prior to start of conditioningXx_NEWLINE_xXPatients who have ASM with eosinophilia and known positivity for the FIP1L1-PDGFR? fusion unless they have demonstrated relapse or disease progression on prior imatinib therapyXx_NEWLINE_xXPrior therapy with DasatinibXx_NEWLINE_xXMust have achieved a minimum response of partial response (PR, nPR, CRi, CR, and MRD-negative CR) (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]) following completion of second-line induction therapy prior to randomization (documentation of response status must be available). Second-line induction therapy must be documented to have been of sufficient duration.Xx_NEWLINE_xXHave two negative medically supervised pregnancy tests prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.Xx_NEWLINE_xXAgree to not donate semen during study drug therapy and for a period after end of study drug therapy.Xx_NEWLINE_xXAgree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. • Agree not to share study medication with another person.Xx_NEWLINE_xXParticipation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.Xx_NEWLINE_xXsubjects with initial presentation of organ confined recurrent prostate cancer (Stages T1c and T2 only) who have been treated with EBRT (conventional, 3D conformal, or IMRT) or proton therapy, two or more years prior, and currently have biopsy proven local recurrence. Previous radiation therapy must be a documented therapeutic dose of 60 to 81Gy or GyE (gray equivalent) for proton therapy;Xx_NEWLINE_xX>90 days post hormone therapy usages, subjects who have or are currently undergoing hormone therapy (GnRH agonist/antagonist) must discontinue hormone therapy and go through a 90 day washout period prior to consideration for study participation, and must remain off hormone therapy throughout the duration of the follow-up period (5 years);Xx_NEWLINE_xXconsidered inappropriate for fludarabine-based therapyXx_NEWLINE_xXNo prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m^2 per day for one week or less) for hyperleukocytosisXx_NEWLINE_xXEach patient will have undergone definitive resection to be eligible for enrollment; this will be followed by standard of care conformal external beam RT with concurrent TMZ; patients are not permitted to have had any other conventional therapeutic intervention other than steroids, or current radiation or TMZ therapy prior to enrollment (TMZ must have been administered > 6 months before enrollment); patients who receive previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies will be excluded and replaced if needed; patients who received immunosuppressive therapy for an autoimmune disorder or an organ transplant and/or require prolonged steroid therapy (> 30 days) will be excludedXx_NEWLINE_xXCutaneous T-cell lymphomas (mycosis fungoides, Sezary syndrome)\r\n* >= Stage III\r\n* Disease progression >= 2 prior regimens, including at least one systemic therapyXx_NEWLINE_xXPatients with cutaneous T-cell lymphomas (e.g. mycosis fungoides, Sezary syndrome) must have:\r\n* Stage III or greater disease\r\n* Disease which has progressed on or failed to respond to at least 2 therapies including one systemic therapyXx_NEWLINE_xXPatients must have had at least one prior therapy to be eligible for either the first or second stage a) Patients are eligible with any number of prior regimens regardless of what those regimens contained (i.e. prior Bortezomib or combination gemcitabine and adriamycin is acceptable).Xx_NEWLINE_xXNo prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy; patients may have received up to 4 months of androgen deprivation therapy (luteinizing hormone releasing hormone [LHRH] agonists, antiandrogens, or both) prior to being enrolled on the studyXx_NEWLINE_xXThyroid dysfunction not responsive to therapyXx_NEWLINE_xXWomen with and without prior therapy are also eligible; priority will be given to those who consent to participating in the pharmacokinetic studiesXx_NEWLINE_xXPrior therapy with E7389 Halichondrin analog (eribulin)Xx_NEWLINE_xXPatient may not have been resistant to any other prior TKI therapy; prior TKI therapy must only have been discontinued due to intoleranceXx_NEWLINE_xXDiagnosis of Ph-positive or Bcr-positive CML in early chronic phase CML (i.e., time from diagnosis 12 months); except for hydroxyurea, patients must have received no or minimal prior therapy, defined as < 1 month (30 days) of prior interferon-alpha (with or without cytarabine) and/or an Food and Drug Administration (FDA)-approved tyrosine kinase inhibitor (TKI); patients with de novo accelerated phase will be treated but analyzed separatelyXx_NEWLINE_xXPatients with B-Cell CLL or PLL who:\r\n* Failed to meet National Cancer Institute (NCI) Working Group criteria 2 for complete or partial response after 2 cycles of therapy with regimen containing fludarabine (or another nucleoside analog, e.g. cladribine [2-CDA], pentostatin) or with disease relapse within 12 months after completing therapy with a fludarabine (or another nucleoside analog) containing regimen\r\n* Failed FCR or pentostatin/cyclophosphamide/rituximab (PCR) combination chemotherapy at any time point\r\n* Patients with novo or acquired “17p deletion” cytogenetic abnormality; patients should have received induction treatment but could be transplanted in 1st CRXx_NEWLINE_xXInclusion Criteria:\n\n        All patients must meet the following inclusion criteria. All tests and eligibility criteria\n        must be completed within four weeks of completion of radiation and chemotherapy, following\n        surgery.\n\n          -  Patients must have sufficient tumor lysate protein that was generated from the\n             surgically obtained tumor material. Patients must also have sufficient DCVax-L product\n             available after manufacturing. These determinations will be made by Cognate\n             BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor,\n             or its designee.\n\n          -  Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this\n             protocol. An independent neuropathologist will review this diagnosis during the\n             enrollment process.\n\n          -  Subjects ?18 and ?70 years of age at surgery who are capable of informed consent.\n             Patients must be able to understand and sign the informed consent documents indicating\n             that they are aware of the investigational nature of this study.\n\n          -  Patients must have a life expectancy of >8 weeks.\n\n          -  Patients must have a KPS rating of ?70 at the baseline visit (Visit 3).\n\n          -  Primary therapy must consist of surgical resection with the intent for a gross or near\n             total resection of the contrast-enhancing tumor mass, followed by conventional\n             external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a\n             biopsy only will be excluded. These primary treatments must be completed at least two\n             weeks prior to first immunization.\n\n          -  Patients may have received steroid therapy as part of their primary treatment. Steroid\n             treatment must be stopped at least 10 days prior to leukapheresis.\n\n          -  Patients must not have progressive disease at completion of radiation therapy.\n             Patients with suspected pseudoprogression will be enrolled and analyzed separately.\n\n          -  Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide\n             essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med\n             352: 987-96, 2005) while being treated with DCVax-L. DCVax-L treatment must be given\n             as described and temozolomide/Temodar treatment schedules must be given essentially\n             according to the Stupp Protocol.\n\n          -  Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white\n             blood count 3600-11,000mm3, absolute granulocyte count ?1,500/mm3, absolute lymphocyte\n             count ?1,000/mm3, and platelet count ?100K/mm3. Eligibility level of hemoglobin can be\n             reached by transfusion.\n\n          -  Adequate liver function (SGPT, SGOT, and alkaline phosphatase ?1.5 times upper limits\n             of normals (ULN) and total bilirubin ?1.5mg/dl), and adequate renal function (BUN or\n             creatinine ?1.5 times ULN) prior to starting therapy.Xx_NEWLINE_xXPatients may have CNS or other sites of extramedullary disease; no cranial irradiation is allowed during the protocol therapyXx_NEWLINE_xXEligible for therapy with either decitabine or azacitidineXx_NEWLINE_xXPrior therapy with modulators of monocyte or TAM function.Xx_NEWLINE_xXPatients with disease of any major organ system that would compromise their ability to withstand therapy.Xx_NEWLINE_xXDocumented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.Xx_NEWLINE_xXPrior therapy with varlilumab or with an anti-CD27 antibody.Xx_NEWLINE_xXReceipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.Xx_NEWLINE_xXProgressive disease despite ongoing androgen deprivation therapy.Xx_NEWLINE_xXPrior therapy with abiraterone, orteronel, ketoconazole, or any other Cytochrome P450 (CYP) 17 lyase inhibitor; enzalutamide or other experimental androgen receptor antagonist; or experimental immunotherapy agent.Xx_NEWLINE_xXBe undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ?6 weeks prior to LAR surgery (Day 0).Xx_NEWLINE_xXEligible for therapy with azacitidine.Xx_NEWLINE_xXProgression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapyXx_NEWLINE_xXPatients who have had prior BMN673 (talazoparib) therapyXx_NEWLINE_xXSubjects who received previous systemic treatment for acute GVHD, except for a maximum of 3 days (72 hours) of 2 mg/kg corticosteroid therapy.Xx_NEWLINE_xXPrior hysterectomyXx_NEWLINE_xXRefractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.Xx_NEWLINE_xXInclusion Criteria:\n\n        Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral\n        blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of\n        care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing\n        residual blast 10-14 days post-induction chemotherapy).\n\n        • Patients that are not candidates to receive standard of care and/or refusing the standard\n        care of therapies will also be considered.\n\n        Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML\n        population (AML with bone marrow or peripheral blast counts 20%):\n\n          -  Cohort 1: Fit to receive intensive remission induction chemotherapy.\n\n          -  Cohort 2: Unfit to receive or not considered a candidate for intensive remission\n             induction chemotherapy.\n\n        Part 1 and 2:\n\n          -  Life expectancy at least 12 weeks.\n\n          -  Hydroxyurea is allowed on study to control total peripheral white blood cell count but\n             must be ceased 24 hours prior to first dose.\n\n          -  Off of prior therapy for 2-4 weeks prior to first dose.\n\n          -  ECOG performance status: 0 to 2.\n\n          -  Resolved acute effects of any prior therapy.\n\n          -  Adequate renal and hepatic function.\n\n        Exclusion Criteria:\n\n          -  Patients with acute promyelocytic leukemia, AML with known central nervous system\n             (CNS) involvement unless the patient has completed treatment for the CNS disease, has\n             recovered from the acute effects of therapy prior to study entry, and is\n             neurologically stable.\n\n          -  Patient is known refractory to platelet or packed red cell transfusions per\n             institutional guidelines.\n\n          -  Prior treatment with a compound targeting CXCR4.\n\n          -  Chronic systemic corticosteroid treatment.\n\n          -  Known or suspected hypersensitivity to recombinant human proteins.\n\n          -  Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin\n             involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort\n             3).\n\n          -  Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3).\n\n          -  Prior treatment with hypomethylating agents or chemotherapy for antecedent\n             myelodysplastic syndrome (MDS) (Part 2, cohort 2)\n\n          -  AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16),\n             or t(15;17) (cohort 2)\n\n          -  Candidates for allogeneic stem cell transplant (Part 2, cohort 2)\n\n          -  Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine\n             or azacitidine or mannitol (Part 2, cohort 2).Xx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while on studyXx_NEWLINE_xXOngoing drug-induced pneumonitis would be exclusion for idelalisib therapy but ibrutinib would be an optionXx_NEWLINE_xXInclusion:\n\n          1. Signed informed consent form (ICF)\n\n          2. Age ? 18 years (Age ? 19 years if required by local regulatory authorities)\n\n          3. ECOG PS of 0-1\n\n          4. Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or\n             primary peritoneal cancer in recurrent stage\n\n          5. prOC (platinum-resistant ovarian cancers) defined as progression within > 1 to < 6\n             months (+ 2 weeks) of completing previous cycle of primary platinum-based therapy, or\n             during or within < 6 months (+ 2 weeks) of starting additional platinum based\n             therapies\n\n          6. Received ? 1 but ? 3 prior platinum-based regimens\n\n          7. Measurable disease according to RECIST 1.1\n\n          8. Left ventricular ejection fraction (LVEF) greater than or equal to at least 45% at\n             baseline assessment if subject is receiving PLD, and/or anthracycline is a concomitant\n             medication\n\n          9. No evidence of active (progressing) brain metastasis. (Treated brain metastasis\n             allowed with a posttreatment magnetic resonance imaging (MRI) or Computed Tomography\n             (CT) of brain showing no active (progressing) brain metastasis). Treatment of brain\n             metastasis may include surgery, radiosurgery (linear accelerator (LINAC), gamma\n             knife), or whole brain irradiation. Surgery for brain metastasis must be > 8 weeks\n             from study entry\n\n         10. Hemoglobin > 9 g/dl. Erythroid growth factors should not have been used in the 2 weeks\n             prior to study entry. Red blood cell transfusions are permitted to maintain the\n             hemoglobin level > 9 g/dl\n\n         11. Adequate bone marrow function in the investigator's opinion\n\n         12. Adequate hepatic function defined by the following:\n\n               -  Total bilirubin < 2 x Upper Limit of Normal (ULN)\n\n               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN\n                  for the referenced lab (< 5 X ULN for subjects with liver metastases)\n\n         13. Adequate renal function defined by the following:\n\n             - Serum creatinine < 2 X ULN for the referenced lab\n\n         14. Subjects of childbearing potential must have a negative serum pregnancy test prior to\n             study entry and must be practicing a highly effective form of contraception\n\n         15. At least 2 weeks since prior radiotherapy and has recovered from any Grade 3\n             toxicities\n\n         16. Life expectancy ? 12 weeks\n\n        Exclusion:\n\n          1. Subjects who have received prior CA4P therapy\n\n          2. Previously having failed treatment with bevacizumab combined with the intended PCC.\n\n             - For clarity: Investigators should not select a bevacizumab + PCC combination for the\n             FOCUS trial if the patient has previously failed that same regimen, however they may\n             select a new PCC regimen to combine with bevacizumab. For example, a patient who\n             failed bevacizumab + weekly paclitaxel would be allowed to enroll in FOCUS only if\n             they are assigned to bevacizumab + PLD for the study.\n\n          3. Previous treatment with greater than three traditional chemotherapy treatment regimens\n\n          4. Untreated brain metastasis or leptomeningeal brain metastasis\n\n          5. Solid organ or bone marrow transplant\n\n          6. Primary platinum-refractory disease (defined as progression during dosing or within\n             one (1) month of completing the last cycle of patients first platinum-containing\n             regimen)\n\n          7. > Grade 2 peripheral neuropathy\n\n          8. Current thrombotic or hemorrhagic disorder/event or history of prior event within 6\n             months of start of Screening\n\n          9. History of prior cerebrovascular event, (including transient ischemic attack) within 6\n             months of start of Screening\n\n         10. Recent history (within 6 months of start of Screening) of angina pectoris, myocardial\n             infarction (including non-Q wave MI), or NYHA Class III and IV congestive heart\n             failure\n\n         11. History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic\n             sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, benign PR\n             interval prolongation only), congenital long QT syndrome or new ST segment elevation\n             or depression or new Q wave on ECG\n\n         12. Known uncontrolled HIV infection\n\n         13. Uncontrolled, clinically significant active infection\n\n         14. Serious non-healing wound, ulcer or bone fracture\n\n         15. Subjects with known hypersensitivity to any of the components of CA4P, paclitaxel,\n             PLD, or bevacizumab (paclitaxel and PLD dependent on whether PI plans they will be\n             dosed with that PCC)\n\n         16. Subjects who are currently or planning on receiving concurrent investigational therapy\n             or who have received investigational therapy for any indication within 30 days of the\n             first scheduled day of dosing\n\n         17. Subjects with any other intercurrent medical condition, including mental illness or\n             substance abuse, deemed by the Investigator to be likely to interfere with a subject's\n             ability to provide informed consent, cooperate and participate in the study, or to\n             interfere with the interpretation of the study results\n\n         18. Subjects with other invasive malignancies, with the exception of non-melanoma skin\n             cancer, or with previous cancer treatment that contraindicates this protocol therapy\n             within last 3 years\n\n         19. Prior radiation therapy to the pelvis or abdomen within 4 weeks of entry into the\n             study\n\n         20. History of fistula, gastrointestinal (GI) perforation or intra-abdominal abscess, or\n             invasive disease/metastases of the bowel which in the investigators opinion may\n             increase the risk of GI perforation with bevacizumab treatment.\n\n         21. Uncontrolled hypertension (HTN)\n\n             - Sustained BP greater than 150 mmHG SBP / 100 mmHG DBP\n\n         22. Uncontrolled elevated proteinuria levels in the investigator's opinion\n\n         23. Corrected QT interval ([QTc] Fridericia) > 480 ms\n\n         24. Significant vascular disease or recent peripheral arterial thrombosis\n\n         25. Subjects with active bleeding or pathologic conditions that carry high risk of\n             bleeding\n\n         26. Subjects who are pregnant or lactatingXx_NEWLINE_xXPatients must have received at least one but no more than 4 prior lines of systemic therapyXx_NEWLINE_xXCastrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapyXx_NEWLINE_xXAny hormonal therapy directed at the tumor must be discontinued at least one week prior to initiation of therapy; continuation of hormone replacement therapies is permittedXx_NEWLINE_xXAny other prior therapy directed at the tumor, including immunologic agents, must be discontinued at least 3 weeks prior to initiation of therapyXx_NEWLINE_xXPatients must have had at least one prior platinum/taxane combination chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatin compound; this initial treatment may include intraperitoneal therapy, high dose therapy, consolidation, noncytotoxic agents, or extended therapyXx_NEWLINE_xXPatients are allowed to receive, but not required to receive biologic (noncytotoxic) therapy as part of their treatment regimen, e.g. bevacizumabXx_NEWLINE_xXIn the unlikely event that patients are still of childbearing potential, these patients must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapyXx_NEWLINE_xXMain inclusion Criteria:\n\n          1. Male or female, at least 18 years of age at the time of informed consent\n\n          2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\n          3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal\n             cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or\n             Neuroblastoma rat sarcoma (NRAS) gene mutations (i.e. tumors must express the KRAS and\n             NRAS wild type (WT), exon 2, 3 and 4).\n\n          4. Failed* treatment for locally advanced or metastatic disease with first-line\n             combination therapy of oxaliplatin and a fluoropyrimidine, with or without\n             bevacizumab, during treatment or < 3 months after the last dose of first-line therapy\n             and within < 3 months of C1/D1.\n\n             Patients who discontinued first-line therapy due to toxicity may be enrolled provided\n             progression occurred < 6 months after the last dose of the first-line therapy regimen.\n\n             or Failed* adjuvant therapy with combination therapy of oxaliplatin and a\n             fluoropyrimidine during treatment or within < 6 months after the last dose of\n             oxaliplatin and within < 6 months of C1/D1.\n\n               -  Failure is defined as radiologic progression\n\n          5. Eligible for FOLFIRI\n\n          6. Measurable disease according to RECIST v1.1\n\n        Main exclusion Criteria:\n\n          1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or\n             irinotecan (CPT-11)\n\n          2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1\n\n          3. Significant gastrointestinal abnormalities\n\n          4. Patients with a significant cardiovascular disease or condition\n\n          5. Abnormal hematologic, renal or hepatic functionXx_NEWLINE_xXPrior treatment with any gene therapy productXx_NEWLINE_xXPrevious therapy with cytotoxic agents for AML; persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or Janus kinase/signal transducers and activators of transcription (JAK/STAT) inhibitors may participate but must have > 1 week off therapy prior to enrollmentXx_NEWLINE_xXPrior therapy:\r\n* There is no waiting period for participants who relapse while receiving therapy if they are free from side effects attributable to such therapy\r\n* Emergent radiation therapy, one dose of intrathecal chemotherapy and up to 7 days of steroids or hydroxyurea are permitted before start of treatment in participants who relapse after completion of frontline therapy; other circumstances must be cleared by principal investigator (PI) or medical designee\r\n* At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for >= 2 weeks, if applicableXx_NEWLINE_xXOngoing immunosuppressive therapy within 14 days prior to the start of study therapy;Xx_NEWLINE_xXSubject has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1. Evaluable target lesions may not have been treated with local therapy; previously treated lesions may only be evaluated as target lesions if they are the only lesions available and have shown objective definite progression after prior treatment. Local therapy must have been completed at least four weeks prior to baseline tumor evaluationXx_NEWLINE_xXPrior therapies:\r\n* Patients may have received one line of non-gemcitabine containing chemotherapy regimen\r\n* Patients may have received prior adjuvant chemotherapy and/or radiation therapy greater than 6 months prior to the time of study enrollment\r\n* Patients may have received “maintenance” therapy, e.g. lower dose capecitabine after completion of adjuvant therapy; this will not be considered as therapy for metastatic disease AND will patients may have been on maintenance therapy within the 6 months prior to initiating gemcitabine plus nab-paclitaxel, i.e. right up until the initiation of first-line therapy for metastatic disease\r\n* Timing of prior therapies:\r\n** At least 14 days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy, and any prior investigational agent\r\n** However, at least 21 days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n** All patients must have completely recovered from all transient side effects related to prior therapies\r\n*** However, any side effects that are expected to be more durable or even permanent (e.g., neurotoxicity or ototoxicity) must have resolved to at least grade 1Xx_NEWLINE_xXPatients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.Xx_NEWLINE_xXPrior therapy with pemetrexedXx_NEWLINE_xXNot a candidate for fludarabine therapy based on either:Xx_NEWLINE_xXRelapse patients should have NOT received chemotherapy for 4 weeks, and no patient should have received nitrosoureas (melphalan, lomustine [CCNU] or mustard); no patient should have received radiation therapy in the previous 42 daysXx_NEWLINE_xXMust have received at least one (1) line of prior systemic therapy that may NOT have included VELCADE (bortezomib)Xx_NEWLINE_xXPrior TherapyXx_NEWLINE_xXPatients to be enrolled in the dose-escalation portion of this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL or T-LL). Patients to be enrolled in the cohort expansion portion of this study (ie, those treated at the recommended phase 2 dose) must have T-cell ALL in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL). T-LL patients are not eligible for the cohort expansion phase.Xx_NEWLINE_xXPatients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they MAY NOT BEGIN TREATMENT ON THIS PROTOCOL UNTIL A MINIMUM OF 7 DAYS HAS ELAPSED SINCE PRIOR INTRATHECAL THERAPY.Xx_NEWLINE_xXPatients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine. For the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years.Xx_NEWLINE_xXPregnant patients may not receive this experimental therapyXx_NEWLINE_xXNo prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are metXx_NEWLINE_xXPatients with will be eligible if they are either in partial response, or have stable disease after no more than two attempts of induction therapyXx_NEWLINE_xXPatients should have finished their prior systemic therapy or radiation therapy, at least 3 weeks before cyclophosphamide or granulocyte colony-stimulating factor (G-CSF)/plerixafor mobilization, and should have finished dexamethasone at least 7 days prior to Plerixafor priming; administration of bisphosphonates needs to be completed at least 2 weeks before cyclophosphamide priming; bisphosphonates can be resumed or started after day 30Xx_NEWLINE_xXFor participation in the Phase II portion, patients must have completed at least one line of prior therapyXx_NEWLINE_xXFor participation in the Phase I portion, patients must have completed either one or two lines of prior therapyXx_NEWLINE_xXTreatment on this protocol may begin as long as the patient has recovered from toxicities of prior therapy at the discretion of the treating physician; patients with non-small cell lung cancer (NSCLC) harboring an EGFR, ALK or ROS-1 alteration must have progressed through at least one prior therapy with appropriate molecularly targeted agentsXx_NEWLINE_xXExpected requirement for hemodialysis while on study therapyXx_NEWLINE_xXReceived >24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drugXx_NEWLINE_xXPatients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRG-analogue therapy for the duration of the trialXx_NEWLINE_xXThe participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the studyXx_NEWLINE_xXPatients must have had 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based fluoropyrimidine-containing chemotherapy plus bevacizumabXx_NEWLINE_xXNo progressive disease at the time of initiation of maintenance therapyXx_NEWLINE_xXAnother experimental anti-amyloid therapy other than NEOD001 within 2 yearsXx_NEWLINE_xXNo more than 4 prior lines of systemic anti-cancer therapy.Xx_NEWLINE_xXAt least 4 months from prior anti-EGFR therapy prior to start of study treatmentXx_NEWLINE_xXHistory of severe anti-EGFR toxicity requiring drug discontinuation or dose-modification within the first 4 months of prior anti-EGFR therapyXx_NEWLINE_xXThe interval from prior treatment to time of study drug administration is at least 1 week (except for hydroxyurea or steroid therapy) with recovery from all prior therapy-related toxicitiesXx_NEWLINE_xXSymptomatic moderate or severe chronic GVHD patients in need of a change of systemic immunosuppressant (IS) therapyXx_NEWLINE_xXImmunosuppressant therapies other than allowed background therapyXx_NEWLINE_xXReceived prior EGFR TKI therapy for recurrent or metastatic SCC (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)Xx_NEWLINE_xXReceipt of at least two line of prior therapy for metastatic renal cell carcinoma (RCC)Xx_NEWLINE_xXOngoing androgen deprivation therapy with an gonadotropin releasing hormone (GnRH) analogue or prior bilateral orchiectomy (medical or surgical castration). For patients who have not had bilateral orchiectomy, there must be a plan to maintain effective GnRH-analogue for the duration of the trial.Xx_NEWLINE_xXProgressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapyXx_NEWLINE_xXHistologically confirmed DLBCL, cluster of differentiation (CD)20 positive by flow or immunohistochemistry (IHC); transformed DLBCL is allowed as long as no prior therapy has been givenXx_NEWLINE_xXNo prior therapy for DLBCL, except =< 1 week of corticosteroids given on an emergent basis or as a temporizing measure (pre-phase where indicated by the treating physician)Xx_NEWLINE_xXPrior therapy for DLBCLXx_NEWLINE_xXIntrathecal therapy with cytarabine is allowed prior to registration for patient convenience; systemic chemotherapy must begin within 72 hours of the first intrathecal treatmentXx_NEWLINE_xXFor patients enrolled to Phase II Cohort B: Previous administration of vaccine therapy targeting NY-ESO-1.Xx_NEWLINE_xXCurrent, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.Xx_NEWLINE_xXHas brain metastasis, unless has completed definitive therapy, is not on steroids, has a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and does not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.Xx_NEWLINE_xXDocumented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.Xx_NEWLINE_xXPrior therapy with an anti-CD27 antibody.Xx_NEWLINE_xXHistory of prior therapy with belinostat or AZD1775Xx_NEWLINE_xXMust have previously received at least one prior chemotherapeutic regimen for RT.Xx_NEWLINE_xXMost prior therapies and prior targeted therapy are allowed and these specific therapies are detailed in the protocol.Xx_NEWLINE_xXNo systemic antineoplastic therapy may have been received between the time of biopsy and the first administration of study treatment.Xx_NEWLINE_xXPrior therapy with IL-12 or prior gene therapy.Xx_NEWLINE_xXPrior therapy:Xx_NEWLINE_xXPrior treatment with CAT-3888 (BL22), moxetumomab pasudotox (CAT-8015, HA22), any pseudomonas-exotoxin-containing compound, or any anti-CD22 directed therapy at any time in the pastXx_NEWLINE_xXPrior allogeneic or autologous HCT or adoptive cellular therapies, including T-cell chimeric antigen receptor (CAR) therapyXx_NEWLINE_xXPatients must be in a documented CR/CRi from either their front-line or first salvage therapy as evidenced by =< 5% bone marrow blasts and absence of extramedullary disease; (for patients with prior MDS who then transformed to AML, therapy received for MDS is not considered prior therapy for AML)Xx_NEWLINE_xXHistory of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)Xx_NEWLINE_xXPatients must not have received any non-cytotoxic therapy for management of recurrent or persistent disease, except hormonal based therapy is allowed; patients are allowed to have previously received, but are not required to have received non-cytotoxic therapy as part of their primary treatment regimenXx_NEWLINE_xXPrior treatment with taxanes if given as full-dose chemotherapy for advanced disease; as neoadjuvant therapy, taxanes cannot be used in 6 months prior to enrollmentXx_NEWLINE_xXCurrent anticoagulant therapy (acetylsalicylic acid [ASA] =< 325 mg per day allowed)Xx_NEWLINE_xXFor the phase I portion of the study, patients who had received prior therapy with nilotinib should have been able to tolerate the dose equivalent to the starting dose of nilotinib in the dose level at which the patient is being entered; patients who previously received nilotinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3 or 4 toxicity not responding to optimal managementXx_NEWLINE_xXPatients must have been off all prior therapy for CML for 2 weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, dasatinib, ponatinib and bosutinib), which should be discontinued 48 hours (hrs) prior to the start of therapy; patients who are receiving nilotinib prior to enrollment do not have to discontinue this agent prior to start of study therapyXx_NEWLINE_xXDefinitive therapy of the primary uveal melanoma must have been performed within 120 days of initiating protocol therapyXx_NEWLINE_xXMust have received at least 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject. DLBCL Dose Expansion Arm:Xx_NEWLINE_xXMust have received at least 2 prior therapies, including a CD20 targeted therapy, alkylating agent or corticosteroid; subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) are eligible with exposure to at least 1 prior therapy. Waldstrom's Macroglobulinemia Dose Expansion Arm:Xx_NEWLINE_xXInclusion Criteria:\n\n        For patients with solid tumors:\n\n          -  documented cKit-positive neoplasms\n\n          -  Patient must have progressive disease as defined by any of the following:\n\n          -  SCLC: patient has progressed after at least 1 prior therapy\n\n          -  GIST : patient has relapsed or has refractory disease, and no further approved\n             effective therapeutic option exists\n\n          -  Patients with other cKit-positive solid tumors: patient has progressed after at least\n             one prior line of therapy and no further approved effective therapeutic option exists\n\n          -  Patient has measurable disease as per RECIST v1.1 criteria\n\n        For patients with AML:\n\n          -  documented cKit-positive acute myelogenous leukemia\n\n          -  Consent to newly obtained bone marrow aspirate\n\n          -  Patient must have progressive disease defined as relapsed or refractory non-PML AML\n             following standard therapy or for whom no effective therapy exists.\n\n          -  Blast count < 50,000/mm3\n\n        Exclusion Criteria:\n\n        For patients with solid tumors:\n\n          -  Patient has central nervous system (CNS) metastatic involvement unless the CNS\n             metastases have been previously treated and the patient is clinically stable and on a\n             stable dose of corticosteroids for at least 4 weeks prior to enrollment.\n\n          -  Patient has the presence of other clinically significant hematologic, cardiac,\n             respiratory, gastrointestinal, renal, hepatic or neurological conditions.\n\n          -  Patient has a history of serious allergic reactions, which in the opinion of the\n             investigator may pose an increased risk of serious infusion reactions\n\n          -  Patient has been previously treated with cKit directed antibodies\n\n          -  Pregnant or nursing women\n\n        For patients with AML:\n\n          -  Patient has received prior allogeneic bone marrow transplant (BMT).\n\n          -  Patient has the presence of other clinically significant cardiac, respiratory,\n             gastrointestinal, renal, hepatic or neurological disease\n\n          -  Patient has a history of serious allergic reactions, which in the opinion of the\n             investigator may pose an increased risk of serious infusion reactions\n\n          -  Patient has been previously treated with cKit directed antibodies\n\n          -  Pregnant or nursing womenXx_NEWLINE_xXSubjects who received prior anthracycline therapyXx_NEWLINE_xX1 to 2 prior therapiesXx_NEWLINE_xXFirst or subsequent relapse following at least one induction therapy regimen containing rituximab in combination with an anthracycline or rituximab in combination with an alkylating agentXx_NEWLINE_xXNo response or disease progression ? 24 months from start of last previous therapyXx_NEWLINE_xXRefractory to rituximab: defined as disease progression while receiving or within 6 months of completing either weekly rituximab induction therapy, or rituximab-based chemoimmunotherapy inductionXx_NEWLINE_xXFor Phase I: For treatment-experienced patients, the following washout periods are required prior to enrollment on the study: 2 weeks wash out after prior local therapy (such as radiation therapy or intra-lesional therapy), 4 weeks wash out after cytotoxic therapy or high dose interleukin-2, and 6 weeks wash out after anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy; for all other therapy not mentioned, a wash out period of at least 5 half-lives will be neededXx_NEWLINE_xXFor Phase II: Any prior systemic therapy for locally advanced or metastatic melanoma; prior local therapy such as radiation or intratumoral injection is allowed; previous systemic treatment for any stage III disease that was subsequently rendered NED (no evidence of disease) by surgery is allowedXx_NEWLINE_xXPatients who have received prior immunotherapiesXx_NEWLINE_xXInclusion Criteria:\n\n        Male or Female, age ? 18 years Patients with higher risk MDS with a blast count < 20% at\n        the time of screening IPSS Int-2 or High Risk Serum Ferritin ? 300 ng/mL at screening.\n\n        Sexually active women must use an effective method of contraception, or must have undergone\n        clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be\n        postmenopausal (defined as amenorrhea for at least 12 months)\n\n        Exclusion Criteria:\n\n        Patients currently receiving any therapy other than AZA for MDS (a ? 4 week washout period\n        for any agent (excluding AZA) used to treat MDS prior to first dose of study treatment is\n        required).\n\n        Patients who have received > 2 cycles of AZA or decitabine at the time of randomization.\n        Patients who have received iron chelation therapy within 1 month of screening.\n\n        Patients who have received growth factors within 1 month of screening. Patients who have\n        received Revlimid within 1 month of screening. Patients who have undergone hematopoietic\n        stem cell transplant. ECOG Performance Status > 2 Systemic diseases (cardiovascular, renal,\n        hepatic, etc.) which would prevent study treatment Patients with uncontrolled systemic\n        hypertension Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or\n        unstable cardiac or coronary artery disease not controlled by standard medical therapy\n        Patients with a diagnosis of or history of clinically relevant ocular toxicity related to\n        iron chelation Diagnosis of liver cirrhosis (either established diagnosis or diagnosis by\n        liver biopsy or central ultrasound reading) Clinical or laboratory evidence of active\n        Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA\n        positive and ALT above the normal range). History of HIV positive test result (ELISA or\n        Western blot) Presence of a surgical or medical condition which might significantly alter\n        the absorption, distribution, metabolism or excretion of study drug Patients with an active\n        malignancy (currently or within the past two years) with the exception of basal cell skin\n        carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in\n        situ. History of drug or alcohol abuse within the 12 months prior to enrollment. History of\n        non-compliance to medical regimens or patients who are considered potentially unreliable\n        and/or not cooperative.\n\n        Patients with a known hypersensitivity to azacitidine, mannitol, or deferasirox. Calculated\n        creatinine clearance <40mL/min Serum creatinine greater than 1.5x ULN at screening Urine\n        protein/creatinine ratio> 1 AST or ALT greater than 3x ULN at screening Direct Bilirubin\n        greater than 1.5x ULN at screening. Patients who received treatment with systemic\n        investigational drug within the past 4 weeks or topical investigational drug within the\n        past 7 days or are planning to receive other investigational drugs while participating in\n        the study Patients participating in another therapeutic clinical trial Pregnant or nursing\n        (lactating) women, where pregnancy is defined as the state of a female after conception and\n        until the termination of gestation, confirmed by a positive hCG laboratory test. Women of\n        child-bearing potential, defined as all women physiologically capable of becoming pregnant,\n        unless they are using effective methods of contraception during dosing of study treatment.\n        Sexually active males unless they use a condom during intercourse while taking drug and for\n        3 months after stopping AZA and should not father a child in this period.Xx_NEWLINE_xXMetastatic disease that has progressed on previous therapy or previous therapy was not toleratedXx_NEWLINE_xXSubjects in the Phase 1b portion and in Group 1 and Group 3 of the Phase 2a portion may have received any number of prior therapies for breast cancer. Subjects in Group 2 of the Phase 2a portion may have received up to 3 lines of therapy in the metastatic setting (not including adjuvant or neoadjuvant therapy)Xx_NEWLINE_xXMust have included trastuzumab, pertuzumab, and trastuzumab emtansine. Subjects starting initial systemic therapy for HER2-positive breast cancer prior to June 2012 are not required to have had pertuzumabXx_NEWLINE_xXOngoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the studyXx_NEWLINE_xXTherapy with other hormonal therapy, including any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES) within 4 weeks prior to receiving first dose of study drug.Xx_NEWLINE_xXSecond-line or higher therapy for any patients with NSCLC with performance status (PS) 0-2Xx_NEWLINE_xXTherapy that does not include cisplatin, carboplatin, gemcitabine, and/or pemetrexedXx_NEWLINE_xXPreviously untreated AML (>= 20% blasts) or AML M6; patients with high-risk (intermediate-2 or\r\nhigh by International Prognostic Scoring System [IPSS] or >= 10% blasts) MDS will also be eligible; prior therapy with hydroxyurea, biological or targeted therapy (e.g. fms-related tyrosine kinase 3 [flt3] inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed; no prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m^2) for emergency use is also allowed as prior therapyXx_NEWLINE_xXAll participants must be on antiretroviral therapy for HIV infection with CD4 count > 50/mm^3 and viral load < 50 copies/mL; participants must be on a stable antiretroviral therapy (ART) regimen that includes at least three agents, as defined below\r\n* If antiretroviral regimen contains zidovudine or strong cytochrome P450, family 3, subfamily A, polypeptide 4 (Cyp3A4) inhibitors (e.g. ritonavir or cobicistat-boosted protease inhibitors) and viral load is suppressed (as measured by HIV viral load =< 50/mL), then antiretroviral therapy must be adjusted to a less toxic therapy not containing these antivirals and must demonstrate stability for at least 4 weeks prior to enrollment\r\n* If on antiviral therapy with zidovudine or protease inhibitors, and viral load is not suppressed (as measured by HIV viral load > 50 copies/mL), then antiretroviral therapy must be adjusted to a less toxic regimen allowing for optimal viral suppression and must demonstrate stability for at least 12 weeks prior to enrollment\r\n* Allowable antiretrovirals include nucleoside or nucleotide inhibitors other than zidovudine, non-nucleoside reverse transcriptase inhibitors including efavirenz, etravirine, rilpivirine, and nevirapine, integrase inhibitors raltegravir or dolutegravir, or entry inhibitors maraviroc or enfuvirtideXx_NEWLINE_xXConcurrent neoplasia requiring cytotoxic therapyXx_NEWLINE_xXRelapsed or refractory B-ALL due to receive salvage 1, 2, 3, 4, 5, or 6; half of the patients, i.e. 5 out of the first 10 patients, and 5 out of 10 patients thereafter, need to be in earlier line of salvage therapy, defined as 1st, 2nd, or 3rd line of salvage therapy; Philadelphia chromosome-positive (Ph+) B-ALL patients must have failed treatment with at least 1 second generation tyrosine kinase inhibitor; patients in salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy; patients with ALL of T cell origin (T-ALL) can not be treatedXx_NEWLINE_xXParticipants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriateXx_NEWLINE_xXPrevious treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and no contraindication, an anti-EGFR therapy.Xx_NEWLINE_xXSix weeks must have elapsed from the time of any antibody therapy that could affect an anti-cancer immune response, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody therapy at the time the patient receives the preparative regimen to allow antibody levels to decline; note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsiesXx_NEWLINE_xXPatients must have received prior fluoropyrimidine, oxaliplatin and irinotecan-based therapy for their disease and had progression or intolerance to these agents that resulted in treatment discontinuationXx_NEWLINE_xXInclusion Criteria:\n\n          1. Male or female patients, > 18 years of age at the time of obtaining informed consent.\n\n          2. Patients with a documented solid tumor malignancy that is locally advanced or\n             metastatic; patients with documented multiple myeloma or non-Hodgkin's lymphoma.\n\n          3. Patients with a malignancy that is either refractory to standard therapy or for which\n             no standard therapy is available.\n\n          4. Patients with a malignancy that is currently not amenable to surgical intervention due\n             to either medical contraindications or non-resectability of the tumor.\n\n          5. Dose escalation portion of study: Patients with measurable or non-measurable disease\n             according to standard response criteria .\n\n          6. MTD Biopsy Cohort ONLY: Patients with measurable disease with primary or metastatic\n             tumor site(s) considered safely accessible for biopsy; patients must consent to\n             undergo 2 tumor biopsies.\n\n          7. MTD PNET Cohort ONLY: Patients with advanced (unresectable or metastatic),\n             histologically-confirmed low or intermediate grade PNET according to the World Health\n             Organization (WHO) 2010 classification. Patients with neuroendocrine tumors (e.g.,\n             gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary is strongly\n             suspected are also eligible. Patients must also have:\n\n               -  A Ki-67 proliferation index < 20%\n\n               -  Demonstrated radiological evidence of disease progression during or following the\n                  last treatment regimen (based on CT, MRI, or Octreoscan®)\n\n               -  Measurable disease according to RECIST v1.1 (determined by CT or MRI). Any\n                  lesions which have been subjected to percutaneous therapies or radiotherapy\n                  should not be considered measureable, unless the lesion has clearly progressed\n                  (per RECIST v1.1) since the procedure.\n\n               -  Received < 2 prior systemic treatments for PNET, at least one of which must have\n                  been an FDA-approved targeted therapy for PNET (i.e., sunitinib [Sutent®] or\n                  everolimus [Afinitor®]). Treatment with a somatostatin analog (SSA) will not be\n                  considered as a systemic treatment for the purposes of eligibility.\n\n          8. Patients with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2,\n             and an anticipated life expectancy of ? 3 months.\n\n          9. Patients, both male and female, who are either not of childbearing potential or who\n             agree to use a medically effective method of contraception during the study and for 3\n             months after the last dose of study drug.\n\n         10. Patients with the ability to understand and give written informed consent for\n             participation in this trial, including all evaluations and procedures as specified by\n             this protocol.\n\n        Exclusion Criteria-Patients:\n\n          1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and\n             fertile men with a WOCBP-partner not using and not willing to use a medically\n             effective method of contraception.\n\n          2. Patients with known central nervous system (CNS) or leptomeningeal metastases not\n             controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS\n             involvement for which treatment is required.\n\n          3. Patients with leukemia (any form) or myelodysplastic syndromes.\n\n          4. MTD PNET Cohort ONLY: Patients with poorly differentiated, high grade (grade 3)\n             neuroendocrine carcinoma, as well as patients with adenocarcinoid, goblet cell\n             carcinoid, or small cell carcinoma, or PNET patients with a Ki-67 proliferation index\n             > 20 %.\n\n          5. Patients with any of the following hematologic abnormalities at baseline:\n\n               -  Absolute neutrophil count < 1,500 per mm3\n\n               -  Platelet count < 100,000 per mm3\n\n          6. Patients with any of the following serum chemistry abnormalities at baseline:\n\n               -  Total bilirubin > 1.5 × the ULN for the institution\n\n               -  AST or ALT > 3 × the ULN for the institution (> 5 × if due to hepatic involvement\n                  by tumor)\n\n               -  Creatinine > 1.5 × ULN for the institution\n\n          7. Patients with any of the following coagulation parameter abnormalities at baseline:\n\n               -  PT (INR) > 1.5 × ULN for the institution\n\n               -  PTT > 1.5 × ULN for the institution\n\n          8. Patients with:\n\n               -  Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism,\n                  within 6 months prior to first study drug administration; patients receiving\n                  systemic anti-coagulation for prophylactic or therapeutic reasons\n\n               -  Active uncontrolled bleeding or a known bleeding diathesis\n\n          9. Patients with a significant cardiovascular disease or condition, including:\n\n               -  Congestive heart failure currently requiring therapy\n\n               -  Need for antiarrhythmic medical therapy for a ventricular arrhythmia\n\n               -  Severe conduction disturbance (e.g., 3rd degree heart block)\n\n               -  Angina pectoris requiring therapy\n\n               -  Known left ventricular ejection fraction < 50% by MUGA or echocardiogram\n\n               -  QTc interval > 450 msec in males, or > 470 msec in females\n\n               -  Uncontrolled hypertension (per the Investigator's discretion)\n\n               -  Class III or IV cardiovascular disease according to the New York Heart\n                  Association's Functional Criteria.\n\n               -  Myocardial infarction within 6 months prior to first study drug administration\n\n         10. Patients with a known or suspected hypersensitivity to any of the components of lipid\n             nanoparticle-formulated DCR-MYC.\n\n         11. Patients with a known history of human immunodeficiency virus or active infection with\n             hepatitis B virus or hepatitis C virus.\n\n         12. Patients with any other serious/active/uncontrolled infection, any infection requiring\n             parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first\n             study drug administration.\n\n         13. Patients with inadequate recovery from an acute toxicity associated with any prior\n             antineoplastic therapy.\n\n         14. Patients with inadequate recovery from any prior surgical procedure, or patients\n             having undergone any major surgical procedure within 4 weeks prior to first study drug\n             administration.\n\n         15. Patients with any other life-threatening illness, significant organ system\n             dysfunction, or clinically significant laboratory abnormality, which, in the opinion\n             of the Investigator, would either compromise the patient's safety or interfere with\n             evaluation of the safety of the study drug.\n\n         16. Patients with a psychiatric disorder or altered mental status that would preclude\n             understanding of the informed consent process and/or completion of the necessary\n             study-related evaluations.\n\n         17. Patients with the inability or with foreseeable incapacity, in the opinion of the\n             Investigator, to comply with the protocol requirements.\n\n        Exclusion Criteria-Treatments:\n\n          1. MTD PNET Cohort ONLY: Greater than 2 prior systemic treatments for the underlying\n             malignancy\n\n          2. Any antineoplastic agent for the primary malignancy (standard or experimental) within\n             4 weeks prior to first study drug administration with the exception of monoclonal\n             antibody therapy, nitrosoureas, and nitrogen mustard for the primary malignancy within\n             6 weeks prior to first study drug administration\n\n          3. Radiotherapy for the primary malignancy within 4 weeks prior to first study drug\n             administration and during study.\n\n          4. Herbal preparations or related over-the-counter preparations/supplements containing\n             herbal ingredients within 2 weeks prior to first study drug administration and during\n             study.\n\n          5. Systemic hormonal therapy within 2 weeks prior to first study drug administration and\n             during study.\n\n          6. Any other investigational treatments during study. This includes participation in any\n             medical device or therapeutic intervention clinical trials.\n\n          7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study\n             drug administration and during Cycle 1 of study; thereafter prophylactic use of growth\n             factors is allowed as clinically indicated.Xx_NEWLINE_xXHistory of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicityXx_NEWLINE_xXPatients may not have received more than 4 prior regimens of therapyXx_NEWLINE_xXPreviously received photodynamic therapy for cholangiocarcinomaXx_NEWLINE_xXRelapsed/refractory disease failing >= 2 prior therapies; an exception is patients with KS, where patients can be previously untreated, relapsed/refractory to one or more prior therapies, or intolerant of a prior therapyXx_NEWLINE_xXPatients must have received at least two lines of systemic therapy for breast cancer in the metastatic setting; patients who are hormone receptor positive must have received at least one line of hormonal therapy AND one line of chemotherapy in the metastatic settingXx_NEWLINE_xXSix weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-cytotoxic T-lymphocyte-associated protein (CTLA)4 antibody therapy, at the time the patient receives the preparative regimen to allow antibody levels to decline \r\n* Note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsiesXx_NEWLINE_xXPatients are permitted to have received prior therapy, but must have received a minimum of 30 Gy to the chest wall with a minimal interval since completion of radiation therapy equal to or greater than 6 months; patients who have previously received more than one course of radiotherapy to the breast and/or chest wall OR have received a cumulative dose to the chest wall in excess of 70 Gy will not be considered eligibleXx_NEWLINE_xXPatients who have received prior chemotherapy are allowed, provided they have been off systemic therapy for 21 days and all acute toxicities have resolved to less than grade 2; patients who have received paclitaxel within 3 months of study entry and have developed documented progressive disease despite therapyXx_NEWLINE_xXPatients who are actively receiving other cytotoxic or antibiologic chemotherapies; for patients with Her-2/neu positive disease, trastuzumab (Herceptin) is NOT ALLOWED on this study, and should be withheld during the 8 weeks of therapy, and can be resumed no sooner than 14 days following completion of protocol therapyXx_NEWLINE_xXReceived more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.Xx_NEWLINE_xXReceipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.Xx_NEWLINE_xXNo prior therapy for AML except hydroxyurea to control countsXx_NEWLINE_xXSubject has attempted \best\ medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classesXx_NEWLINE_xXHas not received systemic therapy for prostate cancer (i.e. luteinizing-hormone-releasing hormone [LHRH] agonist/antagonist therapy)Xx_NEWLINE_xXPrior systemic treatment for advanced liver cancer other than sorafenib-including therapyXx_NEWLINE_xXPatients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient’s last prior therapy before initiation of treatment on clinical trialXx_NEWLINE_xXPatients with previously treated ALL (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (CD22) are also eligible to participate; pediatric patients younger than 18 may be considered with sponsor approval once the MTD has been established in the adult populationXx_NEWLINE_xXMonoclonal antibody therapy less than 1 monthXx_NEWLINE_xXEvidence of continuing adverse effect of prior therapyXx_NEWLINE_xXPrior therapy with an hypoxic cytotoxinXx_NEWLINE_xXMeets the requirements for HD IL-2 therapy per Institutional guidelinesXx_NEWLINE_xXMeets the requirements for ipilimumab therapy per Institutional guidelinesXx_NEWLINE_xXReceived prior HD IL-2 therapy.Xx_NEWLINE_xXUnresolved immune related adverse events following prior biological therapy.Xx_NEWLINE_xXPrior therapy defined as 1 prior systemic therapy for advanced diseaseXx_NEWLINE_xXPatients must be clinically suitable for cryoablation therapyXx_NEWLINE_xXPrior antiangiogenic therapy (e.g., Bevacizumab/Avastin)Xx_NEWLINE_xXNo documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosisXx_NEWLINE_xXPatients with any history of brain or bone metastasis or who have developed progressive disease on first line 5-FU based therapyXx_NEWLINE_xXSubjects must have discontinued additional hormonal (eg bicalutamide, abiraterone, estrogen) therapy prior to the first dose of cabozantinib; no anti-androgen withdrawal period is requiredXx_NEWLINE_xXSubjects who are currently on gonadotropin-releasing hormone (GnRH) agonists or antagonist therapy must continue androgen suppressionXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet ALL of the following criteria to be eligible for inclusion into the\n        study.\n\n          -  Histological or cytological diagnosis of adenocarcinoma of the prostate\n\n          -  Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or\n             bone scan\n\n          -  Currently receiving abiraterone acetate and prednisone and meeting the following\n             criteria:\n\n               -  Any PSA decline within 12 weeks from initiation of abiraterone acetate\n\n               -  Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone\n                  (10-20 mg oral daily)\n\n               -  PSA progression, defined as an increase in PSA which is ?25% above the nadir and\n                  an absolute value of ?2 ng/mL, which is confirmed by a second value ?2 weeks\n                  later.\n\n               -  No evidence of symptomatic or radiographic progression that would require\n                  alternative therapy (e.g., needing radiation therapy for pain or significant\n                  progression of visceral metastases or >33% increase in daily opioid use within 2\n                  weeks prior to randomization).\n\n          -  All patients who have not had a surgical orchiectomy must continue treatment with a\n             luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a\n             castrate level of testosterone.\n\n          -  Patient must fulfill \Prior Therapy\ criteria as follows:\n\n               -  Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant\n                  prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have\n                  passed since the last dose of chemotherapy.\n\n               -  Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is\n                  required.\n\n               -  Experimental therapy: prior non-cytotoxic experimental therapy is permitted\n                  provided a minimum of at least 14 days has passed since completing therapy. Prior\n                  treatment with enzalutamide (MDV3100) is allowed.\n\n               -  Radiation: prior external beam radiation is permitted provided a minimum of at\n                  least 14 days have passed since completing radiotherapy (exception for\n                  radiotherapy: at least 7 days since completing a single fraction of ?800 cGy to a\n                  restricted field or limited-field radiotherapy to non-marrow bearing area such as\n                  an extremity or orbit) at the time of randomization\n\n          -  Must be willing to use effective contraception throughout study treatment and for 3\n             months after completion of study treatment if able to father a child.\n\n          -  Must be willing not to change (add or subtract) bone protecting therapy\n             (bisphosphonates and/or denosumab) during the study unless changed for toxicity.\n\n          -  Written informed consent must be obtained prior to any protocol-specific procedures\n             being performed.\n\n        Exclusion Criteria:\n\n        Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion\n        into the study:\n\n          -  Currently receiving abiraterone acetate in combination with any other anti-cancer\n             agent (except prednisone)\n\n          -  Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain\n             imaging for asymptomatic patients is not required.)\n\n          -  Cord compression requiring surgery or radiation therapy while on abiraterone treatment\n\n          -  Active second malignancy (including lymphoid malignancies such as chronic lymphocytic\n             leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy\n             or at high risk of recurrence during the study; not including adequately treated non\n             melanomatous skin cancer or other solid tumors curatively treated with no evidence of\n             disease in > 3 years\n\n          -  History of allergic reactions to therapeutic antisense oligonucleotides\n\n          -  Active autoimmune disease requiring treatment\n\n          -  Participated in a prior Phase 3 clinical study evaluating custirsen regardless of\n             study arm assignment (i.e., either control or investigational arm), or prior exposure\n             to OGX-427\n\n          -  Uncontrolled medical conditions such as myocardial infarction, uncontrolled\n             hypertension, stroke or treatment of a major active infection within 3 months of\n             randomization, as well as any significant concurrent medical illness that in the\n             opinion of the Investigator would preclude protocol therapy\n\n          -  Planned concomitant participation in another clinical trial of an experimental agent,\n             vaccine, or device. Concomitant participation in observational studies is acceptable.Xx_NEWLINE_xXRelapsed or relapse/refractory MM with at least 1 prior line of therapy for phase 1 and 1 to 5 prior lines of therapy for phase 2.Xx_NEWLINE_xXENTRY CRITERIA:\n\n        DISEASE CHARATERISTICS:\n\n          -  Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at\n             least two different previous regimens.\n\n               -  Refractory disease is defined as progressive disease while on therapy or\n                  progression within 60 days of therapy.\n\n               -  Progressive disease is defined by a 25% increase from the lowest response value\n                  in specified tests.\n\n          -  Measurable disease as defined by at least one of the following:\n\n               -  Serum M-protein ? 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)\n\n               -  Urine M-protein ? 200mg/24hours\n\n               -  Serum free light chains ? 10 mg/dL and abnormal kappa/lambda ratio\n\n        PRIOR/CONCURRENT THERAPY:\n\n          -  No anti-myeloma treatments within 28 days before the start of study treatment.\n\n          -  Must have recovered from side effects of prior treatments.\n\n        PATIENT CHARACTERISTICS:\n\n        Age\n\n        • ? 18 years\n\n        Performance Status\n\n        • ECOG 0, 1, or 2\n\n        Bone Marrow Reserve\n\n          -  Absolute neutrophil count (AGC/ANC) ? 1,000/uL\n\n          -  Platelets ? 30,000/uL\n\n          -  Hemoglobin ? 8g/dL\n\n        Renal Function\n\n        • Glomerular Filtration Rate (GFR) > 45mL/min/1.73m^2\n\n        Hepatic Function\n\n          -  Total bilirubin ? 2.0 X ULN\n\n          -  AST, ALT, ALP ? 3.0 X ULN, or ? 5.0 X ULN (if liver metastases exist)\n\n        Cardiovascular\n\n          -  No congestive heart failure < 6 months\n\n          -  No unstable angina pectoris < 6 months\n\n          -  No myocardial infarction < 6 months\n\n          -  No history of ventricular arrhythmias\n\n          -  No history of supraventricular arrhythmias\n\n          -  No NYHA Class > II CHF\n\n          -  Normal Transthoracic Echocardiogram (TTE) is required for patients with history of EKG\n             abnormalities, CHF, coronary artery disease or other cardiac disease, or with a\n             history of having received adriamycin or doxorubicin\n\n          -  Patients with a left ventricular ejection fraction (LVEF) of less than 50% will be\n             excluded from study entry\n\n        Pulmonary\n\n        • Normal clinical assessment of pulmonary function\n\n        Other\n\n          -  Negative serum pregnancy test if female and of childbearing potential\n\n          -  Women who are not pregnant or nursing\n\n          -  Subjects, both females and males, with reproductive potential must agree to use\n             effective contraceptive measures for the duration of the study\n\n          -  No known autoimmune disease other than corrected hypothyroidism\n\n          -  No known prior organ allograft or allogeneic transplantation\n\n          -  Not HIV positive\n\n          -  No history or evidence of uncontrollable CNS disease\n\n          -  No psychiatric illness/social situation\n\n          -  No other illness that in the opinion of the investigator would exclude the subject\n             from participating in the study\n\n          -  Must provide informed consent and HIPPA authorization and agree to comply with all\n             protocol-specified procedures and follow-up evaluations\n\n          -  Active systemic infection requiring parenteral antibiotic therapy.\n\n          -  No ongoing chronic systemic steroid therapy required.Xx_NEWLINE_xXInclusion Criteria:\n\n        3.1.1 First-line treatment of metastatic colorectal cancer with 3 or more metastases\n        3.1.2At least 10 cycles of combination therapy with an oxaliplatin or irinotecan based\n        regimen per institutional preference (patients may receive 6 cycles, go to surgery, then\n        complete 4 cycles, they may complete all 10 (or more) prior to surgery, or receive any\n        combination as long as they receive at least 10 cycles. ) 3.1.3 Resection or ablation of\n        all metastatic sites that have not achieved complete response with perioperative therapy\n        (regimen). The sequencing of resection, ablation, and 10-12 cycles of combination therapy\n        (regimen) with an oxaliplatin or irinotecan based regimen may be performed according to\n        standard institutional procedure.\n\n        3.1.4 Patients achieving a complete response in a metastatic site by stereotactic body\n        radiation are eligible if the site was not easily accessible by surgery or ablation and a\n        complete response was achieved.\n\n        3.1.5 No severe, uncontrolled concurrent illness that would interfere with protocol\n        therapy.\n\n        3.1.6 No known CNS disease 3.1.7 ECOG Performance Status 0-2 3.1.8 No chemotherapy or\n        radiation therapy within last 3 weeks 3.1.9 For patients who had 3 months of perioperative\n        therapy (regimen), then surgery, then 3 months of therapy (regimen), patients must be off\n        therapy for no more than 8 weeks prior to randomization. For patients who had all their\n        therapy and then surgery, they must be no more than 8 weeks from surgery prior to\n        randomization.\n\n        3.1.10 No concurrent anticancer therapy. 3.1.11 Absolute neutrophil count ? 1,500/uL, Hgb >\n        9.0 g/dl, platelet ? 100,000/uL.\n\n        3.1.12 Total bilirubin ? 1.5x upper limit of normal (ULN) and AST or ALT ? 5x ULN; 3.1.13\n        Creatinine < 1.5 x ULN 3.1.14 Life expectancy of at least 12 weeks. 3.1.15 Age ? 18 years\n        3.1.16 Women of childbearing potential must have a negative pregnancy test. 3.1.17 Men and\n        women of childbearing potential must be willing to consent to using effective contraception\n        while on treatment and for at least 3 months thereafter.\n\n        3.1.18 Voluntary written informed consent.\n\n        Exclusion Criteria:\n\n        3.2.1 Residual metastatic disease after resection/ablation 3.2.2 Clinically significant\n        cardiac disease (e.g., uncontrolled hypertension [blood pressure of >160/90 mmHg on\n        medication], history of myocardial infarction within 6 months,), New York Heart Association\n        (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia.\n        Patients with an atrial arrhythmia must have this condition well controlled on stable\n        medication. Patients with current or recent (within 6 months) unstable angina are also not\n        eligible. Documentation of cardiac medical history to be provided.\n\n        3.2.3 Significant bleeding diathesis or coagulopathy 3.2.4 History of cerebral aneurysms or\n        cerebral arteriovenous malformations. 3.2.5 Patients with recent (within 12 months)\n        arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular\n        accident (CVA), or clinically significant peripheral artery disease should also be\n        excluded.\n\n        3.2.6 Patients with a history of a gastrointestinal fistula or perforation. 3.2.7 Women who\n        are breast-feeding. 3.2.8 Patients who have undergone major surgery, chemotherapy, or\n        radiotherapy within the last 3 weeks.\n\n        3.2.9 Patients on concurrent anticancer therapy.Xx_NEWLINE_xXFor Phase Ib, prior cetuximab or other EGFR-targeted antibody therapy is allowed regardless of the prior treatment settings.Xx_NEWLINE_xXPrior use of chemotherapy (targeted therapy such as erlotinib and crizotinib will be allowed; if a patient was receiving erlotinib and/ or crizotinib as targeted therapy before entering the study they should discontinue that medication 2 weeks before day 1 of the study)Xx_NEWLINE_xXBecause patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bevacizumab, vemurafenib and cobimetinib.Xx_NEWLINE_xXResidual relevant toxicity resulting from previous therapyXx_NEWLINE_xXChronic or high-dose corticosteroid therapyXx_NEWLINE_xXDocumented completion of at least 6 cycles of CHOP-based therapy:Xx_NEWLINE_xXPatient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.Xx_NEWLINE_xXPatients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.Xx_NEWLINE_xXPhase I:\r\n* Patients with prior therapy who do not have alternative treatment of higher priority will be eligible\r\nPhase II:\r\n* Patients should not have been previously treated with cytotoxic drugs or drugs included in IPI-biochemotherapy or regional therapy for metastatic malignant melanoma; prior adjuvant interferon is permitted; prior adjuvant Ipilimumab therapy is not permitted; prior therapy with targeted therapy including but not limited to v-raf murine sarcoma viral oncogene homolog B1 (B-RAF), mitogen-activated protein kinases (MAPK)/extracellular signal-regulated kinase (ERK) kinase (MEK) inhibitors etc. is allowed; at least three weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies and patient has fully recovered from toxicities of drugs; prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicityXx_NEWLINE_xXPrior cytotoxic therapy for at least 4 weeks before treatment on study; treatment within this 4 week window with corticosteroids is permitted as long as the dose is stable or decreasing; radiotherapy within this 4 week window is permitted as long as it is completed prior to initiating therapy and as long as there is assessable disease for response outside of the radiation fieldXx_NEWLINE_xXA single regimen of prior chemotherapy for metastatic melanoma is allowed; patients also may have received other immunotherapy or biologic therapy (including kinase inhibitors, antibodies to checkpoints CTLA4, PD1, PDL1, etc.) for metastatic melanoma and there is a limit of three therapy regimensXx_NEWLINE_xXERLOTINIB HYDROCHLORIDE ARM: Previous anti-EGFR TKI therapyXx_NEWLINE_xXWillingness to discontinue LHRH analogue therapy and for the duration of the studyXx_NEWLINE_xXConcurrent neoplasia requiring cytotoxic therapyXx_NEWLINE_xXInclusion Criteria:\n\n          -  Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without\n             small cell histology. Disease must be either metastatic or locally confined inoperable\n             disease that cannot be treated with definitive intent (no chance for a curative\n             intervention).\n\n          -  Has supplied tumor tissue from a newly obtained biopsy or a biopsy obtained ?12 months\n             prior to study start and an archival specimen, if available, from a site not\n             previously irradiated. Participants in Cohorts 1, 2, and 4 with visceral/measurable\n             lesions must provide a newly obtained biopsy performed after the last line of systemic\n             therapy or a biopsy obtained ?12 months prior to study start and an archival specimen,\n             if available. Participants in Cohorts 3 and 5 must at least provide an archival\n             specimen.\n\n        For Cohorts 1, 2, and 3 only:\n\n          -  Has been treated with:\n\n          -  At least 1 targeted endocrine therapy (defined as second generation antiandrogen\n             therapies that include but are not limited to abiraterone acetate with prednisone,\n             enzalutamide, and next generation targeted agents such as ARN-509).\n\n          -  At least 1 regimen/line of chemotherapy that contained docetaxel.\n\n          -  No more than 2 chemotherapy regimens.\n\n          -  No more than 3 regimens/lines of the aforementioned treatments (having\n             failed/progressed on chemotherapy and targeted endocrine therapy).\n\n        For Cohorts 4 and 5 only:\n\n          -  Failing or showing early signs of failure on current pre-chemotherapy enzalutamide\n             treatment as defined by Prostate Cancer Working Group 3 PCWG3 guidelines. Participants\n             can have failed prior abiraterone treatment before current enzalutamide treatment.\n             Participants must have had a clinically meaningful response to enzalutamide treatment.\n             Enzalutamide must have been initiated no less than 4 weeks prior to the first dose of\n             trial treatment and be continued throughout the study.\n\n        For All Cohorts:\n\n          -  Has documented prostate cancer progression within 6 months prior to screening, as\n             determined by the Investigator, by means of one of the following: 1) PSA progression\n             as defined by a minimum of 3 rising PSA levels with an interval of ?1 week between\n             each assessment where the PSA value at screening should be ?2 ng/mL, OR, 2)\n             Radiographic disease progression in soft tissue or bone with or without PSA\n             progression\n\n          -  Has ongoing androgen deprivation with total serum testosterone <50 ng/dL (<2.0 nM).\n\n          -  Participants receiving bone resorptive therapy (including but not limited to\n             bisphosphonate or Receptor activator of nuclear factor kappa-B ligand [RANK-L\n             inhibitor]) must have been on stable doses for ?4 weeks prior to first dose of study\n             drug.\n\n          -  Has a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG)\n             Performance Scale\n\n          -  Males of reproductive potential must agree to use an adequate method of contraception,\n             starting with the first dose of study drug through 120 days after the last dose of\n             study drug.\n\n          -  Demonstrates adequate organ function.\n\n        Exclusion Criteria:\n\n        For All Cohorts:\n\n          -  Is currently participating and receiving study therapy or has participated in a study\n             of an investigational agent and received study therapy or used an investigation device\n             within 4 weeks of the first dose of study drug.\n\n          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\n             other form of immunosuppressive therapy within 7 days prior to the first dose of study\n             drug.\n\n          -  Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the\n             first dose of study drug or who has not recovered (i.e., ? Grade 1 or at Baseline)\n             from AEs due to mAbs administered more than 4 weeks earlier.\n\n          -  Has had prior chemotherapy, targeted small molecule therapy, or external beam\n             radiation therapy within 4 weeks prior to the first dose of study drug or who has not\n             recovered (i.e., ? Grade 1 or at Baseline) from AEs due to a previously administered\n             agent.\n\n          -  Has a known additional malignancy that has had progression or has required active\n             treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin and\n             squamous cell carcinoma of the skin that has undergone potentially curative therapy.\n\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\n             meningitis.\n\n          -  Has an active autoimmune disease that has required systemic treatment in past 2 years\n             (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive\n             drugs).\n\n          -  Has evidence of interstitial lung disease and/or a history of (non-infectious)\n             pneumonitis that required steroids, or current pneumonitis.\n\n          -  Has an active infection requiring systemic therapy.\n\n          -  Has known psychiatric or substance abuse disorders that would interfere with\n             cooperation with the requirements of the trial.\n\n          -  Has previously participated in any other pembrolizumab (MK-3475) trial, or received\n             prior therapy with an anti-programmed cell death 1 (anti-PD-1, anti-PD ligand 1\n             [anti-PD-L1], and anti-PD-L2 [including ipilimumab or any other antibody or drug\n             specifically targeting T-cell co-stimulation or checkpoint pathways]).\n\n          -  Has a known history of Human Immunodeficiency Virus (HIV).\n\n          -  Has known active Hepatitis B or Hepatitis C.\n\n          -  Has received a live vaccine within 30 days of planned start of study drug.\n\n        For Cohorts 4 and 5 only:\n\n          -  Has received prior chemotherapy (e.g., docetaxel) for mCPRC.\n\n          -  Has any condition (cardiac, neurologic, absorption) other than clinically failing or\n             showing early signs of failure on enzalutamide treatment that would require imminent\n             discontinuation of enzalutamide treatment.Xx_NEWLINE_xXPatient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.Xx_NEWLINE_xXNON-PROGRESSED DIPG (STRATUM 2): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must not have received any other prior therapy for treatment of their central nervous system (CNS) malignancy besides standard radiation therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Patients must meet all of the following inclusion criteria to be eligible to enroll in this\n        study.\n\n          1. Written informed consent obtained prior to any screening procedures and in accordance\n             with federal, local, and institutional guidelines.\n\n          2. Age ?18 years.\n\n          3. Patients with advanced solid malignancies or NHL for which all standard therapeutic\n             options considered useful by the investigator have been exhausted.\n\n          4. Patients must have objective evidence of progressive disease on study entry:\n\n               1. Advanced solid malignancies: Measureable disease as defined by RECIST 1.11.\n\n               2. NHL: Measureable disease including target lesion(s) as defined by the Lugano\n                  Classification2 for initial evaluation and staging.\n\n          5. Patients must have a site of disease amenable to biopsy and be a candidate for biopsy\n             according to the treating institution's guidelines.\n\n          6. Eastern Cooperative Oncology Group (ECOG) performance status of ? 1.\n\n          7. Adequate hepatic function:\n\n               1. Total bilirubin < 1.5 times the upper limit of normal (ULN) (except patients with\n                  Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total\n                  bilirubin of ? 3 times ULN),\n\n               2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 times\n                  ULN (except patients with known liver involvement of their advanced solid\n                  malignancy or NHL who must have their AST and ALT ? 5.0 times ULN).\n\n          8. Adequate renal function: estimated creatinine clearance of ? 60 mL/min, calculated\n             using the formula of Cockroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL);\n             multiply by 0.85 if female.\n\n          9. Female patients of child-bearing potential must agree to use dual methods of\n             contraception (including one highly effective and one effective method of\n             contraception) and have a negative serum pregnancy test at Screening, and male\n             patients must use an effective barrier method of contraception if sexually active with\n             a female of child-bearing potential. For both male and female patients, effective\n             methods of contraception must be used throughout the study and for 3 months following\n             the last dose.\n\n         10. Adequate hematopoietic function: total white blood cell (WBC) count ? 1500/mm3,\n             absolute neutrophil count (ANC) ? 1000/mm3, hemoglobin (Hb) ? 10.0 g/dL, and platelet\n             count ? 75,000/mm3.\n\n         11. Dose Escalation Phase: Patients will be enrolled according to their NAPRT1 status at a\n             ratio of 2:1 (NAPRT1 negative:NAPRT1 positive). The NAPRT1 status must be determined\n             prior to enrollment based on evaluation of a fresh tumor biopsy or archival tissue\n             taken ? 6 months of screening.\n\n         12. Dose Expansion Phase (KPT-9274 ± niacin ER cohort only): Patient tumors NAPRT1 and\n             IDH1 tumor status must be determined at the central laboratory prior to enrollment.\n\n             a. Confirmation of NAPRT1 expression and IDH1 mutation based on evaluation of a fresh\n             tumor biopsy or archival tumor biopsy taken ? 6 months of screening tests as follows:\n\n             i. NAPRT1 positive for expansion cohort I or III\n\n             ii. NAPRT1 negative for expansion cohort II or III\n\n             iii. IDH1 mutation status for expansion cohort IV\n\n         13. Life expectancy of ? 3 months.\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following exclusion criteria are not eligible to enroll in this\n        study.\n\n          1. Female patients who are pregnant or lactating.\n\n          2. Time since the last prior therapy for treatment of advanced solid malignancies or\n             NHL**:\n\n               1. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including\n                  investigational anti-cancer therapy ? 2 weeks prior to C1D1.\n\n               2. Palliative steroids for disease related symptoms < 7 days prior to C1D1.\n                  **Patients must have recovered or stabilized (Grade 1 or to their baseline for\n                  non-hematologic toxicities, ? Grade 2 or to their baseline for hematologic\n                  toxicities) from toxicities related to their previous treatment except for\n                  alopecia. In specific cases, patients with Grade 2 non-hematologic toxicities\n                  will be allowed following approval by the Karyopharm medical monitor.\n\n          3. Patients with known central nervous system (CNS) disease or leptomeningeal\n             involvement, regardless of response to prior therapy, are excluded.\n\n          4. Major surgery within four weeks before C1D1.\n\n          5. Impaired cardiac function or clinically significant cardiac diseases, including any of\n             the following:\n\n               1. Unstable angina or acute myocardial infarction ?3 months prior to C1D1;\n\n               2. Clinically significant heart disease (e.g., symptomatic congestive heart failure;\n                  uncontrolled arrhythmia, or hypertension; history of labile hypertension or poor\n                  compliance with an antihypertensive regimen).\n\n          6. Active infection with completion of therapeutic antibiotics, antivirals, or\n             antifungals within one week prior to C1D1. Prophylactic antibiotics, antivirals or\n             antifungals are permitted.\n\n          7. Patients with a known history of Human Immunodeficiency Virus (HIV); HIV testing is\n             not required as part of this study.\n\n          8. Known, active hepatitis A, B, or C infection; or known to be positive for HCV RNA or\n             HBsAg (HBV surface antigen). Testing is not required.\n\n          9. Patients with significantly diseased or obstructed gastrointestinal tract or\n             uncontrolled vomiting or diarrhea that could interfere with the absorption of\n             KPT-9274.\n\n         10. Serious psychiatric or medical conditions that, in the opinion of the Investigator,\n             could interfere with treatment, compliance, or the ability to give consent.\n\n         11. Active peptic ulcer disease or other active gastrointestinal bleeds.Xx_NEWLINE_xXPatients who have previously received enzalutamide; patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapyXx_NEWLINE_xXHas received other anti-cancer therapy within the following specified intervals prior to Day 1:Xx_NEWLINE_xXInclusion Criteria:\n\n        All subjects must meet the following criteria for inclusion:\n\n          -  ? 18 years of age\n\n          -  Life expectancy of ? 3 months\n\n          -  Histological or cytological evidence of advanced and/or metastatic carcinoma or\n             melanoma , excluding sarcoma\n\n          -  At least 1 measurable disease lesion as defined by RECIST 1.1\n\n          -  Serum creatinine clearance ? 60 mL/min and serum creatinine ? 2.0 x the upper limit of\n             normal (ULN) as determined by either of the following: Estimation as calculated by\n             Cockcroft-Gault equation or Direct measurement by 24-hour urine collection\n\n          -  Total bilirubin ? 1.5 x ULN (unless elevated due to Gilbert's syndrome)\n\n          -  Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ? 2.5 x\n             ULN (<5x ULN if liver metastasis)\n\n          -  Adequate hematological function, defined as absolute neutrophil count ?1.5 x 109/L,\n             hemoglobin ? 9.0 g/dL, and platelet count ? 100 x 109/L\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status ? 2 (corresponds to\n             Karnofsky Performance Status (KPS) ? 60%)\n\n        Subjects entering Part A, B, C, or D must also meet the following additional criterion:\n\n        • Failure to respond to standard therapy, or for whom no appropriate therapies are\n        available (based on the judgement of the Investigator)\n\n        Subjects entering Part D, E, F or G must also meet the following additional criterion:\n\n        • Willing to undergo 1 pre-treatment and 1 on-treatment tumor biopsy\n\n        Subjects entering Part E must also meet the following additional criteria:\n\n          -  Histological or cytological evidence of NSCLC, melanoma, , human papillomavirus (HPV)\n             positive or HPV negative SCCHN (oral cavity, pharynx, hypopharynx, larynx,\n             nasopharyngeal [including undifferentiated nasopharyngeal carcinoma]), or another\n             tumor type to be determined\n\n          -  Failure to respond to standard therapy, or for whom no appropriate therapies are\n             available (based on the judgment of the Investigator The most recent treatment prior\n             to study entry must be an anti-PD-1 or anti-PD-L1 antibody given as either monotherapy\n             or in combination\n\n          -  Subjects with NSCLC Tumors that harbor an actionable genetic alteration for which\n             there is a corresponding approved therapy for that specific alteration (including but\n             not limited to alterations in EGFR, ALK, and ROS) must have progressed on, or had\n             intolerance to, the respective therapy\n\n        Subjects entering Part F must also meet the following additional criteria:\n\n          -  Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone\n             receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-)\n             Breast Cancer by local laboratory testing, based on last available tumor tissue; or\n             another tumor type to be determined\n\n               -  ER/PgR negativity to follow local guidelines\n\n               -  If IHC HER2 2+, a negative FISH test is required\n\n               -  Inflammatory triple negative breast cancer is allowed\n\n          -  Must have received and failed/progressed a cytotoxic chemotherapy as first line\n             therapy per standard of care\n\n          -  No prior anti-PD-1 or anti-PD-L1 therapy\n\n        Subjects entering Part G must also meet the following additional criteria:\n\n          -  Histological or cytological evidence of ACC, mesothelioma, or another tumor type to be\n             determined\n\n               -  Both pleural and peritoneal mesothelioma are allowed\n\n               -  Epithelioid, sarcomatoid, or biphasic mesothelioma subtypes are allowed\n\n          -  Progression after at least first line available therapy\n\n        Exclusion Criteria:\n\n        Subjects are to be excluded from the study if they meet any of the following criteria:\n\n          -  Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine\n             protein, or known hypersensitivity to any excipient in the study drugs\n\n          -  Major surgery within 4 weeks prior to Screening\n\n          -  Subjects who have been treated with chemotherapy, biologic therapy, or other\n             investigational agent within < 5 times the half-life of the agent or < 28 days\n             (whichever is shorter) of starting study drug\n\n        NOTE: Subjects whose immediate prior treatment was with nivolumab may start study drug 2\n        weeks after the last dose of nivolumab\n\n          -  Symptomatic or untreated brain metastases\n\n          -  Primary central nervous system (CNS) malignancy\n\n          -  Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus\n\n          -  Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic\n             steroids\n\n          -  Ongoing systemic bacterial, fungal, or viral infections at Screening\n\n        NOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically\n        excluded if all other inclusion/exclusion criteria are met\n\n          -  Administration of a live vaccine within 6 weeks of first dose of study drug\n\n          -  Administration of any of the following within 1 week prior to the administration of\n             study drug:\n\n               -  Strong inhibitors or inducers of CYP3A4, including grapefruit products and herbal\n                  supplements\n\n               -  P-glycoprotein (P-gp) inhibitors\n\n               -  Warfarin, phenytoin, or other substrates of CYP2C8 or CYP2C9 with a narrow\n                  therapeutic range\n\n               -  Medications associated with QTc interval prolongation or Torsades de Pointes\n\n          -  Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of\n             triplicate readings) NOTE: criterion does not apply to subjects with a right or left\n             bundle branch block\n\n          -  Parts C, D-Annex, and E only: Subjects with active, known, or suspected autoimmune\n             disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due\n             to autoimmune condition only requiring hormone replacement, psoriasis not requiring\n             systemic treatment, or conditions not expected to recur in the absence of an external\n             trigger are permitted to enroll\n\n          -  Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg,\n             gastric bypass surgery, gastrectomy)\n\n          -  Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of\n             the cervix, or prostate intraepithelial neoplasia\n\n          -  Past medical history of interstitial lung disease, drug-induced interstitial lung\n             disease, radiation pneumonitis which required steroid treatment, or any evidence of\n             clinically active interstitial lung disease\n\n          -  History of peptic ulcer and/or gastrointestinal bleed\n\n          -  History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia\n             requiring medication or mechanical control within the last 6 months prior to Screening\n\n          -  Unstable or severe uncontrolled medical condition (eg, unstable cardiac function,\n             unstable pulmonary condition including pneumonitis and/or interstitial lung disease,\n             uncontrolled diabetes) or any important medical illness or abnormal laboratory finding\n             that would, in the Investigator's judgment, increase the risk to the subject\n             associated with his or her participation in the study.Xx_NEWLINE_xXThere is no limit to the number of prior chemotherapy or endocrine therapy regimens allowed; patients with ER(+) AR(+) breast cancer must have had at least 1 prior line of endocrine therapy to be eligible for the phase I portion of the trialXx_NEWLINE_xXPatients who have received prior anti-androgen therapyXx_NEWLINE_xXPrevious immune-mediated therapyXx_NEWLINE_xXPatients requiring continuous, systemic immunosuppressive therapyXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXPatients must have completed at least 1 prior line of systemic therapy; patients who have declined first line therapy or for whom first-line therapy would be clinically inappropriate, will be considered eligible for the trialXx_NEWLINE_xXPrior investigational new generation potent anti-androgen therapy (such as ARN 509).Xx_NEWLINE_xXChemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing with the following exceptions: a. Arm A: A minimum 5-day washout after discontinuation of ibrutinib therapy (or other BTK inhibitors) is required; only those subjects without rapid disease progression during the 5-day washout will be allowed to enroll into Arm A. i. Rapid disease progression is defined as follows:Xx_NEWLINE_xXPart 2d: Patients with non GIST solid tumors with KIT mutations, who are TKI naïve or have been previously treated with KIT directed TKI therapy who are appropriate for KIT directed TKI therapyXx_NEWLINE_xXNo response to last line of therapy i. PD as best response to most recent therapy regimen ii. SD as best response to most recent therapy with duration no longer than 6 month from last dose of therapy ORXx_NEWLINE_xXRefractory post-ASCT i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) ii. If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapyXx_NEWLINE_xXSubjects must have received adequate prior therapy including at a minimum:Xx_NEWLINE_xXPrior CAR therapy or other genetically modified T cell therapyXx_NEWLINE_xXThiazide (e.g HCTZ, Hydrochoirthiazide) or digoxin therapy (e.g Lanoxicaps, Lanoxin)Xx_NEWLINE_xXPatients with prior therapy with paclitaxel or other taxanes.Xx_NEWLINE_xXPrior therapy with bortezomib is allowed; patients who have received prior bortezomib therapy must have received bortezomib > 6 months ago, and must have shown some response; patients that did not respond to prior bortezomib therapy are not eligibleXx_NEWLINE_xXPatients who have received antiandrogens or progestational agents as therapy for prostate cancer must discontinue therapy and demonstrate a rising PSA >= 28 days following discontinuation (antiandrogen withdrawal- AAW) (>= 42 days for bicalutamide or nilutamide); patients who receive megestrol acetate as therapy for \hot flashes\ at a dose of =< 40 mg per day may continue this therapy during this trial; the dose of the megestrol acetate should not be changed during protocol treatment; patients undergoing androgen deprivation using LHRH analogues must continue such agents or undergo orchiectomy to maintain castrate levels of testosteroneXx_NEWLINE_xXRequirement for concurrent systemic glucocorticoid therapy at greater than physiologic replacement dosesXx_NEWLINE_xXAll patients are expected to be followed for at least 1 year after the initiation of therapyXx_NEWLINE_xXPrior therapy with belinostatXx_NEWLINE_xXPrior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past 30 daysXx_NEWLINE_xXPatient has received any second line therapy to treat aGVHD prior to screening.Xx_NEWLINE_xXRelapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.Xx_NEWLINE_xXMust have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.Xx_NEWLINE_xX?1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic responseXx_NEWLINE_xXProgressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)Xx_NEWLINE_xXHistory of a significant allergic reaction attributed to humanized or human monoclonal antibody therapyXx_NEWLINE_xXRelapsed, refractory, or progressive disease following at least 2 prior systemic therapiesXx_NEWLINE_xXPrior treatment with MUC16 targeted therapy (e.g., oregovomab [OvaRex] or abagovomab) including DMUC5754AXx_NEWLINE_xXConcomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drugXx_NEWLINE_xXMDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMAXx_NEWLINE_xXMaximum one prior systemic therapy regimen.Xx_NEWLINE_xXPrior anthracycline therapyXx_NEWLINE_xXPrevious use of mitoxantrone and etoposide combination therapy within the preceding 180 days of screeningXx_NEWLINE_xXsecond-line or greater salvage systemic therapy, orXx_NEWLINE_xXIntolerable toxicity to prior rituximab therapy.Xx_NEWLINE_xXNeoadjuvant endocrine monotherapy is deemed to be a suitable therapy.Xx_NEWLINE_xXPrior anti-estrogen therapy.Xx_NEWLINE_xXPersistent or recurrent cytomegalovirus infection or disease despite at least 7 days of standard therapy or failure of therapy as described below or if unable to tolerate standard therapy. Standard therapy is defined as antiviral therapy with ganciclovir or CMX001 (brincidofovir) as the agents of choice and foscarnet or cidofovir as second line agents. i.Cytomegalovirus infection: defined as the presence of CMV positivity as detected by Polymerase chain reaction (PCR) or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx. ii. Cytomegalovirus disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination. iii. Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy.Xx_NEWLINE_xXHave received at least one prior therapy. Patients who are over age 65 and have not received therapy for AML are also eligible, if they are not candidates for induction chemotherapyXx_NEWLINE_xXSubjects with breast cancer must have been treated with at least two FDA-approved anti-HER2 directed therapies (more than two is also permissible), and subjects with gastric and gastroesophageal junction cancers must have been treated with at least one FDA-approved anti-HER2 directed therapy (more than one is also permissible); and all subjects must have refractory or relapsed/progressive disease during or following their last prior anti-HER2 directed therapy.Xx_NEWLINE_xXSubjects enrolling in the study who have non-breast, non-gastric, non-gastroesophageal junction cancers do not require any prior treatment with anti-HER2 therapy if there is no FDA-approved anti-HER2 agent for their specific cancer type, but they must have refractory or relapsed/progressive disease during or following their last prior anti-cancer therapy.Xx_NEWLINE_xXDyspnea of any cause requiring supplemental oxygen therapy;Xx_NEWLINE_xXPatients must have received prior Rituximab-containing therapy.Xx_NEWLINE_xXInclusion Criteria: -\n\n          -  Inclusion Criteria: -\n\n               1. Age ? 70 years at the time of signing the Informed Consent Form.\n\n               2. Understand and voluntarily provide written informed consent prior to the conduct\n                  of any study related assessments/procedures.\n\n               3. Able to adhere to the study visit schedule and other protocol requirements.\n\n               4. Histologically or cytologically confirmed locally advanced or metastatic Non\n                  Small Cell Lung Cancer who are not candidates for curative surgery or radiation\n                  therapy.\n\n               5. No other current active malignancy requiring anticancer therapy.\n\n               6. Radiographically documented measurable disease per RECIST v 1.1\n\n               7. No prior chemotherapy for the treatment of metastatic disease. Adjuvant\n                  chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12\n                  months prior to signing the ICF and without disease recurrence. Patients with\n                  previously known epidermal growth factor receptor mutation or anaplastic lymphoma\n                  kinase gene translocation must have failed or had intolerance to one treatment\n                  with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic\n                  lymphoma kinase inhibitor therapy, respectively.\n\n               8. Absolute neutrophil count ? 1500 cells/cubic millimetre.\n\n               9. Platelets ? 100,000 cells/cubic millimetre.\n\n              10. Hemoglobin ? 9 grams/decilitre.\n\n              11. Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine\n                  transaminase/serum glutamic pyruvic transaminase ? 2.5 × upperlimit of normal\n                  range or ? 5.0 × upper limit of normal range if liver metastases.\n\n              12. Total bilirubin ? 1.5 millilitre/decilitre (unless there is a known history of\n                  Gilberts Syndrome).\n\n              13. Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault\n                  equation (if renal impairment is suspected 24 hour urine collection for\n                  measurement is required).\n\n              14. Eastern Cooperative Oncology Group performance status 0 or 1.\n\n              15. Females who (1) have undergone hysterectomy (the surgical removal of the uterus)\n                  or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been\n                  naturally postmenopausal for at least 24 consecutive months (ie, has not had\n                  menses at any time during the preceding 24 consecutive months).\n\n              16. Male subjects must: Practice true abstinence or agree to use a condom during\n                  sexual contact with a pregnant female or a female of childbearing potential while\n                  participating in the study, during dose interruptions and for 6 months following\n                  study drug discontinuation, even if he has undergone a successful vasectomy.\n\n                  Exclusion Criteria:\n\n          -  1. Evidence of active brain metastases, including leptomeningeal involvement (prior\n             evidence of brain metastasis are permitted only if treated and stable and off therapy\n             for ? 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of\n             the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.\n\n             2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable.\n             4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology\n             Criteria for Adverse Events v4.0).\n\n             5. Subject has received radiotherapy ? 4 weeks or limited field radiation for\n             palliation ? 2 weeks prior to starting investigational product, and/or from whom ? 30%\n             of the bone marrow was irradiated. Prior radiation therapy to a target lesion is\n             permitted only if there has been clear progression of the lesion since radiation was\n             completed.\n\n             6. Venous thromboembolism within 1 month prior to signing Informed consent form.\n\n             7. Current congestive heart failure (New York Heart Association Class II-IV). 8.\n             History of the following within 6 months prior to first administration of a study\n             drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral\n             artery bypass graft, New York Heart Association Class III-IV heart failure,\n             uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically\n             significant Electrocardiogram abnormality, cerebrovascular accident, transient\n             ischemic attack, or seizure disorder. 9. Subject has a known infection with hepatitis\n             B or C, or history of human immunodeficiency virus infection, or subject receiving\n             immunosuppressive or myelosuppressive medications that would in the opinion of the\n             investigator, increase the risk of serious neutropenic complications.\n\n             10. Subject has an active, uncontrolled bacterial, viral, or fungal infection(s)\n             requiring systemic therapy, defined as ongoing signs/symptoms related to the infection\n             without improvement despite appropriate antibiotics, antiviral therapy, and/or other\n             treatment.\n\n             11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary\n             fibrosis, or pulmonary hypersensitivity pneumonitis.\n\n             12. Treatment with any investigational product within 28 days prior to signing the\n             Informed consent form.\n\n             13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14.\n             Currently enrolled in any other clinical protocol or investigational trial that\n             involves administration of experimental therapy and/or therapeutic devices. 15. Any\n             other clinically significant medical condition, psychiatric illness, and/or organ\n             dysfunction that will interfere with the administration of the therapy according to\n             this protocol or which, in the views of investigator, preclude combination\n             chemotherapy.\n\n             16. Subject has any other malignancy within 5 years prior to randomization. Exceptions\n             include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the\n             cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or\n             incidental histological finding of prostate cancer (TNM stage of T1a or T1b). All\n             treatment of which should have been completed 6 months prior to signing Informed\n             consent form.\n\n             17. Any condition including the presence of laboratory abnormalities, which places the\n             subject at unacceptable risk if he/she were to participate in the study.\n\n             18. Any medical condition that confounds the ability to interpret data from the study.\n\n             19. Females who (1) have not undergone hysterectomy (the surgical removal of the\n             uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have\n             not been naturally postmenopausal for at least 24 consecutive months (ie, has had\n             menses at any time during the preceding 24 consecutive months).Xx_NEWLINE_xXNot previously treated with prior anti-cancer therapy for FLXx_NEWLINE_xXLess than three months since last taxane-containing therapy.Xx_NEWLINE_xXPatient's current disease state must be one for which there is no known curative therapyXx_NEWLINE_xXParticipants must have received at least one prior chemotherapy regimen for AGC;\n             prior therapy does not need to have included HER2-directed therapy.Xx_NEWLINE_xXFirst-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a\n             combination of at least a platinum- and a fluoropyrimidine-based treatment given\n             concurrently; prior therapy does not need to have included a HER2-directed therapy.Xx_NEWLINE_xXMore than one prior line of therapy for advanced gastric cancerXx_NEWLINE_xXBone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.Xx_NEWLINE_xXWashout from any prior investigational therapy of at least five times the T1/2 prior to C1D1Xx_NEWLINE_xXPatients will be excluded if they have received previous therapy with HDAC, DAC, HSP90 inhibitors or valproic acid anticancer therapy. Valproic acid therapy is not allowed for any reason while on this study.Xx_NEWLINE_xXPatients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period, excluding CNS directed therapy upfront for AML patients and continuing for CNS positive patients as described in Section 4.1. Cyto-reduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start or protocol therapy.Xx_NEWLINE_xXPatients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy) would be excluded, as they would not need systemic chemotherapyXx_NEWLINE_xXPrior therapy with idelalisibXx_NEWLINE_xXPrior treatment with anti-HER2 therapy, except trastuzumab or lapatinibXx_NEWLINE_xXSubjects must have received one or more prior systemic therapies for this disease, with disease progression or intolerable toxicity precluding further therapy with prior regimen(s)Xx_NEWLINE_xXPatients must not have received systemic therapy or radiotherapy within the preceding 3 weeks; patients must have recovered from adverse events from previous therapy by the time of registrationXx_NEWLINE_xXFor patients if they have a history of colitis or diarrhea during anti-CTLA4 monoclonal antibody therapy, it is recommended that they have a formal evaluation by a gastroenterologist and a colonoscopy/endoscopy should be considered to demonstrate the absence of active bowel inflammation before initiating IL-2 therapy on this protocolXx_NEWLINE_xXIf a patient had been taking steroids, at least 2 weeks must have passed since the last dose; patients stable on physiologic replacement doses of steroids or other forms of hormone replacement therapy are eligibleXx_NEWLINE_xXNo known Food and Drug Administration (FDA)-approved therapy available that’s expected to prolong survival by greater than 3 monthsXx_NEWLINE_xXSubjects who are refractory* or who have relapsed** following first line AML therapy with cytarabine/anthracycline based chemotherapy, with or without a tyrosine kinase inhibitor. *Refractory to induction therapy is defined as never achieving CR, CRi or CRp (according to International Working Group criteria) after one line of intensive regimen for AML (re-induction, consolidation and/or transplant allowed) including at least one cytarabine containing induction block with a total dose no less than 700mg/m² per cycle and 3 days of an anthracycline with or without a TKI. or **First relapse is defined as untreated hematologic relapse (according to International Working Group criteria) after one line of intensive regimen for AML (re-induction, consolidation and/or transplant allowed) including at least one cytarabine containing induction block with a total dose no less than 700mg/m² per cycle and 3 days of an anthracycline with or without a TKI that induced a CR/CRi/CRp. Subjects are allowed to receive induction, consolidation, transplant and/or maintenance prior to achieving their first CR/CRi/CRp.Xx_NEWLINE_xXFor dose expansion cohorts: Dose expansion portion of study will include two separate cohorts\r\n* One cohort will incorporate patients with esophageal, gastroesophageal junction (GEJ) or gastric carcinomas (squamous cell carcinoma or adenocarcinoma if predominant histology); these patients must have received at least one prior systemic therapy for metastatic disease; patients who had prior neoadjuvant or adjuvant chemotherapy as part of curative intent primary therapy but recurred in less than 6 months would also be eligible; patients with HER2+ disease must have received trastuzumab with disease progression prior to enrollment; patients on this arm may have had prior treatment with drugs targeting the PD-1 pathway, but will be limited to a maximum of 5 patients\r\n* The second cohort will include patients who have progressed on prior PD-1 pathway inhibition (single agent or in combination) in solid tumor types where these drugs are standard of care; the reason for discontinuation of the prior PD-1 pathway drug must not have been for toxicity; eligible tumor types include melanoma, RCC, UC, NSCLC, and SCCHN, but subsequent tumor types wherein relevant agents become an approved standard of care would also become eligibleXx_NEWLINE_xXNo limitations on prior systemic or intrathecal therapiesXx_NEWLINE_xXThere are no restrictions on systemic therapy at enrollmentXx_NEWLINE_xXSystemic sites of disease need to be stable on systemic therapy based on the most recent (within 12 weeks) staging scansXx_NEWLINE_xXPatients must have received one prior approved therapy for metastatic disease and have not curable options, with the exception of HER2+ breast or gastric patients for whom this can be the first line of treatment (no prior therapy)Xx_NEWLINE_xXCurrent therapy with proton pump inhibitorsXx_NEWLINE_xXPrior therapy with a conjugated or unconjugated auristatin derivative.Xx_NEWLINE_xXOngoing systemic therapy (other than a gonadotropin releasing hormone [GnRH] agonist/antagonist) for prostate cancer including, but not limited to:\r\n* Cytochrome P450, family 17 (CYP-17) inhibitors (e.g. ketoconazole, abiraterone)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. ARN-509)\r\n** Note: patients receiving ongoing treatment with enzalutamide will be allowed to join the study\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153)Xx_NEWLINE_xXSerum testosterone level: i) Subjects with no history of androgen deprivation therapy:Xx_NEWLINE_xXPrevious administration of vaccine therapy targeting NY-ESO-1Xx_NEWLINE_xXInclusion Criteria:\n\n        Patients must be ?18 years of age\n\n        Patients must have documented IDH1 and/or IDH2 gene-mutated disease\n\n        Patients must have an advanced hematologic malignancy with an IDH1 and/or IDH2 mutation\n\n        Patient must be able to understand and willing to sign an informed consent\n\n        Patients must have ECOG PS of 0 to 2\n\n        Patients must have adequate hepatic function as evidenced by serum total bilirubin ?1.5\n        upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic\n        involvement\n\n        Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase\n        (ALP) ?3.0 × ULN, unless considered due to involvement by the neoplasm under consideration\n        for treatment\n\n        Patients must have adequate renal function as evidenced by a serum creatinine ?2.0 × ULN or\n        Creatinine clearance 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR)\n        estimation\n\n        Patients must be recovered from any clinically relevant toxic effects of any prior surgery,\n        radiotherapy, or other therapy intended for the treatment of cancer\n\n        Female patients with reproductive potential must have a negative serum pregnancy test\n        within 7 days prior to the start of therapy. Patients with reproductive potential are\n        defined as sexually mature women who have not undergone a hysterectomy, bilateral\n        oophorectomy or tubal occlusion or who have not been naturally postmenopausal (i.e., who\n        have not menstruated at all) for at least 24 consecutive months (i.e., has had menses at\n        any time in the preceding 24 consecutive months)\n\n        Exclusion Criteria:\n\n        Patients who have undergone HSCT within 60 days\n\n        Patients who received systemic anticancer therapy or radiotherapy <14 days prior to their\n        first day of study drug administration\n\n        Patients who received an investigational agent <14 days prior\n\n        Patients who are pregnant or breast feeding\n\n        Patients with an active severe infection who require anti-infective therapy or with an\n        unexplained fever >38.5°C during Screening visits or on their first day of study drug\n        administration (at the discretion of the Investigator, patients with tumor fever may be\n        enrolled)\n\n        Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or\n        LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within\n        approximately 28 days of C1D1\n\n        Patients with a history of myocardial infarction within the last 6 months\n\n        Patients with known unstable or uncontrolled angina pectoris\n\n        Patients with a known history of severe and/or uncontrolled ventricular arrhythmias\n\n        Patients with QTc interval ?450 msec or with other factors that increase the risk of QT\n        prolongation or arrhythmic events\n\n        Patients taking medications that are known to prolong the QT interval\n\n        Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B\n        or C\n\n        Patients with clinical symptoms suggesting active central nervous system (CNS) leukemia or\n        known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is a\n        clinical suspicion of CNS involvement by leukemia during Screening\n\n        Patients with immediately life-threatening, severe complications of hematologic\n        malignancies such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or\n        disseminated intravascular coagulationXx_NEWLINE_xXThe patients may start any Food and Drug Administration (FDA) approved endocrine therapy (with which they have not been previously treated) at week 4 of the trial except for tamoxifenXx_NEWLINE_xXPatients with metastatic disease currently on endocrine therapy must be willing to stop endocrine therapy for 2 weeks prior to starting the study and to switch to a new endocrine therapy on the study (at week 4)Xx_NEWLINE_xXCan be on other endocrine therapy if willing to change a different endocrine therapy agent for the trialXx_NEWLINE_xXMust have at least one FDA approved endocrine therapy option with which the patient has not received prior treatmentXx_NEWLINE_xXPreviously untreated AML (except: emergency leukopheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy)Xx_NEWLINE_xXPatient on anti-coagulation therapy and are unable to stop therapy for the perioperative periodXx_NEWLINE_xXPrior systemic therapy with a gemcitabine containing regimenXx_NEWLINE_xXPatients with relapsed or refractory AML; patients must have failed at least one prior induction regimen for AML; the maximum number of prior lines of induction is 3Xx_NEWLINE_xXPatients with secondary AML or therapy related disease (t-AML) are eligibleXx_NEWLINE_xXHistory of a significant allergic reaction attributed to humanized or human monoclonal antibody therapyXx_NEWLINE_xXSymptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enrollXx_NEWLINE_xXSubjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid-dosing regimen prior to screening MRI may be permitted to enroll with Medical Monitor approvalXx_NEWLINE_xXSubject is eligible for a potentially curative therapy.Xx_NEWLINE_xXPrior Treatments:Xx_NEWLINE_xXPatients may not have received any anti-cancer therapy for their primary relapsed (rel)/refractory (ref) DLBCL with the exception of palliative radiation therapy (RT)Xx_NEWLINE_xXPrimary resistance or acquired resistance (i.e., acquired resistance will be defined as disease progression following a period of response defined as >= 50% decline in PSA within 12 weeks of starting therapy and not otherwise meeting criteria for primary resistance) to any of the following agents/combinations of therapy:Xx_NEWLINE_xXPrior and ongoing zoledronic acid or denosumab therapy is allowedXx_NEWLINE_xXPrior therapy with radium-223 is allowedXx_NEWLINE_xXMust have received 2 or 3 prior lines of conventional molecularly targeted therapyXx_NEWLINE_xXAny prior treatment with topoisomerase I therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or\n             IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative\n             resection, transplantation, or ablative therapies. Tumors of mixed histology are not\n             allowed.\n\n          -  Must have radiographically measurable disease in at least one site not previously\n             treated with radiation, chemoembolization, radioembolization, or other local ablative\n             procedures; a new area of tumor progression within or adjacent to a previously-treated\n             lesion, if clearly measurable by a Radiologist, is acceptable.\n\n          -  May have received prior radiation, chemoembolization, radioembolization, or other\n             local ablative therapies, or hepatic resection if completed ? 4 weeks prior to\n             registration AND if patient has recovered to ? grade 1 toxicity. NOTE: Measurable\n             disease (as required above) must still be present.\n\n          -  May have received prior radiation for bone or brain metastases if patient is now\n             asymptomatic and has completed all radiation and steroid therapy (if applicable) ? 2\n             weeks prior to registration.\n\n          -  Age ? 18 years.\n\n          -  Child-Pugh score of A or B with ? 7 points.\n\n          -  Eastern Cooperative Oncology Group performance status of 0-1.\n\n          -  Willing to provide archived tissue, if available, from a previous diagnostic biopsy.\n\n          -  Must be able to tolerate CT and/or MRI with contrast.\n\n          -  Adequate organ function obtained ? 2 weeks prior to registration:\n\n               -  Absolute Neutrophil Count ? 1500/mm³\n\n               -  Hemoglobin ?9.0 g/dL\n\n               -  Platelets ?100,000/mm³\n\n               -  Serum Creatinine ? 1.5x Upper Limit Normal (ULN)\n\n               -  Creatinine Clearance ? 50 mL/min\n\n               -  Albumin ? 2.8 g/dL\n\n               -  Total Bilirubin ? 1.5 mg/dL or ? 1.5x ULN\n\n               -  Aspartate Aminotransaminase (AST)/Alanine Aminotransaminase (ALT) ? 2.5x ULN (?\n                  5x ULN in patients with liver metastases)\n\n               -  International Normalized Ratio (INR) <1.5x the ULN [INR ? 1.5 is allowed if\n                  anticoagulation is used.]\n\n          -  Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine\n             may harm the fetus or child.\n\n          -  Must not have received prior systemic cytotoxic chemotherapy or targeted therapy for\n             this cancer.\n\n          -  Must not be receiving treatment with other investigational agents.\n\n          -  Must not have a pre-existing >grade 2 peripheral neuropathy.\n\n          -  Must not be receiving immunosuppressive medications, including systemic\n             corticosteroids, aside from the following exceptions: used for adrenal replacement,\n             appetite stimulation, therapy for asthma, bronchitis exacerbation (? 2 weeks),\n             anti-emesis, or pre-medication for procedures (i.e. CT scan).\n\n          -  No known Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)\n             seropositivity.\n\n          -  Must not have undergone liver transplantation.\n\n          -  Must not have serious non-healing wound, ulcer, bone fracture, or abscess.\n\n          -  Must not have undergone a major surgical procedure <4 weeks prior to registration.\n\n          -  Must not have possible histories of pneumonitis or pneumonitis risk factors.\n\n          -  Must not have an active second malignancy other than non-melanoma skin cancer or\n             cervical carcinoma in situ.\n\n          -  Must have no ongoing or active, uncontrolled infections.\n\n          -  Must have no evidence of significant, uncontrolled concomitant diseases including, but\n             not limited to: symptomatic congestive heart failure, unstable angina pectoris,\n             uncontrolled cardiac arrhythmia, myocardial infarction within preceding 12 months,\n             uncontrolled peripheral vascular disease, cerebrovascular accident within preceding 12\n             months, pulmonary disease impairing functional status or requiring oxygen, connective\n             tissue disease including lupus.\n\n          -  Must not have any history of allergic reaction(s) attributed to compounds of similar\n             composition to nab-paclitaxel or gemcitabine.Xx_NEWLINE_xXPatients with prostate cancer must continue to receive gonadotropin-releasing hormone (GnRH) agonist therapy (unless orchiectomy has been done); if a patient has refused GnRH therapy, they may be enrolled on a dose level for which the safety has already been determinedXx_NEWLINE_xXPaclitaxel therapy is appropriate for the patient and is recommended by the Investigator.Xx_NEWLINE_xXKnown metastatic brain or meningeal tumors, unless the subject is >3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of the first dose of study drugXx_NEWLINE_xXReceived Tivantinib as prior therapyXx_NEWLINE_xXPatients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy and are refractory to their most recent line of therapy, as defined as relapse while on therapy or within 60 days from their last line of therapy. If patient has not received either an immunomodulatory drug (IMID) or proteasome inhibitor as a prior therapy then Investigator must notify Novartis prior to the patient enrollment. Patients who have received a prior bone marrow transplant and otherwise meet the inclusion criteria are eligible for this studyXx_NEWLINE_xXAt least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapyXx_NEWLINE_xXReceived regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)Xx_NEWLINE_xXPatients may have received azacitidine, decitabine, or lenalidomide but no “cytotoxic therapy” such as ara-C or anthracyclines; data suggest that failure to respond to azacitidine reduces probability of response to 3+7; hence in the interest of having a relatively homogeneous population, while patients who have received and failed azacitidine or decitabine will be eligible for this study, they will be analyzed separately from patients who have not received these drugsXx_NEWLINE_xXMeasurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapy such as (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ? 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.Xx_NEWLINE_xXCurrent therapy with other systemic anti-neoplastic or anti-neoplastic investigational agentsXx_NEWLINE_xXReceived at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).Xx_NEWLINE_xXDisease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.Xx_NEWLINE_xX> 1 prior regimenXx_NEWLINE_xXUncontrolled Hepatitis B despite appropriate therapy.Xx_NEWLINE_xXRelapsed after achieving remission with a prior therapyXx_NEWLINE_xXSubjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapyXx_NEWLINE_xXNo more than 3 prior lines of therapyXx_NEWLINE_xXPatients may be on specific targeted therapy (erlotinib or crizotinib) as long as they have not had disease progressionXx_NEWLINE_xXPatients must have measurable disease as defined by immune-related complete response (irRC) (Wolchok, 2009); all sites must be evaluated within 4 weeks prior to beginning therapyXx_NEWLINE_xXPreviously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimenXx_NEWLINE_xXPatients may not have received prior systemic or hepatic directed infusional/embolization therapies for advanced uveal melanoma; local therapies such as radiofrequency ablation or cryotherapy for metastatic disease are permitted but must have been performed at least 21 days prior to initiation of study therapy; lesions treated with local modalities such as radiofrequency ablation or cryotherapy may not be used as target lesions unless they demonstrate growth over a minimum of 3 months on subsequent imaging studiesXx_NEWLINE_xXLast received ONT-10 a maximum of 6 months (unless approved by the medical monitor) prior to receiving the first dose of maintenance or retreatment cohort therapyXx_NEWLINE_xXInclusion Criteria: Clinical diagnosis of metastatic uveal melanoma; Written consent from\n        female or male patients aged 18 years and over. Histological or cytological confirmation of\n        melanoma who are suitable for treatment with dacarbazine chemotherapy.\n\n          -  At least one lesion that can be accurately measured at baseline as>/=10mm in the\n             longest diameter. (except lymph nodes which must have short axis ?15 mm) with CT or\n             MRI and which is suitable for accurate repeated measurements\n\n          -  ECOG performance status 0-1\n\n          -  life expectancy >12 weeks\n\n          -  Normal organ and marrow function\n\n          -  Evidence of post-menopausal status, or negative urinary or serum pregnancy test for\n             female pre-menopausal patients\n\n          -  Patients should be able to swallow selumetinib/placebo capsules\n\n        Exclusion Criteria:-Involvement in the planning and/or conduct of the study (applies to\n        both AstraZeneca staff and/or staff at the study site)\n\n          -  Previous randomisation in the present study\n\n          -  Patients cannot have previously been treated with a systemic anti-cancer therapy.\n             Patients can have prior intra-hepatic or non-systemic therapy. -Having received any of\n             the following within the specified timeframe:\n\n        Any prior systemic anti-cancer therapy for the treatment of this current diagnosis, An\n        investigational drug within 30 days of starting treatment or within five half-lives of the\n        compound (whichever is the most appropriate is at the discretion of the Investigator), or\n        have not recovered from side effects of an investigational drug Any non-systemic\n        anti-cancer therapy which has not been cleared from the body by the time of starting study\n        treatment Radiation therapy within 4 weeks prior to starting study treatment, or limited\n        field of radiation for palliation within 7 days of the first dose of study treatment Major\n        surgery within 4 weeks prior to entry into the study (excluding the placement of vascular\n        access) which would prevent administration of study treatment, Any prior investigational\n        therapy comprising inhibitors of RAS, RAF or MEK at any time, Previous treatment with\n        dacarbazine. Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy,\n        excluding alopecia -History of allergic reactions attributed to compounds of similar\n        chemical or biologic composition to selumetinib or dacarbazine\n\n        --Symptomatic brain metastases or spinal cord compression (patients must be treated and\n        stable off steroids and anti-convulsants for at least 1 month prior to entry into the\n        study)\n\n        Cardiac conditions as follows:\n\n          -  Uncontrolled hypertension (BP ?150/95 mmHg despite medical therapy)\n\n          -  Acute coronary syndrome within 6 months prior to starting treatment\n\n          -  Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical\n             therapy - Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,-\n             Prior or current cardiomyopathy\n\n          -  Baseline LVEF <55% measured by echocardiography or MUGA. Appropriate correction to be\n             used if a MUGA is performed\n\n          -  Severe valvular heart disease\n\n          -  Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest\n\n          -  QTcF >450 ms or other factors that increase the risk of QTc prolongation\n\n          -  Any evidence of severe or uncontrolled systemic disease, active infection, active\n             bleeding diatheses or renal transplant, including any patient known to have hepatitis\n             B, hepatitis C or human immunodeficiency virus (HIV)\n\n          -  Refractory nausea and vomiting, chronic gastrointestinal diseases (eg inflammatory\n             bowel disease), or significant bowel resection that would preclude adequate absorption\n\n          -  History of another primary malignancy within 5 years prior to starting study\n             treatment, except for adequately treated basal or squamous cell carcinoma of the skin\n             or cancer of the cervix in situ and the disease under study\n\n          -  Ophthalmologic conditions:\n\n          -  Current or past history of central serous retinopathy\n\n          -  Current or past history of retinal vein occlusion\n\n          -  IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP)\n\n          -  Female patients who are breast-feeding a child and male or female patients of\n             reproductive potential who are not employing an effective method of birth control\n\n          -  Clinical judgement by the Investigator that the patient should not participate in the\n             study.Xx_NEWLINE_xXPatients may have had up to 1 prior line of therapy (cytotoxic therapy only) in the recurrent setting; bevacizumab in the upfront setting is allowed, however bevacizumab or other vascular endothelial growth factor (VEGF) pathway targeted therapy in the recurrent setting is not allowed; hormonal therapy does not count as a prior lineXx_NEWLINE_xXPrior therapy with bevacizumab or other VEGF pathway targeted therapy in the recurrent setting; bevacizumab in the upfront setting is allowedXx_NEWLINE_xXCurrently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollmentXx_NEWLINE_xXAny prior systemic therapy (before randomization) for the treatment of NSCLC (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomizationXx_NEWLINE_xXPatients must have failed one prior line of CT-based therapy for unresectable diseaseXx_NEWLINE_xXPatients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus or EBV infection persistent to standard therapy (as defined below):\r\n* Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood\r\n* CMV, adenovirus or EBV infection persistent despite standard therapy\r\n** For CMV infection:\r\n*** Patients with CMV disease defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR\r\n*** Failure of antiviral therapy defined as the continued presence of pp65 antigenemia (> 1+ cell/100,000 cells) or deoxyribonucleic acid (DNA)emia (as defined by reference lab performing polymerase chain reaction [PCR] assay but usually > 400 copies/ml) after at least 7 days of antiviral therapy OR\r\n*** Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy\r\n** For CMV infection, standard therapy is defined as 7 days therapy with ganciclovir, foscarnet or cidofovir for patients with disease or recurrence after 14 days therapy\r\n** For EBV infection:\r\n*** EBV infection is defined as biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR clinical or imaging findings consistent with EBV lymphoma and elevated EBV viral load in peripheral blood\r\n*** For EBV infection, standard therapy is defined as rituximab given at 375 mg/m^2 in patients for 1-4 doses with a CD20 positive (+) tumor\r\n*** Failure is defined as there was an increase of less than 50% response at sites of disease for EBV lymphoma OR there was a rise or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease\r\n** For adenovirus infection or disease:\r\n*** Adenovirus infection is defined as the presence of adenoviral positivity as detected by PCR, DAA or culture from ONE site such as stool or blood or urine or nasopharynx OR adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from two or more sites such as stool or blood or urine or nasopharynx\r\n*** Standard therapy is defined as 7 days therapy with cidofovir (if renal function permits this agent to be given)\r\n*** Failure is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assayXx_NEWLINE_xXPatients with prior paclitaxel exposure are ineligible unless they are > 6 months from the conclusion of paclitaxel-based therapyXx_NEWLINE_xXPatients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.Xx_NEWLINE_xXFor participants with recurrent SCCHN, prior systemic therapy is allowed if it was given as part of induction or definitive therapy. If participants have received prior combined chemo-radiation therapy, they must be off therapy for at least 3 monthsXx_NEWLINE_xXNeed for antiarrhythmic medical therapy for a ventricular arrhythmiaXx_NEWLINE_xXAngina pectoris requiring therapyXx_NEWLINE_xXPatients with inadequate recovery from acute toxicity associated with any prior antineoplastic therapy.Xx_NEWLINE_xXNo more than 2 prior regimens are allowedXx_NEWLINE_xXPatients must have received at least one prior therapy for MDS; patients could have received transplant for MDSXx_NEWLINE_xXDiagnosed with AML according to the WHO 2008 classification. Note: subjects with secondary AML following Myelodysplastic syndrome or secondary to previous leukemogenic therapy are allowed provided that a record of previous MDS history or leukemogenic therapy history is available.Xx_NEWLINE_xXPatients must have received >= 2 previous lines of therapy that must have included bortezomib and Revlimid; patients must have received 1, but no more than 4 prior treatment regimens or lines of therapy for multiple myeloma; (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)Xx_NEWLINE_xXNo prior therapy with pomalidomide or everolimusXx_NEWLINE_xXPatients must have received prior rituximab-containing therapy.Xx_NEWLINE_xXReceived prior abiraterone acetate, but not within the 3 months prior to study drug dosingXx_NEWLINE_xXPrior therapy with HDAC inhibitors (except for CTCL)Xx_NEWLINE_xXPatients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:Xx_NEWLINE_xXPatients must have had evidence of disease progression while receiving primary androgen suppression therapy by orchiectomy or other primary hormonal therapy and abiraterone (specifically, patients can have received multiple prior additional androgen axis targeting agents including enzalutamide, and prior chemotherapy, but must have had progression while receiving abiraterone either currently or in the past)\r\n* Patients currently on abiraterone may continue with the start of the study drug(s)\r\n* Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g. aberelix); patients who have not undergone bilateral orchiectomy may continue LHRH therapy while on protocolXx_NEWLINE_xXPatients must discontinue all herbal supplements at a minimum of one week prior to initiation of therapy (such information will be collected on each patient)Xx_NEWLINE_xXPatients who are ER+ and/or PR+ and who are receiving anti-hormone therapy for at least three months may continue to receive such therapy during the course of the trialXx_NEWLINE_xXPatients may not have received more than 1 prior line of endocrine therapy in the metastatic settingXx_NEWLINE_xXPatients who are taking any form of other exogenous hormonal therapy within 21 days prior to first dose of orteronel; examples of exogenous hormonal therapy include: vaginal estrogens, transdermal testosterone, etc; the principal investigator (PI) will have the final say regarding what constitutes an exogenous hormonal therapyXx_NEWLINE_xXPrior therapy with abiraterone, or aminoglutethimideXx_NEWLINE_xXPatients must be chemo-naïve, i.e., not have received any prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; prior anthracycline therapy is allowed, but must not exceed a dose of 200 mg/m^2 daunorubicin or equivalent; prior all-trans retinoic acid (ATRA) for suspected APL is allowed; prior methotrexate for central nervous system (CNS) involvement is allowed; patients with prior history of MDS must not have received azacitidine, decitabine, lenalidomide or vorinostatXx_NEWLINE_xXPrior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowedXx_NEWLINE_xXHas received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomizationXx_NEWLINE_xXNOTE: prior therapy with decitabine, clofarabine, idarubicin (idarubicin hydrochloride), or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this studyXx_NEWLINE_xXRelapsed (progressed after prior response) or refractory (failed to achieve at least a partial response) to at least one prior therapy for amyloidosis.Xx_NEWLINE_xXPrior androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist and/or antagonist allowed for either (neo)adjuvant treatment with local therapy or for biochemical relapseXx_NEWLINE_xXLast effective dose of LHRH agonist/antagonist “expired” > 3 months prior to study entry; for example, a patient receiving LHRH agonist injection every 3 months would be eligible provided their last injection was > 6 months prior to day 1 of protocol therapy; a patient receiving LHRH agonist injections every 4 months will be eligible provided last injection was > 7 months prior to day 1 of protocol therapyXx_NEWLINE_xXRelapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.Xx_NEWLINE_xXAdult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.Xx_NEWLINE_xXRefractory to the most recently received therapy; refractory disease is defined as =< 25% response or progression during therapy or within 60 days after completion of therapyXx_NEWLINE_xXSubjects who have received any anti-CMV therapy and investigational anti-CMV drugs at any time posttransplant.Xx_NEWLINE_xXConcomitant use of prohibited therapy (specified in protocol)Xx_NEWLINE_xXPatients eligible for second-line therapy after failing first-line therapy with the regimen FOLFIRINOX.Xx_NEWLINE_xXAngina pectoris requiring therapyXx_NEWLINE_xXPatients with inadequate recovery from acute toxicity associated with any prior antineoplastic therapyXx_NEWLINE_xXMust have one of the following diagnoses:\r\n* Pathologically confirmed chronic myelomonocytic leukemia (CMML) or myelodysplastic syndromes (MDS) with high risk features at the time of referral for trial as defined by:\r\n** Intermediate (INT)-2 or high International Prognostic Scoring System (IPSS) score\r\n** Secondary MDS (defined as MDS developing in a patient with an antecedent hematologic disorder or any patient with prior chemotherapy or radiation exposure)\r\n** INT-1 MDS with excess blasts (>= 5% blasts in bone marrow [BM]) or red blood cell (RBC) transfusion-dependency\r\n** MDS progressing to oligoblastic acute myeloid leukemia (AML) with 21-30% BM blasts\r\n** CMML with >= 5% marrow blasts, or RBC or platelet transfusion-dependency, abnormal karyotype, or proliferative features (white blood cell count >=13,000/uL, splenomegaly on physical examination, or extramedullary disease)\r\n** All patients are required to have failed to respond or relapsed after an initial response to hypomethylating agents 5-azacitidine or decitabine or have refused to receive hypomethylating therapy; failure to respond is defined as failing to achieve a CR, PR or HI after at least 4 cycles of hypomethylating therapy; these patients could have received other therapies or not, but must have received hypomethylating therapy or have refused to receive hypomethylating therapy\r\n* Pathologically confirmed AML patients who have received one or two courses of induction chemotherapy or hypomethylating agent therapy AND no plans for further chemotherapy therapy, but remain with residual disease of < 5% blasts in BM, by morphology, cytogenetics, fluorescent in situ hybridization (FISH), polymerase chain reaction (PCR) or flow cytometryXx_NEWLINE_xXReceived at least 4 weeks of one prior sorafenib containing systemic therapy and then experienced documented radiographic disease progression; or inability to tolerate prior therapy received for at least a minimum period of time.Xx_NEWLINE_xXLocal or loco-regional therapy (i.e., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >= 4 weeks prior to randomizationXx_NEWLINE_xXMore than 1 prior systemic regimen (prior MET inhibitors/antibodies are not allowed; experimental systemic therapy for inoperable HCC given before or after sorafenib counts as separate regimen and is not allowed)Xx_NEWLINE_xXPrior receipt of gene therapy.Xx_NEWLINE_xXFailure of at least one prior therapyXx_NEWLINE_xXRecent initiation (within 6-months) of anti-hypertensive medication (individuals on stable therapy may be enrolled)Xx_NEWLINE_xXReceived other recent antitumor therapyXx_NEWLINE_xXPatients on systemic corticosteroids (except for patients on stable doses of hormone replacement therapy such as hydrocortisone), or other immunosuppressants (e.g., infliximab, mycophenolate mofetil) are excludedXx_NEWLINE_xXSerum creatinine will not be used to exclude patients; patients on renal-replacement therapy (e.g., hemodialysis or peritoneal dialysis) will be eligible to participateXx_NEWLINE_xXNo immunosuppressive therapy within 30 days prior to initiation of protocol therapyXx_NEWLINE_xXPatients with thyroid disease should be excluded unless their T4 is normal or they are on replacement therapyXx_NEWLINE_xXPreviously treated with an anti-Dickkopf-1 (anti-DKK-1) or antibody therapy, or have had a significant allergy to a known pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patientXx_NEWLINE_xXInclusion Criteria:\n\n          1. Lymphoid malignancy that has relapsed or is refractory after two or more treatments\n             that are FDA approved or are commonly used clinically.\n\n          2. Subjects must have progressive disease requiring therapy. Subjects who are candidates\n             for observation only are not eligible.\n\n          3. Subjects are either not currently considered to be candidates or refuse potentially\n             curative therapies including peripheral stem cell or bone marrow transplant\n\n          4. Subjects must have measurable disease as per disease specific criteria\n\n          5. Must have received their last chemotherapy, biologic, radiotherapy, or investigational\n             therapy at least 4 weeks prior to enrollment; 12 weeks from their last\n             radioimmunotherapy; 3 months if the last therapy was bone marrow/ peripheral stem cell\n             transplant.\n\n          6. Age >18 years\n\n          7. ECOG performance status <2\n\n          8. Normal Ejection Fraction on ECHO scan\n\n          9. Subjects must have normal organ and marrow function as defined below:\n\n             Absolute neutrophil count >1000/mL Platelets >75,000/mL For subjects with known marrow\n             infiltration, ANC ?500 and platelets ?30,000 Total bilirubin <1.5 X institutional\n             upper limit of normal (ULN) (<2X ULN for subjects with Gilbert's syndrome) AST (SGOT)\n             and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic involvement <5 X\n             institutional ULN) PT/INR and aPTT within 1.5 X institutional ULN Creatinine <1.5 X\n             institutional ULN OR Creatinine clearance >60 mL/min/1.73 m2 for subjects with\n             creatinine levels above institutional normal\n\n         10. Women of childbearing potential must have had a prior hysterectomy or have a negative\n             serum pregnancy test and be using adequate contraception prior to study entry and must\n             agree to use adequate contraception from study entry through at least 6 months after\n             discontinuation of study drug. Men must also agree to use adequate contraception\n             (hormonal or barrier method of birth control; abstinence) prior to study entry and\n             from study entry through at least 6 months after discontinuation of study drug. Should\n             a woman enrolled in the study or a female partner of a man enrolled in the study\n             become pregnant or suspect she is pregnant while participating in this study or within\n             6 months after discontinuation of study, she should inform the Investigator\n             immediately.\n\n         11. Ability to understand and the willingness to sign a written informed consent document\n\n        Exclusion Criteria:\n\n        Subjects who meet any of the following criteria will not be eligible for participation in\n        the study:\n\n          1. Currently receiving any therapeutic treatment for lymphoid malignancies including\n             other investigational agents\n\n          2. Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors\n\n          3. Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease\n\n          4. History of a Grade 4 allergic reaction attributed to humanized or human monoclonal\n             antibody therapy\n\n          5. Significant intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\n             study requirements\n\n          6. Pregnant women or nursing women\n\n          7. Ongoing malignancies or malignancies in remission <3 years other than the lymphoid\n             malignancies included in this trial. Patients with history of known skin cancers\n             including non-melanotic skin cancers within the past 3 years will not be included in\n             this trial. The following prior malignancies are allowable irrespective of when they\n             occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade\n             local bladder cancer.\n\n          8. Subjects with known HIV infection\n\n          9. Known bleeding disorder or coagulopathy\n\n         10. Subjects receiving heparin, warfarin, or other similar anticoagulants, except for\n             subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be\n             receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.\n\n         11. New York Heart Association Classification II, III, or IV\n\n         12. Subjects with a blood pressure of >140/90 mmHg that is not responsive to medical\n             therapy. Subjects taking antihypertensive medications must be taking ?2 medications to\n             obtain this level of blood pressure control.\n\n         13. Subjects with EKG evidence of ischemia or ?Grade 2 ventricular arrhythmia, subjects\n             who have a history of acute myocardial infarction within 6 months, or subjects with\n             unstable angina.\n\n         14. Subjects with known clinically significant gastrointestinal disease including, but not\n             limited to, inflammatory bowel disease\n\n         15. Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti\n             diarrheal therapyXx_NEWLINE_xXPatient has relapsed or refractory disease and received at least one prior therapy.Xx_NEWLINE_xXAt least one prior therapy;Xx_NEWLINE_xXRefractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;Xx_NEWLINE_xXThe immediate prior treatment regimen must have included an anti-VEGF agent; acceptable anti-VEGF therapy includes bevacizumab, ziv-aflibercept, sunitinib, or sorafenib; for other anti-VEGF therapies, contact the principal investigatorXx_NEWLINE_xXTumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapyXx_NEWLINE_xXPrior unanticipated severe reaction to fluoropyrimidine therapyXx_NEWLINE_xXPrior radioactive iodine must have been completed at least 6 months prior to registration, or there must be documented disease progression since such therapy if it was within 6 months; sites that have received EBRT must have disease progression post-EBRT to be used as sites of measurable diseaseXx_NEWLINE_xXPatients must have received at least one prior line of therapy and also must have received at least one proteasome inhibitor and one immunomodulatory agent (IMiD); for example; one prior line of therapy may consist of all predetermined components of induction followed by autologous stem cell transplantation and maintenanceXx_NEWLINE_xXDOSE ESCALATION COHORT: patients must have had at least one prior therapyXx_NEWLINE_xXMales or non-pregnant, non-breastfeeding females 18 years-of-age or older with histologically confirmed non-Hodgkins lymphoma, without known or clinically suspected CNS involvement, that is refractory to available therapy or for which there is no available therapy.Xx_NEWLINE_xXPatients must have at least ONE of the following: Recurrent/progressive disease at any time prior to study enrollment - regardless of response to frontline therapy. Refractory disease: persistent sites of disease after achieving a best overall response of no response to front line therapy after a minimum of 4 cycles of induction therapy AND patient has never had recurrent/progressive disease. Persistent disease: persistent sites of disease after achieving a best overall response of partial response to frontline therapy after a minimum of 4 cycles of induction therapy AND patient has never had recurrent/progressive disease.Xx_NEWLINE_xXPatients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study:Xx_NEWLINE_xXPatients are eligible 12 weeks after date of autologous hematopoietic stem cell infusion following myeloablative therapy (timed from first day of this protocol therapy).Xx_NEWLINE_xXA minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapy.Xx_NEWLINE_xXNot a candidate for targeted therapy with BRAF or combined BRAF/MEK inhibitors (e.g., failed or did not tolerate prior therapy, BRAF V600 wild-type or due to drug unavailability or standard of care)Xx_NEWLINE_xXThe patient has achieved a first or second CR or CRi. For patients without evidence of MRD in CR/CRi, CR (or CRi) must have been initially identified within 12 months prior to screening. OR The patient has achieved first or second CR or CRi with evidence of MRD as determined locally at least 6 months post stem cell transplant without evidence of acute or chronic graft-versus-host disease post-transplant and has not received immunosuppressant therapy for at least 14 days prior to SL-401 therapy.Xx_NEWLINE_xXPrior therapy with decitabine or azacitidineXx_NEWLINE_xXProgressive disease under last palliative therapy with a history of prior ifosfamide, doxorubicin or taxane therapy for angiosarcoma; up to 4 prior therapies are allowedXx_NEWLINE_xXPatients are allowed to receive, but are not required to receive, non-cytotoxic therapy (such as bevacizumab) as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic therapy for management of recurrent or persistent diseaseXx_NEWLINE_xXPatients may have failed ablative therapyXx_NEWLINE_xXPatients may have an unlimited number of prior therapy regimensXx_NEWLINE_xXPatients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity\r\n* Patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* There will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, peginterferon alfa-2b (Peg-Intron), sorafenib, imatinib, or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the PN; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 before entering this study\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healingXx_NEWLINE_xXSupplementation with vitamin E greater than 100% of the daily recommended dose; any multivitamin containing vitamin E must be stopped prior to initiation of therapyXx_NEWLINE_xXPatients cannot be receiving HAART (highly active anti-retroviral therapy) therapyXx_NEWLINE_xX1-2 lines of prior therapy for advanced or metastatic RCC including at least one antiangiogenic therapy or nivolumab + ipilimumabXx_NEWLINE_xXFailure of rituximab for first-line treatment of PTLD. Note: Subjects with CD20 negative disease are eligible to enroll without prior anti-CD20 therapy after failure of first-line treatment (reduction of immunosuppression is not considered first-line therapy) and discussion with the sponsor's medical monitor.Xx_NEWLINE_xXAll immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) must have resolved completely to baselineXx_NEWLINE_xXReceived prior bevacizumab therapy or had clinically documented reason why not administeredXx_NEWLINE_xXReceived prior paclitaxel therapy or had clinically documented reason why not administeredXx_NEWLINE_xXSteroid therapy for anti-neoplastic intent within 5 daysXx_NEWLINE_xXEvidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entryXx_NEWLINE_xXMen with metastatic prostate cancer that require castration therapy with either using an luteinizing hormone-releasing hormone (LHRH) analogue or surgical castration are eligible; complete androgen blockade using anti-androgen therapy prior to castration or up to approximately 4-6 weeks following castration therapy is permitted to prevent disease flare; thereafter anti-androgen therapy may continue or be discontinued based on treating physicians preference; or\r\n* Any men with prostate cancer who are candidates for castration therapy despite no evidence of definite metastatic disease including patient with biochemical failure or rising PSA are also permitted to enter study provided castration therapy is planned for a minimum of a year; patients with biochemical failure prior to enrollment should have also have already received appropriate salvage therapy; men with prostate cancer who have already started castration therapy are also permitted to enter study provided castration therapy was initiated within one month of study entry; or\r\n* Men with prostate cancer previously treated with castration therapy for management of localized prostate cancer in the adjuvant setting or in combination with radiation therapy are permitted to enter study provided they currently have known metastatic disease and have non-castrate testosterone levels (testosterone > 50 ng/dL)Xx_NEWLINE_xXIf any patient develops symptomatic diabetes requiring drug therapy, he must receive such a therapy, which may include metformin; this must be documented, and the patient will not continue on the studyXx_NEWLINE_xXDose Escalation Phase: Patients have exhausted, or be deemed to not benefit from, further conventional therapy and have evidence of progressive disease on study entry.Xx_NEWLINE_xXArm A: Patients with AML who are 65 years of age or older with refractory or relapsed disease, or who have not received prior therapy but are not eligible to receive intensive frontline chemotherapy (i.e., Acute Group patients);Xx_NEWLINE_xXPatients must have at least one prior trastuzumab-containing regimenXx_NEWLINE_xXSix weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody therapy at the time the patient receives the preparative regimen to allow antibody levels to decline; Note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsiesXx_NEWLINE_xXPrior therapy against VEGF or VEGFRs including, but not limited to bevacizumab, sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is permitted so long as the agent does not have any known activity against DLL4 and the last dose received s at least 6 weeks prior to first dose of MEDI0639.Xx_NEWLINE_xXPatients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.Xx_NEWLINE_xXReceived 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).Xx_NEWLINE_xXPrior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).Xx_NEWLINE_xXPrior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.Xx_NEWLINE_xXOngoing androgen deprivation therapyXx_NEWLINE_xXAny contraindication to gemcitabine therapyXx_NEWLINE_xXBreast feeding must be discontinued for the duration of therapy with vorinostat and the concomitantly used chemotherapy, if applicableXx_NEWLINE_xXNewly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decisionXx_NEWLINE_xXThe participant’s target lesion must be limited to a single biopsy-confirmed tumor; presence of other pulmonary nodules, which may represent synchronous early lung cancer, is allowed as long as no additional therapy is anticipated within 3 months following protocol therapyXx_NEWLINE_xXPatients for whom potentially curative antineoplastic therapy is availableXx_NEWLINE_xXPatients must have not received any prior therapy other than surgery and/or steroidsXx_NEWLINE_xXPatients may have received secondary hormonal manipulations (excluding prior abiraterone acetate, MDV3100 or TAK700) or up to two lines of chemotherapy; all prior therapy except Lupron must have been discontinued for more than 4 weeks before enrollmentXx_NEWLINE_xXPrior therapy with IL-12 or prior gene therapyXx_NEWLINE_xXHCC patients only:\r\n* First line (i.e., no prior systemic therapy) or second-line (with prior first-line sorafenib therapy only) advanced HCC \r\n* Child Pugh class A or B7 liver disease \r\n* Prior chemoembolization, radioembolization, radiofrequency ablation (RFA), or other local ablative therapies are permissible if >= 6 weeks from procedure with evidence of progression or new metastatic disease, if applicable (Phase I)Xx_NEWLINE_xXFirst line advanced HCC (i.e., no prior systemic therapy)Xx_NEWLINE_xXMedical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)Xx_NEWLINE_xXParticipants with HL must be in their second of later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplantXx_NEWLINE_xXReceiving systemic therapy for chronic graft-versus-host disease (topical therapy is allowed)Xx_NEWLINE_xXConcurrent therapy with other anti-neoplastic or experimental agentsXx_NEWLINE_xXPatients must have recurrent SCCHN that has been previously treated with cetuximab as part of potentially curative therapy (i.e. with induction therapy, radiotherapy or chemoradiotherapy); the interval from completion of cetuximab and study treatment should be > 3 monthsXx_NEWLINE_xXOne prior curative regimen (induction, primary or postoperative chemoradiotherapy) should have been given AND all patients should have been exposed to cetuximab as part of prior potentially curative treatment (i.e. with radiotherapy or induction therapy); the last cetuximab dose should be > 3 monthsXx_NEWLINE_xXRelapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion.Xx_NEWLINE_xXInclusion Criteria:\n\n        Among other criteria, patients must meet the following conditions to be eligible for the\n        study:\n\n          1. 18 years of age or older.\n\n          2. Body Weight ? 120 kg.\n\n          3. Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to\n             express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear)\n             cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal\n             adenocarcinoma or non-small cell lung cancer. For the solid tumor expansion cohorts,\n             enrollment is limited to the following solid tumors: melanoma and renal cell\n             carcinoma.\n\n          4. Tumor must be recurrent or treatment refractory with no remaining alternative,\n             approved therapy options, with the following exception: melanoma patients enrolled in\n             the expansion phase must have previously received ipilimumab and, for patients with\n             the BRAF V600E mutation, vemurafenib, or have been offered such therapies and refused,\n             and patients must have progressive disease subsequent to previous therapies.\n\n          5. Measurable or evaluable disease.\n\n          6. Have adequate blood, bone marrow, liver and kidney function as determined by\n             laboratory tests.\n\n          7. If of childbearing potential (male or female), agree to practice an effective form of\n             contraception during study treatment.\n\n          8. Have little or no side effects remaining from prior cancer therapies.\n\n          9. Provide written informed consent.\n\n        Exclusion Criteria:\n\n        Among other criteria, patients who meet the following conditions are NOT eligible for the\n        study:\n\n          1. Known prior primary or metastatic brain or meningeal tumors.\n\n          2. Receiving treatment with immunosuppressive agents, including any systemic steroids.\n\n          3. Active infection requiring systemic therapy, known HIV infection, or positive test for\n             hepatitis B surface antigen or hepatitis C.\n\n          4. Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter\n             patency.\n\n          5. Women who are pregnant or lactating.\n\n          6. Prior allogeneic bone marrow transplant.\n\n          7. Autologous bone marrow transplant within 100 days of first dosing.\n\n          8. Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on\n             treatment type).\n\n          9. Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks\n             prior to first dosing.Xx_NEWLINE_xXPrevious cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapyXx_NEWLINE_xXSubjects must have documented disease progression prior to enrolling into the studyXx_NEWLINE_xXNeed for current chronic corticosteroid therapyXx_NEWLINE_xXNo prior bortezomib is allowedXx_NEWLINE_xXOther investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable)Xx_NEWLINE_xXOther investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable)Xx_NEWLINE_xXSubjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)Xx_NEWLINE_xXSubjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin AXx_NEWLINE_xXPatients who will receive neoadjuvant therapy prior to definitive surgeryXx_NEWLINE_xXPatient must be either primary refractory to one frontline induction therapy or relapsed after one frontline induction therapy; patients who do not achieve complete remission after induction therapy are also eligibleXx_NEWLINE_xXTreated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen with less than 3 weeks from last dose of systemic anticancer therapy, radiation therapy, or therapy with any investigational agentXx_NEWLINE_xXRadiographic evidence of disease progression by RECIST criteria on or after the last anti-cancer therapy within the 6 months prior to randomization.Xx_NEWLINE_xXPatients who have started protocol therapy prior to enrollment\r\n* Please note: patient may still enroll if IT therapy was given within 72 hours of study enrollment as part of the diagnostic lumbar procedureXx_NEWLINE_xXRelapsed is defined as experiencing PD that requires therapy but which is not refractory following the achievement of stable disease (SD) or better to the most recent anti-MM regimen.Xx_NEWLINE_xXPatient received at least 2 prior regimens for MM.Xx_NEWLINE_xXPatient has received any of the following therapies:Xx_NEWLINE_xXPatients must have received adequate prior alkylator therapyXx_NEWLINE_xXPrevious therapy with PomalidomideXx_NEWLINE_xXResistance to high-dose dexamethasone used in the last line of therapyXx_NEWLINE_xXPHASE I: Prior systemic therapy with sorafenib is allowedXx_NEWLINE_xXPHASE II: Prior systemic therapy with sorafenib is allowedXx_NEWLINE_xXNo anti-coagulation therapy is allowed with the exception of low-dose aspirinXx_NEWLINE_xXRituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy. Last rituximab-containing therapy is defined as the last therapy regimen containing at least one full dose of rituximab.Xx_NEWLINE_xXRelapse or disease progression following response to prior rituximab-based therapy, requiring treatment by 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) guidelines.Xx_NEWLINE_xXRituximab-refractory disease, defined as failure to respond to or progression within 6 months of completing rituximab or rituximab-containing combination therapy.Xx_NEWLINE_xXDiscontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.Xx_NEWLINE_xXPart D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapyXx_NEWLINE_xXNo previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;Xx_NEWLINE_xXPreviously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);Xx_NEWLINE_xXFor patients who have received prior anti-cytotoxic T-lymphocyte antigen (CTLA)4 monoclonal antibody therapy (ipilimumab or tremelimumab), there is a risk of bowel perforation with IL-2 therapy; therefore, for these patients if they have a history of colitis or diarrhea during anti-CTLA4 monoclonal antibody therapy, they should have a formal evaluation by a gastroenterologist and a colonoscopy should be considered to demonstrate the absence of active bowel inflammation before initiating IL-2 therapy on this protocolXx_NEWLINE_xXPatients may have had any number of prior therapies, but cannot have previously been treated with a somatostatin analogue or an mechanistic target of rapamycin (mTOR) inhibitor; at least 3 weeks must have elapsed since the last dose of systemic therapy; at least 6 weeks must have elapsed if the last regimen included carmustine (BCNU) or mitomycin C; at least 3 months must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody; if the last regimen included an anti-CTLA4 antibody, radiographic disease progression since this therapy must be documentedXx_NEWLINE_xXParticipating patients must receive medically appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated, and should be under the care of a physician experienced in HIV management; with the exception of treatment with zidovudine and stavudine, patients will be eligible regardless of antiretroviral regimen (no antiretroviral therapy, nonnucleoside reverse transcriptase inhibitors [NNRTI]-based therapy, or protease inhibitor based therapy), provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; the exact regimen used for HIV therapy will be captured on Case Report Forms; as study-specific (antiretroviral therapy-based) strata fill, however, only patients fitting the remaining open strata will be accruedXx_NEWLINE_xXDuring Phase II enrollment: prior therapy with cisplatin with the exception of when given concurrently with radiation therapy (cisplatin will be allowed as prior therapy during Phase I enrollment)Xx_NEWLINE_xXA sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment in this study, to allow the effects of prior therapy to have abated:Xx_NEWLINE_xXHas received prior anthracycline therapyXx_NEWLINE_xXHas received prior taxane therapyXx_NEWLINE_xXPatients with hormone receptor-positive disease must have progressed on or following hormone therapyXx_NEWLINE_xXSubjects who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.Xx_NEWLINE_xXSubjects who are considered to require concurrent therapy with another influenza antiviral medication.Xx_NEWLINE_xXReceived prior therapies including:Xx_NEWLINE_xXc. carfilzomib. Demonstrated disease progression on or within 60d of completion of carfilzomib therapyXx_NEWLINE_xXRelapse or disease progression following response to prior rituximab-based therapy, as defined by 2007 RRCML criteria, which requires therapy.Xx_NEWLINE_xXPrevious anti-CD20 radioimmunotherapy (RIT) or non-rituximab anti-CD20 therapy (such as obinutuzumab) within 6 months prior to randomization. Patients who have received previous anti-CD20 RIT or non-rituximab anti-CD20 therapy (such as obinutuzumab) must have attained a partial or complete response lasting at least 6 months, and must have recovered from any hematologic or other toxicity.Xx_NEWLINE_xXPrevious anti-lymphoma monoclonal antibody therapy (excluding anti-CD20 therapy and anti-CD20 RIT), chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months prior to randomization.Xx_NEWLINE_xXPatients must have had no prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per low- or intermediate-risk neuroblastoma therapy (P9641, A3961, ANBL0531) prior to determination of MYCN amplification and histologyXx_NEWLINE_xXPrior therapy with other histone deacetylase (HDAC) inhibitors, including valproic acidXx_NEWLINE_xXPrior therapy with heat shock protein (HSP)-90 inhibitorsXx_NEWLINE_xXImmunosuppressive therapy within the last 3 monthsXx_NEWLINE_xXFor phase I patients only: Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulatorsXx_NEWLINE_xXAny progression during treatment if the len/dex combination was the subject's most recent line of therapyXx_NEWLINE_xXPatients must not have received any systemic corticosteroid therapy for 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalentXx_NEWLINE_xXPatients may have a history of prior (non-colonic) malignancies, provided there is no current clinical evidence of persistent or recurrent disease and the patient is on no active therapy, including hormonal therapyXx_NEWLINE_xXConcurrent anti-androgen therapyXx_NEWLINE_xXHematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicatedXx_NEWLINE_xXFor subjects who are deemed to be eligible for high-dose interleukin-2 (IL-2) and elect to receive this therapy, such subjects must have progressive disease post-IL-2 to enter this study; such subjects must also have received and have had progressive disease after therapy with one of the agents listedXx_NEWLINE_xXSubject must have progressive disease after therapy consisting of one of the Food and Drug Administration (FDA)-approved agents for therapy of metastatic renal cell carcinoma, including but not limited to: sorafenib, sunitinib, or temsirolimusXx_NEWLINE_xXRecurrent disease:\r\n* Patient > 5 years old (yo) must have recovered CD4 count to > 350 cells/mm3 OR have disease free interval > one year from completion of cytotoxic therapy\r\n* Patients < 5yo must have recovered CD4 count to > 360 cells/mm3 OR have disease free interval > six months from completion of cytotoxic therapyXx_NEWLINE_xXPersistent or progressive cancer following the completion of the standard therapy phase of the trial will not, in and of itself, preclude receipt of immunotherapy; however, patients will not receive immunotherapy if they have an ECOG performance status of 3 or 4 or, for children =< 10 years of age, Lansky =< 50; furthermore, patients will be removed from the trial if they develop requirements for anti-neoplastic therapy (e.g. radiation therapy) for progressive disease during the trialXx_NEWLINE_xXPrevious anti-androgen therapy and progression after withdrawalXx_NEWLINE_xXPrior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.Xx_NEWLINE_xXOther than surgery, patients may not have therapy for this recurrence (including radiation); supportive care such as steroids or anti-epileptics does not constitute treatment of recurrenceXx_NEWLINE_xXThe participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatmentsXx_NEWLINE_xXThe participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapyXx_NEWLINE_xXThe participant has received more than 2 prior regimens of systemic therapy in the metastatic settingXx_NEWLINE_xXDISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the\n        prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c)\n        Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or\n        para-aortic nodal involvement Regional lymph node involvement below the common iliac level\n        allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA\n        no more than 150 (mandatory) No distant metastases\n\n        PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100%\n        Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or\n        concurrent second cancer except basal cell skin cancer No major medical or psychiatric\n        illness that would prevent completion of treatment or interfere with follow-up\n\n        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\n        chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior\n        radiotherapy Surgery: No prior radical surgery for carcinoma of the prostateXx_NEWLINE_xXFailed previous antifungal therapy or expected to live < 3 days.Xx_NEWLINE_xXSteroids: Dose should be stable or decreasing for at least one week prior to starting therapy; corticosteroid therapy is permissible only for the treatment of increased intracranial pressure in patients with malignancies in the CNS or for spinal cord compression; corticosteroid should be used at the lowest dose to control symptoms and discontinued if possibleXx_NEWLINE_xXFor phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy but no more than two previous cytotoxic therapies and are evaluableXx_NEWLINE_xXPrior monoclonal antibody: participants having received prior in vivo monoclonal anti-GD2 antibodies for biologic therapy or for tumor imaging AND experienced a severe allergic reaction while receiving prior anti-GD2 therapy; (Note: participants who have received previous therapy with anti-GD2 monoclonal antibodies are eligible for this study, provided they did not experience a severe allergic reaction with the antibody)Xx_NEWLINE_xXConfirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment.Xx_NEWLINE_xXMust agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.Xx_NEWLINE_xXMust agree to not donate semen during study drug therapy and for a period after end of study drug therapy.Xx_NEWLINE_xXAgree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.Xx_NEWLINE_xXAnticoagulant drug therapy,Xx_NEWLINE_xXHodgkin disease (HD)\r\n * Patients with HD will be eligible if they fail to achieve a CR following conventional therapy\r\n * Patients who relapse following conventional therapy, but fail to achieve a second CR (or for any other reason cannot undergo autologous transplantation) will be eligible\r\n * Patients who relapse after an autologous transplant will be eligibleXx_NEWLINE_xXAny current renal replacement therapyXx_NEWLINE_xXPatients must have received at least one prior line of therapy and their disease has relapsed..Xx_NEWLINE_xXAt least a 2-week recovery from prior therapy toxicity.Xx_NEWLINE_xXDISEASE CHARACTERISTICS:\n\n          -  Histologically confirmed metastatic melanoma, meeting any of the following criteria:\n\n               -  Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy\n\n               -  No longer responding to standard therapy OR have refused standard therapy\n\n          -  Unresectable disease\n\n          -  Measurable or evaluable disease\n\n          -  No clinical ascites\n\n          -  No symptomatic pleural effusion\n\n        PATIENT CHARACTERISTICS:\n\n          -  Life expectancy ? 12 weeks\n\n          -  Karnofsky performance status 70-100%\n\n          -  Bilirubin ? 3.0 mg/dL\n\n          -  Albumin ? 3.0 g/dL\n\n          -  Alkaline phosphatase < 5 times upper limit of normal (ULN)\n\n          -  Serum glucose > 60 mg/dL\n\n          -  Amylase < 1.5 times ULN\n\n          -  Absolute neutrophil count > 1,500/mm³\n\n          -  Platelet count > 100,000/mm³\n\n          -  No New York Heart Association class III-IV heart failure\n\n          -  No serious infection requiring treatment with antibiotics\n\n          -  No known allergy to E. coli drug products (e.g., sargramostim [GM-CSF])\n\n          -  Not pregnant or nursing\n\n          -  Negative pregnancy test\n\n          -  Fertile patients must use 2 forms of effective contraception\n\n        PRIOR CONCURRENT THERAPY:\n\n          -  See Disease Characteristics\n\n          -  At least 4 weeks since prior anticancer therapy\n\n          -  At least 4 weeks since prior surgery and recovered\n\n          -  No concurrent participation in another investigational drug studyXx_NEWLINE_xXPatients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy; b. untreated, smoldering (i.e. not rapidly progressive) relapsesXx_NEWLINE_xXPatients must not have received prior anti-disialoganglioside (GD2) antibody therapyXx_NEWLINE_xXNo prior systemic therapy for HCCXx_NEWLINE_xXNo prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imagingXx_NEWLINE_xXChemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry. AEs from prior therapy must have resolved or stabilized so that there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first.Xx_NEWLINE_xXNo prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.Xx_NEWLINE_xXPatients must have recovered from the acute effects of prior liver-directed therapy (e.g., radiation therapy [RT], radiofrequency ablation [RFA], MWA or transarterial chemoembolization [TACE]) and a minimum of 4 weeks must have passed since the last procedure and protocol therapyXx_NEWLINE_xXMust have had one prior line of systemic therapy for AL; Note: patients who do not achieve at least a PR to frontline therapy in 3 months may be eligible after discussion with study chairXx_NEWLINE_xXInvestigational products or therapy other than ASP8273Xx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonistsXx_NEWLINE_xXOngoing systemic therapy (other than a luteinizing hormone-releasing hormone agonists [LHRH] agonist/antagonist) for prostate cancer including, but not limited to:\r\n* CYP-17 inhibitors (e.g. ketoconazole, abiraterone)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. ARN-509)\r\n* Immunotherapy (e.g. sipuleucel-T)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium- 153)Xx_NEWLINE_xXPatients must have refractory disease, disease relapse or progression after at least two prior systemic chemotherapy or immunotherapy regimens\r\n* Note: Exceptions may be made if a patient is deemed unfit for first-line salvage therapy by the treating physician; such cases should be clearly documentedXx_NEWLINE_xXPatients may have received previous NY-ESO-1 vaccine therapyXx_NEWLINE_xXPatients should have a diagnosis of AML (de novo or transformed from hematologic malignancies), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) with one of the following features: (A) patients with MDS or CMML should have failed prior therapy with a hypomethylating agent and/or with lenalidomide (cohorts 2 and 3); (B) patients with AML should have failed any prior therapy or have relapsed after prior therapy (cohorts 2 and 3); for patients in cohort 3 prior therapy should have included a FLT3 inhibitor; (C) patients with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML; the World Health Organization (WHO) classification will be used for AML; these patients will be assigned to cohort 1; patients with MDS, CMML or AML who have received no prior therapy are eligible if age 65 and greater or if, at the time of enrollment, are not candidates to receive or refuse standard therapy (cohort 1 only)Xx_NEWLINE_xXRefractory patients:\r\n* Patients must have received at least two attempts at remission induction, which may consist of up to two different therapy courses; Children's Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is one remission attemptXx_NEWLINE_xXPatient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of lifeXx_NEWLINE_xXSpecimens for cytogenetic analysis are required, and must be obtained prior to therapy initiation; for patient with refractory disease, the diagnostic specimen may be usedXx_NEWLINE_xXCorticosteroids should not be used as anti-emetic therapy; corticosteroid therapy is not permissible except for the following indications: \r\n* As treatment or prophylaxis for anaphylactic reactions\r\n* As a treatment for symptoms of cytarabine (Ara-C) syndrome (including fever, rash, or conjunctivitis)\r\n* Physiologic replacement stress-dosing as indicated for suspected or confirmed adrenal insufficiencyXx_NEWLINE_xXPatients who have tested positive for a v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation may have received prior BRAF inhibitor therapy as a prior line of systemic therapy; patients may have received up to 2 prior lines of therapy with a checkpoint inhibitor (CPI), which may have included pembrolizumab, nivolumab, or ipilimumab; these agents may have been administered as single-agent treatment, in combination with each other, or in combination with other agents; patients who have received prior treatment with ipilimumab must have relapsed after achieving a response to prior ipilimumab treatment; this response may have been achieved with ipilimumab administered as single-agent therapy or in combination with another treatment; patients who have received prior treatment with pembrolizumab or nivolumab must have progression of disease after at least 4 doses of either drug alone or in combination with other agentsXx_NEWLINE_xXSubjects who have received prior oncolytic therapy or prior therapy with and toll-like receptor (TLR) agonist including topical agents; subjects that have received experimental vaccines or other immune therapies should be discussed with the medical monitor or the primary investigator (PI) to confirm eligibilityXx_NEWLINE_xXFor transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;Xx_NEWLINE_xXPrior therapy with agents targeting immune coinhibitory receptors.Xx_NEWLINE_xXHas had prior hormonal therapy such as Lupron or oral anti-androgensXx_NEWLINE_xXTissue Procurement Inclusion Criteria:\n\n        Patients will be eligible for tissue procurement for the Vigil™ manufacturing process, if\n        they meet all of the following criteria:\n\n          1. Histologically or cytologically confirmed diagnosis of NSCLC.\n\n          2. Age ? 18 years.\n\n          3. Locally advanced or metastatic disease that is progressive after one prior\n             platinum-based systemic chemotherapy regimen\n\n               1. Adjuvant therapy will count as a line of therapy if administered within 6 months\n                  of relapse).\n\n               2. Subjects with EGFR or ALK mutations should also have received appropriate\n                  targeted therapy.\n\n          4. No systemic therapy, immunologic therapy or investigational therapy within 3 weeks and\n             no radiation therapy within 1 week prior to tumor procurement for vaccine manufacture.\n\n          5. Planned standard of care surgical procedure (e.g., tumor biopsy or palliative\n             resection or thoracentesis) and expected availability of a cumulative mass of ~10-30\n             grams tissue (\golf-ball\ size) or pleural fluid estimated volume ? 500mL (must be\n             primary tap) for immunotherapy manufacture.\n\n          6. At least one area of cancer, not intended for vaccine manufacture, that is measureable\n             by RECIST 1.1 criteria.\n\n          7. At least one tumor, not intended for vaccine manufacture, that is considered\n             appropriate for on-treatment biopsy. The same tumor may suffice for both on-treatment\n             biopsy and RECIST 1.1 measurement so long as imaging occurs prior to biopsy.\n\n          8. ECOG Performance Status ? 1\n\n          9. Estimated survival ? 6 months.\n\n         10. Ability to understand and the willingness to sign a written informed consent document\n             for tissue harvest.\n\n        Tissue Procurement Exclusion Criteria:\n\n        Patients meeting any of the following criteria are not eligible for tissue procurement for\n        the Vigil™ manufacturing:\n\n          1. Any localized anticancer therapy (e.g., radiation, radiofrequency ablation,\n             cryotherapy) to tumor intended for vaccine manufacture unless unequivocal evidence of\n             post-treatment disease progression of the target tumor.\n\n          2. Medical condition requiring any form of chronic systemic immunosuppressive therapy\n             (steroid or other) except physiologic replacement doses of hydrocortisone or\n             equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily for\n             < 30 days duration\n\n          3. Known history of other malignancy unless having undergone curative intent therapy\n             without evidence of that disease for ? 3 years except cutaneous squamous cell and\n             basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other\n             in situ cancers are allowed if definitively resected.\n\n          4. Brain metastases unless treated with curative intent (gamma knife or surgical\n             resection) and without evidence of progression for ? 4 months.\n\n          5. Any documented history of autoimmune disease with exception of Type 1 diabetes on\n             stable insulin regimen, hypothyroidism on stable dose of replacement thyroid\n             medication, vitiligo, or asthma not requiring systemic steroids.\n\n          6. Known history of allergies or sensitivities to gentamicin.\n\n          7. History of or current evidence of any condition (including medical, psychiatric or\n             substance abuse disorder), therapy, or laboratory abnormality that might confound the\n             results of the study, interfere with the patient's participation for the full duration\n             of the study, or is not in the best interest of the patient to participate, in the\n             opinion of the treating Investigator.\n\n          8. Known HIV or chronic Hepatitis B or C infection.\n\n          9. History of pneumonitis or interstitial lung disease.\n\n        Study Enrollment Inclusion Criteria:\n\n        Patients will be eligible for registration into the trial if they meet all of the following\n        inclusion criteria:\n\n          1. Successful manufacturing of at least 4 vials of Vigil™.\n\n          2. ECOG Performance Status ? 1\n\n          3. Estimated survival ? 4 months.\n\n          4. Disease that is measurable by RECIST 1.1 criteria.\n\n          5. Adequate organ function as defined by the following laboratory values:\n\n             Absolute granulocyte count ? 1,500/mm3 Absolute lymphocyte count ? 500/mm3 Platelets ?\n             75,000/mm3 Hemoglobin ? 9 g/dL Creatinine ? 1.5x institutional upper limit of normal\n             Total bilirubin ? 1.5x institutional upper limit of normal AST(SGOT) and ALT(SGPT) ?2x\n             institutional upper limit of normal or\n\n             ?5x institutional upper limit of normal if liver metastases INR / PT and aPTT ? 1.5 x\n             ULN (if not using anticoagulants) Immunological Thyroid Stimulating Hormone within\n             institutional limits\n\n          6. Subject has recovered to CTCAE Grade 1 or better from all adverse events associated\n             with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or\n             symptoms must be recovered to CTCAE Grade 2 or better.\n\n          7. If female of childbearing potential, has a negative urine or serum pregnancy test. If\n             the urine test is positive or cannot be confirmed as negative, a negative serum test\n             will be required for study entry.\n\n          8. Investigator deems the patient to have a tumor appropriate for on-treatment biopsy and\n             patient agrees to provide tissue biopsy at Cycle 5 (Week 9) for correlative studies.\n\n          9. Ability to understand and the willingness to sign a written informed protocol specific\n             consent.\n\n        Study Enrollment Exclusion Criteria:\n\n        In addition to the procurement exclusion criteria, patients will NOT be eligible for study\n        registration and enrollment if meeting any of the following criteria:\n\n          1. Any anti-neoplastic therapy between tissue procurement for vaccine manufacture and\n             start of study therapy.\n\n          2. Live vaccine used for the prevention of infectious disease administered < 30 days\n             prior to the start of study therapy.\n\n          3. Post-surgery complication that in the opinion of the treating investigator would\n             interfere with the patient's study participation or make it not in the best interest\n             of the patient to participate.Xx_NEWLINE_xXMM that is refractory to the most recent treatment regimen. Refractory is defined as ? 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy.Xx_NEWLINE_xXPatients with specific contraindications to the use of anti-EGFR therapy such as pulmonary fibrosis, interstitial pneumonia historyXx_NEWLINE_xXHave received between 1-2 prior cytotoxic treatments, not to include belinostat, RDHAP, or autologous or allogeneic stem cell transplant; radiation which was pre-planned to occur at the conclusion of systemic cytotoxic therapy will not be considered a separate prior therapy; radiation administered for potential recurrent or relapsed disease will be considered a separate prior therapyXx_NEWLINE_xXPrior therapy with at least one first line standard therapy including check point inhibitors such as pembrolizumab, nivolumab, or ipilimumab\r\n* Note: six weeks must have elapsed from the time of any of these prior antibody therapies that could affect an anti-cancer immune response, at the time the patient receives the preparative regimen to allow antibody levels to decline\r\n* Note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsiesXx_NEWLINE_xXSix weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody therapy, at the time the patient receives the preparative regimen to allow antibody levels to decline\r\n* Note: patients who have previously received ipilimumab and have documented GI toxicity must have a colonoscopy with normal colonic biopsiesXx_NEWLINE_xXPrior or on-going therapy:\r\n* No previous systemic (topical allowed) therapy for acute GvHD --except for a maximum (and ideally less) of 48 hours of prior glucocorticoid (GC) therapy, > 0.5 mg/kg/day of MePDSL or equivalent after the onset of acute GvHD\r\n* An exception to the above exists for patients with prior acute GvHD (of any site) who received GC therapy, experienced a complete response (CR), were tapered off GC and recurred >= 15 days later; such are eligible after review by the PI or his designee\r\n* For patients with SR, no prior stipulations – beyond prior IASA – will be specified\r\n* The use of on-going acute GvHD prophylaxis will be continued as above (if in the rare case this is not possible due to toxicity, discussion with, and approval by the study PI is required)\r\n* Moreover, the use of any other IST is allowed if acute GvHD of the GIT develops while the patient is off all IST; IST may be restarted at the discretion of the attending physician after discussion with the PI of this study\r\n* Treatment with oral budesonide is to be started or continued at full dose\r\n* Please consult with the study PI regarding any questions or concerns of study eligibilityXx_NEWLINE_xXRelapsed or refractory to the most recently received therapy. Relapsed is defined as documented evidence of PD after achieving at least SD for ? 1 cycle. Refractory disease is defined as ? 25% response (i.e., patients never achieved minimal response or better) or progression during therapy or within 60 days after completion of therapy.Xx_NEWLINE_xXPatients with persistent or recurrent disease must have received definitive chemoradiation therapy as first line therapy; patients with advanced (stage IVB) disease may have received palliative radiation therapyXx_NEWLINE_xXPrior therapy:\r\n* Patients must have received at least one prior standard cytotoxic regimen such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) or doxorubicin hydrochloride, etoposide phosphate, vincristine sulfate, cyclophosphamide, and prednisone (EPOCH) - unless they were not candidates for this therapy\r\n* Patients must have received prior brentuximab vedotin - unless they were not candidates for this therapy\r\n* Patients must have received prior autologous stem cell transplant unless they refused or were not candidates for stem cell transplantXx_NEWLINE_xXPresence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.Xx_NEWLINE_xXLiver-directed therapy (hepatic artery chemoembolization [HACE], hepatic artery embolization [HAE], selective internal radiation therapy [SIRT]) or peptide receptor radionuclide therapy (PRRT) =< 56 days of first dose of study drugXx_NEWLINE_xXReceived the last administration of an anticancer targeted small molecule therapy (e.g. sunitinib, sorafenib, pazopanib, axitinib, everolimus, temsirolimus, ridaforolimus) =< 14 days prior to study registration or have not recovered from the side effects of such therapyXx_NEWLINE_xXPrior therapy allowed but, no prior therapy with nab-paclitaxel, paclitaxel, temozolomide, dacarbazine or bevacizumabXx_NEWLINE_xXPatients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months; these patients can have received any amount of prior chemotherapy to enter this trialXx_NEWLINE_xXLess than 4 prior systemic cancer therapies (with the exception of hormonal agents), including experimental agents, prior HER-family TKI therapies, and prior docetaxel and other taxane therapy; there are no limits to the number of prior therapies for Part 1Xx_NEWLINE_xXOral or transdermal estrogen therapy is not allowedXx_NEWLINE_xXPatients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab–based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy:\r\n* Trastuzumab\r\n* Trastuzumab + chemotherapy or hormonal therapy\r\n* Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab)\r\n* Ado-trastuzumab (Kadcyla)\r\n* NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permittedXx_NEWLINE_xXFinancial clearance for proton therapy treatment prior step 2 registrationXx_NEWLINE_xXNot be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)Xx_NEWLINE_xXPrior or current androgen deprivation therapyXx_NEWLINE_xXWithin three days of starting the induction phase of therapy for ALL (B-cell, T-cell, or mixed phenotype)Xx_NEWLINE_xXPatients, who have experienced disease progression despite initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through anti-androgen withdrawal prior to being eligible; the minimum timeframe to document failure of anti-androgen withdrawal will be four weeks; patients on second-line (or beyond) hormonal maneuvers, and patients who had no PSA decline on combined androgen blockade as first line therapy, need not progress through anti-androgen withdrawal (AAW) in order to be eligibleXx_NEWLINE_xXPrior therapy with inhibitors of IGF-1 (example [ex]: AMG-479, OSI-906)Xx_NEWLINE_xXHave received more than 3 prior CTX regimensXx_NEWLINE_xXPatients who are not biochemically euthyroid; patients with known history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy for at least 3 monthsXx_NEWLINE_xXContinuous anticoagulation therapy; patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusionXx_NEWLINE_xXMyeloablative preparative regimen (for SAA any conditioning therapy allowed)Xx_NEWLINE_xXCOHORT A SPECIFIC INCLUSION: Histologically confirmed IDHwt, retinoblastoma (RB) intact, grade II or III glioma that has recurred after first line therapy (consisting of at least maximum feasible surgical resection and radiation therapy); there is no limit on the number of prior therapies or types of therapies patients can have receivedXx_NEWLINE_xXNo limit on number of prior therapiesXx_NEWLINE_xXcompleted or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at ScreeningXx_NEWLINE_xXCohort 2: Soft tissue sarcoma of intermediate or high grade with evidence of disease progression by either CT or MRI scan, or clinical judgment on or after the last cancer therapy within 6 months prior to the start of study treatment. Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation. Patients who have previously received anthracyclines are eligible if cumulative exposure is <375 mg/m2 for doxorubicin and liposomal doxorubicin or <675 mg/m2 for EPI.Xx_NEWLINE_xXAre unable to receive anthracycline therapy due to previous toxicity.Xx_NEWLINE_xX-  Must be greater than 18 years of age at the time of consent.\n\n          -  Must have persistent, recurrent or metastatic HNSCC; histologic documentation of the\n             primary tumor is required via the pathology report.\n\n          -  Must have had at least 1 prior systemic chemotherapeutic regimen for management of\n             persistent, recurrent or metastatic HNSCC. Patients must not have any curative therapy\n             options, or be intolerant of, or decline standard of care therapy for persistent,\n             recurrent or metastatic disease.\n\n          -  Any prior therapy directed at the malignant tumor, including radiation therapy,\n             chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at\n             least 28 days prior to lymphodepletion\n\n          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n          -  Patients must be seronegative for the HIV antibody,\n\n          -  Female patients of childbearing potential must be willing to practice an approved\n             method of birth control starting at the time of informed consent and for 1 year after\n             the completion of the lymphodepletion regimen.\n\n        Exclusion Criteria:\n\n          -  Patients who have received prior cell therapy, except for prior LN-145.\n\n          -  Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or\n             equivalent).\n\n          -  Patients who currently have prior therapy-related toxicities greater than Grade 1\n             according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; (see Appendix\n             Section 16.4), except for alopecia or vitiligo prior to enrollment.\n\n          -  Patients with documented Grade 2 or greater diarrhea or colitis as a result of\n             previous immunotherapy within six months from screening.\n\n          -  History of severe immediate hypersensitivity reaction to cyclophosphamide,\n             fludarabine, IL-2., or aminoglycosides.\n\n          -  Patients with active systemic infections, coagulation disorders or other active major\n             medical illnesses of the cardiovascular, respiratory or immune system.\n\n          -  Patients with symptomatic and/or untreated brain metastases.\n\n          -  Have any form of primary immunodeficiency, such as severe combined immunodeficiency\n             disease or acquired immune deficiency syndrome (AIDS).\n\n          -  Diagnosis of end-stage renal disorder requiring hemodialysis.\n\n          -  Patients who have a left ventricular ejection fraction (LVEF) < 45%.\n\n          -  Patients who have a FEV1 (forced expiratory volume in one second) of less than or\n             equal to 60 % of normal or walk a distance less than 80% predicted in a 6-min walk\n             test or demonstrate evidence of hypoxia during that test.Xx_NEWLINE_xXConcurrent systemic corticosteroid therapy;Xx_NEWLINE_xXPrior therapy with hormonal progestin agents;Xx_NEWLINE_xXPatients treated at collaborating sites and current St. Jude patients who are on therapy or within 3 years of completion of therapy must be =< 24 years old; all other St. Jude patients must be =< 21 years oldXx_NEWLINE_xXHas disease that is suitable for local therapy administered with curative intentXx_NEWLINE_xXHormonal therapy must have been discontinued =< 14 days prior to initiation of study therapy; however, continuation of ovarian suppression is allowedXx_NEWLINE_xXImmune therapy (monoclonal antibody therapy, checkpoint inhibitors) within 4 weeks.Xx_NEWLINE_xXAny previous gene therapy using an integrating vector.Xx_NEWLINE_xXSubject has received prior therapy with a BH3 mimetic.Xx_NEWLINE_xXSubject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.Xx_NEWLINE_xXPrior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens, luteinizing hormone releasing hormone (LHRH) agonist/antagonists; prior therapy with 5-alpha-reductase inhibitors is allowed; LHRH therapy allowed if begun within 4 weeks of day 1; up to 30 days of bicalutamide is allowed if it is stopped two weeks prior to day 1Xx_NEWLINE_xXUse of second line systemic therapy for treatment of acute GVHD prior to administration of ibrutinibXx_NEWLINE_xXPatients previously treated with anti-GITR therapy.Xx_NEWLINE_xXPrior therapy with bevacizumabXx_NEWLINE_xXA self-reported current practice of yoga or any other mind-body therapy, including but not limited to meditation or hypnosis therapy in the past 30 days prior to study enrollmentXx_NEWLINE_xXMen > 18 diagnosed with prostate cancer for which antiandrogen therapy (ADT) (castration therapy) is being prescribed for at least 16 weeks; castration may be achieved surgically or using gonadotrophin releasing hormone (LHRH) agonists (i.e. leuprolide, goserelin, etc.) or LHRH antagonists (i.e. degarelix)Xx_NEWLINE_xXHormone replacement therapy in the last three monthsXx_NEWLINE_xXINR > 1.3 (or > 3 if on anticoagulant therapy)Xx_NEWLINE_xXCompleted preoperative therapy and are on their presurgical rest periodXx_NEWLINE_xXConcurrent endocrine therapy permissibleXx_NEWLINE_xXNo history of (H/O) allergic reaction to iron therapyXx_NEWLINE_xXCurrently undergoing phase I complete decongestive therapy (CDT)Xx_NEWLINE_xXCurrent metformin therapyXx_NEWLINE_xXMedical indication for androgen deprivation therapy (ADT) via luteinizing hormone-releasing hormone (LHRH) analog +/- oral anti-androgenXx_NEWLINE_xXSystemic immune suppression or systemic therapy for cGVHD started within preceding 4 weeksXx_NEWLINE_xXThere must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than sandostatin or BIS-phosphonate therapy)Xx_NEWLINE_xXPrior hepatic arterial therapy or hepatic radiation therapy; prior surgical resection or ablation of liver metastases is acceptable; patients must be at least one month beyond prior radiotherapy or surgery, and 6 months beyond chemotherapy and have recovered from all therapy-associated toxicitiesXx_NEWLINE_xXSubjects who are not medically well enough to receive study therapy as determined by the investigatorXx_NEWLINE_xXPatients who have difficulty walking or may not be able to complete the physical therapy measuresXx_NEWLINE_xXBe on androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy; all patients will be required to be on ADT during the study periodXx_NEWLINE_xXWilling to come to MD Anderson (MDA) for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA’s Regional Care CentersXx_NEWLINE_xXSteroid hormone use (antiandrogen therapy [ADT]) within the past 12 monthsXx_NEWLINE_xXPatient must have had a complete response (CR)/partial response (PR)/stable disease (SD), 4-6 weeks after completing last fraction of radiation therapyXx_NEWLINE_xXOngoing anticoagulant, statin and/or anti-platelet therapyXx_NEWLINE_xXPrevious or ongoing physical therapy treatments are acceptableXx_NEWLINE_xXChronic renal failure in renal replacement therapyXx_NEWLINE_xXNo prior chemotherapy or radiation therapy for osteosarcoma; subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTXXx_NEWLINE_xXEvidence of complete response at three months post-treatment; maintenance therapy is permitted as long as there is no evidence of diseaseXx_NEWLINE_xXNewly diagnosed, in need of a new line or therapy, or at a treatment decision making timepoint.Xx_NEWLINE_xXPatients considered by PIs/protocol team to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and/or undergoing 2nd HCT)Xx_NEWLINE_xXPatients planning to start any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the studyXx_NEWLINE_xXNo therapy restrictionsXx_NEWLINE_xXHistory of intolerance to negative pressure wound therapyXx_NEWLINE_xXPatients who are eligible for chemoradiation therapy of the head and neckXx_NEWLINE_xXPatients with cGvHD who have been exposed to one or more line of therapy, are eligible, providing they are refractory to, or dependent on, glucocorticoids (usually prednisone [PDN]); (in fact, it is anticipated that the majority of patients will be resistant to multiple lines of therapy); in the case in which the glucocorticoid dose-regimens cannot be confirmed accurately the use of one additional line of therapy will substituteXx_NEWLINE_xXPatients who may have previously received SP-SAP on the studyXx_NEWLINE_xXPatients being treated with antibacterial agents, other than any of the following:\r\n* Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis\r\n* Topical antibiotics\r\n* Central venous catheter antibiotic lock therapy\r\n* Note: prophylactic antifungal therapy is NOT an exclusion criterionXx_NEWLINE_xXLifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (Zinecard) therapyXx_NEWLINE_xXPatients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapyXx_NEWLINE_xXSubjects who will need conventional therapy during the course of the studyXx_NEWLINE_xXParticipants must be receiving systemic glucocorticoid therapy for cGVHD; all immunosuppressive therapy may include but not be limited to tacrolimus, sirolimus, CellCept, cyclosporine, and systemic corticosteroid must be at stable doses for 28 days prior to the first cell infusionXx_NEWLINE_xXProgressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapyXx_NEWLINE_xXNo current chemo or radio-therapyXx_NEWLINE_xXBe diagnosed with bone metastases subsequent to breast (female subjects only) or prostate carcinoma, and will have received zoledronate or denosumab therapy for at least 3 months at the time of enrollmentXx_NEWLINE_xXPilot: Patients having been treated for stage III ovarian cancer, and received either intraperitoneal therapy/intravenous therapy or Intravenous therapy onlyXx_NEWLINE_xXReceiving or planning to receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonistXx_NEWLINE_xXConcurrent antiandrogen therapy allowed but not requiredXx_NEWLINE_xXPrior therapy:\r\n* Patients who have undergone 1 previous surgery for tibial pseudarthrosis repair will be eligible to enter the study if they have refracture; use of BMP-2 in the prior surgery is permitted, however patients with prior exposure must be screened for antibodies to BMP-2, bovine collagen, and rhBMP-2 neutralizing antibodies; prior use of BMP-2 is allowed but will be recorded as a possible compounding factor\r\n* Patients who have had 2 or more prior surgeries for pseudarthrosis repair are ineligibleXx_NEWLINE_xXPrevious antiangiogenic therapyXx_NEWLINE_xXHave received prior investigational anti-androgen therapy, including ARN-509Xx_NEWLINE_xXHave received at least one prior therapy for WMXx_NEWLINE_xXPart 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than one line of systemic therapy in the recurrent/metastatic setting.Xx_NEWLINE_xXFor patients who will receive enzalutamide monotherapy, failure or intolerance of prior sorafenib is required for enrollment; for patients who will receive combination therapy, prior sorafenib is excludedXx_NEWLINE_xXPatients must not have received prior regional therapy such as ablation, embolization, or radiation therapy for at least 2 weeks prior to the first dose of study treatment; patients who receive such therapy should have evidence of radiologic progression at this site or other progressing measurable diseaseXx_NEWLINE_xXUntreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents or hypomethylating agents for this diagnosis. Patients with other prior cancer diagnoses are allowed as long as they have no measurable disease, are not undergoing active therapy, and have a life expectancy of ? 4 months.Xx_NEWLINE_xXUntreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents for this diagnosis.Xx_NEWLINE_xXFor the dose escalation cohorts, any prior number of MDS therapies, including hypomethylating agents, are permitted; for the dose expansion cohort, subjects must be azacitidine naïve, but otherwise any prior number of MDS therapies are permitted; treatment naïve patients are eligible for both the dose escalation and expansion cohorts if they are unfit for or refuse intense therapyXx_NEWLINE_xXHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyXx_NEWLINE_xXPatients with ovarian cancer not medically fit for diagnostic laparoscopy prior to initiation of therapyXx_NEWLINE_xXIs expected to require any other form of systemic or localized antineoplastic therapy while on studyXx_NEWLINE_xXAny number of prior therapies are allowedXx_NEWLINE_xX(Part B only) Histologically confirmed DLBCL/MCL/FL/PTCL/MF/CLL on the basis of excisional lymph node or extranodal tissue biopsy; diagnosis of relapsed/refractory disease defined as 1) recurrence of disease after a Complete Response (CR), or 2) Partial Response (PR), Stable Disease (SD) at completion of treatment regimen preceding entry into study, subjects must not be candidates for standard therapy, subjects who have not received Stem Cell Translplant (SCT) must be ineligible to receive SCT.Xx_NEWLINE_xXSorafenib was the only systemic therapy for HCC and was discontinued for disease progression or intolerance (Main Global and ME2 Cohorts only).Xx_NEWLINE_xXThe participant received one prior systemic therapy regimen, excluding prior sorafenib, for the treatment of HCC (OLE Cohort only).Xx_NEWLINE_xX?1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy. A participant with a lesion(s) that has previously been treated with locoregional therapy is also eligible, if the lesion has documented progression after locoregional treatment and is measureable.Xx_NEWLINE_xXHepatic locoregional therapy following prior systemic therapy or within 28 days prior to randomization.Xx_NEWLINE_xXChronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.Xx_NEWLINE_xXConsidered inappropriate for intensive remission induction therapy by an investigatorXx_NEWLINE_xXPrior use of probiotics within 3 months prior to enrollmentXx_NEWLINE_xXProgression through at least one prior line of endocrine therapyXx_NEWLINE_xXPatients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (phase I program) or initiating radiation therapy to the esophagusXx_NEWLINE_xXCompleted medically indicated physical therapyXx_NEWLINE_xXPatients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapyXx_NEWLINE_xXHave a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), light therapy (e.g., currently receiving ultraviolet A [UVA]/ultraviolet B [UVB] therapy), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physicianXx_NEWLINE_xXThere are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial; any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of oxaliplatin-based therapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapyXx_NEWLINE_xXPatients must not have received or implemented any other medical therapy, alternative therapy, or physical therapy for the treatment of joint pain/stiffness within 28 days prior to registration; therapeutic massage is allowedXx_NEWLINE_xXGrade >= 3 thrombocytopenia (platelets < 50 x 10^9/L) after the first 3 months of therapy with the TKI for patients with CML and platelets < 100 x 10^9/L for patients with MF after the first 3 months of therapy; thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the TKIXx_NEWLINE_xXSubject is anticipated to have therapy with TKI continued for >= 3 monthsXx_NEWLINE_xXPatients must be able to complete the baseline S1013 FACT EGFRI 18 within 3 days prior to initiation of EGFRI therapyXx_NEWLINE_xXNo concurrent full dose anticoagulant therapy; =< 1 mg/day of Coumadin for preventing catheter clots allowedXx_NEWLINE_xXNo documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosisXx_NEWLINE_xXThere must be no prior second-line or third line therapies for aGVHD (with exception of mycophenolate mofetil [MMF]) or second or third line therapies for cGVHD (other than extracorporeal photopheresis, rituximab or MMF); second and third line therapies for aGVHD and cGVHD are as defined by the British Committee on Standards in Hematology and reproduced in the GVHD Policy of the Blood and Marrow Transplant program (version 1-13); all prior therapies other than corticosteroids, tacrolimus, sirolimus or cyclosporine must be completed and discontinued; patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxisXx_NEWLINE_xXPrior therapy with romidepsinXx_NEWLINE_xXPrevious intrapleural therapy for MPE on the same sideXx_NEWLINE_xXPatients must not be receiving anti-myeloma therapy (including maintenance therapy)Xx_NEWLINE_xXCompletion of two years monthly zoledronic acid therapyXx_NEWLINE_xXAt least 3 months into the maintenance phase, with at least 6 months left of\n             maintenance therapyXx_NEWLINE_xXNo limitations exist for type or amount of prior therapyXx_NEWLINE_xXNewly diagnoses or needing a new line of therapy and have not yet made a treatment decisionXx_NEWLINE_xXAny musculoskeletal problems that would interfere with the NET therapyXx_NEWLINE_xXConcomitant trastuzumab and anti-endocrine therapies are permitted; if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollmentXx_NEWLINE_xXPatients will be undergoing initial therapy for their disease or undergoing first salvage treatment, i.e. patients who fail therapy, or respond and relapse after initial therapyXx_NEWLINE_xXPrevious therapy with cetuximab within 6 months of consentXx_NEWLINE_xXPatient must be willing to remain on corticosteroid therapy for 4 days postoperativelyXx_NEWLINE_xXClinically suitable for cryoablation therapyXx_NEWLINE_xXPrevious therapy with urate oxidaseXx_NEWLINE_xXPrior therapy with hydroxyurea, interferon, anagrelide, ruxolitinib, hypomethylating agents, Revlimid, thalidomide, steroids, other JAK inhibitors is allowed for AML patients who are back in chronic phase MPN, prior induction chemotherapy is allowedXx_NEWLINE_xXNeed for intravenous therapy more frequently than every 3 weeks or inability to time intravenous therapy treatment before and after the studyXx_NEWLINE_xXInitiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomizationXx_NEWLINE_xXPatients undergoing active antibiotic therapyXx_NEWLINE_xXNo patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancerXx_NEWLINE_xXPatients who had esophageal therapy with Halo radiofrequency ablation in the past, or esophagectomyXx_NEWLINE_xXAny prior therapy with radium-223, samarium, or strontiumXx_NEWLINE_xXIf patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligibleXx_NEWLINE_xXReceipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to calendar day of vaccinationXx_NEWLINE_xXFOR THE 31 SUBJECTS ENROLLED IN YEAR 1: If patients are on immunosuppressive therapy for treatment of GVHD, then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligibleXx_NEWLINE_xXTiming from prior therapy: Stratum 1: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent therapy.Xx_NEWLINE_xXPrior hysterectomyXx_NEWLINE_xXUse of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowedXx_NEWLINE_xXIf patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligibleXx_NEWLINE_xXReceipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to vaccinationXx_NEWLINE_xXPrior use of selective estrogen receptor modulators (SERMS) and aromatase inhibitors (AIs) for prevention or therapy, except for a maximum of 3 months and at least 12 months priorXx_NEWLINE_xXRequire chronic anticoagulation or anti-platelet therapyXx_NEWLINE_xXPrior malignancies.Xx_NEWLINE_xXNo cancer therapy in the prior 3 months (excluding chemoprevention agents)Xx_NEWLINE_xXEXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Use of secondary therapy for acute GVHD at any time (defined as any systemic therapy intended to treat acute GVHD besides corticosteroids)Xx_NEWLINE_xXPatients must be able to take oral medications, although a brief period of IV therapy (< 4 days) is permitted at trial entryXx_NEWLINE_xXUse of any systemic antifungal therapy for > 72 hours during the week prior to study drug initiationXx_NEWLINE_xXIs taking risk reduction therapy with tamoxifenXx_NEWLINE_xXPregnant women are naturally excluded given condition of cisplatin therapyXx_NEWLINE_xXConsidered at high risk for relapse as defined by:\r\n* The presence of >= 1 of the following: failure to achieve complete response (CR) post initial treatment; relapsed disease with an initial remission duration of < 12 months; or extranodal involvement at the start of pre-transplant salvage therapyXx_NEWLINE_xXHave had antibiotic therapy, probiotic supplements, or professional cleaning within the previous 3 monthsXx_NEWLINE_xXRequire antibiotic therapy prior to oral cleaningXx_NEWLINE_xXPatient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)Xx_NEWLINE_xXELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient has had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)Xx_NEWLINE_xXMDS – may have achieved CR through either hypomethylating agent therapy, induction chemotherapy, or other therapyXx_NEWLINE_xXMDS – low/intermediate-1 International Prognostic Scoring System (IPSS) risk category patients are eligible only if they have failed prior therapy or are transfusion-dependentXx_NEWLINE_xXLow grade NHL – with < 6 month duration of CR between courses of conventional therapyXx_NEWLINE_xXWaldenstrom’s macroglobulinemia – must have failed 2 courses of therapyXx_NEWLINE_xXPatients who take immunosuppressive medication, i.e. steroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injectionXx_NEWLINE_xXIs taking immunosuppressive therapyXx_NEWLINE_xXDaily therapy with H2 blockers or protein pump inhibitorsXx_NEWLINE_xXUndergoing salvage therapyXx_NEWLINE_xXPrior history or current use of tamoxifen or anti-estrogen therapyXx_NEWLINE_xXPrevious ablative therapy for Barrett’s esophagusXx_NEWLINE_xXPrior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollmentXx_NEWLINE_xXCurrent use of statin therapyXx_NEWLINE_xX3. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:Xx_NEWLINE_xXHave a central line in place prior to IV study therapyXx_NEWLINE_xXPatients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinationsXx_NEWLINE_xXPrior endoscopic therapy for BEXx_NEWLINE_xXUnresolved toxicities from prior therapyXx_NEWLINE_xXSubjects who have received hormonal contraception and/or hormone therapy in the past 3 months are not eligibleXx_NEWLINE_xXPrior therapy with anthracyclinesXx_NEWLINE_xXSubjects must have received at least one line of hormonal therapy in the metastatic setting.Xx_NEWLINE_xXSubjects who are eligible as per the Investigator's assessment and according to the local label for treatment with exemestane and everolimus as a second line or greater of hormone therapy in a metastatic setting.Xx_NEWLINE_xXPatients on long term (> 6 months) anti-androgen therapy (e.g. flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen; patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required)Xx_NEWLINE_xXSubjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.Xx_NEWLINE_xXVaccine based therapy: 3 monthsXx_NEWLINE_xXUse of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively.Xx_NEWLINE_xXNo prior systemic therapy EXCEPT patients may be consented and enrolled if they have already started mFOLFIRINOX for up to four cyclesXx_NEWLINE_xXPatients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligibleXx_NEWLINE_xXCurrently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone [GnRH] agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors); testosterone replacement is allowed but treatment should be stable during the entire studyXx_NEWLINE_xXAny prior systemic therapy is permitted (except cisplatin or carboplatin)Xx_NEWLINE_xXPatients who have received prior romidepsin use are eligibleXx_NEWLINE_xXPatients who have previously received SCH727965Xx_NEWLINE_xXInclusion Criteria:\n\n        Diagnosis of locally advanced or metastatic cancer that has progressed despite standard\n        therapy or for which no effective standard therapy exists and histological confirmation of\n        one of the following diseases indicated below:\n\n        Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic\n        adenocarcinoma. In addition, tumors of any histological origin with documented genetic\n        alterations upstream in the Wnt signaling pathway are eligible with prior agreement with\n        Novartis.\n\n        Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented\n        RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43\n        mutation. In addition, patients with tumors of any histological origin with documented\n        genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are\n        eligible with prior agreement with Novartis\n\n        LGK974 with PDR001: Dose escalation: patients with the following cancers that were\n        previously treated with anti-PD-1 therapy and whose best response on that therapy was\n        progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with\n        esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior\n        anti-PD-1 therapy.\n\n        LGK974 with PDR001: Dose expansion: patients with pancreatic cancer, or TNBC, or melanoma,\n        or head and neck cancer.\n\n        Exclusion Criteria:\n\n          -  Impaired cardiac function\n\n          -  Impairment of gastrointestinal function or gastrointestinal disease that may\n             significantly alter the absorption of oral LGK974 (e.g., ulcerative diseases,\n             uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel\n             resection)\n\n          -  Brain metastases that have not been adequately treated\n\n          -  Malignant disease other than that being treated in this study\n\n          -  Laboratory abnormalities as specified in the protocol\n\n          -  Osteoporosis, severe or untreated osteopenia\n\n          -  Bone fractures within the past year\n\n          -  Pathologic bone fracture\n\n          -  Active, known or suspected autoimmune disease or severe hypersensitivity reactions to\n             other monoclonal antibodies\n\n        Other protocol-defined inclusion/exclusion criteria may applyXx_NEWLINE_xXCurrent disease state must be one for which there is currently no known curative therapy.Xx_NEWLINE_xXConcurrent therapy with other seizurogenic medications.Xx_NEWLINE_xXPrior treatment with pneumotoxic drugs within past year. If prior therapy in lifetime, then excluded if history of pulmonary toxicities from administration.Xx_NEWLINE_xXTreatment with chemotherapy, hormone therapy, or other investigational therapy within 3 weeks of first study doses; patients with non-adenocarcinoma of the prostate who may be on luteinizing hormone-releasing hormone agonist/antagonist therapy may continue useXx_NEWLINE_xXVaccine-based and/or viral therapy: 3 monthsXx_NEWLINE_xXUse of systemic antibacterial, antifungal, or antiviral medications for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is allowed perioperativelyXx_NEWLINE_xXPrior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.Xx_NEWLINE_xXSubjects disease must have relapsed or be refractory to at least 2 prior lines of therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline.Xx_NEWLINE_xXPrior treatment with any prior gene therapy productXx_NEWLINE_xXRelapsed after > or = 2 lines of prior therapy that must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and, where approved and available, a CD38-directed cytolytic antibody in any order during the course of treatment OR refractory to PI, IMiD, and CD38- directed cytolytic antibody,Xx_NEWLINE_xXParticipants must have been on adjuvant endocrine therapy, either tamoxifen or aromatase inhibitor (AI), for at least 6 months without any significant adverse events leading to drug interruption for more than 1 month, and must not have had any change in endocrine therapy in the past 6 months; ongoing use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed; concurrent gonadotrophin releasing hormone (GNRH) agonist is allowedXx_NEWLINE_xXDiagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance up until the first year off therapyXx_NEWLINE_xXPatients must be willing to complete a bilateral mammogram at baseline with repeat exam after 12 cycles of protocol therapy; patients who have had a mammogram within 1 month prior to registration to protocol therapy will not need to repeat the examXx_NEWLINE_xXHormone replacement therapy within the last 6 monthsXx_NEWLINE_xXHormone therapy, including vaginal estrogen creamsXx_NEWLINE_xXCurrent use of nicotine replacement therapy (NRT)Xx_NEWLINE_xXRegular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)Xx_NEWLINE_xXRequire chronic anticoagulation or anti-platelet therapyXx_NEWLINE_xXSubject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.Xx_NEWLINE_xXRelapsed or is refractory to previous therapy, orXx_NEWLINE_xXPatients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of subjects on stable therapy for more than six monthsXx_NEWLINE_xXcontraindication to anticoagulant therapyXx_NEWLINE_xXPrior trastuzumab therapyXx_NEWLINE_xXIf receiving antiretroviral therapy:                \r\n* Receipt of antiretroviral therapy for at least 3 months prior to entry\r\n* No change in antiretroviral therapy within 30 days prior to entryXx_NEWLINE_xXIf not receiving antiretroviral therapy:                \r\n* CD4-cell count >= 350 cells/mm³ within 90 days prior to study entry\r\n* No plans to start antiretroviral therapy prior to week 28Xx_NEWLINE_xXPatients treated with neoadjuvant hormonal therapy only are not eligibleXx_NEWLINE_xXNo history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowedXx_NEWLINE_xXPatients who have not previously received a bevacizumab-containing regimen (i.e., this must be the first bevacizumab-containing therapy administered to the patient)Xx_NEWLINE_xXPatient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapyXx_NEWLINE_xXPatients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]Xx_NEWLINE_xXThere will be no therapy restrictionsXx_NEWLINE_xXAndrogen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.Xx_NEWLINE_xXPrior therapy is allowedXx_NEWLINE_xXMust be treatment naive (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., high intensity focused ultrasound [HiFu])Xx_NEWLINE_xXNeoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation [HiFu])Xx_NEWLINE_xXPrevious EGFR-directed therapyXx_NEWLINE_xXSubjects receiving androgen deprivation therapy (ADT)Xx_NEWLINE_xXHas not received prior therapy with CTLA-4, PD-1/PD-L1 inhibitors, other co-stimulatory or co-inhibitory immune checkpoint antibody therapies (e.g. LAG3, TIM3, CD137, KIR3DL, CD70, and CD27) for distant metastatic melanoma; patients who have received MAPK inhibitors are allowed on condition that they have recovered from adverse events to at most grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and at least 15 days have elapsed between last dose of MAPK inhibitors and C11-AMT imaging; patients who have previously received CTLA-4 inhibitors in the adjuvant setting are allowed to participate as long as they discontinued CTLA-4 treatment at least 30 days ago; patients who have previously received adjuvant PD- 1 inhibitors are excludedXx_NEWLINE_xXAny systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomyXx_NEWLINE_xXNeoadjuvant chemotherapy or radiation therapy prior to prostatectomy\r\n* Including focal ablation techniques (high-intensity focused ultrasound therapy [HiFu])Xx_NEWLINE_xXAndrogen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgeryXx_NEWLINE_xXNo prior local therapy to target lesionXx_NEWLINE_xXPatients must have prior bilateral orchiectomy or be on continuous LHRH analogue therapy for the duration of studyXx_NEWLINE_xXIntention to start therapyXx_NEWLINE_xXHistory of pneumonitis requiring hospitalization or systemic immune suppressive therapyXx_NEWLINE_xXPatients must be anti-angiogenic therapy naiveXx_NEWLINE_xXPrimary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone; (note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone [LHRH] agonists [Lupron or Trelstar], other anti-androgens, and/or abiraterone or enzalutamide may be in use)Xx_NEWLINE_xXPatients will have been originally diagnosed with prostate carcinoma and have undergone what was considered definitive non-prostatectomy therapy for localized diseaseXx_NEWLINE_xXIf the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: *Patient has undergone potentially curative therapy for all prior malignancies \r\n*No evidence of active/recurrent disease within 5 yearsXx_NEWLINE_xXNot on current androgen deprivation therapy or plan for withdrawal of androgen deprivation therapyXx_NEWLINE_xXAndrogen deprivation therapy prior to PET imagingXx_NEWLINE_xXScheduled to begin therapyXx_NEWLINE_xXPrior androgen deprivation therapyXx_NEWLINE_xXPatients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatmentXx_NEWLINE_xXHormone deprivation therapyXx_NEWLINE_xXPatients should not have begun therapy, or, needed research imaging can be performed within 2-5 days of starting therapyXx_NEWLINE_xXPatients must have a known site of disease; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligibleXx_NEWLINE_xXCan be on androgen deprivation therapy if dose is stable for >= 1 weekXx_NEWLINE_xXPrior treatment of prostate cancer including brachytherapy, radiation therapy, cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapyXx_NEWLINE_xXPatients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)Xx_NEWLINE_xXPatients who have received and/or are scheduled to receive a combination of the following cardiotoxic chemotherapy agents:\r\n* Anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin); antimetabolites (5-fluorouracil); alkylating agents (busulfan, cisplatin, cyclophosphamide, ifosfamide); anthraquinones (mitoxantrone); antimicrotubules (paclitaxel, vinca alkaloids [vinblastine, vincristine]); biological agents (interferon-alpha, interleukin-2); hormone-modifying therapy (androgen-deprivation therapy, aromatase inhibitors); tyrosine-kinase inhibitors (bevacizumab, imatinib, lapatinib, sorafenib, sunitinib, trastuzumab); rituximab; docetaxel (Taxotere); any other potentially cardiotoxic treatmentXx_NEWLINE_xXPatients must have high-risk neuroblastoma with at least ONE of the following:\r\n* Recurrent/progressive disease at any time; biopsy is not required, even if there is a partial response to intervening therapy\r\n* Refractory disease (i.e. less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy); no biopsy is required for eligibility for this studyXx_NEWLINE_xXDiagnosis of unresectable and/or metastatic clear cell renal cell carcinoma; 10 patients will be enrolled who have had no prior anti-angiogenic therapy; 10 patients will be enrolled who have had one prior anti-angiogenic therapyXx_NEWLINE_xXPatients who have received no prior therapy are eligible, as well as those who have received prior treatmentXx_NEWLINE_xXSubjects must have had no prior therapy for cancer of the rectumXx_NEWLINE_xXSubjects must have had no prior therapy for cancer of the esophagusXx_NEWLINE_xXPatients undergoing neoadjuvant endocrine therapyXx_NEWLINE_xXNo therapy other than Sandostatin since last Octreoscan + diagnostic CTXx_NEWLINE_xXPatients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowedXx_NEWLINE_xXPatients who may not have received trastuzumab within the prior 6 months for any other reasonXx_NEWLINE_xXPrior systemic cancer therapyXx_NEWLINE_xXMen who undergo neoadjuvant treatment with androgen deprivation therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excludedXx_NEWLINE_xXPatients preparing to receive therapy for pancreas cancer, including patients enrolled in HRPO# 201201124 or other clinical trials, are eligibleXx_NEWLINE_xXAny types and amounts of prior therapy will be allowed for this studyXx_NEWLINE_xXParticipants should not have had prior curative local treatment for prostate cancer, including no radiotherapy or prostatectomy; a maximum 90 days of systemic androgen deprivation therapy prior to registration is allowedXx_NEWLINE_xXPatient must be planning to receive chemoradiation therapy with cisplatinXx_NEWLINE_xXPatient must not require a minor surgical procedure (i.e., Broviac line or infusaport placement) =< 7 days prior to beginning therapy, and the wound must be healed prior to initiation of therapyXx_NEWLINE_xXPatients are deemed suitable for therapy with ADT and EBRTXx_NEWLINE_xXPatients who have had prior prostatectomy or prior androgen therapyXx_NEWLINE_xXIf planning therapeutic systemic therapy, willing to undergo biopsy for research purposes only after drug dosing in LCCC1214Xx_NEWLINE_xXRequires therapy with agents that have a predisposition for hepatoxicityXx_NEWLINE_xXHas received prior systemic anti-cancer therapy including investigational agents for the current malignancy.Xx_NEWLINE_xXChronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment, except concomitant antiviral systemic therapy for chronic hepatitis B or C.Xx_NEWLINE_xXPrior MAGE-A3/A6-targeting therapyXx_NEWLINE_xXNote, the line of therapy limit does not apply to the biopsy substudy cohorts.Xx_NEWLINE_xXPatients are relapsed from or refractory to at least 1 previous line of therapyXx_NEWLINE_xXPreviously treated with any prior mIDH1 targeted therapyXx_NEWLINE_xX-  Patient must have a histologically confirmed (biopsy-proven) diagnosis of follicular\n             B-cell non-Hodgkin lymphoma (WHO classification: follicular center grades 1, 2, and 3a\n             [3b patients are not eligible]), with no evidence of transformation to large cell\n             histology.\n\n          -  Patient must meet criteria for High Tumor Burden (higher risk) as defined by either\n             the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria [at least one\n             criterion] OR the follicular lymphoma international prognostic index (FLIPI) [score of\n             3, 4, or 5].\n\n          -  Patient must have Stage II, III or IV disease.\n\n          -  Baseline measurements and evaluations (PET/ CT) must be obtained within 10 weeks of\n             randomization to the study. Patient must have at least one objective measurable\n             disease parameter.\n\n          -  Age ? 18 years.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n\n          -  Ability to understand and willingness to sign Institutional Review Board\n             (IRB)-approved informed consent.\n\n          -  Willing to provide mandatory tissue samples (if sufficient tissue available) for\n             research purposes.\n\n          -  Adequate organ function as measured by the following criteria:\n\n               -  Absolute Neutrophil Count (ANC) ? 1000/mm³\n\n               -  Hemoglobin ? 8 g/dL\n\n               -  Platelets ?75,000/mm³\n\n               -  Creatinine clearance ? 50 mL/min, calculated with the use of 24-hour creatinine\n                  clearance or by Cockcroft-Gault formula\n\n               -  Total Bilirubin ? 1.5x Upper Limit of Normal (ULN) or ? 3x ULN for patients with\n                  documented Gilbert's syndrome\n\n               -  Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ? 2.5x ULN\n\n               -  Alkaline Phosphatase <5x ULN\n\n          -  All females of childbearing potential (not surgically sterilized and between menarche\n             and 1 year post menopause) must have a blood or urine test to rule out pregnancy\n             within 2 weeks prior to registration.\n\n          -  Women must not be pregnant or breastfeeding.\n\n          -  Patient must have had no prior chemotherapy, radiotherapy or immunotherapy for\n             lymphoma. For purposes of this trial, prednisone or other corticosteroids used for\n             non-lymphomatous conditions will not be considered as prior chemotherapy. In addition,\n             a prior/recent short course (<2 weeks) of steroids for symptom relief of\n             lymphoma-related symptoms will not make a patient ineligible.\n\n          -  Patient must have no recent history of malignancy except for adequately treated basal\n             cell or squamous cell skin cancer, Stage I melanoma of the skin, or in situ cervical\n             cancer. Individuals in documented remission without treatment for ? 2 years prior to\n             enrollment may be included at the discretion of the investigator.\n\n          -  Patient must have no active, uncontrolled infections.\n\n          -  Patients must be tested for hepatitis B virus (HBV), hepatitis B surface antigen\n             (HBsAg+) and hepatitis C (HCV) antibody within 6 weeks of registration. Patients who\n             are chronic carriers of HBV with positive HBsAg+ and positive HCV serology are\n             excluded, as chemotherapy and B-cell depleting therapy have been associated with virus\n             reactivation and fulminant hepatitis. NOTE: Patients with a past or resolved HBV\n             infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence\n             of HBsAg) may be included if HBV DNA is undetectable. If enrolled, patients must be\n             willing to undergo monthly HBV DNA testing. Patients with positive HCV antibody must\n             be negative for HCV by polymerase chain reaction (PCR) to be eligible for study\n             participation.\n\n          -  HIV positive patients are not excluded, but to enroll, must meet all of the below\n             criteria:\n\n               -  HIV is sensitive to antiretroviral therapy.\n\n               -  Must be willing to take effective antiretroviral therapy if indicated.\n\n               -  No history of CD4 prior to or at the time of lymphoma diagnosis <300 cells/mm³.\n\n               -  No history of AIDS-defining conditions.\n\n               -  If on antiretroviral therapy, must not be taking zidovudine or stavudine.\n\n               -  Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia during\n                  therapy and until at least 2 months following the completion of therapy or until\n                  the CD4 cells recover to over 250 cells/mm³, whichever occurs later.\n\n          -  Evidence of significant, uncontrolled concomitant diseases that could affect\n             compliance with the protocol or interpretation of results or that could increase risk\n             to the patient.\n\n          -  No major surgery within 2 weeks prior to cycle 1, other than for diagnosis.\n\n          -  A condition that precludes oral route of administration (venetoclax).\n\n          -  No known allergies to both xanthine oxidase inhibitors and rasburicase.\n\n          -  Patient must not require the use of warfarin (because of potential drug-drug\n             interactions that may potentially increase the exposure of warfarin). Blood thinners\n             of other classes are permitted.\n\n          -  Patient may not receive the following agents within 7 days prior to the first dose of\n             venetoclax:\n\n               -  Strong and moderate CYP3A inhibitors\n\n               -  Strong and moderate CYP3A inducers\n\n               -  Consumed grapefruit, grapefruit products, Seville oranges (including marmalade\n                  containing Seville oranges), or star fruit within 3 days prior to the first dose\n                  of venetoclax.\n\n          -  Patient must not have serious medical or psychiatric illness likely to interfere with\n             participation in this clinical study.Xx_NEWLINE_xXConcurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitorsXx_NEWLINE_xXHad at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.Xx_NEWLINE_xXHas AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects will be eligible for the study if they:\n\n          1. Are of or older than the legal age in the respective countries at the time when\n             written informed consent is obtained\n\n          2. Have histologically or cytologically confirmed advanced (unresectable) or metastatic\n             biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma (CCA),\n             gallbladder cancer and carcinoma of Ampulla of Vater. This includes clinical diagnosis\n             of biliary tract cancer with histological confirmation of adenocarcinoma.\n\n          3. Have received and failed one and only one prior line of systemic treatment for\n             advanced or metastatic disease with radiologic evidence of disease progression. This\n             prior line of systemic treatment must also contain gemcitabine\n\n          4. Have received at least 6 doses of gemcitabine containing treatment in first line\n             (Adjuvant therapy is not regarded as 1st line therapy)\n\n          5. Have radiographically measurable disease based on Response Evaluation Criteria in\n             Solid Tumours (RECIST) v1.1 as assessed by Independent Central Review (ICR) (For Part\n             1)\n\n          6. Have no evidence of biliary duct obstruction, unless obstruction is controlled by\n             local treatment or, in whom the biliary tree can be decompressed by endoscopic or\n             percutaneous stenting with subsequent reduction in bilirubin to below or equal to 1.5\n             × upper level of normal (ULN)\n\n          7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          8. Are able to understand and willing to sign the informed consent form\n\n          9. Have adequate organ and hematological function:\n\n               1. Hematological function, as follows:\n\n                    -  Absolute neutrophil count (ANC) ? 1.5 × 109/L\n\n                    -  Platelet count ? 100 × 109/L\n\n               2. Renal functions, as follows:\n\n                  • Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73m2\n\n               3. Hepatic function, as follows:\n\n                    -  Albumin ? 3 g/dL\n\n                    -  Total bilirubin ? 1.5 × ULN\n\n                    -  Aspartate aminotransferase and alanine aminotransferase ? 5 × ULN\n\n        Exclusion Criteria:\n\n        Subjects will be ineligible for the study if they:\n\n          1. Are currently on or have received anti-cancer therapy within the past 3 weeks before\n             receiving the first dose of study medication\n\n          2. Are currently on or have received radiation or local treatment within the past 3 weeks\n             for the target lesion(s) before receiving the first dose of study medication\n\n          3. Have evidence of multiple (? 2) peritoneal metastases or ascites at baseline as\n             assessed by ICR (For Part 1). (Ascites which can be attributed by non-malignant causes\n             is not excluded.)\n\n          4. Have had major surgical procedures within 14 days prior to first dose of study\n             medication\n\n          5. Have a known metastatic brain lesion(s), including asymptomatic and well controlled\n             lesion(s)\n\n          6. Have malabsorption syndrome, diseases significantly affecting gastrointestinal\n             function, resection of the stomach or small bowel, or difficulty in swallowing and\n             retaining oral medications which in the opinion of the Investigator could jeopardize\n             the validity of the study results\n\n          7. Have uncontrolled intercurrent illness including, but not limited to, ongoing or\n             active infection, unstable angina pectoris, cardiac arrhythmia, diabetes,\n             hypertension, or psychiatric illness/social situations that would limit compliance\n             with study requirements\n\n          8. Have any history of other malignancy unless in remission for more than 1 year\n             (non-melanoma skin carcinoma and carcinoma-in-site of uterine cervix treated with\n             curative intent is not exclusionary)\n\n          9. Are female patients who are pregnant or breast feeding\n\n         10. Have been previously treated with varlitinib or have been previously treated with\n             capecitabine as first line therapy for advanced or metastatic disease. For patients\n             who have previously received capecitabine as a radiosensitizer or as part of their\n             adjuvant therapy and their disease has relapsed for more than 6 months after their\n             last dose of capecitabine adjuvant therapy, their capecitabine therapy will not be\n             considered as a line of systemic chemotherapy for metastatic/advanced disease, and\n             thus they can participate in the study\n\n         11. Have received any investigational drug (or have used an investigational device) within\n             the last 14 days before receiving the first dose of study medication\n\n         12. Have unresolved or unstable serious toxicity (? common terminology criteria for\n             adverse events [CTCAE] 4.03 Grade 2), with the exception of anemia, asthenia, and\n             alopecia, from prior administration of another investigational drug and/or prior\n             cancer treatment\n\n         13. Have a known positive test for human immunodeficiency virus, hepatitis C (treatment\n             naïve or after treatment without sustained virologic response), or hepatitis B\n             infection with hepatitis B virus deoxyribonucleic acid exceeding 2000 IU/mL\n\n         14. Have a known history of drug addiction within last 1 year which, in the opinion of the\n             Investigator, could increase the risk of non-compliance to investigational product\n\n         15. Need continuous treatment with proton pump inhibitors during the study period\n\n         16. Have a history of (non-infectious) pneumonitis that required steroids or current\n             pneumonitis, or have a history of interstitial lung disease or current interstitial\n             lung disease\n\n         17. Have any history or presence of clinically significant cardiovascular, respiratory,\n             hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,\n             neurologic or psychiatric disease or any other condition which in the opinion of the\n             Investigator could jeopardize the safety of the patient or the validity of the study\n             results\n\n         18. Have a baseline corrected QT interval (Fridericia's formula) (QTcF) > 450 ms or\n             patients with known long QT syndrome; torsade de pointes; symptomatic ventricular\n             tachycardia; an unstable cardiac syndrome in the past 3 months before screening visit;\n             > class 2 New York Heart Association heart failure; or > class 2 angina pectoris; or\n             receiving quinidine, procainamide, disopyramide, amiodarone, dronedarone, arsenic,\n             dofetilide, sotalol, or methadone. Please also see prohibited medication/therapy\n             (Section 5.4.10.1)Xx_NEWLINE_xXInclusion Criteria (Key factors listed):\n\n          -  Eastern Cooperative Oncology Group Performance Status of ?2.\n\n          -  Confirmed malignancy with relapsed/refractory disease after ?2 lines of standard\n             systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM or MCL and\n             for DLBCL-ABC and FL, after ?2 lines of standard systemic therapy.\n\n          -  Presence of measurable disease through various assessments depending on specific\n             cancer type.\n\n          -  Current medical need for therapy of the B-lymphoid malignancy due to disease-related\n             symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or PD.\n\n        Exclusion Criteria (Key factors listed):\n\n          -  Known central nervous system malignancy.\n\n          -  History of other malignancies except for some which have been adequately treated\n             (e.g., local cancers of the skin, cervix or breast cancers, non-invasive bladder\n             cancer, prostate or other cancers of stages 1 or 2 in complete remission).\n\n          -  Significant cardiovascular disease or electrocardiogram (ECG) abnormalities\n\n          -  Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder,\n             uncontrolled peptic ulcer disease, oral anticoagulation medications.\n\n          -  Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start\n             of drug therapy.\n\n          -  Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse\n             effects.\n\n          -  Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to\n             start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants,\n             grapefruit).Xx_NEWLINE_xXPatients must have had evidence of having relapsed, progressed or become refractory to conventional therapyXx_NEWLINE_xXPrior exposure to CBT-1Xx_NEWLINE_xXPatients can have had any number of prior therapies, including but not limited to molecularly targeted therapies and anti-angiogenic therapies, however they must have had prior chemotherapy with either temozolomide or lomustineXx_NEWLINE_xXIs expected to require any other form of antineoplastic therapy while participating in the trialXx_NEWLINE_xXA minimum of 2 prior lines of therapy including an IMiD and a PI and is refractory to pomalidomide and/or daratumumabXx_NEWLINE_xXKnown intolerance to steroid therapyXx_NEWLINE_xXInclusion Criteria:\n\n        All Patients\n\n          -  Histologically or cytologically confirmed MM; CLL/SLL, LPL, MZL; or MCL OR\n             histologically proven, de novo, DLBCL\n\n          -  ECOG performance status of 0 to 2\n\n          -  18 years of age or older\n\n          -  Life expectancy of at least 6 months\n\n          -  Platelets ? 100,000/µL (if full-dose anticoagulation therapy is used, platelets ?\n             150,000/µL are required)\n\n          -  WBC count ? 3000/µL\n\n          -  Absolute neutrophil count ? 1500/µL\n\n          -  Hemoglobin ? 9 g/dL (last transfusion, if any, must be at least 1 week prior to study\n             registration, and no transfusions are allowed between registration and dosing)\n\n          -  Estimated glomerular filtration rate ? 30 mL/min/1.73 m2\n\n          -  Alanine aminotransferase < 3 × upper limit of normal (ULN)\n\n          -  Bilirubin < 1.5 × ULN\n\n          -  International normalized ratio (INR) < 2.5\n\n          -  If patient is on full-dose anticoagulation therapy, the anticoagulation therapy must\n             be reversible and reversal of the anticoagulation therapy must not be\n             life-threatening, as judged by the Investigator\n\n          -  Patients who have undergone stem cell transplant must be at least 100 days from\n             transplant\n\n          -  Patient is judged by the Investigator to have the initiative and means to be compliant\n             with the protocol and be within geographical proximity to make the required study\n             visits\n\n          -  Patient or his or her legal representative has the ability to read, understand, and\n             provide written informed consent for the initiation of any study-related procedures\n\n          -  Female patients of childbearing potential must have a negative pregnancy test within\n             24 hours of dosing\n\n          -  Women of childbearing potential and men who are able to father a child must agree to\n             use an effective method of contraception (eg, oral contraceptives, double-barrier\n             methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera)\n             during the study and for 12 months following administration of the study drug\n\n        Patients with Multiple Myeloma\n\n          -  At least 2 prior regimens, which must include at least 1 approved proteasome inhibitor\n             (bortezomib, carfilzomib, or ixazomib) and at least 1 approved immunomodulatory agent\n             (thalidomide, lenalidomide, or pomalidomide), with or without maintenance therapy,\n             unless patients are ineligible to receive such agents.\n\n          -  Bone marrow biopsy within 28 days of CLR 131 infusion demonstrating at least 5% plasma\n             cell involvement\n\n          -  Progressive disease defined by any of the following:\n\n               -  25% increase in serum M-protein from the lowest response value during (or after)\n                  last therapy and/or absolute increase in serum M-protein of ? 0.5 g/dL\n\n               -  25% increase in urine M-protein from the lowest response value during (or after)\n                  last therapy and/or absolute increase in urine M-protein of ? 200 mg/24 h\n\n               -  25% increase in bone marrow plasma cell percentage from the lowest response value\n                  during (or after) last therapy. Absolute bone marrow plasma cell percentage must\n                  be ? 10% unless prior CR when absolute bone marrow plasma cell percentage must be\n                  ? 5%.\n\n               -  25% increase in serum FLC level from the lowest response value during (or after)\n                  last therapy; the absolute increase must be > 10 mg/dL\n\n               -  New onset hypercalcemia > 11.5 mg/dL\n\n          -  Measurable disease defined by any of the following:\n\n               -  Serum M-protein > 0.5 g/dL\n\n               -  Urine M-protein > 200 mg/24 h\n\n               -  Serum FLC assay: Involved FLC level ? 10 mg/dL provided serum FLC ratio is\n                  abnormal.\n\n               -  Measurable plasmacytoma\n\n          -  Patients who are non-secretors will be considered for accrual on a case-by-case basis\n             by the Sponsor and will require an Investigator plan to define PD prior to enrollment\n             and to assess clinical benefit after treatment.\n\n        Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic\n        Lymphoma, or Marginal Zone Lymphoma\n\n          -  Prior treatment with at least 2 prior regimens, which may include chemotherapy, an\n             approved anti-CD20 antibody with or without maintenance therapy, and an approved\n             targeted agent, unless patients are ineligible to receive such agents\n\n          -  Patients with Helicobacter pylori+ mucosa-associated lymphoid tissue lymphoma must\n             have received 1 prior antibiotic regimen for H pylori\n\n          -  At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable\n             extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm\n\n        Patients with Mantle Cell Lymphoma\n\n          -  Prior treatment with at least 1 prior regimen\n\n          -  At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable\n             extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm\n\n        Patients with Diffuse Large B-Cell Lymphoma\n\n          -  Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab\n             and an anthracycline. Relapsed disease is defined as either recurrence of disease\n             after a CR or PD after achieving a partial response (PR) or SD. Refractory disease is\n             defined as failure to achieve at least SD with any 1 line of therapy or with PD ? 3\n             months of the most recent chemotherapy regimen.\n\n          -  At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable\n             extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm\n\n        Exclusion Criteria:\n\n          -  Ongoing Grade 2 or greater toxicities due to previous therapies. Stable, tolerable\n             Grade 2 AEs (eg, neuropathy) may be allowed.\n\n          -  Prior external-beam RT resulting in greater than 20% of total bone marrow receiving\n             greater than 20 Gy.\n\n          -  Prior total body or hemi-body irradiation\n\n          -  Extradural tumor in contact with the spinal cord or tumor located where swelling in\n             response to therapy may impinge upon the spinal cord\n\n          -  Central nervous system involvement unless previously treated with surgery or\n             radiotherapy with the patient neurologically stable and off corticosteroids\n\n          -  For patients with CLL/SLL, LPL, or MZL, transformation to a more aggressive form of\n             NHL\n\n          -  Ongoing chronic immunosuppressive therapy\n\n          -  Clinically significant bleeding event within prior 6 months\n\n          -  Ongoing anti-platelet therapy (except low-dose aspirin [eg, 81 mg daily] for\n             cardioprotection)\n\n          -  PTT > 1.3 × ULN\n\n          -  INR > 2.5\n\n          -  Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2\n             weeks of eligibility-defining bone marrow biopsy.\n\n          -  History of hypersensitivity to iodine\n\n          -  Any other concomitant serious illness or organ system dysfunction that in the opinion\n             of the Investigator would either compromise patient safety or interfere with the\n             evaluation of the safety of the test drug including, but not limited to,\n             myelodysplastic syndromes; New York Heart Association class III-IV heart disease;\n             unstable angina pectoris; serious cardiac arrhythmia requiring medication or a\n             pacemaker/automatic implantable cardioverter defibrillator; myocardial infarction\n             within the past 6 months; uncontrolled hypertension; severe peripheral vascular\n             disease; ongoing hemodialysis or peritoneal dialysis; poorly controlled severe chronic\n             obstructive pulmonary disease; ongoing/active infection requiring antibiotics; and\n             uncontrolled hypothyroidism or hyperthyroidism\n\n          -  Major surgery within 6 weeks of enrollment\n\n          -  Known history of human immunodeficiency virus, hepatitis C, or hepatitis B infection\n\n          -  Pregnancy or breast-feedingXx_NEWLINE_xXWell differentiated, low, intermediate, or high-grade, gastrointestinal mid-gut (arising from the lower jejunum, ileum, appendix, cecum, and proximal colon) NET with documented disease progression within 6 months prior to start of study treatment and evidence of radiographic disease progression based on scans performed not more than 15 months apart. Patients may have received 1 or more prior lines of anticancer therapy, such as somatostatin analogues, targeted agents, or liver-directed intra-arterial therapy, but are NOT eligible if they have received prior systemic cytotoxic chemotherapy or peptide receptor radionuclide therapy (PRRT).Xx_NEWLINE_xXWell differentiated, low, intermediate, or high-grade, pancreatic NET with documented disease progression within 6 months prior to start of study treatment and evidence of radiographic disease progression based on scans performed not more than 15 months apart. Patients may have received 1 or more prior lines of anticancer therapy, such as somatostatin analogues, targeted agents, or liverdirected intra-arterial therapy, and up to 1 prior line of systemic cytotoxic chemotherapy, but are NOT eligible if they have received more than 1 prior line of systemic cytotoxic chemotherapy or if they have received prior peptide receptor radionuclide therapy (PRRT)Xx_NEWLINE_xXAfter progression on or intolerance to prior ALK or ROS inhibitor therapy:\r\n* A minimum washout period of at least 5 days between the last dose of ALK or ROS tyrosine kinase therapy (TKI) therapy and the first dose of study treatment is required; a shorter washout period may be considered in the event of disease flare, after discussion with the sponsor\r\n* Patients must have recovered from treatment toxicities to =< grade 1 or to their pretreatment levels except for adverse events (AEs) that in the investigator’s judgment do not constitute a safety risk for the patientXx_NEWLINE_xXNo prior therapy for IDC or ILCXx_NEWLINE_xXHistory of having undergone any local ablative therapy to liver prior to enrollment on the trialXx_NEWLINE_xXPatients on testosterone replacement therapy who are unwilling to discontinueXx_NEWLINE_xXAny prior systemic or investigational therapy for pancreatic cancerXx_NEWLINE_xXWomen should have received no prior therapy for their diseaseXx_NEWLINE_xXongoing chronic immunosuppressive therapyXx_NEWLINE_xXAny types and amounts of prior therapy will be allowed for this studyXx_NEWLINE_xX- No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imagingXx_NEWLINE_xX- Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomyXx_NEWLINE_xXSuspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :Xx_NEWLINE_xXBeing considered for salvage therapyXx_NEWLINE_xXAndrogen deprivation therapy (ADT) in the past 3 monthsXx_NEWLINE_xXDocumented normal LVEF for at least 6 months after the initiation of recommended HF therapyXx_NEWLINE_xXPatient will be undergoing a FDG-PET scan as part of staging or response assessment for malignancy; Note: the patient may be newly-diagnosed, currently receiving therapy, or have already completed therapy; the presence of identifiable tumor on the PET scan is not requiredXx_NEWLINE_xXIf the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: \r\n* Patient has undergone potentially curative therapy for all prior malignancies\r\n* No evidence of active/recurrent diseaseXx_NEWLINE_xXKnown history of ablative or excisional therapy to the cervix within the preceding 12 months.Xx_NEWLINE_xXNo prior therapy for pancreas cancer is allowed*Xx_NEWLINE_xXUse of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permittedXx_NEWLINE_xXPatients must be eligible for and must be planning to undergo androgen deprivation therapyXx_NEWLINE_xXUndergoing salvage therapyXx_NEWLINE_xXHave no contraindication to short-term atorvastatin therapyXx_NEWLINE_xXReceived any systemic therapy within 21 days prior to planned B-WARM therapy\r\n* Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapyXx_NEWLINE_xXPatients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exceptions of octreotide long-acting release (LAR) (for neuroendocrine tumors) and endocrine therapy (for prostate, breast, or gynecologic malignancies)Xx_NEWLINE_xXUse, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplementsXx_NEWLINE_xXIf receiving an antiandrogen as part of first-line hormonal therapy, must have shown progression of disease off the antiandrogen prior to enrollmentXx_NEWLINE_xXMust be willing to continue androgen deprivation therapy while on study, if no prior orchiectomyXx_NEWLINE_xXReplacement hormone therapy initiated before study entry is permittedXx_NEWLINE_xXReplacement hormone therapy initiated before study entry is permittedXx_NEWLINE_xXMay continue ongoing trastuzumab therapyXx_NEWLINE_xXEpisodes of hepatic encephalopathy within the last 4 weeks. Patients with prior episodes of hepatic encephalopathy who are clinically stable on lactulose, neomycin, and/or xifaxan therapy are allowed.Xx_NEWLINE_xXPrior therapy with crizotinib.Xx_NEWLINE_xXNo prior therapy for disease under studyXx_NEWLINE_xXHistory cancer with no limitation on prior lines of therapy in the metastatic settingXx_NEWLINE_xXPatients must have completed all therapy for curative intent at least six months prior to chart auditXx_NEWLINE_xXMust be candidates to receive endocrine therapy and palbociclib or ribociclib as first-line treatment for their advanced disease. Patients will be considered eligible for study enrollment if they have started on treatment with a standard dose and schedule of palbociclib or ribociclib and endocrine therapy (aromatase inhibitor or fulvestrant) as long as they have not started palbociclib or ribociclib treatment for longer than 4 weeks from time of study enrollment, have sufficient tissue to perform the proposed tissue analysis and must meet all other eligibility criteria. Endocrine therapy can be initiated up to 4 weeks prior to starting palbociclib or ribociclib.Xx_NEWLINE_xXRefractory or relapsed after at least 1 prior line of therapy for whom no effective standard therapy is available per investigator's assessment. • Participants who are either treatment-naive to, relapsed after, or refractory to ibrutinib, idelalisib, or any other investigational B cell receptor (BCR) pathway inhibitors not directly targeting spleen tyrosine kinase (SYK) are allowed.Xx_NEWLINE_xXDocumented disease progression during or immediately after last therapy according to any of the aforementioned criteria.Xx_NEWLINE_xXRequires additional therapy, as determined by the investigator.Xx_NEWLINE_xXHave received anti-CD38 antibody therapy and do not fulfill a 120-day washout period before receiving TAK-079.Xx_NEWLINE_xXDisease progression within 12 months prior to study enrollment.Xx_NEWLINE_xXIntolerance to TKI therapy will be defined as 1 of the following:Xx_NEWLINE_xXPersistent acute toxicities from prior anti-cancer therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Age ? 18 years\n\n          -  Metastatic colorectal cancer\n\n          -  Progression on or following standard therapy, or no standard therapy (phase Ib).\n             Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy\n             regimens (phase II)\n\n          -  Written documentation of mutant or wild-type RAS\n\n          -  Life expectancy ? 3 months\n\n          -  ECOG performance status ? 2\n\n        Exclusion Criteria:\n\n        Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other\n        EGFR inhibitors\n\n          -  Previous treatment with MEK-inhibitors\n\n          -  History of severe infusion reactions to monoclonal antibodies.\n\n          -  Symptomatic or untreated leptomeningeal disease\n\n          -  Symptomatic brain metastasis\n\n          -  Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed\n             by ophthalmologic examination at baseline that would be considered a risk factor for\n             CSR/RVO and history of keratitis.\n\n          -  Acute or chronic pancreatitis\n\n          -  Clinically significant cardiac disease\n\n          -  Not adequate hematologic, renal and hepatic functionXx_NEWLINE_xXSubsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;Xx_NEWLINE_xXPatients who are progressing on current fulvestrant therapy (patients who have had\n             fulvestrant therapy in the past and were subsequently treated with other therapies or\n             those who are starting fulvestrant as their next line of ET are eligible for the\n             study).Xx_NEWLINE_xXSubjects must have received adequate prior therapy including at a minimum:Xx_NEWLINE_xXPrior CAR therapy or other genetically modified T cell therapyXx_NEWLINE_xXPrior CD19 targeted therapyXx_NEWLINE_xXKnown intolerance to CD20 monoclonal antibody therapyXx_NEWLINE_xXThere is no limit to the number of prior therapiesXx_NEWLINE_xXInclusion criteria for the Phase 1:\n\n          1. Subjects must have a metastatic or unresectable locally advanced malignant solid\n             tumor, histologically confirmed by the Laboratory of Pathology, NCI. Efforts will be\n             made, as much as possible, to enroll subjects with tumor types with known increased\n             expression of CEA or MUC-1 (such as lung, breast, ovarian, prostate, colorectal,\n             pancreatic, bladder, gastric, cervix, etc.).\n\n          2. Subjects may have measurable or nonmeasurable but evaluable disease. Subjects with\n             surgically resected or ablated metastatic disease at high risk of relapse are also\n             eligible.\n\n             Prior therapy: Subjects must have completed or had disease progression on at least one\n             prior line of disease-appropriate therapy for locally advanced or metastatic disease,\n             or not be candidates for therapy of proven efficacy for their disease.\n\n          3. Subjects with EGFR or ALK genomic tumor aberrations should have disease progression on\n             FDA-approved therapy for these aberrations.\n\n          4. There should be a minimum of 4 weeks from any prior chemotherapy, immunotherapy and/or\n             radiation, with the exception of hormonal therapy for prostate and breast cancers,\n             HER2-directed therapy for HER2+ breast cancer (3+ IHC or FISH+), maintenance therapy\n             for colorectal or pancreatic cancer, and erlotinib in EGFR-mutated lung cancer under\n             the condition that subjects are on these therapies for at least two months before\n             start of trial treatment. There should be a minimum of 6 weeks from any prior antibody\n             therapies (such as ipilimumab or anti-PD1/PDL1) due to prolonged half-life.\n\n          5. Subjects must have recovered (Grade 1 or baseline) from any clinically significant\n             toxicity associated with prior therapy. Typically, this is 3-4 weeks for subjects who\n             most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C,\n             for which 6 weeks is needed for recovery.\n\n          6. Men or women, age ? 18 years.\n\n          7. Eastern Cooperative Oncology Group (ECOG) performance status ? 1 or Karnofsky ? 70%.\n\n          8. Subjects must have normal organ and marrow function as defined below\n\n             a. Serum creatinine ? 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl)\n             ? 40 mL/min (if using the Cockcroft-Gault formula below): i. Female CrCl = [(140 - age\n             in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dL] ii. Male CrCl =\n             [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dL] b.\n             Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ? 3 x the ULN c.\n             Total bilirubin ? 1.5 x ULN OR in subjects with Gilbert's syndrome, a total bilirubin\n             ? 3.0 x ULN d. Hematological eligibility parameters (within 16 days of starting\n             therapy): i. Platelet count ? 100,000/µL ii. Absolute neutrophil count (ANC) ? 1/ µL\n\n          9. Subjects must have baseline pulse oximetry > 90% on room air.\n\n         10. The effects of CV301 on the developing human fetus are unknown. For this reason, women\n             of child-bearing potential (WOCBP) and men must agree to use adequate contraception\n             (hormonal or barrier method of birth control; abstinence) prior to trial entry and for\n             the duration of trial participation and for a period of 4 months after the last\n             vaccination therapy. Should a woman become pregnant or suspect she is pregnant while\n             she or her partner is participating in this trial, she should inform her treating\n             physician immediately.\n\n         11. Subjects with prostate cancer must continue to receive GnRH agonist therapy (unless\n             orchiectomy has been done).\n\n         12. Subjects must be able to understand and be willing to sign a written informed consent\n             document.\n\n        Inclusion criteria for the Phase 1b and Randomized Phase 2:\n\n          1. Histologically confirmed non-squamous NSCLC, metastatic or unresectable locally\n             advanced. Actionable EGFR mutations and ALK/ROS-1 translocations targetable with FDA\n             approved therapy must be evaluated and found not to be present by standard methods.\n             Expression of PD-L1 must have been determined with a validated method or tumor sample\n             must be available for PD-L1 expression determination.\n\n          2. Patient population:\n\n             • Phase 1b, Cohort 1 (Nivolumab + CV301): Patients with progression on or after prior\n             platinum, with or without switch maintenance chemotherapy are eligible\n\n             • Phase 1b, Cohort 2 and Phase 2 (Pembrolizumab + CV301): Patients must have been on\n             Pembrolizumab as first-line therapy for NSCLC as per FDA approved indications in first\n             line for at least 11 weeks and assessed by RECIST to have CR, PR, or SD at week 12\n             (+/- 1 week).\n\n             As of June 2017, FDA-approved indications for front-line treatment include 2\n             indications for Pembrolizumab:\n\n               -  As a single agent for the first-line treatment of patients with metastatic NSCLC\n                  whose tumors have high PD-L1 expression (Tumor Proportion Score (TPS) ?50%) as\n                  determined by an FDA-approved test, with no EGFR or ALK genomic tumor\n                  aberrations.\n\n               -  In combination with pemetrexed and carboplatin, as first-line treatment of\n                  patients with metastatic nonsquamous NSCLC. This indication is approved under\n                  accelerated approval based on tumor response rate and progression-free survival.\n                  Continued approval for this indication may be contingent upon verification and\n                  description of clinical benefit in the confirmatory trials.\n\n             Pemetrexed single agent maintenance after the initial 4 cycles of pemetrexed in\n             combination with carboplatinum and Pembrolizumab is allowed and optional as per\n             investigator or institutional standard practice.\n\n          3. In case of metastatic recurrence of a previous early stage NSCLC, any chemotherapy or\n             radiation therapy must have finalized more than 12 months before the start of the\n             first-line treatment, either Pembrolizumab alone or in combination with pemetrexed and\n             carboplatinum.\n\n          4. ECOG performance status 0 and 1.\n\n          5. Men or women, age ? 18 years\n\n          6. Have normal organ and marrow function as defined below:\n\n               -  Serum creatinine ? 1.5 x upper limit of normal (ULN) OR creatinine clearance\n                  (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula below):\n\n                  i. Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum\n                  creatinine in mg/dL] ii. Male CrCl = [(140 - age in years) x weight in kg x 1.00]\n                  / [72 x serum creatinine in mg/dL]\n\n               -  ANC > 1/µL\n\n               -  Platelets ? 100 000/µL\n\n               -  Hemoglobin > 9 g/dL\n\n               -  Total bilirubin ? 1.5 x institutional ULN or direct bilirubin < ULN if total\n                  bilirubin > 1.5-3.0 x ULN\n\n               -  AST/ALT < 2.5 × institutional ULN, or < 5 x ULN, if liver metastases are present\n\n          7. Have measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI)\n             per RECIST 1.1.\n\n          8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory\n             tests, and other trial procedures.\n\n          9. Able to understand and be willing to sign a written informed consent document.\n\n         10. WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate\n             method to avoid pregnancy for 23 weeks (30 days plus the time required for Nivolumab\n             to undergo five half-lives) after the last dose of investigational drug (Phase 1b,\n             Cohort 1). WOCBP should use an adequate method to avoid pregnancy for at least 4\n             months (as per approved Pembrolizumab prescribing information) after the last dose of\n             investigational drug (Phase 1b, Cohort 2 and Phase 2).\n\n         11. Women of childbearing potential must have a negative serum or urine pregnancy test\n             (minimum sensitivity 25 IU/L or equivalent units of ?-human choriogonadotropin (HCG))\n             at screening. They must have confirmation by a negative urine pregnancy test within 24\n             hours prior to the first dose of Nivolumab (Phase 1b, Cohort 1), or within 24 hours\n             prior to the first dose of Pembrolizumab in the setting of this trial (Phase 1b,\n             Cohort 2 and Phase 2).\n\n         12. Men who are sexually active with WOCBP must use any contraceptive method with a\n             failure rate of less than 1% per year. Men receiving Nivolumab and who are sexually\n             active with WOCBP will be instructed to adhere to contraception for a period of 31\n             weeks after the last dose of investigational product. Women who are not of\n             childbearing potential (ie, who are postmenopausal or surgically sterile) as well as\n             azoospermic men, do not require contraception.\n\n         13. Subjects must have, prior to trial treatment, at least 10 unstained tissue slides (or\n             a tissue block from which 10 slides can be cut) from a prior biopsy or surgical\n             resection for submission for research purposes. Optional for Phase 1b. Mandatory for\n             Phase 2.\n\n        Exclusion Criteria:\n\n          1. Subjects with EGFR mutations, ALK or ROS-1 translocations candidates to targeted\n             therapy.\n\n          2. Squamous histology of NSCLC.\n\n          3. Other concurrent investigational agents (subjects are eligible to enroll 4 weeks after\n             completion of prior investigational agent).\n\n          4. More than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC with\n             the exception of the Phase 1 portion, in which multiple therapies are allowed in all\n             tumor types. Any prior chemotherapy regimen different from pemetrexed-carboplatinum in\n             combination with Pembrolizumab as first-line chemotherapy for candidates to\n             Pembrolizumab maintenance of first line (Phase 1b and Phase 2).\n\n          5. Concurrent chemotherapy or radiotherapy or other immunotherapy not explicitly allowed\n             by inclusion criteria for that phase of study.\n\n          6. Subjects treated with PD-1/L1 or any other experimental immunotherapeutic agents\n             outside the parameters established in the inclusion criteria, are excluded from\n             enrollment into Phase 1b and 2, but can be enrolled into Phase 1.\n\n          7. Other malignancy within last 5 years with an estimated risk of recurrence higher than\n             50%. Examples of low risk of recurrence malignancies are non-melanoma skin cancer, in\n             situ cervical, superficial bladder cancer, colorectal cancer stage I and II, breast\n             cancer stages I and II, prostate cancer stages I and II, etc.\n\n          8. Patients with metastatic lesions in the brain.\n\n          9. History of allergy or untoward reaction to prior vaccination with vaccinia virus,\n             aminoglycoside antibiotics or egg products; history of allergy to smallpox\n             vaccination.\n\n         10. Active infection within 72 hours prior to vaccination.\n\n         11. Subjects should have no known evidence of being immunocompromised as listed below:\n\n               1. Human immunodeficiency virus (HIV) positivity, chronic hepatitis infection,\n                  including B and C\n\n               2. Active, known or suspected autoimmune disease. Subjects are permitted to enroll\n                  if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to\n                  autoimmune condition only requiring hormone replacement, psoriasis not requiring\n                  systemic treatment, or conditions not expected to recur in the absence of an\n                  external trigger\n\n               3. Immunosuppressive therapy post-organ transplant\n\n               4. Asplenia is an exclusion for Phase 1b and Phase 2, but is not an exclusion for\n                  Phase 1.\n\n         12. Altered immune function, including, but not limited to: inflammatory bowel disease;\n             active infectious enteritis; eosinophilic enteritis; lupus erythematosus; ankylosing\n             spondylitis; scleroderma; multiple sclerosis. These criteria do not include all\n             diseases with an immune-related component, but are not auto-immune in nature or have a\n             primary alteration in the general immune function that may interfere with the vaccine\n             mechanism of action, for example celiac disease.\n\n         13. Concurrent chronic use of systemic steroids, except for physiologic doses of systemic\n             steroids for replacement, defined as 5 mg of prednisone per day or equivalent, or\n             local (topical, nasal, ophthalmic or inhaled) steroid use or prior concomitant use\n             with chemotherapy. Systemic steroids must have been discontinued ? 2 weeks prior to\n             randomization. Prior use of corticoids in short-term schemes (duration shorter than 3\n             days) for indications such as prophylaxis of reactions to intravenous contrast for\n             imaging studies or chemotherapy-related AEs are not considered part of this exclusion.\n             Prior use of corticoids for brain metastasis ending before day -14 is not considered\n             part of this exclusion criteria.\n\n         14. Subjects with interstitial lung disease that is symptomatic or may interfere with the\n             detection or management of suspected drug-related pulmonary toxicity.\n\n         15. Pregnant or breastfeeding women.\n\n         16. Clinically significant cardiomyopathy, coronary disease, heart failure New York Heart\n             Association class III or IV, or cerebrovascular accident within 1 year.\n\n         17. Uncontrolled intercurrent illness, which would interfere with the ability of the\n             subject to carry out the treatment program.\n\n         18. Any other condition, which would, in the opinion of the Principal Investigator or\n             Medical Monitor, indicate the subject is a poor candidate for treatment with CV301 or\n             would jeopardize the subject or the integrity of the data obtained.\n\n         19. Medical or psychological impediment to compliance withXx_NEWLINE_xXHormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registrationXx_NEWLINE_xXPrior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapyXx_NEWLINE_xXCurrent hormone replacement therapy (HRT), selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) use; if yes, the wash-out period is 30 days before diagnostic core needle biopsy\r\n* Note: local therapy (i.e. estrogen cream) will be permitted due to low systemic absorption of estrogen\r\n* Note: if patient is registered prior to completed washout, diagnostic core needle biopsy date will need to be providedXx_NEWLINE_xXHas relapsed (disease progression after most recent therapy) or refractory (failure to achieve Complete Response [CR] or Partial Response [PR] to most recent therapy) classical Hodgkin Lymphoma.Xx_NEWLINE_xXMale or female patients, ages 12 years and older, with relapsed or refractory B-ALL who have failed, or are intolerant to, any established therapy; or for whom no other treatment options are available.Xx_NEWLINE_xXInclusion Criteria:\n\n        Main inclusion criteria all patients, Part 1 and Part 2:\n\n          -  Male or female, at least 18 years of age at the time of informed consent\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\n          -  Life expectancy >3 months assessed during Screening\n\n          -  Documented (histologically- or cytologically-proven) solid tumor malignancy that is\n             locally advanced or metastatic, and that is refractory to standard therapy or for\n             which no standard therapy is available or accessible\n\n          -  Tumor documented to be KRAS WT by local assessment (i.e. the tumor must express the\n             KRAS WT, exon 2, 3 and 4)\n\n        Additional main inclusion criteria applicable to Part 2 ONLY:\n\n          -  Measurable disease according to RECIST v1.1 that has been confirmed by computed\n             tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to Cycle\n             1/Day 1 (C1/D1)\n\n          -  Tumor documented to be KRAS WT by local assessment according to institutional\n             standards.\n\n          -  Basket Cohort ONLY:\n\n               -  Confirmed MET-amplification by local assessment\n\n               -  No prior therapy with MET-targeting agents (except a subset of patients having\n                  received prior therapy with a MET-targeting TKI)\n\n               -  Willingness to undergo a pre- and post-dosing biopsy (maximum of 2 biopsies) from\n                  primary or metastatic tumor site(s) considered safely accessible for biopsy\n\n          -  NSCLC Cohort ONLY:\n\n               -  Documented METex14 mutations (patients need not be MET-amplified and may have\n                  received prior therapy with a MET-targeting TKI). Patients with malignancies\n                  other than NSCLC may be considered for entry to this cohort following discussion\n                  with the Sponsor's Medical Monitor(s).\n\n        Exclusion Criteria:\n\n        Main exclusion criteria all patients, Part 1 and Part 2:\n\n          -  Any antineoplastic agent for the primary malignancy (standard or investigational)\n             without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest,\n             prior to C1/D1, except: nitrosoureas and mitomycin C within 6 weeks prior to C1/D1\n\n          -  Immunosuppressive or systemic hormonal therapy within 2 weeks prior to C1/D1 with\n             specified allowed exceptions\n\n          -  Use of hematopoietic growth factors within 2 weeks prior to C1/D1\n\n          -  Active second malignancy or history of another malignancy within the last 3 years,\n             with specified allowed exceptions\n\n          -  Central nervous system (CNS) malignancy including primary malignancies of the CNS\n             and/or known, untreated CNS or leptomeningeal metastases, or spinal cord compression;\n             patients with any of these not controlled by prior surgery or radiotherapy, or\n             symptoms suggesting CNS involvement for which treatment is required\n\n          -  Inadequate recovery from an acute toxicity associated with any prior antineoplastic\n             therapy\n\n          -  Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any\n             prior surgical procedure\n\n          -  Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within\n             1 month prior to C1/D1, unless adequately treated and stable\n\n          -  Active uncontrolled bleeding or a known bleeding diathesis\n\n          -  Significant cardiovascular disease or condition\n\n          -  Abnormal hematologic, renal or hepatic function\n\n        Additional main exclusion criteria applicable to Part 2 ONLY:\n\n          -  Prior therapy with MET-inhibiting agents (exceptions will be a subset of patients that\n             will be entered to the Basket Cohort after having received prior therapy with a\n             MET-targeting TKI, and patients entered to the NSCLC Cohort who may have received\n             prior therapy with a MET-targeting TKI)\n\n          -  Prior therapy with antibody to hepatocyte growth factor (HGF)\n\n          -  Basket Cohort ONLY: Tumor status demonstrating MET-polysomy in the absence of\n             MET-amplification, as specified. Patients in the NSCLC Cohort with polysomy are\n             eligible.\n\n          -  Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is\n             documented progression of the lesion following the radiotherapyXx_NEWLINE_xXFor phase Ib only: Pretreated patients, and not amenable to further therapy with curative intent. This part is open to pretreated patients regardless of the number of previous treatment lines. For phase II only: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent.Xx_NEWLINE_xXFailed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-secondary hormone CRPC)Xx_NEWLINE_xXPatients must have been receiving single agent ibrutinib therapy at the time of disease progression; patient may have received other therapy in combination with ibrutinib earlier in their treatment course; prior obinutuzumab therapy is also permittedXx_NEWLINE_xXPrimary ibrutinib resistance, defined by progressive disease within the first 2 months of first initiating ibrutinib therapyXx_NEWLINE_xX