Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteriaXx_NEWLINE_xXPatients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)Xx_NEWLINE_xXOther protocol specified criteriaXx_NEWLINE_xXOther protocol specified criteriaXx_NEWLINE_xXPatients fulfilling the following criteria will be eligible for entry into this study:Xx_NEWLINE_xXPatients must be considered to be suitable RIC alloHCT candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used to judge eligibility.Xx_NEWLINE_xXDe novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:Xx_NEWLINE_xXPathologic criteria:Xx_NEWLINE_xXHistology slides reviewed and agreement between two clinical pathologists (not required to be at same institution) that pathology fulfills COMET eligibility criteria. In cases of disagreement between the two pathology reviews about whether or not a case fulfills the eligibility criteria, a third pathology review will be required.Xx_NEWLINE_xXAt least two sites of biopsy for those cases where mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteriaXx_NEWLINE_xXPatients must meet one of the following criteria:\r\n* Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:\r\n** Tissue must have been collected within 6 months prior to pre-registration to Step 0\r\n*** Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:\r\n**** Enrollment onto another investigational study is not permitted\r\n**** Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted\r\n***** Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy\r\n**** A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0\r\n** Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR\r\n* Results from one of the designated outside laboratories indicate a “rare variant” that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:\r\n** The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected “rare variant”\r\n** Patients with an applicable “rare variant” must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step\r\n** Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met\r\n*** NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH\r\n*** NOTE: Tumor tissue for the confirmation of “rare variant” by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratoryXx_NEWLINE_xXINTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIAXx_NEWLINE_xXPOST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIAXx_NEWLINE_xXELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomizationXx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicableXx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgeryXx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXRe-registration Eligibility Criteria (for patients who crossover from arm 1 nivolumab alone to dual agent nivolumab and ipilimumab upon progression)Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR STEP 0Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR STEP 1Xx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients must be eligible for at least one of the currently active investigational treatment arms (S1612B or S1612C); if the patient does not meet eligibility criteria for at least one active investigational arm, then the patient is not eligible for S1612Xx_NEWLINE_xXEligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument \r\nNote: participants in group 1 will not receive protocol-directed therapyXx_NEWLINE_xXNaF PET/CT OPTIONAL SUB-STUDY ELIGIBILITY CRITERIAXx_NEWLINE_xXINDUCTION ELIGIBILITY CRITERIA-STEP 1Xx_NEWLINE_xXPOST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)Xx_NEWLINE_xXPatients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)Xx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIA (STEP 1)Xx_NEWLINE_xXPatients must have met eligibility criteria for the screening stepXx_NEWLINE_xXELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):Xx_NEWLINE_xXNo G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteriaXx_NEWLINE_xXNote: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteriaXx_NEWLINE_xXRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria belowXx_NEWLINE_xXRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteriaXx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)Xx_NEWLINE_xXELIGIBILITY CRITERIA (STEP 1)Xx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIA (STEP 1)Xx_NEWLINE_xXRANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)Xx_NEWLINE_xXPatient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621D based on the presence of an actionable mutation; note that treatment assignment may be to primary cohort A for patients with TSC1 or TSC2 loss of function mutations, primary cohort B for patients with other PI3K/MTOR pathway mutations, a histology specific biomarker positive expansion cohort if the criteria to open such a cohort are met, or a biomarker negative expansion cohort if the criteria to open such a cohort are metXx_NEWLINE_xXPatients crossing over from monotherapy to combination therapy do not have to be fully rescreened; however, they do need to meet performance status, organ function, and blood parameters and not meet any of the exclusion criteriaXx_NEWLINE_xXIn emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy\r\n* Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances:\r\n** Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)\r\n** Uncorrectable coagulopathy\r\n* For a patient to maintain eligibility for AHEP1531 when emergent treatment is given, the following must occur:\r\n** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment\r\n* Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aimsXx_NEWLINE_xXPlease note: patients who do not meet the above criteria because of Gilbert’s syndrome are still eligibleXx_NEWLINE_xXMeets protocol-specified criteria for qualification and contraceptionXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea) or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registrationXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology)Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): ECOG performance status 0-2Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent\r\n* Patients with WBC count above 20 x10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drugXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of isolated extramedullary relapse (i.e., testicular or CNS)Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Patient must not have Burkitt’s lymphoma/leukemia based on the WHO criteriaXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registrationXx_NEWLINE_xXPatients must meet the following laboratory criteria:Xx_NEWLINE_xXELIGIBILITY FOR SCREENINGXx_NEWLINE_xXPatients screened for this trial should be expected to meet the criteria for treatmentXx_NEWLINE_xXAssessment of HER2 status in patients with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.Xx_NEWLINE_xXGrade I meningiomas will be allowed as long as they meet criteria for progressionXx_NEWLINE_xXAdditional criteria may apply. MELANOMA (pembrolizumab only)Xx_NEWLINE_xXAdditional criteria may applyXx_NEWLINE_xXAt the time of study entry, blood counts performed within 2 weeks prior to study entry must meet the following criteria:Xx_NEWLINE_xXSurgery to the lesion in question is allowed if size criteria outlined above are metXx_NEWLINE_xXMust have transfusion-dependent anemia that meets the following criteria:Xx_NEWLINE_xXPatients who are receiving any other investigational agents concurrently; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteriaXx_NEWLINE_xXNOTE: platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before registrationXx_NEWLINE_xXSubjects with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at the Screening Visit, the following criteria are met:Xx_NEWLINE_xXCRITERIA FOR DONOR ELIGIBILITY:Xx_NEWLINE_xXInclusion Criteria\n\n        Each patient must meet all of the following inclusion criteria to be enrolled in the study:\n\n        Phase 1b and Phase 2\n\n          1. Advanced or metastatic breast cancer.\n\n          2. Histological or cytological confirmation of ER+ status (defined as > 1% positive tumor\n             cells), and histological or cytological confirmation of HER2-negative (HER2-) status\n             by local laboratory testing using criteria in the American Society of Oncology\n             (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.[44]\n\n          3. Female patients 18 years of age or older who:Are postmenopausal for at least 1 year\n             before the Screening visit, where menopause is defined by: Age ? 55 years and 1 year\n             or more of amenorrhea\n\n             Age < 55 years and 1 year or more of amenorrhea, with an estradiol assay < 20 pg/mL\n             oSurgical menopause with bilateral oophorectomy\n\n             Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone\n             agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of\n             ovarian suppression.\n\n          4. Patients who have a history of brain metastasis are eligible for the study provided\n             that all the following criteria are met:\n\n               -  Brain metastases which have been treated\n\n               -  No evidence of disease progression for ? 3 months or hemorrhage after treatment\n\n               -  Off-treatment with dexamethasone for 4 weeks before administration of the first\n                  dose of MLN0128\n\n               -  No ongoing requirement for dexamethasone or anti-epileptic drugs\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n\n          6. Clinical laboratory values as specified below within 4 weeks before the first dose of\n             MLN0128:\n\n               -  Bone marrow reserve consistent with absolute neutrophil count (ANC) ? 1.5 x\n                  10^9/L; platelet count ? 100 x 10^9/L; hemoglobin ? 9 g/dL\n\n               -  Total bilirubin ? 1.5 x the upper limit of the normal range (ULN), aspartate\n                  aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN (? 5 x ULN\n                  if liver metastases are present)\n\n               -  Creatinine clearance ? 50 mL/min based either on Cockcroft-Gault estimate or\n                  based on a 12- or 24-hour urine collection\n\n               -  Fasting serum glucose ? 130 mg/dL and fasting triglycerides ? 300 mg/dL\n\n          7. Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of\n             institutional standard of normal as measured by echocardiogram (ECHO) or multiple\n             gated acquisition scan (MUGA) within 4 weeks before the first dose of MLN0128 (ie, if\n             the institutional standard of normal is 50%, LVEF may be as low as 45% to be eligible\n             for the study).\n\n          8. Able to provide paraffin blocks or a minimum of 10 unstained slides of available\n             archival tumor tissues (paraffin blocks are preferred). If archival tumor tissue is\n             not available, a tumor biopsy may be performed before the patient begins treatment\n             with MLN0128. If fewer than 10 slides are available or the tumor content/area\n             requirements are not met, study eligibility will be determined upon discussion with\n             the sponsor.\n\n          9. Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and\n             suitable venous access for the study-required blood sampling.\n\n         10. Voluntary written consent must be given before the performance of any study related\n             procedure not part of standard medical care, with the understanding that consent may\n             be withdrawn by the patient at any time without prejudice to future medical care.\n\n             Phase 1b Only: In addition to the previously mentioned inclusion criteria, each\n             patient must meet the following inclusion criterion to be enrolled in the phase 1b\n             portion of the study:\n\n         11. Patients may have SD or disease progression during their most recent treatment with\n             exemestane or fulvestrant, or everolimus in combination with either exemestane (any\n             country) or fulvestrant (US only). Exemestane or fulvestrant in combination with\n             MLN0128 can also be initiated as a new line of therapy.\n\n             Phase 2 Only: In addition to the previously mentioned inclusion criteria, each patient\n             must meet all of the following inclusion criteria to be enrolled in the phase 2\n             portion of the study:\n\n         12. Measureable disease defined as follows:\n\n               -  At least 1 extra-osseous lesion that can be accurately measured in at least 1\n                  dimension. The lesion must measure ? 20 mm with conventional imaging techniques\n                  or ? 10 mm with spiral CT or MRI, or\n\n               -  Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable\n                  disease as defined above\n\n         13. Patients must have had disease progression during treatment with everolimus in\n             combination with either exemestane (any country) or fulvestrant (US only) (duration of\n             treatment ? 4 weeks) and must have tolerated everolimus treatment in combination with\n             exemestane (any country) or fulvestrant (US only) adequately according to the treating\n             physician's judgment. Everolimus in combination with exemestane or fulvestrant is not\n             required to be the most recent treatment before enrollment, but progression on the\n             most recent anticancer therapy is required for enrollment.\n\n        Exclusion Criteria\n\n        Patients meeting any of the following exclusion criteria are not to be enrolled in the\n        study:\n\n        Phase 1b and Phase 2\n\n          1. Prior anticancer therapy or other investigational therapy within 2 weeks before\n             administration of the first dose of MLN0128 (except for exemestane or fulvestrant,\n             which should be continued). Treatment with everolimus must be discontinued 2 weeks\n             before administration of the first dose of MLN0128.\n\n          2. Chronic concomitant therapy with bisphosphonates or denosumab for the prevention of\n             bone metastases. Concomitant treatment with bisphosphonates or denosumab is permitted\n             for treatment of osteoporosis or management of existing bone metastases if initiated\n             at least 4 weeks before administration of the first dose of MLN0128.\n\n          3. Initiation of treatment with hematopoietic growth factors, transfusions of blood and\n             blood products, or systemic corticosteroids (either IV or oral steroids, excluding\n             inhalers) within 1 week before administration of the first dose of MLN0128 (patients\n             already receiving erythropoietin on a chronic basis for ? 4 weeks are eligible).\n\n          4. Previous treatment with dual PI3K/mTOR inhibitors or TORC1/2 inhibitors.\n\n          5. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI\n             disease, or for an unknown reason that may alter the absorption of MLN0128.\n\n          6. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%;\n             patients with a history of transient glucose intolerance due to corticosteroid\n             administration may be enrolled in this study if all other inclusion/exclusion criteria\n             are met.\n\n          7. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease,\n             active central nervous system disease, active infection, or any other condition that\n             could compromise participation of the patient in the study.\n\n          8. Known human immunodeficiency virus infection.\n\n          9. History of any of the following within the last 6 months before administration of the\n             first dose of MLN0128:\n\n               -  Ischemic myocardial event, including angina requiring therapy and artery\n                  revascularization procedures\n\n               -  Ischemic cerebrovascular event, including transient ischemic attack and artery\n                  revascularization procedures\n\n               -  Requirement for inotropic support (excluding digoxin) or serious (uncontrolled)\n                  cardiac arrhythmia (including atrial flutter/fibrillation, ventricular\n                  fibrillation, or ventricular tachycardia)\n\n               -  Placement of a pacemaker for control of rhythm\n\n               -  New York Heart Association Class III or IV heart failure\n\n               -  Pulmonary embolism\n\n         10. Significant active cardiovascular or pulmonary disease before administration of the\n             first dose of MLN0128, including:\n\n               -  Uncontrolled hypertension (ie, systolic blood pressure > 180 mm Hg; diastolic\n                  blood pressure > 95 mm Hg)\n\n               -  Pulmonary hypertension\n\n               -  Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or\n                  pulse oximetry on room air\n\n               -  Significant valvular disease; severe regurgitation or stenosis by imaging\n                  independent of symptom control with medical intervention; or history of valve\n                  replacement\n\n               -  Medically significant (symptomatic) bradycardia\n\n               -  History of arrhythmia requiring an implantable cardiac defibrillator\n\n               -  Baseline prolongation of the rate-corrected QT interval (QTc; eg, repeated\n                  demonstration of QTc interval > 480 ms, or history of congenital long QT\n                  syndrome, or torsades de pointes)\n\n         11. Diagnosed or treated for another malignancy within 2 years before administration of\n             the first dose of MLN0128 or previously diagnosed with another malignancy and have any\n             evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in\n             situ of any type are not excluded if they have undergone complete resection.\n\n             Phase 1b Only: In addition to the previously mentioned exclusion criteria, patients\n             meeting the following exclusion criterion are not to be enrolled in the phase 1b\n             portion of the study:\n\n         12. More than 3 prior chemotherapy regimens for locally advanced or metastatic disease.\n\n             Phase 2 Only: In addition to the previously mentioned exclusion criteria, patients\n             meeting the following exclusion criterion are not to be enrolled in the phase 2\n             portion of the study:\n\n         13. More than 1 prior chemotherapy regimen for locally advanced or metastatic disease.Xx_NEWLINE_xXInclusion Criteria:\n\n        Key Inclusion Criteria:\n\n        Subjects must meet all of the following criteria to be included:\n\n          1. Male aged between 50 and 80 years (inclusive) with histologically documented\n             clinically localized, adenocarcinoma of the prostate.\n\n          2. Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).\n\n          3. At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.\n\n          4. At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.\n\n          5. Recent (? 6 months prior to study entry) negative bone scan and computerized\n             tomography (CT) scan of abdomen/pelvis.\n\n          6. Life expectancy of at least 5 years.\n\n          7. Subjects should have adequate bone marrow function defined as an absolute peripheral\n             granulocyte count ? 1,500 and platelet count of ? 100,000, adequate hepatic function\n             with a bilirubin ? 1.5 mg/dl and serum glutamic-pyruvic transaminase (SGPT) < 4x the\n             upper limits of normal, adequate renal function defined as serum creatinine ? 2.0\n             mg/dl\n\n          8. Subjects must have a coagulation profile (prothrombin time [PT], partial\n             thromboplastin time [PTT]) not more than 2-times the upper limit of normal and no\n             history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants within\n             5-days of the Ad5-SGE-REIC/Dkk-3 injections is limited to local use only (for control\n             of central line patency).\n\n          9. Subject is willing to refrain from sexual activity or agrees to use a barrier\n             contraceptive device (e.g. condom) for 8-weeks after treatment with\n             Ad5-SGE-REIC/Dkk-3.\n\n         10. Subjects must sign an informed consent indicating that they are aware of the\n             investigational nature of the study.\n\n        Key Exclusion Criteria\n\n        Subjects meeting any of the following criteria will be excluded:\n\n          1. Prior primary radiation treatment to the prostate.\n\n          2. Severe bladder outlet obstructive disorder (AUA >25) or urinary track retention.\n\n          3. Chemotherapy, immunotherapy or other investigational study drug within the past 4\n             weeks.\n\n          4. Unable to tolerate TRUS.\n\n          5. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric\n             disorders, that in the opinion of the investigator put the subject at significant\n             risk, are not eligible.\n\n          6. Subjects who are HIV positive or have active hepatitis B or C infections are not\n             eligible.\n\n          7. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune\n             disease or subjects taking immunosuppressive drugs such as corticosteroids\n             continuously for > 4 months [> 5 mg hydrocortisone/day] are ineligible.\n\n          8. As a result of medical review, physical examination, the Principal Investigator (or\n             medically qualified nominee) considers the subject unfit for the study.Xx_NEWLINE_xXPatients enrolled in the expansion cohort must have at least one measureable lesion as defined by the RECIST 1.1 criteriaXx_NEWLINE_xXELIGIBILITY CRITERIA FOR ENROLLMENTXx_NEWLINE_xXPatients enrolled in the study will meet standard criteria for whole breast XRT or chest wall XRT for patients who have had mastectomiesXx_NEWLINE_xXPre-registration Eligibility Inclusion Criteria for the PIK3CA Mutant Cohort (closed 03/17/2016)Xx_NEWLINE_xXHave disease that can be clinically evaluated for improvement or progression. In the dose-expansion phase of the study, subjects must have disease that is measurable, as defined by the RECIST Version 1.1 criteria for solid tumors (Eisenhauer et al, 2009) or the Lugano criteria for lymphoma (Cheson et al, 2014).Xx_NEWLINE_xXMeets one of the sets of the following criteria:Xx_NEWLINE_xXSteroid treatment within seven (7) days prior to study treatment. Patients that require intermittent use of bronchodilators, topical steroids or local steroid injections will not be excluded from the study. Patients who have been stabilized to 10 mg Prednisolone PO QD (or equivalent), daily (or less) at least seven (7) days prior to study drug administration are allowed. Phase 2 Tumor-specific Eligibility Criteria Phase 2 patients must meet the cohort-specific inclusion/exclusion criteria in addition to the general inclusion/exclusion criteria for Phase 1 and Phase 2 study listed above. Cohort 1: Patient Population: Relapsed/Refractory SCLCXx_NEWLINE_xXBlood counts performed within 28 days prior to randomization must meet the following criteria:Xx_NEWLINE_xXSubjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met; subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post-transplant, they have no evidence of active graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 daysXx_NEWLINE_xXPlatelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollmentXx_NEWLINE_xXMust meet criteria for high-risk MGUS or low-risk smoldering myeloma as described below:Xx_NEWLINE_xXHas MM defined by the IMWG criteria with evidence of disease progression and:Xx_NEWLINE_xXDONOR: Donors must meet all criteria for donation as per 21 Code of Federal Regulations (CFR)1271 Subpart CXx_NEWLINE_xXClinicopathological diagnosis of Waldenstrom macroglobulinemia, and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom macroglobulinemiaXx_NEWLINE_xXPatients enrolling after only 1 failed induction attempt must meet at least one of the following additional eligibility criteria of high risk: ? 60 years of age adverse cytogenetics or molecular characteristicsXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet the following criteria to be included:\n\n          -  Willing and able to read, understand and sign an informed consent form\n\n          -  Confirmed diagnosis by enrolling physician of WAIHA\n\n          -  Must use medically acceptable contraception\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the following criteria are to be excluded:\n\n          -  Subject unable or unwilling to comply with the protocol\n\n          -  Active non-hematologic malignancy or history of non-hematologic malignancy in the 3\n             years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in\n             situ)\n\n          -  Positive for HIV or hepatitis C antibody\n\n          -  Positive for hepatitis B surface antigen\n\n          -  Any exposure to an investigational drug or device within the 30 days prior to\n             screening\n\n          -  IVIG treatment within 60 days of screening\n\n          -  Plasmapheresis or immunoadsorption within 60 days of screening\n\n          -  Subject has any current medical condition that, in the opinion of the Investigator,\n             may compromise their safety or compliance, preclude successful conduct of the study,\n             or interfere with interpretation of the resultsXx_NEWLINE_xXScreening laboratory values must meet the following criteria:Xx_NEWLINE_xXMeets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.Xx_NEWLINE_xXRAEB-2 per WHO MDS criteria (10% to <20% BM blasts)Xx_NEWLINE_xXPatients must have available two UCB units fulfilling the following criteria:Xx_NEWLINE_xXAdditional graft selection criteria specified in section 2.5Xx_NEWLINE_xXPatients must meet ONE of the criteria outlined in either a, b, c OR d:Xx_NEWLINE_xXParticipant must meet the following criteria as indicated on the clinical laboratory tests:Xx_NEWLINE_xXParticipant meets the following criteria as indicated on the clinical laboratory tests:Xx_NEWLINE_xXIf the participant has developed overall grades II-IV acute GVHD, the following criteria must be met to be randomized:Xx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXEach patient must meet the following criteria:Xx_NEWLINE_xXPatients must not meet any of the following criteria:Xx_NEWLINE_xXInclusion Criteria:\n\n        To be eligible for this study, a patient must meet all of the following inclusion criteria:\n\n          1. Be at least 18 years of age.\n\n          2. Has signed the current approved informed consent form.\n\n          3. Has a histologically confirmed diagnosis of malignant melanoma.\n\n          4. Has at least two separate cutaneous lesions suitable for punch biopsies (at least 3 mm\n             diameter).\n\n          5. For women of childbearing potential and men, agree to use a highly effective method of\n             contraceptive from screening, through the study, and for at least 4 weeks after the\n             last dose of study drug.\n\n          6. For women of childbearing potential, must have a negative pregnancy test (serum or\n             urine) on Day 1 prior to initiating study treatment, and are not nursing.\n\n          7. Be willing and able to comply with the schedule, treatment, and biopsies specified by\n             this protocol.\n\n        Exclusion Criteria:\n\n        Patients with any of the following will be excluded from participation in the study:\n\n          1. Has performance status Grade 2 or higher (Eastern Cooperative Oncology Group [ECOG]\n             criteria).\n\n          2. Has ongoing acute clinical adverse events NCI CTCAE Grade 2 or greater resulting from\n             prior cancer therapies (except alopecia).\n\n          3. Has had within the past 6 months the occurrence or persistence of one or more of the\n             following medical conditions that could not be controlled with usual medical care\n             (e.g., required emergency care or hospitalization): angina, congestive heart failure,\n             diabetes, seizure disorder.\n\n          4. Has had within the past 6 months the occurrence of one or more of the following\n             events: myocardial infarction, cerebrovascular accident, hemorrhage (CTC Grade 3 or\n             4), chronic liver disease (meeting criteria for Child-Pugh Class B or C), a second\n             active malignancy requiring ongoing treatment during the trial, organ transplantation.\n\n          5. Has had within the 4 weeks prior to initiation of study drug, or is expected to have\n             during the study period, surgery requiring general anesthesia\n\n          6. Has, at screening, serologic laboratory tests meeting one or more of the following\n             criteria:\n\n               -  An indeterminate or positive test for antibody to human immunodeficiency virus\n                  (HIV-1 or -2).\n\n               -  An indeterminate or positive test for antibody to hepatitis C virus (HCV), unless\n                  documented to have no detectable viral load on two independent samples.\n\n               -  A positive test for hepatitis B surface antigen (HBsAg).\n\n          7. Has, at screening, safety laboratory tests meeting one or more of the following\n             criteria:\n\n               -  Hemoglobin <9.0 g/dL\n\n               -  Absolute neutrophil count (ANC) <1,500/?L\n\n               -  Platelets <100,000/?L\n\n               -  Creatinine >2.0x ULN\n\n               -  Serum aspartate transaminase (AST) >3x ULN\n\n               -  Serum alanine transaminase (ALT) >3x ULN\n\n               -  Total bilirubin >1.5x ULN (unless due to Gilbert's Syndrome)\n\n               -  International normalized ratio (INR) >1.5x ULN (unless on therapeutic\n                  anti-coagulation).\n\n          8. Has been previously treated with approved or investigational immunotherapy including\n             oncolytic viruses, or agents directed at CTLA-4, PD-1, or PD-L1 (\checkpoint\n             inhibitors\).\n\n          9. Has previously received other anti-cancer therapy within 2 weeks prior to Day 1,\n             including radiation therapy or chemotherapy. For investigational anti-cancer\n             therapies, the interval will be determined in consultation with the Medical Monitor.\n\n         10. Has, within 2 weeks prior to Day 1, been regularly taking a medication prohibited\n             based on CYP3A4 interaction.\n\n         11. Has, at the planned initiation of study drug, an uncontrolled infection.\n\n         12. Has any other medical or personal condition that, in the opinion of the Investigator,\n             may potentially compromise the safety or compliance of the patient, or may preclude\n             the patient's successful completion of the clinical trial.Xx_NEWLINE_xXMust meet criteria for high risk disease\r\n* Patients with INSS stage 2a/2b with MYCN amplification regardless of age or additional biologic featuresXx_NEWLINE_xXMeet protocol-specified lab requirementsXx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment; patients may receive growth factor support prior to initiating therapy but must remain off of growth factor for at least 7 days before starting therapy and must meet eligibility on cycle 1, day 1; patients who complete the consent process but do not meet hematologic eligibility within 30 days may be re-consented and enrolled on study if they ultimately do meet eligibility requirements before day +180; no patients may initiate therapy after day +180 and they must meet all remaining eligibility criteriaXx_NEWLINE_xXNOTE: Patients are expected to initiate therapy as close to day +100 as possible; no patient may initiate therapy before day +70 and initiation of therapy beyond day +130 is allowed ONLY for patients who meet all eligibility criteria except for hematologic parameters, in which case patients may be delayed until their hematologic laboratories meet criteria but no later than day +180; regardless of the time of therapy initiation, patients must meet all eligibility criteria and must have completed all consent documentation and screening procedures within the specified windowXx_NEWLINE_xXDONOR: Failure to meet institutional criteria for stem cell donationXx_NEWLINE_xXINCLUSION CRITERIA FOR STRATUM C: Patients must have a histologically confirmed primary brain tumor that is recurrent, progressive or refractory; inclusion criteria encompasses all types of brain tumors (e.g. gliomas, embryonal tumors or any other type of brain tumor as long as other eligibility criteria are met;\r\n* Patients with high-grade gliomas are eligible for this clinical trial at least 2 weeks after completion of radiotherapy independent of tumor progression/recurrence as long as they are not enrolled on any other therapeutic clinical trial and there is macroscopic residual disease\r\n* Patients with other concomitant tumors associated with CMMRD syndrome including gastrointestinal polyps/adenomas and carcinomas, lymphomas and leukemias will be eligible as long as they are not requiring anticancer therapy directed against these other cancers and meet all other eligibility criteriaXx_NEWLINE_xXStudy subjects < 18 years of age who cannot undergo the leukapheresis procedure, do not meet the disease staging and/or the size criteria for frequent blood donationsXx_NEWLINE_xXMeet standard criteria for RIT:\r\n* < 25% marrow involvement with FL\r\n* No evidence of myelodysplasiaXx_NEWLINE_xXPatients previously treated with anti-CD19 CAR or other adoptive cell therapies will be eligible if all other eligibility criteria are met but will be evaluated as a separate strata from CAR-naive patients in the expansion phase; circulating CAR T cells must be < 5% in peripheral bloodXx_NEWLINE_xXMust meet the following clinical laboratory criteria at study entry:Xx_NEWLINE_xXELIGIBILITY FOR SCREENING: Weighs at least 12 kgXx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF TREATMENT: EBV positive tumorXx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF TREATMENT: Hemoglobin (Hgb) > 8.0 (may be a transfused value)Xx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF TREATMENT: Pulse oximetry of > 90% on room airXx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients should have been off other investigational therapy for 30 days prior to infusionXx_NEWLINE_xXPatients from Stratum I who fulfill the following criteria:Xx_NEWLINE_xXPatients from Stratum I or Stratum III who fulfill the following criteria:Xx_NEWLINE_xXThe presence of any of the following criteria will exclude the patient from the study:Xx_NEWLINE_xXTumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria; these criteria include encasement of great vessels, vertebral invasion or undue peri-operative riskXx_NEWLINE_xXPROCUREMENT CRITERIAXx_NEWLINE_xXMeet the following laboratory parameters, per the reference range, at least once during the screening period: ANC of at least 1000/?L (Subjects may use growth factor support to achieve ANC eligibility criteria), AST and ALT not higher than 3 x ULN, Calculated creatinine clearance of at least 30 mL/min using a modified Cockcroft-Gault calculation, platelet count of at least 30,000 mm³ (independent of transfusion for 2 weeks), hemoglobin of at least 8.0 g/dL (subjects may receive blood transfusion to achieve hemoglobin eligibility criteria), and total bilirubin not higher than 1.5 x ULN (subjects with Gilbert's Syndrome may have bilirubin higher 1.5 x ULN).Xx_NEWLINE_xXPatients with a diagnosis of MM as defined by the 2014 IMWG diagnostic criteriaXx_NEWLINE_xXMANUFACTURING SJCAR19: Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresisXx_NEWLINE_xXNote: Hematology and other lab parameters that are =< grade 2 but still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.Xx_NEWLINE_xXDiagnosis of MDS according to WHO 2016 criteriaXx_NEWLINE_xXMeet the following disease activity criteria:Xx_NEWLINE_xXEligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day -2 or -1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n** Inclusion criteria exceptions: Hematologic function parameters will not be included as a pre-infusion eligibility criterion (because lymphodepletive chemotherapy is expected to cause pancytopenia).Xx_NEWLINE_xXEligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day -2 or -1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n* Exclusion criteria additions:\r\n** Use of corticosteroids within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).\r\n** Neurologic symptoms suggestive of an active central nervous system condition.\r\n** Signs or laboratory markers of active infection or systemic inflammatory response.Xx_NEWLINE_xXGRAFT CRITERIA:Xx_NEWLINE_xXParticipants must have pathologically confirmed primary myelofibrosis according to World Health Organization (WHO) criteria or secondary myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria\r\n* Intermediate-2/ high-risk disease as per Dynamic International Prognostic Scoring System (IPSS) (DIPSS) criteria OR\r\n* Intermediate-1 risk disease with one of the following additional unfavorable features known to impact the survival adversely\r\n** Red cell transfusion dependency\r\n** Unfavorable Karyotype\r\n** Platelet count =< 100 x 10^9/LXx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXPregnant patients do not meet inclusion criteria for radiation therapy.\r\n* Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.Xx_NEWLINE_xXParticipants must meet appropriate molecular eligibility criteriaXx_NEWLINE_xXADDITIONAL COHORT 1 ELIGIBILITY CRITERIAXx_NEWLINE_xXADDITIONAL COHORT 2 ELIGIBILITY CRITERIAXx_NEWLINE_xXELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT\r\n* Once research participants meet eligibility to proceed with Rickham placement, they will be deemed accrued on to the studyXx_NEWLINE_xXELIGIBILITY TO PROCEED WITH CAR T CELL INFUSIONXx_NEWLINE_xXMeet any criteria necessary for the safe and proper use of the induction and consolidation agents involved in this trialXx_NEWLINE_xXELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDYXx_NEWLINE_xXDisease progression by IWG criteria since last therapyXx_NEWLINE_xXAdditional cohort-specific criteria may apply.Xx_NEWLINE_xXInclusion and Exclusion Criteria - Part 1 Inclusion Criteria - Part 1\n\n        • Subject has provided informed consent prior to initiation of any study-specific\n        activities/procedures or subject's legally acceptable representative has provided informed\n        consent prior to any study-specific activities/procedures being initiated when the subject\n        has any kind of condition that, in the opinion of the investigator, may compromise the\n        ability of the subject to give written informed consent.\n\n          -  Age ? 18 at time of informed consent\n\n          -  Biopsy-proven DLBCL excluding DLBCL that represents transformation of indolent NHL\n             Note: Lymphoblastic Lymphoma and Burkitt Lymphoma histology are not eligible\n\n          -  Subject has ? 1 characteristic feature of high-risk DLBCL:\n\n             o High-risk first complete remission (defined as interim PET-CT positive or < complete\n             remission to frontline chemotherapy AND achieved complete remission to\n             platinum-containing salvage)\n\n             o Relapse within 1 year of diagnosis\n\n               -  Secondary aaIPI > 1 (see Appendix D)\n\n               -  Partial response/partial metabolic response after minimum of 2 cycles of\n\n               -  platinum-containing salvage chemotherapy\n\n               -  C-myc rearrangement\n\n          -  aHSCT with high-dose chemotherapy following first (or later) salvage treatment.\n\n          -  PET-CT negative (Deauville score ? 3) 90 days (± 30 days) post aHSCT\n\n          -  Available relapsed and/or diagnostic pathology formalin-fixed paraffin-embedded (FFPE)\n             tumor block or slide samples at the time of enrollment including the successful\n             identification of malignant clone sequences by the central laboratory.\n\n          -  MRD plasma sample collected ? 3 weeks from post aHSCT PET-CT scan\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status ? 2.\n\n          -  Adequate organ function determined ? 3 weeks prior to enrollment defined as follows:\n\n             o Hematological: Absolute neutrophil count (ANC) ? 1.0 x 109/L Platelet count ? 75 x\n             109/L Hemoglobin ? 8 g/dL\n\n             o Renal: Creatinine clearance ? 50 mL/min Cockcroft-Gault equation\n\n             o Hepatic: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x\n             upper limit of normal (ULN) Total bilirubin < 2 x ULN (unless Gilbert's Disease or if\n             liver involvement with lymphoma)\n\n          -  Subject will be available to complete all protocol-required study visits or\n             procedures, and/or to comply with all required study procedures to the best of the\n             subject's and investigator's knowledge including but not limited to:\n\n          -  Completion of up to a 24-month run-in period\n\n          -  Completion of all regularly scheduled study visits including blood draws for\n\n          -  MRD assessment, clinical disease state assessment, PET-CT scans (ie, at time of MRD\n             positivity or relapse), assignment to treatment with blinatumomab\n\n        Other Inclusion Criteria may apply\n\n        Exclusion Criteria - Part 1\n\n        • Clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia,stroke,\n        severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain\n        syndrome, and psychosis\n\n          -  Evidence of CNS involvement with DLBCL\n\n          -  Current autoimmune disease or history of autoimmune disease with potential of CNS\n             involvement\n\n          -  Prior anti-CD19 directed therapies\n\n          -  Prior alloHSCT\n\n          -  Received radiation ? 2 weeks prior to enrollment\n\n          -  Known infection with human immunodeficiency virus or chronic infection with hepatitis\n             B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti-hepatitis C\n             virus positive)\n\n          -  History of malignancy other than DLBCL within the past 3 years with the following\n             exceptions:\n\n             o Malignancy treated with curative intent and with no known active disease present for\n             ? 3 years before enrollment and felt to be at low risk for recurrence by the treating\n             physician\n\n             o Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of\n             disease\n\n             o Adequately treated cervical carcinoma in situ without evidence of disease\n\n               -  Adequately treated breast ductal carcinoma in situ without evidence of disease\n\n               -  Prostatic intraepithelial neoplasia without evidence of prostate cancer\n\n               -  Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in\n                  situ\n\n          -  Subject has known hypersensitivity to immunoglobulins or any of the products or\n             components to be administered during dosing.\n\n          -  History or evidence of any other clinically significant disorder, condition or disease\n             (with the exception of those outlined above) that, in the opinion of the investigator\n             or Amgen physician, if consulted, would pose a risk to subject safety or interfere\n             with the study evaluation, procedures or completion.\n\n          -  Women who are pregnant or breastfeeding or planning to become pregnant or breastfeed\n             while receiving blinatumomab and for an additional 48 hours after the last treatment\n             dose of blinatumomab. (Females of child bearing potential should only be included\n             after a negative highly sensitive urine or serum pregnancy test.)\n\n          -  Women of childbearing potential unwilling to use an acceptable method of effective\n             contraception while receiving blinatumomab and for an additional 48 hours after last\n             dose of blinatumomab. Note: The pregnancy, breastfeeding and contraceptive\n             requirements are specific to blinatumomab. The investigator is responsible for\n             providing the subject (male and female) with pregnancy and breastfeeding (female only)\n             avoidance requirements for other medications given during the study.\n\n          -  Currently receiving treatment in another investigational device or drug study or less\n             than 30 days since ending treatment on another investigational device or drug study.\n             Other investigational procedures while participating in this study are excluded.\n\n        Inclusion and Exclusion Criteria - Part 2 Inclusion Criteria - Part 2\n\n          -  MRD-positive assessment (by NGS analysis) at enrollment or at any time during the\n             run-in 1 period\n\n          -  PET-CT negative (defined by Deauville criteria ? 3) at run-in 2 performed ? 3 weeks\n             from MRD-positive assessment at run-in 1. Historical PET-CT are allowed if performed ?\n             6 weeks from day 1 (first dose of blinatumomab) and subject has no clinical signs or\n             symptoms suggestive of disease progression (eg, increase in lactate dehydrogenase\n             [LDH] not otherwise explained)\n\n          -  Adequate organ function determined ? 2 week prior to treatment assignment with\n             blinatumomab as follows:\n\n               -  Hematological:\n\n        ANC ? 1.0 x 109/L Hemoglobin ? 8 g/L Platelet count ? 75 x 109/L o Renal: Creatinine\n        clearance ? 50 mL/min Cockcroft-Gault equation\n\n        o Hepatic: AST and ALT < 3 x ULN Total bilirubin < 2 x ULN (unless Gilbert's Disease or if\n        liver involvement with lymphoma)\n\n        Exclusion Criteria - Part 2 Subject has active infection requiring systemic therapy Any\n        change in the part 1 eligibility criteria during the run-in period.\n\n        Other Exclusion Criteria may applyXx_NEWLINE_xXHave a CAR T cell product likely to meet release criteria based on available in-process testing, as reviewed and acknowledged by the individual(s) listed on the protocol’s delegation of authority log who are authorized to make this determinationXx_NEWLINE_xXMeet the clinical laboratory criteria as specified in the protocolXx_NEWLINE_xXSubject has a diagnosis of high-grade glioma, medulloblastoma, ependymoma or Diffuse intrinsic pontine glioma (DIPG) that is recurrent or progressive. Subjects with neurofibromatosis type 1 (NF-1) associated tumors are eligible if the meet all other eligibility criteria.Xx_NEWLINE_xXHistory of transfusion is acceptable and transfusions may be given to meet eligibility requirementsXx_NEWLINE_xXNote: transfusions are permitted to meet these platelet and hemoglobin criteria if the reason for the cytopenias are judged to be secondary to marrow involvement with tumor per principal investigator (PI) or PI designeeXx_NEWLINE_xXPRE-SCREENING ELIGIBILITYXx_NEWLINE_xXSTUDY TREATMENT ELIGIBILITYXx_NEWLINE_xXSubjects who fail to meet the above criteriaXx_NEWLINE_xXProgressive disease at study entry defined as 1 or more of the following 3 criteria:Xx_NEWLINE_xXPatients with a diagnosis of NF1 and GIST who do not meet other eligibility criteria may enroll on the NF1 natural history study, and will be followed on this study; should they require therapy for GIST based on evidence of progression, they may then enroll on studyXx_NEWLINE_xXCRITERIA FOR SCREENINGXx_NEWLINE_xXCRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATIONXx_NEWLINE_xXCRITERIA FOR SCREENING: Any known contraindication to leukapheresisXx_NEWLINE_xXCRITERIA FOR SCREENING: Any known and irreversible contraindication to huJCAR014 therapyXx_NEWLINE_xXEligibility criteria for additional lines of MTB recommended targeted therapy:\r\n* Patient’s disease has progressed on the first line (or previous line) of MTB recommended targeted therapy or patient could not tolerate the targeted treatment\r\n* Patients must meet eligibility criteria as defined previouslyXx_NEWLINE_xXPRE-ASCT ELIGIBILITY CRITERIAXx_NEWLINE_xXELIGIBILITY CRITERIA TO BEGIN CONSOLIDATION THERAPYXx_NEWLINE_xXFULL STUDY INCLUSION CRITERIA: Hemoglobin (Hb) >= 8 g/dL, without blood transfusion or erythropoietin within 6 weeks before the start of study treatment\r\n* Note: patients receiving chronic low-dose erythropoietin for chronic renal failure are allowed provided no dose adjustment is undertaken within 6 weeks before signing consent for full study and until safety follow-up visit and provided that they fulfill conditions of eligibility criteriaXx_NEWLINE_xXPatients must meet eligibility in at least 1 of the following 6 groups:Xx_NEWLINE_xXCROSS-OVER ELIGIBILITY CRITERIAXx_NEWLINE_xXLYMPHODEPLETION: Subjects must have autologous transduced activated T-cells that meet the certificate of analysis (CofA) acceptance criteriaXx_NEWLINE_xXAcceptable haematological function defined as (Patients can be transfused to meet the haemoglobin entry criteria):Xx_NEWLINE_xXTransfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permittedXx_NEWLINE_xXSubjects must meet all of the following criteria to be included in this study:Xx_NEWLINE_xXSubjects who meet any of the following criteria will be excluded from this study:Xx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXThe participant meets any of the criteria for treatment discontinuation in the parent study.Xx_NEWLINE_xXHistologically documented diagnosis of Ph+ CML, in accelerated or blast phase. One of the following parameters is required to meet criteria for accelerated CML:Xx_NEWLINE_xXPatients who fail corticosteroid taper defined as fulfilling either one of the following criteria:Xx_NEWLINE_xXPersons who do not meet the age and organ function criteria specified aboveXx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITYXx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXParticipant requires, or is likely to require, more than a two-week course of corticosteroids for intercurrent illness; participant must complete the course of corticosteroids 2 weeks before screening to meet eligibilityXx_NEWLINE_xXProgressive disease despite ongoing androgen deprivation or chemotherapy. Progressive disease is defined by 1 or more of the following criteria:Xx_NEWLINE_xXPatients for the expansion cohort must have a CTC (TelomeScan) drawn in the screening phase if other eligibility criteria are met, and must be CTC-positive in order to be eligible for enrollment in the expansion cohortXx_NEWLINE_xXTransfusions are not allowed to meet eligibility criteriaXx_NEWLINE_xXFor Phase 1a LY3300054 monotherapy or combination therapy, previous immunotherapy is acceptable if the following criteria are met:Xx_NEWLINE_xXDONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271Xx_NEWLINE_xXELIGIBILITY FOR OBSERVATION ARMXx_NEWLINE_xXSubject meets the reproductive criteria as follows:Xx_NEWLINE_xXConcurrent palliative radiotherapy for local pain-control may be allowed provided the subject completes the first cycle of treatment, does not meet criteria of progressive disease, and treated lesions will not be included in the target/non-target lesion assessment.Xx_NEWLINE_xXPRE-REGISTION ELIGIBILITYXx_NEWLINE_xXREGISTRATION ELIGIBILITYXx_NEWLINE_xXELIGIBILITY CRITERIA FOR nEGFR TESTINGXx_NEWLINE_xXMeet criteria for neoadjuvant chemotherapy or primary breast surgery, as determined by primary oncologist and surgeonXx_NEWLINE_xXELIGIBILITY CRITERIA FOR STUDY THERAPYXx_NEWLINE_xXPatients must have radiographic evidence of recurrent/progressive GBM after prior therapy (biopsy or resection and chemoradiation); 1st recurrence of GBM only, per Response Assessment in Neuro-Oncology Criteria (RANO) criteria. Histologically documented transformation from a lower grade gliomas will be considered first recurrence.Xx_NEWLINE_xXPatients with clonal evolution and no other criteria for accelerated phase will be eligible for this studyXx_NEWLINE_xXAny number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteriaXx_NEWLINE_xXDocumented evidence of newly diagnosed, symptomatic MM, by IMWG criteria within five years of enrollmentXx_NEWLINE_xXPatients who have progressive disease or relapse (as defined by the IWCLL criteria) at or any time before registration on this studyXx_NEWLINE_xXPatients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and:\r\n* Have no active graft versus host disease (GVHD) and require no immunosuppression\r\n* Are more than 6 months from transplantXx_NEWLINE_xXPHASE I: Patients must meet pre-entry requirements as specifiedXx_NEWLINE_xXPHASE II: Patients must meet pre-entry requirements as specifiedXx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXMust meet one or more of the consensus criteria for initiating treatment MM Participants:Xx_NEWLINE_xXThere is no limit to the number of prior treatment regimens provided that performance status and life expectancy meet the criteria aboveXx_NEWLINE_xXMust meet eligibility criteria for initiation of part A with the exception of being allowed to have prior nivolumab in part A of this protocolXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nAll patients must have evaluable disease; biomarker-only disease is not considered evaluable; eligibility of breast cancer with bone only disease is a principal investigator (PI) decision on an individual patient basisXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= 1,500/mcLXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPlatelets >= 100,000/mcLXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C arm or MEDI+O+C armXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentiallyXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgeryXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiencyXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5 mL fresh blood within 28 days before study enrollment)Xx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollmentXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent dependency on total parenteral nutrition (TPN) or IV fluid hydrationXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPregnant and breastfeeding women are excluded from this studyXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional studyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have measurable disease as defined by RECIST v1.1Xx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): ECOG performance status =< 2Xx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Absolute neutrophil count >= 1,500/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): White blood cell (WBC) >= 3,000/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Platelets >= 100,000/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Hemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosingXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Total bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 X ULNXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Creatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2Xx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients 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 STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): \r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agentsXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Adequately controlled blood pressure (SBP < 140 mmHg and DBP < 90 mmHg) on a maximum of three anti-hypertensive medicationsXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PIXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): \r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluationsXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Ability of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C or MEDI+O+C armXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentiallyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertensionXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgeryXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthmaXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiencyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736Xx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollmentXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)Xx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollmentXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent dependency on TPN or IV fluid hydrationXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPregnant and breastfeeding women are excluded from this studyXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHIV-positive patients on antiretroviral therapy are ineligible; however, patients with long-standing (> 5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/uL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactionsXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHBV- or HCV-positive patients are ineligibleXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nKnown history of previous clinical diagnosis of tuberculosisXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicatedXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permittedXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nConcurrent enrollment in another clinical study, unless it is an observational noninterventional clinical study or the follow-up of an interventional studyXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY)\r\nDocumentation of germline BRCA1 and BRCA2 mutation (gBRCAm) status will be requested for eligibility; a documented deleterious gBRCAm obtained in a CLIA-certified laboratory, including but not limited to Myriad Genetics, either by multi-gene panels or individual testing, will be required prior to study enrollment; variants of uncertain significance (VUS) of BRCA1 and BRCA2 are not considered deleterious mutation; patients with VUS or deleterious mutation in other genes without gBRCAm or patients with negative BRCA testing are still eligibleXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY)\r\nPatients must have measurable disease as defined by RECIST v1.1Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsyXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcLXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosingXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 × ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 × ULNXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agentsXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluationsXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have received prior PARP inhibitors (PARPi) are ineligible; for this study, BSI-201 (iniparib) is not considered as PARPiXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapyXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgeryXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiencyXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCurrent dependency on TPN or IV fluid hydrationXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPregnant and breastfeeding women are excluded from this studyXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV or HCV-positive patients are ineligibleXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nKnown history of previous clinical diagnosis of tuberculosisXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicatedXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow up of an interventional studyXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nSpecific criteria for the NSCLC cohort:\r\nHistologically or cytologically confirmed advanced NSCLC with at least one prior line of platinum-based chemotherapy (or treatment with epidermal growth factor receptor [EGFR] or anaplastic lymphoma kinase [ALK] tyrosine kinase inhibitors if tumors harbor an EGFR-sensitizing mutation or ALK translocation respectively)Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nFor MEDI+C NSCLC arm only, adequately controlled blood pressure (SBP < 140 mm Hg and DBP < 90 mmHg) on a maximum of three antihypertensive medicationsXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C arm (NSCLC patients only)Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPresence of measurable disease as defined by RECIST v1.1Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsyXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nECOG performance status =< 2Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= 1,500/mcLXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nWhite blood cell (WBC) >= 3,000/mcLXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPlatelets >= 100,000/mcLXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosingXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional ULN; for subjects with liver metastases, AST or ALT =< 5 × ULNXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert`s disease, bilirubin =< 3 X ULNXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nFor NSCLC cohort MEDI+C arm only:\r\nSpot urine protein/creatinine ratio =< 1 OR 24 hour urine protein =< 1000 mgXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with cediranib, either in combination or monotherapy are not eligibleXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agentsXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PIXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluationsXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients who have had prior PARP inhibitors; for this study, BSI-201 (iniparib) is not considered as PARPiXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertensionXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgeryXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthmaXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiencyXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients with prior history of pneumonitis and/or interstitial lung disease will be excludedXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollmentXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5mL fresh blood within 28 days before study enrollment)Xx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollmentXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCurrent dependency on total parenteral nutrition (TPN) or IV fluid hydrationXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPregnant and breastfeeding women are excluded from this studyXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHIV-positive patients on anti-retroviral therapy are ineligible; however, patients with long-standing (> 5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/uL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactionsXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHBV- or HCV-positive patients are ineligibleXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nKnown history of previous clinical diagnosis of tuberculosisXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicatedXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permittedXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAll patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsyXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have undergone bilateral surgical castration or must agree to continue on gonadotropin releasing hormone (GnRH) agonists/antagonists for the duration of the studyXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2Xx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcLXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcLXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcLXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosingXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented or suspected Gilbert’s disease, bilirubin =< 3 X ULNXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2Xx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatient must be capable of understanding and complying with protocol requirements and is willing to give informed consentXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior treatment with olaparib or other PARP inhibitorsXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapyXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received any other type of investigational agent within 28 days before the first dose of study treatmentXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received radionuclide treatment within 6 weeks prior to the first dose of the study treatmentXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient is unable to swallow tablets or capsulesXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiencyXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736Xx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV-or HCV-positive patients are ineligibleXx_NEWLINE_xXELIGIBILITY CRITERIA- ENROLLMENT AND HARVESTXx_NEWLINE_xXELIGIBILITY CRITERIA- HARVESTXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Autologous transduced peripheral blood T-cells with >= 15% expression of 14g2a.zetaXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: ECOG performance score of 2 or lessXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Platelet > 20,000 mcLXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Total bilirubin < 3 x IULNXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum creatinine < 2 x IULNXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Pulse oximetry of > 95% on room airXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Patients who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to enrollment on this studyXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not be currently receiving any investigational drugsXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a history of hypersensitivity to murine protein-containing productsXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: No cardiomegaly or bilateral pulmonary infiltrates on chest radiograph; patients may have pulmonary metastatic lesionsXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a tumor potentially causing airway obstructionXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not be currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporineXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have received a tumor vaccine within previous six weeksXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a known hypersensitivity to rat monoclonal antibodiesXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: No previous severe allergic reaction to hepatitis B vaccine, polio vaccine or tetanus, diphtheria, pertussis vaccine (DTP, Tdap, DT or Td)Xx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a life-threatening allergy to baker’s yeast or other components of the vaccines; no history of allergic reactions to the antibiotics neomycin, streptomycin or polymyxin BXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have had a coma or long or multiple seizures within 7 days after a dose of DTP or Tdap unless a cause other than the vaccine was indicatedXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have evidence of previous or current infection with hepatitis B virusXx_NEWLINE_xXAny number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteriaXx_NEWLINE_xXLysate must meet release criteriaXx_NEWLINE_xXSubject for whom tumor lysate does not meet release criteriaXx_NEWLINE_xXSubject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness; subject must complete the course of corticosteroids 2 weeks before screening to meet eligibilityXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: ECOG performance 0-1Xx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: Radiographic evidence of pancreatic cancer recurrenceXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: Patient is on supplemental home oxygenXx_NEWLINE_xXDONOR ELIGIBILITY CRITERIA:Xx_NEWLINE_xXHave measurable disease based on immune related response criteria (irRC) criteriaXx_NEWLINE_xXPatients are required to meet the following criteria to proceed to AHSCT:Xx_NEWLINE_xXPATIENT CRITERIA FOR PROCEEDING WITH CD8+ MEMORY T-CELL INFUSION:Xx_NEWLINE_xXPatient Inclusion Criteria\n\n        Patients must meet all of the following inclusion criteria to be eligible for enrollment\n        into the study:\n\n          -  Histologically or cytologically confirmed metastatic or unresectable solid tumor.\n\n          -  Has failed treatment with all standard therapies for their malignancy.\n\n          -  Adequate Karnofsky Performance Status.\n\n          -  An expected survival of at least 3 months.\n\n          -  Adequate organ and bone marrow function.\n\n          -  Signed informed consent form for study participation prior to screening.\n\n        Patient Exclusion Criteria\n\n        Patients presenting with any of the following will be excluded in the study:\n\n          -  Clinically significant disease as defined by the protocol.\n\n          -  Surgical therapy or other therapies within period as defined by the protocol.\n\n          -  Any condition that will interfere with compliance with the protocol as determined by\n             investigator.Xx_NEWLINE_xXPatients whose tumors are deemed unresectable by clinical/imaging criteriaXx_NEWLINE_xXCOHORT A SPECIFIC ELIGIBILITY CRITERIA:Xx_NEWLINE_xXCOHORT B SPECIFIC ELIGIBILITY CRITERIA:Xx_NEWLINE_xXConfirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia [CML], polycythemia vera [PV], myelodysplastic syndrome [MDS], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase [LDH], anemia, palpable splenomegaly)Xx_NEWLINE_xXThere is a high likelihood that the patient, in the opinion of the principal investigator (PI) or lead associate investigator (LAI), will meet the research phase eligibility criteria and proceed to transplant after induction phase therapy is completedXx_NEWLINE_xXHas measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, or lymphoma that fulfills the Deauville PET CriteriaXx_NEWLINE_xXPatients are required to meet criteria for initiation of therapy for their B-NHL according to published guidelines by the National Comprehensive Cancer Network (NCCN)Xx_NEWLINE_xXPatient has not met criteria for withdrawal from the base protocolXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Research participant without clinically significant encephalopathy/new focal neurologic deficitsXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Research participant is not receiving systemically administered steroid therapy; glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowedXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air and no dyspnea at restXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Absolute lymphocyte count < 500/ul or patient has received lymphodepleting chemotherapy administered at least 24 hours prior to T cell infusionXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Normal serum sodium levels without need for supplementationXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: ALT (SGPT): =< 5 x ULNXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Patients must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of scheduled T cell infusion\r\n* A fever above 38.2 C AND clinical signs of infection within 48 hours of T cell infusionXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: If a patient has received anthracycline chemotherapy after enrollment, they must have demonstrated adequate cardiac function at any time following latest administration of an anthracycline chemotherapy (does NOT need to be within 48 hours of T cell infusion) defined as shortening fraction > 28% by echocardiogram or an ejection fraction > 50% by MUGAXx_NEWLINE_xXPART 2: Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent; patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met; these patients will have Part 1 endpoints transcribed from medical recordsXx_NEWLINE_xXAt the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria:Xx_NEWLINE_xXRecurrent or refractory disease according to NCI criteriaXx_NEWLINE_xXMeet criteria for a current major depressive episode or suicidalityXx_NEWLINE_xXELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENTXx_NEWLINE_xXELIGIBILITY FOR ENROLLMENT AND TO PROCEED WITH CAR T CELL INFUSIONXx_NEWLINE_xXPROTOCOL-SPECIFIC CRITERIA:Xx_NEWLINE_xXELIGIBILITY TO UNDERGO LYMPHODEPLETION:Xx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Research participant has completed prescribed lymphodepletionXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room airXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Not requiring pressor support, not having symptomatic cardiac arrhythmiasXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal rangeXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Total bilirubin =< 2.0 mg/dLXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Research participant without clinically significant encephalopathy/new focal deficitsXx_NEWLINE_xX(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): No clinical evidence of uncontrolled active infectious processXx_NEWLINE_xXPROTOCOL-SPECIFIC CRITERIA:Xx_NEWLINE_xXELIGIBILITY TO PROCEED WITH PBMC COLLECTIONXx_NEWLINE_xXELIGIBILITY TO UNDERGO LYMPHODEPLETION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresisXx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresisXx_NEWLINE_xXELIGIBILITY CRITERIA TO UNDERGO OPTIONAL T CELL ABLATION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresisXx_NEWLINE_xXPatients must meet the following clinical criteria to receive CMVpp65-CTL infusionsXx_NEWLINE_xXThe subject has a histologic or cytologic diagnosis of a DTC tumor (including poorly differentiated thyroid cancer but not anaplastic thyroid cancer) that is metastatic or unresectable and fulfills the following criteria:\r\n* Subjects must have progressive disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria when comparing baseline scans to those obtained within the prior 14 months AND\r\n* Subject must have radioiodine (RAI)-refractory disease based on at least one of the following:\r\n** Prior dose of RAI exceeding 600mCi\r\n** Progression of disease within 18 months following a dose of >= 100mCi\r\n** Presence of target lesions as defined by modified RECIST criteria which do not take up RAIXx_NEWLINE_xXAny pancreatic adenocarcinoma that does not meet criteria for borderline resectable diseaseXx_NEWLINE_xXUnilateral or bilateral disease meeting study criteriaXx_NEWLINE_xXAll subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the studyXx_NEWLINE_xXDONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)Xx_NEWLINE_xXIf total bilirubin is =< 2, fractionation is not required for eligibility determinationXx_NEWLINE_xXPatients must meet IWCLL 2008 Guideline [13] criteria for active disease requiring treatment. Each patient with NHL must meet all of the following inclusion criteria to be enrolled on the study:Xx_NEWLINE_xXPatients must have relapsed or refractory disease after at least one prior therapy and not have traditional options available or decline these. All patients must meet all of the following inclusion criteria to be enrolled on the study:Xx_NEWLINE_xXInclusion Criteria:\n\n        All subjects must meet the following criteria for admission into the study:\n\n          1. Signed informed consent has been obtained.\n\n          2. Subject is at least 21 years of age.\n\n          3. Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS) will be based on a\n             combination of histological, clinical, and immunophenotypical criteria. The\n             histological criteria will be based on skin biopsy from the most representative skin\n             area. The diagnostic criteria used for each subject will be specified in the case\n             report forms and the specific classification of MF or SS will be identified. The TNMB\n             system will be used to classify the stage of disease (See Section 8.4 for details).\n\n          4. Completion of the mSWAT assessment.\n\n          5. A history of pruritus that meets following criteria:\n\n             At Screening Day -7:\n\n               -  present on a daily basis for greater than one month prior to Screening Day -7,\n\n               -  NRS for Pruritus score ?5 as rated by the subject at the Day -7 Visit. Note: If\n                  the score is <5 and subject is taking or has taken a medication which may be\n                  affecting pruritus (e.g. systemic antihistamine or topical steroid), and if\n                  Investigator and subject agree, subject may washout or continue washout of\n                  medication and return for Day -7 Visit procedures after washout.\n\n             At Baseline Period 1 Day 0:\n\n               -  NRS for Pruritus score of at least 5 recorded in the subject diary on at least 4\n                  of the 7 days preceding Baseline Period 1 Day 0.\n\n          6. Pruritic treatment area of 5-95% of the subject's total treatable body surface area.\n\n          7. Subject can be expected to reliably follow treatment instructions and visit schedule.\n\n          8. Non-pregnant, non-lactating females of childbearing potential who agree to use\n             medically acceptable forms of birth control (abstinence, hormonal contraceptives,\n             diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout\n             the study or females of non-childbearing potential (surgically sterile [hysterectomy\n             or bilateral tubal ligation] or post-menopausal ? 1 year). A negative urine pregnancy\n             test must be confirmed at Baseline screening for all female subjects who are not\n             post-menopausal > 1 year or surgically sterile.\n\n          9. The subject agrees not to begin any new concomitant medications during their\n             participation in the study, with the exception of medications necessary to treat\n             infection, and to continue any concomitant medication throughout the study.\n\n         10. Subject has no visual or motor impairments that will make it difficult to complete the\n             Daily Diary or apply the study medication.\n\n         11. Subject is able to speak, read, and write English and agrees to participate and comply\n             with the study procedures.\n\n         12. Subject has a body mass index (BMI) between 18.5 and 30.5 kglm2 (see Appendix C, Body\n             Mass Index Table) (subjects in PK subset only).\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the following criteria will be excluded from study participation:\n\n          1. Pregnant or lactating female.\n\n          2. History of clinically significant heart failure.\n\n          3. Myocardial infarction within the past six months.\n\n          4. A history of ventricular arrhythmia requiring treatment.\n\n          5. Any medical condition which would, in the Investigator's opinion, preclude the subject\n             from successfully participating in the study.\n\n          6. A known allergy to naloxone hydrochloride or any excipient in the formulation.\n\n          7. Previous naloxone use for pruritus.\n\n          8. Positive urine drug screen at Day 0 for opiates. Positive urine drug screen for\n             anything other than opiates not explained, e.g., by concomitant medication, would also\n             exclude the subject.\n\n          9. Treatment with any of the following during the restricted time period prior to Day -7,\n             and at any time during the study, is not allowed:\n\n        Medication/Treatment Restriction:\n\n        Systemic narcotic analgesics (e.g. morphine, codeine) 7 days, Topical antihistamines to any\n        skin surface [e.g. Zonalon® (doxepin)] 7 days, Other investigational drugs (excluding any\n        therapies for the treatment of MF or SS) 30 daysXx_NEWLINE_xXGroup C: Cohort C1A: Subjects age ? 18 years with relapsed/refractory AML by WHO criteria; Cohort C2: Subjects age ? 18 years with relapsed/refractory AML with MLL; Cohort C3: Subjects with previously untreated AML by WHO criteria and who would have met disease eligibility criteria for Group A or B but refuse or are unable to receive chemotherapy and hypomethylating agent as determined by the treating physicianXx_NEWLINE_xXEligibility criteria cannot be waivedXx_NEWLINE_xXELIGIBILITY CRITERIA FOR PRE-REGISTRATIONXx_NEWLINE_xXELIGIBILITY CRITERIA FOR REGISTRATION: Leukocytes >= 3,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR REGISTRATION: platelets >= 100,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)Xx_NEWLINE_xXNote: patients enrolled after chemotherapy do not have to meet the above criteriaXx_NEWLINE_xXHAPLOIDENTICAL RELATED DONOR: Haploidentical donors that will undergo marrow harvest with general anesthesia; subjects will undergo anesthesia consultation, and meet criteria for eligibility/enrollment; cluster of differentiation 34 positive (CD34+) fraction will be determinedXx_NEWLINE_xXDONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelinesXx_NEWLINE_xXINCLUSION FOR INTRAMURAL INJECTION: \r\n* Subject must have lesion(s) amenable to HSV1716 administration by needle if superficial; by needle and/or catheter if deep or pulmonary, via interventional radiology without undue risk\r\n* Lesion(s) must meet size criteria\r\n* In the first two dose levels, subjects must have localized disease that meets size criteria; localized is defined as a single lesion; however, more than one lesion may be acceptable if they are contiguous\r\n* In the third dose level, subjects must have one to three lesions meeting size criteria\r\n* The arm (route of administration) will be chosen by the investigator and patient/parent based on multiple considerations and subject to approval by the principal investigatorXx_NEWLINE_xXPART II: All eligibility requirements and exclusion criteria as described in PART 1 must be fulfilled within 14 days of receiving subsequent doses; testing completed from Part 1 may be accepted as long as completed within this time frame (+/- 1 day)Xx_NEWLINE_xXPROCUREMENT ELIGIBILITY:Xx_NEWLINE_xXPROCUREMENT ELIGIBILITY:Xx_NEWLINE_xXTREATMENT ELIGIBILITY:Xx_NEWLINE_xXTREATMENT ELIGIBILITY:Xx_NEWLINE_xXPatients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are metXx_NEWLINE_xXGRAFT CRITERIA:Xx_NEWLINE_xXPatients older than 21 will be considered for eligibility at the discretion of the principal investigator (PI)Xx_NEWLINE_xXMedium-risk disease, defined by 1 of the following criteria:Xx_NEWLINE_xXHigh-risk disease, defined by MLL rearrangement AND meets the following criteria:Xx_NEWLINE_xXAny patient not meeting the eligibility criteriaXx_NEWLINE_xXSubject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. In case of multiple laboratory data within this period, the most recent data should be used to determine eligibility.Xx_NEWLINE_xXPositive 68Ga-PSMA-R2 PET/CT scan for central eligibility assessment. Patients who receive 68Ga-PSMA-R2 as part of separate clinical protocol are eligible (must meet all study eligibility criteria)Xx_NEWLINE_xXMust meet the following laboratory criteria:Xx_NEWLINE_xXCriteria 1 Waldenström macroglobulinemiaXx_NEWLINE_xXCriteria 6 Known moderate or severe persistent asthma within the past 2 yearsXx_NEWLINE_xXBlood counts performed within 4 weeks prior to study entry must meet the following criteria:Xx_NEWLINE_xXFulfilment of diagnostic criteria for AL amyloidosisXx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXPatient must meet required laboratory values at the screeningXx_NEWLINE_xXSubjects must meet the following laboratory parameters:Xx_NEWLINE_xXPatient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:Xx_NEWLINE_xXSymptomatic altered hearing > grade 2 by NCI-CTCv4 criteriaXx_NEWLINE_xXMust meet the following laboratory parameters:Xx_NEWLINE_xXMust meet following requirements:Xx_NEWLINE_xXpatients with CRPC must meet PCWG3 criteria for disease progression at trial entryXx_NEWLINE_xXSubjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was >100 days prior to study enrolment; no active infection(s); subjects meets the remainder of the eligibility criteria outlined in this protocol.Xx_NEWLINE_xXFemale patients are eligible for the study if they meet the following criteria:Xx_NEWLINE_xXSubjects with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Subject meets the remainder of the eligibility criteria.Xx_NEWLINE_xXSubjects after prior allogeneic SCT are allowed if the allogeneic transplant was performed >=2 years prior to study treatment, and if subject has no active Graft-versus- host disease (GVHD) requiring treatment, and meet the remaining eligibility criteria.Xx_NEWLINE_xX-  Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.Xx_NEWLINE_xXWillingness to avoid pregnancy or fathering children as per protocol-defined criteria.Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects who meet the following criteria will be eligible to participate in the Long-Term\n        Follow-Up study:\n\n          1. All adult and pediatric subjects who received at least one GM T cells infusion in a\n             previous Celgene sponsored or Celgene alliance partner sponsored study, and have\n             discontinued, or completed the post-treatment follow-up period in the parent treatment\n             protocol, as applicable.\n\n          2. Subject (and, parental/legal representative, when applicable) must understand and\n             voluntarily sign an Informed Consent Form/Informed Assent Form prior to any\n             study-related assessments/procedures being conducted.\n\n          3. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n        Exclusion Criteria:Xx_NEWLINE_xXHigh risk AML (see NCCN risk criteria)Xx_NEWLINE_xXLow risk AML (see NCCN risk criteria)Xx_NEWLINE_xXA diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097)\r\n* Major criteria are: \r\n** BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type\r\n** Keratocyst of the jaw prior to age 20\r\n** Palmar or plantar pitting\r\n** Lamellar calcification of the falx cerebri\r\n** Medulloblastoma\r\n** First degree relative with BCNS\r\n* Minor criteria are: \r\n** Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals\r\n** Macrocephaly\r\n** Cleft/lip or palate\r\n** Fibroma of the heart or ovary\r\n** Ocular abnormalities\r\n** Other rare abnormalities listed in the article by Bree et al\r\n* For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a patched 1 (PTCH1) gene mutationXx_NEWLINE_xXPatients with an active or uncontrolled infection; patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteriaXx_NEWLINE_xXNote: Hematology and other lab parameters that are ? grade 2 BUT still meet criteria for study entry are allowed; furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapyXx_NEWLINE_xXDonors regardless of match and selection criteria must:\r\n* Not be affected by the same disease making the patient eligible for alloHCT; disease carriers may be permitted depending on the clinical situation\r\n* Meet donor criteria as outlined in University of Minnesota protocol MT2012-14C: Procedure Guidelines for Related Hematopoietic Stem Cell DonorsXx_NEWLINE_xXSubjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.Xx_NEWLINE_xXInclusion Criteria:\n\n        Patients eligible for inclusion in this study have to meet all of the following criteria:\n\n          -  Patient must have had at least one prior line of therapy for their disease and must\n             not be beyond 4th progression/relapse of disease (5 maximum prior lines).\n\n          -  Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the\n             section \condition\. Patients must have measurable disease as per appropriate\n             guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised\n             Response Criteria for Malignant Lymphoma - Cheson et al 2007).\n\n          -  Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be\n             a candidate for tumor biopsy according to the treating institution's guidelines.\n             Exceptions may be considered after discussion with the sponsor.\n\n        Exclusion Criteria:\n\n        Patients eligible for this study must not meet any of the following criteria:\n\n          -  History of severe hypersensitivity reactions to other mAbs.\n\n          -  Impaired cardiac function or clinically significant cardiac disease.\n\n          -  Active, known or suspected autoimmune disease or a documented history of autoimmune\n             disease within three years prior to screening with a few exceptions as per protocol.\n\n          -  Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated\n             for skin rash or with replacement therapy for endocrinopathies should not be excluded.\n\n          -  Patient with second primary malignancy within < 3 years of first dose of study\n             treatment.\n\n          -  Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.\n\n        Other protocol-defined inclusion/exclusion criteria may apply.Xx_NEWLINE_xXCardiopulmonary function criteria:Xx_NEWLINE_xXMeets criteria for 1 of the 4 defined study cohortsXx_NEWLINE_xXADDITIONAL INDUCTION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXCONSOLIDATION CRITERIA:Xx_NEWLINE_xXMAINTENANCE CRITERIA:Xx_NEWLINE_xXPHASE 1 SPECIFIC ELIGIBILITY CRITERIAXx_NEWLINE_xXPHASE 2 SPECIFIC ELIGIBILITY CRITERIAXx_NEWLINE_xXGENERAL ELIGIBILITY CRITERIAXx_NEWLINE_xXPatients with liver metastases who do not meet the eligibility parameters may only be enrolled at the discretion of the principal investigator (PI)Xx_NEWLINE_xXSTUDY ELIGIBILITY CRITERIA FOR OVERALL STUDY PARTICIPATION (INITIAL REGISTRATION FOR COHORT 1; ONLY REGISTRATION FOR COHORTS 1A & 1B):Xx_NEWLINE_xXELIGIBILITY CRITERIA TO INITIATE TREATMENT (FOR SECONDARY REGISTRATION - COHORT 1 PARTICIPANTS ONLY):Xx_NEWLINE_xXMeet laboratory parameter requirements at study entryXx_NEWLINE_xXActive disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment:Xx_NEWLINE_xXDONOR: Failure to meet institutional criteria for donation as described in the Standard Practice GuidelinesXx_NEWLINE_xXELIGIBILITY CRITERIA: TREATMENT PROTOCOLXx_NEWLINE_xXELIGIBILITY CRITERIA PRIOR TO FIRST VACCINATIONXx_NEWLINE_xXPatients with prior progressive disease who do not meet criteria above, are eligible as long as they have not been off treatment for > 3 months prior to enrollment on NANT 2011-04Xx_NEWLINE_xXSubjects must meet certain laboratory criteriaXx_NEWLINE_xXAny of the dosimetric treatment criteria as defined have not been met; patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as defined in this protocol and will come off the study; any subsequent adjuvant radiation will be delivered at the discretion of the treating physicianXx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXCandidates for liver transplantation (listed or screened) according to one of the following criteria:\r\n* Milan criteria (one lesion < 5 cm or 3 or fewer lesions each < 3 cm)\r\n* University of California San Francisco (UCSF) Downstaging criteria (one lesion less than 8 cm or 2-3 lesions each less than 5 cm with sum of maximum dimensions less than 8 cm, or 4-5 lesions each less than 3 cm with sum of maximum dimensions less than 8 cm)\r\n* UCSF All-Comers criteria (UNOS stage T3 disease beyond UCSF Downstaging criteria)Xx_NEWLINE_xXSECONDARY ELIGIBILITY CRITERIA FOR GENE-MODIFIED HSPC INFUSIONXx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR HSPC TRANSPLANTATIONXx_NEWLINE_xXPHASE II: For participation in the imaging research studies, patients must meet the additional following criteria:Xx_NEWLINE_xXELIGIBILITY TO RECEIVE T CELL INFUSION:Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR SECOND CELL INFUSION:Xx_NEWLINE_xXSubjects must meet all the initial eligibility criteria except for the requirement regarding previous anti-GD2-CAR therapyXx_NEWLINE_xXPatients must meet pre-entry requirements as specifiedXx_NEWLINE_xXPatients with significant hepatic dysfunction (not meeting liver function tests [LFT] eligibility criteria)Xx_NEWLINE_xXPatients must meet the pre-entry requirements specifiedXx_NEWLINE_xXPlease contact study investigator and/or consult protocol document for specific details on laboratory criteriaXx_NEWLINE_xX-\n\n        All patients must meet the following inclusion criteria:\n\n          1. Metastatic or unresectable locally advanced NSCLC\n\n          2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion\n\n          3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\n          5. Minimum age of 18 years\n\n          6. Adequate hematological and biological function\n\n          7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any\n             study-specific evaluation\n\n        Phase 2 Cohorts must also meet the following inclusion criteria:Xx_NEWLINE_xXOTHER ELIGIBILITY CRITERIA (APPLIES TO BOTH COHORT A AND COHORT B UNLESS SPECIFIED)Xx_NEWLINE_xXPatients should not meet criteria for post PV or post ET-myelofibrosis (MF)Xx_NEWLINE_xXPatients should not meet criteria for post PV or post ET-myelofibrosis (MF)Xx_NEWLINE_xXDONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)Xx_NEWLINE_xXSubject must meet the following criteria as indicated on the clinical laboratory tests:Xx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteriaXx_NEWLINE_xXDisease Related Criteria:Xx_NEWLINE_xXPrior Therapy Criteria:Xx_NEWLINE_xXClinical/Laboratory Criteria:Xx_NEWLINE_xXSpecimen Submission Criteria:Xx_NEWLINE_xXRegulatory Criteria:Xx_NEWLINE_xXNSCLC patients must meet criteria for MET and/or Axl expression or,Xx_NEWLINE_xXHNSCC patients must meet criteria for MET and/or Axl expression or,Xx_NEWLINE_xXDiagnosis of PMF according to the revised WHO criteria; or PET-MF or PPV-MF according to the IWG-MRT criteriaXx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXGraft-versus-host disease criteria:Xx_NEWLINE_xXHave had chemotherapy or investigational therapy, with the exception of hydroxyurea, within 4 weeks of study entry; previous treatment at any time with either ruxolitinib or decitabine as single agents will not exclude eligibility; previous stem cell transplant will also not exclude eligibility as long as other inclusion/exclusion criteria have been metXx_NEWLINE_xXPatients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.Xx_NEWLINE_xXPatients must meet pre-entry requirementsXx_NEWLINE_xXPatients with standard-risk acute GVHD, according to refined Minnesota Criteria. Refined Minnesota Criteria are available at https://redcap.ahc.umn.edu/surveys/?s=bNmFhseJIf. Standard-risk acute GVHD according to the refined Minnesota Risk Criteria requires meeting one of the criteria below:Xx_NEWLINE_xXSTEP 2 REGISTRATION (RANDOMIZATION CRITERIA):Xx_NEWLINE_xXOnce all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received.Xx_NEWLINE_xXActive disease meeting ? 1 of the following IWCLL 2008 criteria for requiring treatmentXx_NEWLINE_xXMeet the following laboratory parameters:Xx_NEWLINE_xXActive disease meeting ? 1 of the following IWCLL 2008 criteria for requiring treatment.Xx_NEWLINE_xXMeet the following laboratory parameters:Xx_NEWLINE_xXOn an effective combination cART regimen, generally a 3-drug regimen based on Department of Health and Human Services (DHHS) treatment guidelines\r\n* Patients must be on cART >= 4 weeks; and\r\n* Evidence of viral suppression defined as HIV viral load < 200 copies/mL; and \r\n* No symptomatic AEs > grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) criteria probably or definitely attributed to cART; and\r\n* No laboratory AEs noted on protocol defined screening laboratories > grade 1 by CTCAE criteria probably or definitely attributed to cART, with exceptions noted below\r\n* Note: if cART is modified during the screening period, patients must be on an effective new regimen for >= 2 weeks and otherwise meet eligibility criteria\r\n* Most patients have viral loads that are suppressible to < 50 copies/mL, but about 25% of patients will occasionally have blips up to 400–500 copies/mL, which do not appear to correlate with lack of viral suppression in most studies; thus, an HIV viral load of =< 400 copies/mL for an occasional “blip” will be allowed, if there is documentation of an HIV viral load < 200 on the same regimen and no significant treatment interruptionXx_NEWLINE_xXInclusion Criteria:\n\n        For Part 1:Patients must have one of the following diagnoses:\n\n          -  Aggressive systemic mastocytosis (ASM) as confirmed by World Heath Organization (WHO)\n             diagnostic criteria.\n\n          -  Systemic mastocytosis-associated hematologic non-mast cell disease (SM-AHNMD) as\n             confirmed by WHO diagnostic criteria, and the patient also has at least 1 C-finding\n             attributable to systemic mastocytosis (SM). The AHNMD must be myeloid, with the\n             following exceptions that are excluded: Acute myeloid leukemia (AML), Myelodysplastic\n             syndrome (MDS) that is very high- or high-risk as defined by the International\n             prognostic scoring system for myelodysplastic syndromes (IPSS-R) and Philadelphia\n             chromosome positive malignancies.\n\n          -  Mast cell leukemia (MCL) as confirmed per WHO diagnostic criteria.\n\n          -  Histologically- or cytologically- confirmed myeloid malignancy as confirmed by IWG-MRT\n             or WHO diagnostic criteria that is relapsed or refractory to standard treatments. AML,\n             MDS that is very high- or high-risk as defined by the IPSS-R, and Philadelphia\n             chromosome positive malignancies are excluded.\n\n          -  Upon discussion with the sponsor, other relapsed or refractory, potentially\n             avapritinib-responsive hematologic neoplasms (e.g., evidence of aberrant KIT or\n             platelet derived growth factor receptor (PDGFR) signaling) may be considered for\n             enrollment.\n\n        For Part 2:\n\n          -  Group 1: ASM as confirmed by WHO diagnostic criteria.\n\n          -  Group 2: SM-AHNMD as confirmed by WHO diagnostic criteria, that also has at least 1\n             C-finding attributable to SM. The AHNMD must be myeloid, with the following exceptions\n             that are excluded: AML, MDS that is very high- or high-risk as defined by the IPSS-R,\n             and Philadelphia chromosome positive malignancies.\n\n          -  Group 3: MCL as confirmed per WHO diagnostic criteria.\n\n        Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n\n        Exclusion Criteria:\n\n          -  QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds\n\n          -  Platelet count <25,000/mL\n\n          -  Absolute neutrophil count <500/mL\n\n          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x the upper\n             limit of normal (ULN); >5 × ULN if associated with clinically suspected liver\n             infiltration by mastocytosis or another disease for which the patient enrolled into\n             the study\n\n          -  Total bilirubin >1.5 × ULN; >3 × ULN if associated with liver infiltration by the\n             disease being treated or in the presence of Gilbert's Disease\n\n          -  Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min\n\n          -  Brain malignancy or metastases to the brain\n\n          -  History of a seizure disorder or requirement for anti-seizure medication\n\n          -  Known risk of intracranial bleeding, such as a brain aneurysm or history of subdural\n             or subarachnoid bleedingXx_NEWLINE_xXIn the Phase 2 portion of the protocol only, subjects must have measurable disease according to response criteria appropriate for their type of cancer (as explained in Section 9.1).Xx_NEWLINE_xXPatients with multifocal or multicentric disease are eligible as long as at least one area meets eligibility criteriaXx_NEWLINE_xXThe patient must meet one of the following (a) or (b) or (c):Xx_NEWLINE_xXThe patient must meet one of the following (a) or (b) or (c):Xx_NEWLINE_xXPROSPECTIVE SCREENING ELIGIBILITY CRITERIA:Xx_NEWLINE_xXNote: supportive care (e.g. transfusion of red blood cells) is allowed to meet eligibility criteriaXx_NEWLINE_xXMeet baseline laboratory data criteriaXx_NEWLINE_xXDiagnosis of AML according to WHO criteria 2016.Xx_NEWLINE_xXPrior therapy criteria must be metXx_NEWLINE_xXPRE-REGISTRATION (PRE-SURGERY) ELIGIBILITY CRITERIAXx_NEWLINE_xXREGISTRATION (POST-SURGERY) ELIGIBILITY CRITERIAXx_NEWLINE_xXPre-registration eligibility criteria continue to be metXx_NEWLINE_xXInclusion Criteria:\n\n        Patients must meet all of the following inclusion criteria in order to be entered into the\n        study:\n\n          1. Age 18 or older\n\n          2. Patient has signed informed consent\n\n          3. Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of\n             the following:\n\n        i. Histological confirmation ii. Magnetic resonance imaging (MRI) result with early\n        enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm.\n        Patient must also have evidence of cirrhosis or have chronic hepatitis B.\n\n        iii. Contrast enhanced computed tomography (CT) with early enhancement and delayed\n        enhancement washout of at least one solid liver lesion > 1cm. Patient must also have\n        evidence of cirrhosis or have chronic hepatitis B.\n\n        d. Patient must not be suitable for treatment by resection or percutaneous ablation at time\n        of study entry.\n\n        Patients not suitable for ablation due to lesion location may be enrolled\n\n        e. Patient MUST meet at least ONE of the following criteria:\n\n        i. Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1\n\n        f. Patient has a life expectancy of at least 6 months\n\n        g. Absence of occlusive thrombus to the main portal trunk\n\n        Exclusion Criteria:\n\n        If patients meet any of the following criteria they may not be entered into the study:\n\n          1. Current or previous treatment with chemo- or radiation therapy or sorafenib\n\n          2. Previous treatment with any form of transarterial embolization for HCC\n\n          3. Patients with current or history of any other cancer except non-melanomatous skin\n             cancer\n\n          4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an\n             effective method of contraceptive\n\n          5. Performance status ECOG > 2\n\n          6. Child-Pugh scores >7\n\n          7. Active gastrointestinal bleeding\n\n          8. Evidence of uncorrectable bleeding diathesis\n\n          9. Extra-hepatic spread of the HCC\n\n         10. Total Bilirubin > 3 mg/dL\n\n         11. >50% tumor involvement of the liver\n\n         12. Infiltrative or diffuse HCC\n\n         13. Encephalopathy not adequately controlled medically\n\n         14. Presence of ascites not controlled medically\n\n         15. Presence of medically relevant localized or systemic infection, other than hepatitis\n             B, C, D, E or G\n\n         16. Any contraindication for MRI (eg. metallic implants)\n\n         17. Allergy to contrast media that cannot be managed with prophylaxis\n\n         18. Allergy to iodized oil\n\n         19. Any contraindication to arteriography\n\n         20. Any contraindication for doxorubicin administration, including the following:\n\n        i. White Blood Cell count (WBC) <3000 cells/mm?\n\n        ii. Absolute Neutrophil <1500 cells/mm?\n\n        iii. Cardiac ejection fraction <50%\n\n        iv. Other condition deemed exclusionary by physician\n\n        u. Any contraindication for hepatic embolization, including the following:\n\n        i. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior\n        to chemoembolization\n\n        ii. Hepatofugal blood flow\n\n        iii. Serum creatinine > 2mg/dL\n\n        iv. Uncorrectable impaired clotting\n\n          1. Platelet <50,000/mm?\n\n          2. International Normalized Ratio (INR) > 1.4\n\n          3. Activated Prothrombin Time (aPTT) less than 21 or greater than 40\n\n             v. AST > 5X upper limit of normal for lab\n\n             vi. ALT > 5X upper limit of normal for labXx_NEWLINE_xXPatients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)Xx_NEWLINE_xXMM diagnostic criteria (all 3 required);Xx_NEWLINE_xXSerum LDH > 2 x ULN (Upper limit of normal); 9. For Cohort B subject must be ? 65 years of age at the time of signing the informed consent form (ICF) and transplant non-eligible (TNE); excluding the subjects who meet the Cohort A criteria 10. For Cohort C subject must be after first autologous stem cell transplantation (ASCT) for NDMM and meet the following criteria:Xx_NEWLINE_xXAML (including secondary AML) diagnosed as per WHO criteriaXx_NEWLINE_xXPart 1 Dose Escalation subjects must meet 1 of the following criteria:Xx_NEWLINE_xXPart 2 Dose Expansion subjects must meet 1 of the following criteria:Xx_NEWLINE_xXDisease evaluable for response by specific appropriate criteria.Xx_NEWLINE_xXALT <3 × ULN NOTE: Laboratory results obtained during screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may retest the subject and the subsequent within range screening result may be used to determine the subject's eligibility.Xx_NEWLINE_xXIndication for treatment consistent with IWCLL criteria, i.e. at least one of the following criteria should be metXx_NEWLINE_xXDisease that is measurable as defined by RECIST v1.1, mINRC, Revised Response Criteria for Malignant Lymphoma, RANO criteria (as appropriate) or evaluable by nuclear medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable measuresXx_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 confirmed Ewing's Sarcoma Family of Tumors (ESFT).\n\n          2. Age ?2 years.\n\n          3. Estimated survival ? 6 months.\n\n          4. Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS).\n\n          5. Metastatic disease\n\n          6. Refractory or intolerant to at least 1 line of systemic chemotherapy.\n\n          7. 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          8. 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          9. 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. 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 history of allergies or sensitivities to gentamicin.\n\n          6. 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          7. Known HIV or chronic Hepatitis B or C infection.\n\n        Study Enrollment Inclusion Criteria:\n\n        Patients will be eligible for registration if they meet all of the following inclusion\n        criteria:\n\n          1. Successful manufacturing of at least 4 vials of Vigil.\n\n          2. Karnofsky performance status (PS) ?80%.\n\n          3. Estimated survival ? 6 months.\n\n          4. Normal organ and marrow function as defined below:\n\n             Absolute granulocyte count ?1,500/mm3 Absolute lymphocyte count ?400/mm3 Platelets\n             ?100,000/mm3 Total bilirubin ? institutional upper limit of normal AST(SGOT)/ALT(SGPT)\n             ?2x institutional upper limit of normal Creatinine <1.5 mg/dL\n\n          5. 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          6. 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          7. Ability to understand and the willingness to sign a written informed protocol specific\n             consent.\n\n        Study Enrollment Exclusion Criteria:\n\n        Measureable disease is not a requirement for enrollment onto the trial.\n\n        In addition to the procurement exclusion criteria, patients will NOT be eligible for study\n        registration and randomization if meeting any of the following criteria:\n\n          1. Any anti-neoplastic therapy between tissue procurement for Vigil manufacture and start\n             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_xXPRE-REGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXPretreatment clinical laboratory values must meet protocol-defined parameters during the screening phaseXx_NEWLINE_xXPatient meets the eligibility criteria outlined aboveXx_NEWLINE_xXINDUCTION ELIGIBILITY:Xx_NEWLINE_xXCONSOLIDATION ELIGIBILITY:Xx_NEWLINE_xXPatients who do not meet parent protocol criteria to continue study treatment.Xx_NEWLINE_xXBlood counts performed within 28 days prior to randomization must meet the following criteria:Xx_NEWLINE_xXPatient meets all sub-protocol specific criteria of each applicable sub-protocolXx_NEWLINE_xXPositive serology for HTLV 1 or 2. Furthermore and prior to lymphodepleting chemotherapy, a subject meeting the following criteria is not eligible for participation in the study:Xx_NEWLINE_xXPatients must meet the following laboratory criteria at screening:Xx_NEWLINE_xXDocumented progressive metastatic CRPC will be based on at least one of the following criteria:Xx_NEWLINE_xXPatients must have progressive mCRPC defined by meeting at least one of the following criteria:Xx_NEWLINE_xXSubjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.Xx_NEWLINE_xXSubjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.Xx_NEWLINE_xXPatients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:\r\n* Post molar GTN\r\n** For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:\r\n*** A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR\r\n*** A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR\r\n*** A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)\r\n* Choriocarcinoma\r\n** Histologically proven non-metastatic choriocarcinoma OR\r\n** Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lungXx_NEWLINE_xXFor Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.Xx_NEWLINE_xXPretreatment clinical laboratory values must meet protocol-defined parameters during the Screening phaseXx_NEWLINE_xXParticipants must meet protocol specified hematology and chemistry lab parameters criteriaXx_NEWLINE_xXPatients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and\r\n* Have no active graft-versus-host disease (GVHD) and require no immunosuppression\r\n* Are more than 6 months from transplantXx_NEWLINE_xXAfrican American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screeningXx_NEWLINE_xXPatients are permitted to washout current drug therapy to meet these entry criteria if they have a known diagnosis of Cushing's disease.Xx_NEWLINE_xXSPECIMEN SUBMISSION CRITERIA:Xx_NEWLINE_xXREGULATORY CRITERIA:Xx_NEWLINE_xXSTEP 2 RANDOMIZATION REGULATORY CRITERIA:Xx_NEWLINE_xXLaboratory criteria as:Xx_NEWLINE_xXPatients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are metXx_NEWLINE_xXSubjects must have confirmed diagnosis of unresectable HCC with any of the following criteria:Xx_NEWLINE_xXAt least one measurable target lesion according to mRECIST meeting the following criteria:Xx_NEWLINE_xXIn emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP0731 without a biopsy\r\n* Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:\r\n** Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)\r\n** Uncorrectable coagulopathy\r\n* For a patient to maintain eligibility for AHEP0731 when emergent treatment is given, the following must occur:\r\n** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP0731 eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment\r\n** If the patient receives AHEP0731 chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aimsXx_NEWLINE_xXPatients taking ruxolitinib at the time of enrollment must be deemed to have had a suboptimal response (less than partial response per IWG criteria) to ruxolitinib single-agent therapy or deemed to have progression of disease (per IWG criteria)Xx_NEWLINE_xXHistory of prior therapy that satisfies one of the following criteria:Xx_NEWLINE_xXNormal LVEF per institutional criteria as determined by either ECHO or MUGA scanning.Xx_NEWLINE_xXScreening laboratory values must meet the following criteria and should be obtained within 30 days (45 if biopsy is repeated) prior to study treatment:Xx_NEWLINE_xXSubject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:Xx_NEWLINE_xXSubject must meet the following criteria as indicated on the clinical laboratory tests:Xx_NEWLINE_xXPatients must meet the following laboratory criteria:Xx_NEWLINE_xXInclusion Criteria:\n\n        A woman will be eligible for inclusion in this study if she meets all of the following\n        criteria:\n\n          -  Age >18 to <70 years old.\n\n          -  Has known ER and PR status\n\n          -  Has HER2 nonamplified disease, confirmed by FISH\n\n          -  Has known menopausal status (see Section 7.3 for criteria)\n\n          -  Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC\n             invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable\n             provided that 1 primary meets the inclusion criteria.\n\n          -  Meets 1 of the 3 following criteria:\n\n               -  T1-3N1-3M0 if ER positive or negative\n\n               -  T2-3N0M0 if ER positive or negative\n\n               -  T1N0M0 if ER and PR negative\n\n          -  Has complete surgical resection of the primary breast tumor: either lumpectomy or\n             mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins\n             for both invasive and ductal carcinoma in situ (DCIS)\n\n          -  Has had no prior chemotherapy unless >5 years ago\n\n          -  Has an ECOG Performance Status (PS) 0-1\n\n          -  Has laboratory values of: See protocol for specific details\n\n          -  Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline\n             phosphatase (ALP) within the ranges shown below. In determining eligibility the more\n             abnormal of the 2 values (AST or ALT) should be used. See protocol for specific\n             details\n\n          -  Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional\n             standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be\n             used if MUGA is not available, but the same modality must be used consistently\n             throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be\n             WNL by institutional standard.\n\n          -  Has no evidence of metastatic disease outside of breast by physical examination and\n             chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal,\n             chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic\n             disease\n\n          -  Has had baseline bilateral mammography\n\n          -  It has been <84 days since the date of definitive surgery (eg, mastectomy or, in the\n             case of a breast-sparing procedure, axillary dissection) with adequate wound healing,\n             as determined by the Treating Physician\n\n          -  Has a negative serum pregnancy test within 7 calendar days prior to registration\n             (female patients of childbearing potential [not surgically sterilized and between\n             menarche and 1 year postmenopause])\n\n          -  If fertile, patient has agreed to use an acceptable method of birth control (barrier\n             contraceptive only) to avoid pregnancy for the duration of the study and for a period\n             of 3 months thereafter\n\n          -  Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix\n             VI).\n\n          -  Has signed a Patient Informed Consent Form\n\n          -  Has signed a Patient Authorization Form\n\n        Exclusion Criteria:\n\n        A woman will be excluded from this study if she meets any of the following criteria:\n\n          -  Has any evidence of metastatic disease following surgical resection of the primary\n             tumor including: positive surgical margins, staging work-up, or physical examination\n             suspicious for malignant disease\n\n          -  Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin\n             ulcerations, or inflammatory changes)\n\n          -  Has Stage IV breast cancer (M1 disease on TNM staging system)\n\n          -  Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate\n             80\n\n          -  Has had neoadjuvant chemotherapy for this breast cancer\n\n          -  Has ever had a myocardial infarction (MI) or has a history of heart failure,\n             uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or\n             electrocardiographic evidence of acute ischemic changes\n\n          -  Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone\n             replacement therapy), or radiation therapy. Must discontinue prior to registering on\n             the study.\n\n          -  Is receiving concurrent investigational therapy or has received such therapy within\n             the past 30 calendar days\n\n          -  Has peripheral neuropathy >Grade 1\n\n          -  Has had a major organ allograft or condition requiring chronic immunosuppression (ie,\n             kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients\n             who have received corneal transplants or cadaver skin or bone transplants are\n             eligible.\n\n          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including\n             serious viral (including clinically defined AIDS), bacterial or fungal infection; or\n             history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating\n             Physician to be clinically significant, precluding informed consent\n\n          -  Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is\n             known to be HIV positive\n\n          -  Has a history of other malignancy within the last 5 years (except cured basal cell\n             carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the\n             diagnosis or assessment of any of the study drugs\n\n          -  In an obese patient to whom the Treating Physician would not be comfortable\n             administering full doses of study drugs as calculated by the BSA. Obese patients will\n             be treated based on actual body weight. Obese patients treated with full doses based\n             on actual BSA are eligible.\n\n          -  Is pregnant or breastfeeding\n\n          -  Is deemed unable to comply with requirements of studyXx_NEWLINE_xXAny individual that does not meet the eligibility criteria for transplantation or donor eligibility will not be a part of this trialXx_NEWLINE_xXAdditional criteria may apply.Xx_NEWLINE_xXAdditional criteria may apply.Xx_NEWLINE_xXNote: Patients who fail to meet the inclusion/exclusion criteria should not, under any circumstances, be initiated on study treatment; there can be no exceptions to this rule, although during protocol development, discussions about certain criteria are possible and may be amended, depending on new data and specific study requirements; where patients that do not meet the inclusion criteria are incorrectly started on treatment, or where patients subsequently fail to meet the study criteria post initiation, the investigator should inform the AZD2014 team immediately; the AZD2014 team is to ensure all such contacts are appropriately documentedXx_NEWLINE_xXPlatelets >= 75 K/uL (platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment)Xx_NEWLINE_xXClinicopathological diagnosis of Waldenstrom’s macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom’s macroglobulinemiaXx_NEWLINE_xXAdult patients with intermediate or high-risk smoldering multiple myeloma (SMM) are eligible; patients need to have clonal bone marrow plasma cells >= 10% and/or monoclonal spike in blood of >= 3 g/dL and/or monoclonal urine component (Bence jones proteinuria) >= 500 mg/24 hours and need to meet subject inclusion criteria and exclusion criteria as per belowXx_NEWLINE_xXPatients who meet eligibility for the protocol but are not candidates to receive further chemotherapy may be treated on Arm CXx_NEWLINE_xXNote: Transfusions/infusions to meet eligibility criteria are not allowed but if in the opinion of the Principal Investigator, it is beneficial, the patient may be rescreened after receiving one of these procedures.Xx_NEWLINE_xXPatients for whom the delivery of APBI is not feasible or any of the dosimetric treatment criteria have not been metXx_NEWLINE_xXNote: Laboratory assessments used to support the hypercalcemia, renal failure, anemia, bone lesions (CRAB) criteria in the International Myeloma Working Group (IMWG) 2014 diagnostic criteria of MM are performed at the time of diagnosis; these assessments are not required to be performed within the 21 days of initiation of protocol therapyXx_NEWLINE_xXClinicopathological diagnosis of Waldenstrom macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom macroglobulinemia or serum immunoglobulin M (IgM) > 6000 mg/dL and measurable diseaseXx_NEWLINE_xXA survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:Xx_NEWLINE_xXMelanoma-related operative procedures not corresponding to criteria described in the protocol.Xx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXPersistence of clinically relevant therapy related toxicity from previous chemotherapy and/or radiotherapy; this does not include hemoglobin or other hematologic or laboratory criteria, as long as eligibility criteria are met as outlined aboveXx_NEWLINE_xXSubjects must meet the following criteria:Xx_NEWLINE_xXScreening laboratory values should be used to confirm subject eligibility. Laboratory results may be retested if necessary to confirm eligibility.Xx_NEWLINE_xXMeet the clinical laboratory criteria as specified in the protocolXx_NEWLINE_xXMust meet the following clinical laboratory criteria at study entry:Xx_NEWLINE_xXRequires treatment with a strong cytochrome P450 (CYP) 3A inhibitor Eligibility Criteria for Open-label Substudy Treatment Arm C The Inclusion/Exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as eitherXx_NEWLINE_xXPatients may have had enucleation of one eye, as long as the remaining eye meets the eligibility criteriaXx_NEWLINE_xXMust be off prior systemic therapies for 2 weeks prior to enrollment; patients that have been previously treated with systemic therapy adjuvantly or for metastatic disease remain eligible as long as they continue to meet all other eligibility criteria (oligometastatic, no visceral metastasis > 5 cm, eligible for SABR)Xx_NEWLINE_xXMust meet one of the following two criteria:Xx_NEWLINE_xXInclusion Criteria For entire trial:\n\n          -  Adult > or = 18 years old\n\n          -  has signed the Informed Consent Form\n\n          -  has tumor tissue available for the analysis as described in the protocol\n\n          -  has an Eastern Cooperative Oncology Group performance status ?2\n\n          -  has adequate bone marrow and organ function as defined in the protocol\n\n          -  is able to swallow and retain oral medication\n\n          -  has either measurable or non-measurable disease as per RECIST 1.1.\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - escalation phase - all above\n        plus has a histologically/cytologically confirmed metastatic and/or recurrent solid tumors\n        for whom no standard therapy exists.\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, renal cell\n        carcinoma cohort - all of above first 7 criteria plus has an histologically/cytologically\n        confirmed Renal Cell Cancer as detailed in the protocol\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, pancreatic\n        NeuroEndocrine Tumor cohort\n\n        - all of above first 7 criteria plus has an histologically/cytologically confirmed\n        pancreatic NeuroEndocrine Tumor as detailed in the protocol\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, mTOR\n        inhibitor-pretreated patients' cohort - all of above first 7 criteria plus has a\n        histologically and/or cytologically confirmed solid malignancy as described in the protocol\n\n        Inclusion Criteria for the breast cancer cohorts in escalation and expansion phases, - all\n        of above first 7 criteria plus is post-menopausal and has a histologically and/or\n        cytologically confirmed diagnosis of breast cancer as described in the protocol\n\n        Specific Inclusion Criteria at the time of cross-over (breast cancer, expansion phase),\n\n        - Patient randomized to the alpelisib and exemestane combination who has a radiologically\n        documented progressive disease as detailed in the protocol\n\n        Exclusion Criteria:\n\n          -  Patient has received previous treatment with a PI3K and/or AKT and/or mTOR inhibitor\n             (mTOR inhibitor is allowed in expansion cohorts where patients should have areceived a\n             prior mTOR inhibitor)\n\n          -  Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs\n\n          -  Patient with primary central nervous system (CNS) tumor or CNS tumor involvement as\n             detailed in the protocol\n\n          -  Patient with diabetes mellitus, or documented steroid-induced diabetes mellitus\n\n          -  Patient has a history of another malignancy within 2 years prior to starting study\n             treatment as described in the protocol\n\n          -  Patient who has not recovered to grade 1 or better (except alopecia) from related side\n             effects of any prior antineoplastic therapy as detailed in the protocol\n\n          -  Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or\n             mitomycin C) prior to starting study treatment\n\n          -  Patient who has received radiotherapy ? 4 weeks prior to starting study drugs, with\n             exception of palliative radiotherapy (? 2 weeks prior to starting study drugs), who\n             has not recovered from side effects of such therapy to baseline or Grade ? 1 and/or\n             from whom ? 30% of the bone marrow was irradiated\n\n          -  Patient who has undergone major surgery ? 4 weeks prior to starting study treatment or\n             who has not recovered from side effects of such procedure\n\n          -  Patient has a clinically significant cardiac disease or impaired cardiac function or\n             any severe and/or uncontrolled medical conditions as detailed in the protocol\n\n          -  Patient who is currently receiving medication with a known risk of prolonging the QT\n             interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be\n             discontinued or switched to a different medication prior to starting study drug\n             treatment\n\n          -  Patient who has participated in a prior investigational study within 30 days prior to\n             enrollment as described in the protocol\n\n          -  Patient who is currently receiving treatment with drugs known to be moderate or strong\n             inhibitors or inducers of isoenzymes CYP34A or CYP2C8 as described in the protocol.\n             Switching to a different medication prior to start of treatment is allowed\n\n          -  Patient with impaired gastrointestinal (GI) function or GI disease that may\n             significantly alter the absorption of oral alpelisib, everolimus, exemestane\n\n          -  Patient with known positive serology for human immunodeficiency virus\n\n          -  Patients who have received live attenuated vaccines within 1 week of start of study\n             drug and during the study as specified in the protocol.\n\n          -  Pregnant or nursing (lactating) woman as detailed in the protocol.\n\n          -  Patient who does not apply highly effective contraception during the study and through\n             the duration as defined in the protocol\n\n          -  Patients in the mTOR inhibitor-pretreated cohorts: all of above first 19 criteria plus\n             have discontinued prior mTOR inhibitor therapy due to non-tolerable toxicityXx_NEWLINE_xXELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS:Xx_NEWLINE_xXBaseline hematologic studies and chemistry profiles must meet the following criteria:Xx_NEWLINE_xXInclusion Criteria:\n\n        Patients in both treatment groups must meet all of the following criteria to be considered\n        eligible to participate in the study:\n\n          -  Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic\n             adenocarcinoma of the colon or rectum that is resistant to available treatment options\n\n          -  Radiographically documented evidence of disease progression.\n\n          -  Life expectancy of at least 6 weeks, in the investigator's opinion, at the time\n             disease progression is documented.\n\n          -  Considered surgical candidates on the basis of co-morbidity risks, number and sites of\n             metastases, and ability to withstand general anesthesia.\n\n          -  Able to provide written informed consent.\n\n        Patients in Group A must also meet all of the following additional criteria:\n\n          -  ECOG performance status score of 0, 1, or 2.\n\n          -  Adequate hematologic function, defined as follows:\n\n               1. absolute neutrophil count (ANC) ?1500 /mL\n\n               2. hemoglobin ?9 g/dL\n\n               3. platelets ?75,000 /mL\n\n          -  Adequate hepatic function, defined as follows:\n\n               1. bilirubin ?1.5 times the upper limit of normal (x ULN)\n\n               2. aspartate transaminase (AST) ?3 x ULN, or ?5 x ULN if liver metastases are\n                  present\n\n               3. alanine transaminase (ALT) ?3, x ULN, or ?5 x ULN if liver metastases are present\n\n          -  Adequate renal function, defined as creatinine ?2.0 mg/dL.\n\n          -  Adequate coagulation function, defined as follows:\n\n               1. International Normalized Ratio (INR) ?1.5 or between 2 and 3 if the patient is\n                  receiving anticoagulation\n\n               2. partial thromboplastin time (PTT) ?5 seconds above the ULN Note: Patients\n                  receiving full-dose anticoagulation therapy must be receiving a stable dose of\n                  oral anticoagulant therapy or low-molecular-weight heparin.\n\n          -  Clinically significant toxic effects of chemotherapy (excluding alopecia),\n             radiotherapy, hormonal therapy, or prior surgery must have resolved to Grade 1 or\n             better, with the exception of peripheral neuropathy, which must have resolved to Grade\n             2 or better.\n\n          -  Agrees to contraceptive use while on study if sexually active\n\n        Exclusion Criteria:\n\n        Patients in either treatment group who meet any of the following criteria will be excluded\n        from participating in the study:\n\n          -  Hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis,\n             and/or a large volume of ascites.\n\n          -  Concurrent cancer of any other type, except skin cancers other than melanoma.\n\n          -  A positive test result for HIV or any hepatitis other than A at screening.\n\n          -  Considered by the investigator to be unsuitable for participation in the study\n\n        Patients in Group A who meet any of the following criteria will be excluded from\n        participating in the study:\n\n          -  Received FDA-approved chemotherapy within 3 weeks of Day 0, or bevacizumab (or similar\n             drugs) within 4 weeks of Day 0, or radiation therapy at any site within 4 weeks of Day\n             0\n\n          -  Investigational anticancer therapy within 4 weeks of Day 0\n\n          -  Positive reaction to the skin test for allergy to mouse antigen\n\n          -  History of hypersensitivity reaction that, in the opinion of the investigator, poses\n             an increased risk of an allergic reaction to the RENCA macrobeads, particularly any\n             known allergy to murine antigens or body tissues.\n\n          -  Ongoing or active infection, symptomatic congestive heart failure, unstable angina\n             pectoris, serious cardiac arrhythmias (with the exception of well controlled atrial\n             fibrillation), active bleeding, or psychiatric illness, or social situations that\n             could interfere with the patient's ability to participate in the study.Xx_NEWLINE_xXPrior therapy and screening lab criteria must be metXx_NEWLINE_xXExceptions to eligibility will not be granted for this studyXx_NEWLINE_xXSubjects have active disease meeting the IWCLL 2008 published criteria.Xx_NEWLINE_xXMust meet the following laboratory parameters:Xx_NEWLINE_xXPrior treatment according to protocol-defined criteriaXx_NEWLINE_xXAny of the following cardiac criteria:Xx_NEWLINE_xXPatients must meet all of the following criteria to be enrolled in the study:Xx_NEWLINE_xXPatients with brain metastasis are eligible for participation ONLY if they have been treated with definitive surgery or radiation (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 12 week intervalXx_NEWLINE_xXSubject must meet the following criteria as indicated on the clinical laboratory tests.Xx_NEWLINE_xXLow risk pathologic features (by AJCC 2010 criteria)Xx_NEWLINE_xXPatients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteriaXx_NEWLINE_xXModerate to severe steroid-refractory cGVHD as defined by all following criteria:Xx_NEWLINE_xXParticipants may have received any number of prior therapies as long as they have adequate performance status and meet all other eligibility criteriaXx_NEWLINE_xXSubjects should not have severe peritoneal metastases. The following criteria were applied:Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXPHASE I PORTION ELIGIBILITY CRITERIAXx_NEWLINE_xXPHASE II PORTION ELIGIBILITY CRITERIAXx_NEWLINE_xXPresence of chronic diarrhea (> grade 1 by Common Toxicity Criteria [CTC] criteria), short bowel syndrome, pancreatic insufficiency, or malabsorptionXx_NEWLINE_xXBilateral breast cancers that individually meet eligibility criteria are allowedXx_NEWLINE_xXRe-Induction Criteria (if applicable):Xx_NEWLINE_xXMeet the clinical laboratories criteria as specified in the protocolXx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXWilling to undergo biopsy for research purposes only; Note: if possible, the pre-treatment biopsy should be performed after all other eligibility criteria are confirmedXx_NEWLINE_xXInclusion Criteria:\n\n          1. Randomized in the parent study, PCYC-1115-CA\n\n          2. Informed consent for Study PCYC-1116-CA\n\n          3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study\n\n        Exclusion Criteria:Xx_NEWLINE_xXSymptomatic altered hearing > grade 2 by NCI-CTCv4 criteriaXx_NEWLINE_xXlaboratory criteria at screening:Xx_NEWLINE_xXPATHOLOGICAL CRITERIA:Xx_NEWLINE_xXDISEASE AND PRIOR STATUS CRITERIA:Xx_NEWLINE_xXNo concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteriaXx_NEWLINE_xXMust have met the following clinical laboratory criteria:Xx_NEWLINE_xXELIGIBILITY TO PROCEED TO OVA:Xx_NEWLINE_xXFURTHER ELIGIBILITY DETAILS FOR PATIENTS WITH OPERABLE DISEASE (COHORT 2):Xx_NEWLINE_xXParticipants must have met all criteria to be enrolled on the main protocol for receipt of neratinib; at the time of enrollment on the extension phase for cohorts 1 and 3, patients must have experienced progression of non-CNS disease by RECIST 1.1 criteriaXx_NEWLINE_xXHas hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet eligibility criteria will not be allowed.Xx_NEWLINE_xXPatients must meet pre-entry requirements as specifiedXx_NEWLINE_xXPatients must have an indication for treatment by 2008 IWCLL CriteriaXx_NEWLINE_xXREGISTRATION ELIGIBILITYXx_NEWLINE_xXIs willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy; The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:Xx_NEWLINE_xXThere are other criteria--please discuss with your doctor.Xx_NEWLINE_xXThere are other criteria--please discuss with your doctor.Xx_NEWLINE_xXSubjects must meet the following laboratory parameters:Xx_NEWLINE_xXLysate must meet release criteriaXx_NEWLINE_xXSubject for whom tumor lysate does not meet release criteriaXx_NEWLINE_xXSubject requires or is likely to require more than a two week course of corticosteroids for intercurrent illness; subject must complete the course of corticosteroids 2 weeks before screening to meet eligibilityXx_NEWLINE_xXResistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the following criteria:Xx_NEWLINE_xXPatients must meet the following laboratory criteria:Xx_NEWLINE_xXAbsence of macroscopic disease after upfront surgery (i.e., TxNx and TxN0; TxN+ and T1-3Nx are eligible if the T/N stage categories meet the criteria above)Xx_NEWLINE_xXRANDOMIZATION ELIGIBILITY CRITERIAXx_NEWLINE_xXPRIOR TO POST-TRANSPLANT IMMUNOTHERAPY (COHORT 2): Able to produce at least 2 doses of fusion vaccine to be considered evaluable; patients who are unable to produce at least 2 doses of fusion vaccine, but otherwise meet eligibility criteria for post-transplant immunotherapy, will be treated with pidilizumab (MDV9300) alone and will be replacedXx_NEWLINE_xXAdequate hematologic function Arm A (except for CLL subjects with significant BM involvement by biopsy) must meet the following criteria:Xx_NEWLINE_xXIn the event of significant BM involvement, the above hematologic criteria will not be required for enrollment eligibilityXx_NEWLINE_xXDIAGNOSTIC CRITERIAXx_NEWLINE_xXCRITERIA FOR RANDOMIZATION\r\n* Participants must meet the following criteria to qualify for HD-ADE versus Clo/AraC randomization; participants who do not meet these criteria may still be enrolled, but will be treated on HD-ADE arm and will NOT be randomizedXx_NEWLINE_xXCRITERIA FOR ASSIGNMENT TO THE LOW-RISK ARM OF THE PROTOCOL:Xx_NEWLINE_xXLOW RISK MEDULLOBLASTOMA (patients must meet all of the following criteria):Xx_NEWLINE_xXLOW RISK HIGH-GRADE GLIOMA (patients must meet all of the following criteria):Xx_NEWLINE_xXCRITERIA FOR ASSIGNMENT TO THE INTERMEDIATE-RISK ARM OF THE PROTOCOLXx_NEWLINE_xXPatients less than 3 years of age at diagnosis must meet one of the two following criteria:Xx_NEWLINE_xXCRITERIA FOR ASSIGNMENT TO THE HIGH-RISK ARM OF THE PROTOCOLXx_NEWLINE_xXThe patient currently does not meet the protocol’s eligibility/enrollment criteria for any reasonXx_NEWLINE_xXThere is a high likelihood that the patient, in the opinion of the principal investigator (PI) will meet the protocol’s eligibility/enrollment criteria to proceed to transplant after standard therapy is completedXx_NEWLINE_xXCRITERIA FOR ALL SUBJECTS:Xx_NEWLINE_xXPatients who fulfil the diagnostic criteria of HLH.Xx_NEWLINE_xXSpecific eligibility criteria stratum 1:\r\n* Disease status: \r\n** Radiographic disease progression as defined for stratum 3 (below) is not required for trial entry\r\n** Patient does not have clinical symptoms from the plexiform neurofibromaXx_NEWLINE_xXSpecific eligibility criteria stratum 2:\r\n* Disease status: \r\n** Radiographic disease progression as defined for stratum 3 (below) is not required for trial entry\r\n** Patient has clinical symptoms from the plexiform neurofibromaXx_NEWLINE_xXSpecific eligibility criteria stratum 4:\r\n* Disease status: \r\n** Age between 6 and 18 months of age\r\n** Patients must have a symptomatic and/or life threatening plexiform neurofibroma(s)Xx_NEWLINE_xXDONOR: Failure to meet FHCRC criteria for stem cell donationXx_NEWLINE_xXSubject must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.Xx_NEWLINE_xXDONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelinesXx_NEWLINE_xXDONOR: Failure to meet institutional criteria for donation as described in the Standard Practice GuidelinesXx_NEWLINE_xXAdditional criteria apply, please contact the investigator for more informationXx_NEWLINE_xXAdditional criteria apply, please contact the investigator for more informationXx_NEWLINE_xXSubject must meet all of the following criteria on the laboratory tests. In case of multiple laboratory data within this period, the most recent data should be used.Xx_NEWLINE_xXThe presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:Xx_NEWLINE_xXHaving documented disease progression on enzalutamide defined by 1 or more of the following criteria:Xx_NEWLINE_xXPRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA:Xx_NEWLINE_xXREGISTRATION (STEP 1) ELIGIBILITY CRITERIA:Xx_NEWLINE_xXKey Eligibility Criteria:\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\n          -  Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI\n\n          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors version\n             1.1 (RECIST 1.1)\n\n          -  Documented evidence of an EGFR mutation known to be associated with an EGFR TKI\n             sensitivity\n\n          -  No T790M mutation or small cell transformation including an assessment from tumor\n             biopsy obtained while on or subsequent to the most recent EGFR TKI therapy\n\n          -  Acceptable laboratory results as indicated by protocol\n\n          -  Acceptable cardiac function as indicated by protocol\n\n        Key Exclusion Criteria:\n\n          -  Receiving medication that prolongs QT interval, with a risk of causing Torsades de\n             Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the\n             medication\n\n          -  Family history of long QTc syndrome\n\n          -  Symptomatic central nervous system (CNS) lesions\n\n          -  Radiation therapy within 2 weeks prior to the first dose of study medication\n\n          -  Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose\n             of study medication\n\n          -  Concurrent active malignancy requiring systemic treatment\n\n          -  Any other serious uncontrolled medical disorders or psychological conditions that may\n             interfere with study conduct including but not limited to: clinically significant\n             active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus\n             [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive\n             heart failure, poorly-controlled hypertension or diabetes, concurrent active\n             malignancy, or psychiatric condition that may interfere with the patient's ability to\n             follow study procedures\n\n          -  Pregnant or breast-feedingXx_NEWLINE_xXMeets local transplant center eligibility requirements for HCTXx_NEWLINE_xXPrevious exposure to BTKi therapy and meets at least one of the below criteria:Xx_NEWLINE_xXBlood transfusion to meet the following laboratory requirements will not be allowedXx_NEWLINE_xXPatient must meet eligibility criteria for allogeneic transplantationXx_NEWLINE_xXSubjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other I/E criteria are metXx_NEWLINE_xXMultiple lesions that don’t meet the criteria as satellite lesionsXx_NEWLINE_xXCriteria for the Phase 1b:Xx_NEWLINE_xXCohort-specific criteria for Phase 2:Xx_NEWLINE_xXCriteria:Xx_NEWLINE_xXCriteria:Xx_NEWLINE_xXCriteria:Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATIONXx_NEWLINE_xXDONOR: meet other blood bank criteria for blood product donation (as determined by NBAH Blood Center screening history and laboratory studies)Xx_NEWLINE_xXFour or more American College of Rheumatology (ACR) criteria as revised by Hochberg for the classification of SLE or 4 or more of the Systemic Lupus International Collaborating Clinics (SLICC) criteriaXx_NEWLINE_xXDONOR: Donors must meet the selection criteria as defined by the BMT Policy ManualXx_NEWLINE_xXPatients with multicentric or bilateral disease are eligible if the target lesions meet the other eligibility criteria; samples from all available tumors are requested for research purposesXx_NEWLINE_xXPatients aged >= 80 are not excluded; however, candidates in this age group should be thoroughly evaluated before enrollment in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy; in addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to; patients should not be enrolled in the study should there be any hesitation on any of these considerations; baseline criteria for all patients enrolled on the study must be carefully evaluated and all criteria followed appropriatelyXx_NEWLINE_xXPatients must meet laboratory, and bone marrow histological criteria for primary myelofibrosis as defined by World Health Organization (WHO) diagnostic criteria as follows: WHO diagnostic criteria for PMF Proposed Criteria for PMF Major CriteriaXx_NEWLINE_xXELIGIBILITY FOR BLAST COLLECTION (PROCUREMENT)Xx_NEWLINE_xXIndividuals who meet the eligibility criteria for EGFR germline mutation testing but who do not have advanced cancer may enroll for EGFR germline mutation testing only and will not be eligible for the treatment or not otherwise specified (NOS) armsXx_NEWLINE_xXAdditional criteria may applyXx_NEWLINE_xXAdditional criteria may applyXx_NEWLINE_xXApplicable disease criteriaXx_NEWLINE_xXHas, at screening, serologic laboratory tests meeting one or more of the following criteria:Xx_NEWLINE_xXHas, at screening, safety laboratory tests meeting one or more of the following criteria:Xx_NEWLINE_xXCardiac or peripheral vascular disease meeting any of the following criteria:Xx_NEWLINE_xXMust meet the criteria for relapsed and/or refractory disease according to the IWCLL guidelines (Hallek, 2008) to ? 1 prior treatment (with the exception of Arm B) and have evidence of disease progression requiring treatment at the time of study entry as follows: a. For Arms A and C, subjects must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor with the following exceptions: i. Chemoimmunotherapy is not required if subjects have specific comorbidities that preclude the use of standard chemoimmunotherapy meeting at least 1 of the following criteria;Xx_NEWLINE_xXSubjects in Cohort 2 of Arm C must meet the following criteria:Xx_NEWLINE_xXPatients may have a history of brain metastasis provided certain protocol criteria are metXx_NEWLINE_xXParticipant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:Xx_NEWLINE_xXDiagnosis of AML or MDS according to the WHO criteriaXx_NEWLINE_xXINCLUSION CRITERIA - HPC-A CELL DONOR: Meets donation eligibility requirements as outlined by 21 Code of Federal Regulations (CFR) 1271Xx_NEWLINE_xXAssessment of HER2 status in subjects with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.Xx_NEWLINE_xXPatients who have an active or uncontrolled infection are not eligible; patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteriaXx_NEWLINE_xXALC ? 900/?l (Note: Patients with AML are not required to meet these hematologic criteria).Xx_NEWLINE_xXInclusion Criteria:\n\n        Entry criteria include the following:\n\n          1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or\n             biopsy proven:\n\n             1.1 Baltimore Criteria- Bilirubin ?2 mg/dL and at least 2 of the following clinical\n             findings:\n\n               -  Ascites (radiographic or physical exam)\n\n               -  Weight gain of ?5% compared to the day of conditioning-- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  Hepatomegaly; increased over baseline.\n\n             1.2 Modified Seattle Criteria: At least two of the following\n\n               -  Bilirubin ?2 mg/dL\n\n               -  Ascites (radiographic or physical exam) and/or weight gain ?5% above baseline\n                  weight (defined as weight on the first day of conditioning- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  hepatomegaly increased over baseline\n\n             1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and\n             have biopsy proven VOD are eligible.\n\n          2. Patient must also provide written informed consent.\n\n        Exclusion Criteria:\n\n          -  Use of any medication which increases the risk of hemorrhage is disallowed. Use of\n             heparin or other anticoagulants is disallowed within 12 hours unless being used for\n             routine central venous line management, fibrinolytic instillation for central venous\n             line occlusion, intermittent dialysis or ultrafiltration of CVVH.\n\n          -  Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring >\n             15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and\n             requiring > 300cc of packed red blood cells/24 hours, or an adult patient weighing 70\n             kg and requiring >3 units of packed red blood cells/24 hours) to replace blood loss,\n             OR bleeding from a site which in the Investigator's opinion constitutes a potential\n             life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of\n             amount of blood loss, at any point from the date of SCT through the date of severe VOD\n             diagnosis.\n\n          -  Hemodynamic instability as defined by a requirement for multiple pressors, or\n             inability to maintain mean arterial pressure (for children: to maintain mean arterial\n             pressure within 1 standard deviation of age-adjusted levels) with single pressor\n             support.\n\n          -  Woman who are pregnant.Xx_NEWLINE_xXPlatelet transfusions to help patients meet eligibility criteria are not allowed within 3 days prior to screening complete blood count (CBC) or cycle 1, day 1 treatmentXx_NEWLINE_xXAll baseline laboratory requirements will be assessed and should be obtained within 14 days of first dose of study drug. Screening laboratory values must meet the following criteria:Xx_NEWLINE_xXThe two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:Xx_NEWLINE_xXPrior therapy must meet all of the following criteria:Xx_NEWLINE_xXFor leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator [PI]):Xx_NEWLINE_xXMeasurable disease by RECIST v1.1 for subjects with solid tumors without glioma, by modified RANO criteria for subjects with glioma, or by the revised IWG criteria for subjects with AITLXx_NEWLINE_xXDONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 case report form (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271Xx_NEWLINE_xXRegarding eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 127Xx_NEWLINE_xXHistologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with HPV 16 and/or 18 and meeting the following eligibility criteria for either Cohort 1 or Cohort 2;Xx_NEWLINE_xXSubjects who fail to meet the above criteriaXx_NEWLINE_xXPatient understands if he or she is randomized to receive molecularly guided treatment, they must meet all inclusion and exclusion criteria in the drug specific appendix for which they were randomizedXx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Subject must currently be participating in an Astellas sponsored linsitinib trial that\n             has ended with respect to the overall study analysis.\n\n          -  Subject must not have met criteria for discontinuation or have progressed on the\n             current linsitinib study in which they are participating.\n\n          -  Subject must be deriving benefit from continued treatment.Xx_NEWLINE_xXSubject must meet the following criteria as indicated on the clinical laboratory tests*:Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR CROSSOVER REGISTRATIONXx_NEWLINE_xXMeet all eligibility criteria with the exception of:\r\n* Prior therapy with trametinib will be permitted\r\n* All laboratory parameters must be met as outlined except for ALT and total bilirubin, which must meet criteria for continued therapy\r\n* Patients who are eligible for cross-over will not need to undergo another ophthalmologic examinationXx_NEWLINE_xXOther criteria apply.Xx_NEWLINE_xXOther criteria apply.Xx_NEWLINE_xXPatients diagnosed with AML meeting one of the following criteria:\r\n* Newly diagnosed, age 60 and older\r\n* High risk cytogenetics and molecular abnormalities (National Comprehensive Cancer Network [NCCN] criteria)\r\n* Relapsed or refractory to prior chemotherapy\r\n* Secondary AMLXx_NEWLINE_xXFor the 7-10% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least 2 of the following criteria: \r\n* Circulating myeloid precursors \r\n* White blood cell (WBC) > 10,000/uL\r\n* Increased fetal hemoglobin (HgbF) for age\r\n* Sargramostim (GM-CSF) hypersensitivity\r\nOR, patients must have been previously diagnosed with JMMLXx_NEWLINE_xXCANCER-RELATED CRITERIAXx_NEWLINE_xXCARDIOPULMONARY FUNCTION CRITERIAXx_NEWLINE_xXGENERAL CRITERIAXx_NEWLINE_xXAll of the criteria listed aboveXx_NEWLINE_xXRecurrent GBM per RANO criteriaXx_NEWLINE_xXSpecifically, subjects must meet one or more of the following criteria:Xx_NEWLINE_xXPRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])Xx_NEWLINE_xXSECONDARY ELIGIBILITYXx_NEWLINE_xXInclusion Criteria:\n\n        Patients are eligible if they:\n\n          1. have undergone noncardiac surgery;\n\n          2. are ?45 years of age;\n\n          3. have suffered MINS based upon fulfilling one of the following criteria: A. Elevated\n             troponin or CK-MB measurement with one or more of the following defining features i.\n             ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of\n             breath, pulmonary edema); ii. development of pathologic Q waves present in any two\n             contiguous leads that are ?30 milliseconds; iii. electrocardiogram (ECG) changes\n             indicative of ischemia (i.e., ST segment elevation [?2 mm in leads V1, V2, or V3 OR ?1\n             mm in the other leads], ST segment depression [?1 mm], OR symmetric inversion of T\n             waves ?1 mm) in at least two contiguous leads; iv. new LBBB; or v. new or presumed new\n             cardiac wall motion abnormality on echocardiography or new or presumed new fixed\n             defect on radionuclide imaging B. Elevated troponin measurement after surgery with no\n             alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury; AND\n\n          4. provide written informed consent to participate within 35 days of suffering their\n             MINS.\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following criteria will be excluded:\n\n          1. hypersensitivity or known allergy to dabigatran;\n\n          2. history of intracranial, intraocular, or spinal bleeding;\n\n          3. hemorrhagic disorder or bleeding diathesis;\n\n          4. known hepatic impairment or liver disease expected to have an impact on survival;\n\n          5. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart\n             valve, venous thromboembolism, atrial fibrillation);\n\n          6. currently using or plan to initiate rifampicin, cyclosporine, itraconazole,\n             tacrolimus, ketoconazole, or dronedarone;\n\n          7. women who are pregnant, breastfeeding, or of childbearing potential who refuse to use\n             a medically acceptable form of contraception throughout the study;\n\n          8. investigator considers the patient unreliable regarding requirement for study\n             follow-up or study drug compliance; OR\n\n          9. previously enrolled in the MANAGE Trial.\n\n        Also excluded will be patients in whom any of the following criteria persist beyond 35 days\n        of their suffering MINS:\n\n          1. the attending surgeon believes it is not safe to initiate therapeutic dose\n             anticoagulation therapy;\n\n          2. the attending physician believes ASA, intermittent pneumatic compression, or elastic\n             stockings are not sufficient for venous thromboembolism (VTE) prophylaxis and that the\n             patient requires a prophylactic-dose anticoagulant;\n\n          3. the patient has an indwelling epidural or spinal catheter that cannot be removed, or\n             the first dose of dabigatran will occur within 4 hours of epidural catheter removal;\n             OR\n\n          4. estimated glomerular filtration rate (eGFR) <35 ml/min as estimated by calculated\n             creatinine clearance.\n\n          5. it is expected that the patient will undergo cardiac catheterization for MINS.\n\n        Exclusion Criteria Specific to Patients in the Omeprazole Factorial Component of the Trial:\n\n        Patients meeting any of the following criteria:\n\n          1. hypersensitivity or known allergy to omeprazole;\n\n          2. requirement for a proton pump inhibitor, an H2-receptor antagonist, sucralfate,\n             atazanavir, clopidogrel, or misoprostol;\n\n          3. esophageal or gastric variceal disease; OR\n\n          4. patient declines participation in the omeprazole arm of MANAGE.Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXAdditional criteria exist.Xx_NEWLINE_xXPatients who have received an autologous hematopoietic stem cell infusion to support non-myeloablative therapy (such as 131I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.Xx_NEWLINE_xXPatients who have an active or uncontrolled infection are excluded. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.Xx_NEWLINE_xXEligibility for autologous SCTXx_NEWLINE_xXHas progressive disease at time of enrollment defined as one or more of the following criteria: PSA progression defined by PCWG2 criteria or soft tissue disease progression defined by RECIST 1.1 or bone disease progression defined by PCWG2 criteria Able to swallow and retain orally administered medication.Xx_NEWLINE_xXGeneral Eligibility Criteria (All Parts)Xx_NEWLINE_xXSpecific Eligibility Criteria, Part AXx_NEWLINE_xXSubjects must meet general eligibility criteria.Xx_NEWLINE_xXSpecific Eligibility Criteria, Part BXx_NEWLINE_xXSubjects must meet general eligibility criteria. The specific eligibility criteria listed here will apply to subjects enrolling to different cohorts of Part B.Xx_NEWLINE_xXSpecific Eligibility Criteria, Part C - Subjects must meet general eligibility criteria.Xx_NEWLINE_xXSpecific Eligibility Criteria, Part D - Subjects must meet general eligibility criteriaXx_NEWLINE_xXEligibility based on prior treatment with CIT depends on the mechanistic class of the drug and the cohort for which the participant is being considered, as described below. In addition, all criteria pertaining to adverse events attributed to prior cancer therapies must be met All Cohorts (Dose-Escalation in Phase 1a and Dose-Escalation, Backfill, and Expansion in Phase 1b):Xx_NEWLINE_xXOther protocol defined criteria may applyXx_NEWLINE_xXPatients may not have clinically symptomatic hypothyroidism; testing is not required for eligibilityXx_NEWLINE_xXAll patients must have evidence of progressive disease on study entry.Previously untreated patients who are not chemotherapy candidates on Arm 2 may have advanced disease (without clear progression). There is no upper limit on the number of prior treatments provided that all inclusion criteria are met and exclusion criteria are not met.Xx_NEWLINE_xXOngoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.Xx_NEWLINE_xXLaboratory values meeting the following criteria:Xx_NEWLINE_xXELIGIBILITY PRIOR TO INITIATING CT-011:Xx_NEWLINE_xXELIGIBILITY FOR 2.4 MG/KG DOSING IN THE NEW COHORTXx_NEWLINE_xXPatients eligible for HSCT at the time of screening. However, patients who meet one or both of the following criteria may be eligible for study participation:Xx_NEWLINE_xXHistologic confirmation not required if other diagnostic criteria are met;Xx_NEWLINE_xXNo concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteriaXx_NEWLINE_xXVital signs criteria defined as 3 or more of the following at Baseline:Xx_NEWLINE_xXLiver toxicity criteria based on local laboratory results obtained within 24 hours of Baseline:Xx_NEWLINE_xXMeet at least one of the criteria below:Xx_NEWLINE_xXPatients must meet criteria for acute lung injuryXx_NEWLINE_xXMM diagnostic criteria (all 3 required):Xx_NEWLINE_xXFailure to meet any of the criteria set forth in Section 3.1.Xx_NEWLINE_xXOther tumor histologies\r\n * Patients with tumor histologies not listed above will be considered on a case by case basis; to be eligible for this study, such patients must have an expected probability of survival =< 20% with other therapeutic modalities and must minimal disease criteria as defined in eligibility criteriaXx_NEWLINE_xXHigh risk renal cancer per modified UISS criteriaXx_NEWLINE_xXSTEP 1 ELIGIBILITY CRITERIAXx_NEWLINE_xXSTEP 2 ELIGIBILITY CRITERIAXx_NEWLINE_xXPatients who had prior lung resection are eligible provided they fulfill the rest of the eligibility criteriaXx_NEWLINE_xXSubject must meet all of the following criteria on the laboratory tests that will be performed within 7 days prior to enrollment. In case of multiple laboratory data within this period, the most recent data should be used.Xx_NEWLINE_xXPatients previously treated with carfilzomib are eligible as long as they meet the following criteria:Xx_NEWLINE_xXPatients must meet pre-entry requirementsXx_NEWLINE_xXCRITERIA FOR LEUKAPHERESIS:Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXREGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIAXx_NEWLINE_xXCenters that standardly use positron emission tomography (PET) or magnetic resonance spectroscopy (MRS) to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility; both PET and MRS are not mandatory for study eligibilityXx_NEWLINE_xXUsability Test interview participants must meet criteria above and may also include patients who have undergone one or more cycles of treatmentXx_NEWLINE_xXPatient eligibility criteria for entry into the project include:Xx_NEWLINE_xXFCG eligibility criteria include:Xx_NEWLINE_xXPatients already meeting the criteria for metabolic syndrome as defined by the Adult Treatment Panel III criteria which requires 3/5 parameters encompassing glucose control, blood pressure, lipids and waist circumference; patients with 2 of the parameters at baseline will be allowed enrollment provided that one of those risk factors is hypertension (>= 130/>= 85 mm Hg)Xx_NEWLINE_xXThrombocytopenia with untransfused platelet counts < 20 x 10^9/L in the out-patient or in the in-patient setting and one of the following criteria:Xx_NEWLINE_xXPatient’s disease status should meet criteria as outlined by institutional master protocolXx_NEWLINE_xXInclusion Criteria:\n\n        For inclusion in the study, patients should fulfill the following criteria:\n\n          1. Aged at least 18 years.\n\n          2. Histologically or cytologically documented Stage IV NSCLC.\n\n          3. Confirmed tumor PD-L1 status prior to randomization.\n\n          4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.\n\n          5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.\n\n          6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance\n             status of 0 or 1.\n\n          7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer\n             vaccines.\n\n        Exclusion Criteria:\n\n        Patients should not enter the study if any of the following exclusion criteria are\n        fulfilled:\n\n          1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.\n\n          2. Active or prior documented autoimmune or inflammatory disorders.\n\n          3. Brain metastases or spinal cord compression unless the patient's condition is stable\n             and off steroids.\n\n          4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human\n             immunodeficiency virus.Xx_NEWLINE_xXSubject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.Xx_NEWLINE_xXOne of the below criteria must be met based on patient's therapy:Xx_NEWLINE_xXPatients whose laboratory values do not meet protocol criteriaXx_NEWLINE_xXPATIENT ELIGIBILITY CRITERIAXx_NEWLINE_xXCAREGIVER ELIGIBILITY CRITERIAXx_NEWLINE_xXAre overweight or obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 25 kg/m^2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians’ clearance to assess full eligibility) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 inXx_NEWLINE_xXFCG has been invited to participate in the trial with a patient who meets eligibility criteriaXx_NEWLINE_xXMeet all screening requirementsXx_NEWLINE_xXIf a biological parent does not live in the home (or has died), the co-parent does not have to be a biological parent; therefore, co-parents may be step-parents, lesbian, gay, bi-sexual or transgender (LGBT) partners, grandparents, aunts, uncles, etc if they otherwise meet eligibility criteriaXx_NEWLINE_xXHSCT DYADS: Participants must not meet the exclusion criteria for HSCT patients and HSCT CGsXx_NEWLINE_xXMeet screening criteriaXx_NEWLINE_xXPHASE 1: PARENT ELIGIBILITY: Patient is at least 1.5 years from treatmentXx_NEWLINE_xXPHASE 2: PEER MENTOR ELIGIBILITY: At least 1.5 years from treatmentXx_NEWLINE_xXPHASE 2: PATIENT ELIGIBILITY: At least 1.5 years from treatmentXx_NEWLINE_xXCRITERIA FOR SURVIVORS:Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:Xx_NEWLINE_xXADDITIONAL CRITERIAXx_NEWLINE_xXMeet standard clinical criteria for being a caregiver (able to drive and take care of patient)Xx_NEWLINE_xXSubstance abuse or dependence or met criteria within past yearXx_NEWLINE_xXPatients must meet eligibility criteria for induction of myelosuppressive chemotherapy as defined by clinical standardsXx_NEWLINE_xXMeet the screening criteria for psychological distress (National Comprehensive Cancer Network (NCCN) distress > 2).Xx_NEWLINE_xXEligibility criteria same as stage IXx_NEWLINE_xXChildren who do not meet the above criteriaXx_NEWLINE_xXChildren who meet the above criteria, but whose treating oncologist advises against study participation for physical health, mental health (parent or child) or logistical reasonsXx_NEWLINE_xXMeet screening criteriaXx_NEWLINE_xXThe patient is enrolled on a COG trial that uses criteria for unrelated donor HSCT, which conflict with our eligibility criteriaXx_NEWLINE_xXPATIENTS ELIGIBILITY CRITERIAXx_NEWLINE_xXFOCUS GROUP (PHASE 1) ELIGIBILITY CRITERIA:Xx_NEWLINE_xXUSER/USABILITY TESTING (PHASE 2) ELIGIBILITY CRITERIA:Xx_NEWLINE_xXRANDOMIZED CONTROL TRIAL (RCT) (PHASE 3) ELIGIBILITY CRITERIA:Xx_NEWLINE_xXPATIENTS ELIGIBILITY CRITERIA:Xx_NEWLINE_xXCAREGIVERS ELIGIBILITY CRITERIA:Xx_NEWLINE_xXFor Aim 2, all patients must meet the following criteria:Xx_NEWLINE_xXPatients are to be excluded from randomization for Aim 2 of this study if they meet any of the following criteria:Xx_NEWLINE_xXKnown allergies to oxaliplatin (or other platinum agents), leucovorin, 5-FU, nab-paclitaxel (or other taxanes) or gemcitabine Exclusion Criteria Specific to Bevacizumab-Containign Arms (Arms A, B, and F) (Patients who meet any of the following criteria will be excluded from enrollment into bevacizumab-containing Arms A, B, and F:)Xx_NEWLINE_xXChronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID) Exclusions specific to Arms A and F (HCC) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arms A and F:)Xx_NEWLINE_xXPresence of islet cell neoplasms Exclusions Specific to Arm E (Metastatic Esophageal Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm E:)Xx_NEWLINE_xXClinicopathological diagnosis of Waldenstrom’s macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom’s macroglobulinemiaXx_NEWLINE_xXBlast count ? 20% (WHO criteria)Xx_NEWLINE_xXSubjects with bilateral disease are eligible if they meet other eligibility criteriaXx_NEWLINE_xXPATIENT PARTICIPANT ELIGIBILITY CRITERIA (PHASE 1 & 2)Xx_NEWLINE_xXCLINICIAN PARTICIPANT ELIGIBILITY CRITERIAXx_NEWLINE_xXSTAKEHOLDER PARTICIPANT ELIGIBILITY CRITERIAXx_NEWLINE_xXFamily caregiver identified by a lung cancer patient who meets the eligibility criteria listed aboveXx_NEWLINE_xXPATIENT ELIGIBILITY REQUIREMENTS:Xx_NEWLINE_xXFAMILY CAREGIVER ELIGIBILITY REQUIREMENTS:Xx_NEWLINE_xXONCOLOGIST ELIGIBILITY REQUIREMENTS:Xx_NEWLINE_xXBe planning to receive a conditioning regimen for stem cell transplant (SCT) consisting of cyclophosphamide and total body irradiation and must meet inclusion criteria for SCT which include:Xx_NEWLINE_xXPatients who are not eligible to receive SCT with cyclophosphamide and total body irradiation (TBI) conditioning because they do not meet transplant criteria are also not eligible for this phenylephrine studyXx_NEWLINE_xXPatients may undergo electrolyte repletion therapy to meet eligibility requirementsXx_NEWLINE_xXmeet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)Xx_NEWLINE_xXEligibility will not be restricted by race or sexXx_NEWLINE_xXParticipants must have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trialXx_NEWLINE_xXDONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donationXx_NEWLINE_xXIf women have had a hysterectomy and still have their ovaries, they must meet the FSH criteria described aboveXx_NEWLINE_xXPATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXPATIENT REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXGENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621 screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol; patients must be enrolled onto a subprotocol within 8 weeks (56 days) of treatment assignmentXx_NEWLINE_xXANNUAL SCREENING REGIMEN ELIGIBILITY CHECKXx_NEWLINE_xXParticipants must meet any one of the following 6 criteria:Xx_NEWLINE_xXMEDICAL ELIGIBILITY CRITERIA FOR PERTAINING TO HIGH RISK GROUPS UNDERGOING RPFNAXx_NEWLINE_xXSPECIMEN SUBMISSION AND SUBSTUDY CRITERIAXx_NEWLINE_xXREGULATORY CRITERIAXx_NEWLINE_xXSpecific Criteria by Stratum: Stratum 1: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1 must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s).Xx_NEWLINE_xXPATIENT ELIGIBILITY (AS PER SELF-REPORT)Xx_NEWLINE_xXHave a personal history of melanoma and/or family history of melanoma (see definition under child eligibility criteria below)Xx_NEWLINE_xXELIGIBILITY FOR THE OPTIONAL SUB-STUDYXx_NEWLINE_xXDaily smoker for ? 6 months, smoking approximately ? 5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependenceXx_NEWLINE_xXELIGIBILITY FOR THE 2-YEAR EXTENSIONXx_NEWLINE_xXGENERAL ELIGIBILITY (ALL PATIENTS):Xx_NEWLINE_xXELIGIBILITY FOR MYELOABLATIVE CONDITIONINGXx_NEWLINE_xXELIGIBILITY FOR REDUCED INTENSITY CONDITIONING:Xx_NEWLINE_xXDONOR: related donors must meet eligibility criteria as per BMT Standard Operating Procedures (SOP) 1002Xx_NEWLINE_xXIF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENTS ONLY NEEDS TO MEET INCLUSION CRITERIA 1 THROUGH 5AXx_NEWLINE_xXPatient is not enrolled on an investigational nonmyeloablative HCT protocol, in which case protocol 2546 serves as an independent primary treatment protocol and the patient must meet the following inclusion and exclusion criteria:Xx_NEWLINE_xXIF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENT ONLY NEEDS TO MEET EXCLUSION CRITERIA 1 THROUGH 3Xx_NEWLINE_xXDONOR: Failure to meet local criteria for stem cell donationXx_NEWLINE_xXEligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 monthsXx_NEWLINE_xXCompleted all eligibility questionsXx_NEWLINE_xXELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIALXx_NEWLINE_xXSubjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > 100 days prior to study enrolment, no active infection; subject meets the remainder of the eligibility criteria outlined in the study protocol.Xx_NEWLINE_xXA radiological diagnosis of recurrent/relapsed or progressive disease according to RANO criteria.Xx_NEWLINE_xXELIGIBILITY CRITERIA FOR NORMAL-WEIGHT WOMEN IN PILOT STUDYXx_NEWLINE_xXThe patient’s 4DCT-ventilation image meets the heterogeneity criteriaXx_NEWLINE_xXDo not fit age criteriaXx_NEWLINE_xXInclusion Criteria:\n\n          1. Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell\n             tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal\n             cancer) or Hodgkin's lymphoma\n\n          2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)\n\n          3. Eastern Cooperative Oncology Group (ECOG) performance status ? 2 (Appendix B: ECOG\n             Scoring)\n\n          4. Age ? 18 years\n\n          5. Ability to understand the purposes and risks of the trial and has signed a\n             IRB-approved informed consent form\n\n          6. Willingness and ability to comply with all protocol required procedures\n\n          7. For men and women of child-bearing potential, use of effective contraceptive methods\n             during the study\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following criteria will not be eligible for study entry:\n\n          1. Known infection with human immunodeficiency virus (HIV)\n\n          2. Serious nonmalignant disease or conditions that in the opinion of the investigator\n             and/or ImaginAb could compromise protocol objectives\n\n          3. Patients who have had splenectomy.\n\n          4. Patients who have any splenic disorders that in the opinion of the investigator and/or\n             ImaginAb could compromise protocol objectives.\n\n          5. Patients who are currently receiving any other investigational agent\n\n          6. Pregnant women or nursing mothers\n\n          7. Hepatic laboratory values:\n\n               1. Bilirubin > 1.5 x ULN (institutional upper limits of normal)\n\n               2. Albumin < 2 g/dL\n\n               3. Other local safety laboratory test results (clinical chemistry and hematology)\n                  are determined to be exclusionary by the Investigator.\n\n          8. Known sensitivity to glutamic acid or glutamate.Xx_NEWLINE_xXCastration-resistant disease according to PCWG2 criteriaXx_NEWLINE_xXLess than 1 year since cryotherapy, external beam radiation therapy, or HIFU, or 2 years since brachytherapy; does not meet above criteria of suspicious PSA elevationXx_NEWLINE_xXCRITERIA FOR HEALTHY VOLUNTEERS: Subject meets all criteria above but does not have a clinical diagnosis of respiratory diseaseXx_NEWLINE_xXPatients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteriaXx_NEWLINE_xXPatients must meet eligibility criteria for 131I-MIBG therapyXx_NEWLINE_xXDisease is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (1.1 or original version) or other tumor response criteria from an MSKCC Institutional Review Board (IRB)-approved clinical research protocol\r\n* This criterion does not apply to patients with myeloproliferative neoplasm; the presence of active myeloproliferative neoplasm will be determined by applicable disease-specific diagnostic criteria and patient assessment by the patient’s oncologist and trial investigators (eg, manifestations of active myeloproliferative neoplasm [MPN] such as splenomegaly, abnormal blood counts, etc)Xx_NEWLINE_xXPatients will be eligible for this study regardless of prior treatment, as long as they meet other eligibility criteria; therefore, patients who are newly diagnosed, post-operative, post-radiation or post-chemotherapy are eligibleXx_NEWLINE_xXDoes not meet above criteria of suspicious PSA elevationXx_NEWLINE_xXFor patients enrolled on the fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) trial (HRPO# 201201124), their eligibility would include eligibility from that trial as well as the inclusion criteria outlined aboveXx_NEWLINE_xXMeets the criteria below for the appropriate cohort:Xx_NEWLINE_xXSTEP 3: ELIGIBILITY CRITERIA PRIOR TO TREATMENT OR OBSERVATIONXx_NEWLINE_xXSubject must meet the following criteria as indicated on the clinical laboratory tests:Xx_NEWLINE_xXDoes not meet histologic criteriaXx_NEWLINE_xXSubjects must satisfy one of the following conditions pertaining to their eligibility to undergo orthotopic liver transplantation (OLT):\r\n* HCC that is within Milan Criteria, i.e., TACE is indicated as a “bridge” to OLT (Group I); or\r\n* HCC that is outside Milan Criteria, i.e., TACE is indicated as a means of “down-staging” into transplant eligibility (Group II)Xx_NEWLINE_xX- Castration-resistant disease as defined by PCWG2 criteriaXx_NEWLINE_xXRequired patient clinical data is not available for evaluation of eligibility criteriaXx_NEWLINE_xXPatients with brain metastases are eligible provided they meet all other eligibility criteria and do not require corticosteroids or enzyme-inducing anticonvulsants and provided it is felt clinically that they will not require radiotherapy in the three (3) weeks subsequent to their participation in the studyXx_NEWLINE_xXThe participant must meet the following criteria relevant to their specific diagnosis:Xx_NEWLINE_xXPRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])Xx_NEWLINE_xXSECONDARY ELIGIBILITYXx_NEWLINE_xXHas met protocol-specified criteria for qualification and contraceptionXx_NEWLINE_xXMust meet at least 1 of the following 3 criteria for progressive metastatic disease, according to Prostate Cancer Working Group 2 (PCWG2) criteria:Xx_NEWLINE_xXPART A ELIGIBILITY CRITERIAXx_NEWLINE_xXPART B ELIGIBILITY CRITERIAXx_NEWLINE_xXWill include all prospective trial participants in this study that come from Twitter in response of our SM recruitment interventions, provided they meet the specific trial's eligibility criteriaXx_NEWLINE_xXPersons who do not meet the eligibility criteria of any of the trials open to accrual will be excluded from participation, and persons who may be eligible (e.g., disease/histology, stage, prior treatment) but do not meet additional trial-specific requirements such as insurance or allergy to drug)Xx_NEWLINE_xXInclusion and exclusion criteria for the ETRIC randomized study will be the same as the\n        eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901\n        (NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or\n        Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical,\n        BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared\n        to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free\n        Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility\n        criteria.\n\n        Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on\n        April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May\n        13, 2016.\n\n        Additional inclusion criteria specific for the ETRIC study will include:\n\n          1. Adult patients (? 18 years)\n\n          2. Speaking and reading proficiency in English (as most of this study's instruments have\n             not been translated and validated in languages other than English)\n\n          3. Willing and able to provide informed consent\n\n          4. Stated willingness to comply with study procedures and reporting requirements\n\n        Exclusion Criteria: N/AXx_NEWLINE_xXPBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.Xx_NEWLINE_xXPatients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:Xx_NEWLINE_xXAdditional Criteria for Patients Eligible to Restart DasatinibXx_NEWLINE_xXOther criteria may apply, please contact the investigator for additional informationXx_NEWLINE_xXOther criteria may apply, please contact the investigator for additional informationXx_NEWLINE_xXInclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have healthy peristomal skin\n\n          -  Are within 12 weeks post op\n\n        Exclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have a fistula, wound, lesion or suspected infection in the peristomal area\n\n          -  Are in-patient in healthcare facilityXx_NEWLINE_xXDemonstrate adequate organ function, all screening labs must be performed within 10 days of treatment initiation; labs must meet eligibility criteria within 4 days of cycle 1 day 1Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXREGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xXCRITERIA FOR PLASMA GENOTYPINGXx_NEWLINE_xXCRITERIA FOR SYSTEMIC THERAPY WITH ERLOTINIBXx_NEWLINE_xXHave a history of brain metastasis provided that all of the following criteria are met:Xx_NEWLINE_xX