Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessedXx_NEWLINE_xXPatients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard Food and Drug Administration (FDA)-approved systemic curative or palliative antitumor therapies do not exist or are no longer effective or for which MK-3475 (pembrolizumab) is FDA-approved as standard of care therapyXx_NEWLINE_xXPatients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:\r\n* Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR\r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survival\r\n* NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXPatients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR \r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survivalXx_NEWLINE_xXStandard risk 1: Patient must be < 11 years of age at enrollmentXx_NEWLINE_xXStandard risk 2: Patients must be >= 11 and < 25 years of age at enrollmentXx_NEWLINE_xXNo waiting period for patients who relapse while receiving standard maintenance therapyXx_NEWLINE_xXPatient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapyXx_NEWLINE_xXFor patients 65-69 years of age, patient must be deemed not suitable for standard intensive induction chemotherapy at the discretion of the local investigator, or must have refused standard intensive chemotherapyXx_NEWLINE_xXEligible for standard induction chemotherapy according to their treating physicianXx_NEWLINE_xXPatient must meet at least one of the following criteria: a. Progressed or recurrent despite standard therapy, b. No standard therapy exists for this malignancy, c. Patient is intolerant of standard therapy, d. Patient is not a candidate for standard therapy, e. For AML and MDS patients: patient is not a candidate for allogeneic hematopoietic stem cell transplantation, f, For sarcoma patients: f-1. Patient has disease that is metastatic or unresectable, f-2. Patient with metastatic disease has had at least one prior line of therapy for metastatic disease, f-3. No curative multimodality options existXx_NEWLINE_xXPhase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.Xx_NEWLINE_xXPatients with AML who are candidates for standard induction chemotherapy as first line treatment.Xx_NEWLINE_xXPart B: Participants with one histologically or cytologically confirmed malignant advanced solid tumor, for which no standard therapy is available which may convey clinical benefit and/or participants must have progressed after at least 1 prior chemotherapy regimen in the metastatic setting, and for which carboplatin (for Part B1), gemcitabine (for Part B2), or cisplatin (for Part B3) would be considered standard of care.Xx_NEWLINE_xXNeuroblastoma- Patients that have relapsed following standard of care therapy (such as high risk patients, patient presenting after age 15 months or MYCN amplified, and only following (for eligible patients) high-dose chemotherapy followed by hematopoietic stem cell transplantation and maintenance therapy with retinoic acid and antibody therapy) or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy.Xx_NEWLINE_xXMedulloblastomas (At relapse after standard of care therapy [surgery, chemotherapy and/or radiation] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXGliomas (At relapse after standard of care therapy [surgery and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXEpendymomas (At relapse after standard of care therapy [surgery with or without radiation] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXChoroid plexus tumors (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXCraniopharyngiomas (At relapse after standard of care therapy [surgery or suppressive therapy] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXDysembryoplastic neuroepithelial tumors (DNETs) (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXMeningiomas (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXPrimitive Neuroectodermal Tumors (PNETs) (At relapse after standard of care therapy [surgery, chemotherapy, and/or radiation] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXGerm cell tumors (At relapse after standard of care therapy [surgery, and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)Xx_NEWLINE_xXRenal Wilms tumor (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted chemotherapy) Renal cell carcinoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Malignant rhabdoid tumor (At diagnosis, as there is no known curative therapy) Clear Cell Sarcoma- (At relapse after standard of care therapy [radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Germ Cell tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)Xx_NEWLINE_xXLiver Tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)Xx_NEWLINE_xXFor sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria:\r\n* Patient is in second salvage or more and B1931022 has been considered and ruled out as a treatment option; OR\r\n* Patient was treated on the standard of care arm of B1931022 and failed therapyXx_NEWLINE_xX2. Part A, must have a histologically or cytologically documented, incurable, or metastatic solid tumor that has progressed on, or been intolerant to, all standard systemic therapy options for the tumor type in the metastatic setting, or must have a tumor type for which no such standard systemic option exists;Xx_NEWLINE_xXSubjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy existsXx_NEWLINE_xXPatients who, in the judgment of their treating physician, have available standard of care therapies will be excludedXx_NEWLINE_xXHas received at least 2 prior regimens of standard treatmentXx_NEWLINE_xXParticipants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologiesXx_NEWLINE_xXParticipants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy existsXx_NEWLINE_xXHER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXPatients not able to receive standard-dose cisplatin based on the judgement of the treating medical oncologistXx_NEWLINE_xXDiagnosis of advanced/metastatic solid malignancy for which no standard treatment option exists that will confer clinical benefitXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXPatients who are women of childbearing potential must have a negative pregnancy test documented =< 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of careXx_NEWLINE_xXTumor progression after receiving standard/approved chemotherapy or where there is no approved therapyXx_NEWLINE_xXMust have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate.Xx_NEWLINE_xX1. Written informed consent must be obtained prior to any screening procedures\n\n          2. Male or female patients ? 18 years of age who present with one of the following:\n\n             Arms 1-3:\n\n               -  Refractory/relapsed AML following ?1 prior therapies and are deemed by the\n                  investigator not to be candidates for standard therapy, including re-induction\n                  with cytarabine or other established chemotherapy regimens for patients with AML\n                  (patients who are suitable for standard re-induction chemotherapy or\n                  hematopoietic stem cell transplantation and willing to receive it are excluded)\n\n               -  De novo AML patients who are suitable for treatment with decitabine (patients who\n                  are suitable for standard induction chemotherapy or hematopoietic stem cell\n                  transplantation and willing to receive it are excluded)\n\n               -  High risk MDS (patients who are suitable for standard re-induction chemotherapy\n                  or hematopoietic stem cell transplantation and willing to receive it are\n                  excluded)\n\n             Arms 4-5:\n\n               -  Refractory / relapsed AML following ?1 prior therapies (Arms 4a & 5a)\n\n               -  High risk MDS who have failed hypomethylating agent therapy (Arms 4b & 5b) (Note:\n                  hypomethylating agent failure is defined as progressive disease on\n                  hypomethylating agent therapy or lack of clinically meaningful response as deemed\n                  by investigator after at least 4 cycles of hypomethylating agent therapy.)\n\n          3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 2\n\n          4. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to\n             the institutions guidelines and be willing to undergo a bone marrow aspirate\n             and/biopsy at screening, during and at the end of therapy on this study. Exceptions\n             may be considered after documented discussion with Novartis.\n\n          5. Arms 1-3: Patients must be fit for standard treatment with decitabine as determined by\n             the investigator and as per local decitabine package insert.Xx_NEWLINE_xXPART I: participants must have histologically confirmed malignancy that is metastatic or unresectable and resistant to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXFailure or intolerance to at least two prior lines of standard chemotherapies with each containing one or more of the following agents:Xx_NEWLINE_xXParticipants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.Xx_NEWLINE_xXProgressed following all standard of care therapies for advanced breast cancer. ORXx_NEWLINE_xXPatients must be candidates for standard of care treatment consisting of chemotherapy (cisplatin) and radiationXx_NEWLINE_xXPatients are eligible for available approved standard therapiesXx_NEWLINE_xXPatients with advanced/metastatic cancer, with measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant to standard therapy, and for whom no effective therapy is available. Patients must fit into one of the following groups:Xx_NEWLINE_xXDisease that has progressed on standard therapy or for whom there is no other therapy option availableXx_NEWLINE_xXHistologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effectiveXx_NEWLINE_xXCOHORT 2: Is eligible for treatment with a standard cytarabine and anthracycline or similar intensive induction chemotherapy, or is willing to receive intensive induction therapy; if subject is not considered eligible for treatment with standard or similar intensive induction chemotherapy due to comorbidities or other factors, or is unwilling to receive intensive induction therapy will be allowed to participate in this studyXx_NEWLINE_xXPatients without a curative therapy or whose tumor does not have standard chemotherapyXx_NEWLINE_xXReceived standard of care treatment for primary malignancy and standard of care treatment for relapsed cancerXx_NEWLINE_xXPatients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.Xx_NEWLINE_xXHistologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of careXx_NEWLINE_xXFor all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.Xx_NEWLINE_xXHave documented relapse or refractoriness after at least 1 line (MB and ARMS subjects) or 2 lines (NB and ES subjects) of standard-of-care therapy, including each of the following:Xx_NEWLINE_xXHistologically-diagnosed, advanced Gl tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Dose Expansion Phase)Xx_NEWLINE_xXHistologically-diagnosed advanced colorectal tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Phase 1b)Xx_NEWLINE_xXDiagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXDose escalation phase only: Subject not responding to standard therapy or for whom no standard treatment existsXx_NEWLINE_xXDose expansion phase: Subject not responding to standard therapy or for whom no standard treatment exists with:Xx_NEWLINE_xXAllowable prior therapy\r\n* Phase 1: Progressed on standard of care therapy, if one is available\r\n* Phase 2: MPNST with 0-3 prior cytotoxic systemic therapies (no prior radiotherapy is necessary)Xx_NEWLINE_xXPatients who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option; eligible patients should not have available therapies that will convey clinical benefitXx_NEWLINE_xXDocumented radiographic or clinical disease progression on no more or less than one previous line of standard therapyXx_NEWLINE_xXPatients must have a histologically confirmed nonhematological, metastatic or locally advanced, incurable malignancy for which paclitaxel is clinically appropriate. Patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligible.Xx_NEWLINE_xXAML SA expansion group 1: histologically or cytologically proven AML with a FLT3 ITD or TKD mutation previously determined by local testing that is R/R to standard therapy or for whom standard treatments are contraindicatedXx_NEWLINE_xXAML SA expansion group 2: histologically or cytologically proven AML with intermediate or unfavorable risk cytogenetics in the absence of a detectable FLT3 ITD or TKD mutation as previously determined by local testing that is R/R to standard therapy or for whom standard treatments are contraindicatedXx_NEWLINE_xXAML/MDS combination treatment (dose escalation and expansion): histologically or cytologically proven AML or MDS as defined by WHO criteria and IPSS-R, respectively, that is: R/R to standard therapy, or AML: who are unfit for, or unwilling to receive standard induction therapy, or MDS: eligible to receive azacitidineXx_NEWLINE_xXHistological documentation of locally advanced, recurrent or metastatic solid malignancy that has progressed after standard therapy appropriate for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Subjects should not have received more than 5 prior lines of therapy for advanced disease including both standards of care and investigational therapies. Subjects whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority approved appropriate targeted therapy for their tumor types before enrollment.Xx_NEWLINE_xXPresence of at least one measurable lesion according to RECIST v1.1. c-i) FGF401 single agent-Phase I and Phase II, Group 3: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists. c-ii) FGF401 single agent-Phase II, Groups 1 and 2: HCC patients previously treated with sorafenib for advanced HCC with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment c-iii) FGF401 in combination with PDR001:Advanced HCC patients who have received up to 2 previous lines of systemic treatment and one treatment must have included sorafenib with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatmentXx_NEWLINE_xXHistopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.Xx_NEWLINE_xXPathologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.Xx_NEWLINE_xXHistologic evidence of advanced solid tumors (excluding central nervous system (CNS) primary tumors) non-resectable, refractory to standard therapies, or patient cannot receive or refuses standard therapy.Xx_NEWLINE_xXPatients with AML refractory to primary induction chemotherapy, relapsed disease, or age >= 60 and not appropriate for standard cytotoxic therapy due to age, performance status, and/or adverse risk factors according to the treating physicianXx_NEWLINE_xXFor solid tumors other than melanoma, (in Part 4 or 5 [dose confirmation only]), participants must have a malignancy that is incurable and has either: (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participants and treating physician. There is no limit to the number of prior treatment regimens, but prior treatment(s) should not include compounds targeting programmed cell death 1 (PD-1), PD-1 ligand 1 (PD-L1), BRAF, or mitogen-activated protein kinase (MEK). Treatment must end at least 4 weeks prior to randomization.Xx_NEWLINE_xXhave metastatic or unresectable advanced solid tumors that have recurred or progressed following standard therapy orXx_NEWLINE_xXno longer be candidates for standard therapy orXx_NEWLINE_xXhave tumors for which there is no standard therapyXx_NEWLINE_xXHas a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available. Subjects with melanoma who are ineligible to receive or have declined ipilimumab treatment, or who are refractory or intolerant to ipilimumab may enroll.Xx_NEWLINE_xXPatients must have histopathologically /cytologically confirmed advanced solid tumor which is refractory to standard therapeutic options, or for which there are no standard therapeutic options, or for whom paclitaxel is an appropriate palliative treatment option (patients for whom paclitaxel or nab-paclitaxel are established treatment options with a proven survival benefit in first line will be excluded)Xx_NEWLINE_xXAll subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.Xx_NEWLINE_xXParticipants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologiesXx_NEWLINE_xXHave a histologically confirmed diagnosis of an advanced solid tumor or lymphoma that has progressed in spite of at least one prior line of treatment, and for which additional effective standard therapy is not available. For this study, effective standard therapy is defined as treatment that has been shown to be curative and/or to prolong survival. In addition, subjects who are considered to not be candidates for standard therapy or who decline standard therapy are eligible for this study; in such cases, documentation of the reason for omitting or declining a standard therapy is required.Xx_NEWLINE_xXA patient with low grade glioma who has failed standard therapyXx_NEWLINE_xXReceived 1 or 2 prior standard of care regimens for advanced or metastatic diseaseXx_NEWLINE_xXParticipant must have metastatic CRPC or AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants with AML who are candidates for stem cell transplantation must have been offered this therapeutic option. Must meet additional criteria specific for each diagnosis, metastatic CRPC and relapsing/remitting AML, as described in the protocol.Xx_NEWLINE_xXHistologically confirmed diagnosis of advanced or metastatic solid tumors, disease should have progressed following at least one line of therapy and no other standard therapy with proven clinical benefit is availableXx_NEWLINE_xXAt least one line of prior combination and no other standard therapy with proven clinical benefit is available.Xx_NEWLINE_xXMust have received at least one prior line chemotherapy regimen and no other standard therapy with proven clinical benefit is available.Xx_NEWLINE_xXHistologically or cytologically confirmed solid tumors of the types specified below, with incurable, locally advanced or metastatic disease that has failed standard therapy or for which no standard treatment option exists. For Ovarian CancerXx_NEWLINE_xXProgression after standard systemic therapy or a lack of available effective therapy, in the assessment of the Investigator.Xx_NEWLINE_xXProgression after standard systemic therapy or a lack of available effective therapy, in the assessment of the Investigator.Xx_NEWLINE_xXPatients must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma if standard treatment is appropriate. Treatment naive patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.Xx_NEWLINE_xXDeemed a suitable candidate for radiation therapy by the treating radiation oncologist as documented in a standard pretreatment visit per standard practice at each participating institutionXx_NEWLINE_xXPrior standard or investigational anti-cancer therapy, as specified below:Xx_NEWLINE_xXstandard of care androgen deprivation treatmentXx_NEWLINE_xXParticipants must have received, and then progressed, relapsed, or been intolerant to, all standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy existsXx_NEWLINE_xXExpansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.Xx_NEWLINE_xXMen and Women > 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status < 2; 2a. Eligibility: U.S. Sites Includes subjects with loco-regional disease that have relapsed/recurred within 6 months of chemo-radiation and who have no standard of care. Includes patients (subjects) with metastatic disease having injections into only superficial lesions that have failed (includes progression, relapse or intolerance) or not be a candidate for approved therapies. Note, patients (subjects) that have approved therapies available, which might confer clinical benefit, may be enrolled as long as the physician properly explains the nature of the treatment, and obtains consent \. Includes patients (subjects) with metastatic disease having at least one deep tumor injection who have failed (includes progression, relapse or intolerance) all approved lines of therapy prior to enrollment unless they are not an appropriate candidate for a particular approved therapy or no approved therapy exists. Note: There is no limit on the number of prior therapies that a patient (subject) may have received prior to enrollment in any cohort. 2b. Eligibility: Canadian Sites Subjects with advanced or metastatic solid tumors that have disease progression after treatment with approved, available therapies (in site's country) for the cancer type or for whom available therapies have limited benefit and the subject refuses the available therapy. Includes subjects with locoregional disease that have relapsed/recurred within 6 months of chemo-radiation; or who have no standard of care or beneficial options. No limit on the number of prior treatments;Xx_NEWLINE_xXHas failed (refractory) or relapsed after no more than 2 prior regimens, and for whom for whom no other standard therapy options are available.Xx_NEWLINE_xXHistological or cytological diagnosis of advanced/metastatic solid tumor malignancy; or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is available..Xx_NEWLINE_xXno standard therapeutic options available (to be supplemented)Xx_NEWLINE_xXPatients must have histologically confirmed metastatic or unresectable malignancy that is refractory to standard therapy or for which no standard therapy exists and where irinotecan is deemed a reasonable treatment optionXx_NEWLINE_xXParticipants who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible participants should not have available therapies that will convey clinical benefit and/or are not suitable options per the treating physician's judgmentXx_NEWLINE_xXHistologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriateXx_NEWLINE_xXStandard treatment is not availableXx_NEWLINE_xXTreatment with targeted agents, immunotherapy, or hormones is allowed; patients are only eligible if they have received and failed, or have been intolerant to standard treatments known to confer clinical benefitXx_NEWLINE_xXDose escalation cohorts of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor, who have progressed despite standard therapy, or for whom no standard therapy is available.Xx_NEWLINE_xXDose expansion groups of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ053 single agent no treatment with an anti-PD-L1 inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups:Xx_NEWLINE_xXMalignancies for which there is no standard therapy, or previously treated locally advanced, refractory/relapsed or metastatic disease for which local curative surgery, curable radiotherapy, or satisfactory systemic anticancer therapy is no longer availableXx_NEWLINE_xXParticipants must have a pathologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.Xx_NEWLINE_xXPatients must have histological diagnosis of melanoma or non-small cell lung cancer (biopsy will be done per standard of care, if needed to prove metastatic melanoma and/or NSCLC as well as for clinically relevant mutation analysis); additional biopsy will be per standard of careXx_NEWLINE_xXAll melanoma patients may be tested for BRAF as part of routine standard of care, but is not a requirement for the trial; all NSCLC patients may be tested for with EGFR and ALK as part of standard of care, but is not a requirement of the trialXx_NEWLINE_xXNot pregnant per radiation oncology standard proceduresXx_NEWLINE_xXPhase 1a: histological or cytological confirmation of a solid, malignant tumor, excluding CNS tumors, that is refractory to standard therapies or for which no standard therapies exist.Xx_NEWLINE_xXPatients must have previously received and progressed on standard-of-care therapy(ies).Xx_NEWLINE_xXPatients with other immune checkpoint naïve histologically/ cytologically confirmed advanced solid tumor type that has received and progressed on standard-of-care therapy(ies).Xx_NEWLINE_xXMust have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.Xx_NEWLINE_xXThe patient must have histologic or cytologic evidence of a malignant solid tumor and must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit.Xx_NEWLINE_xXMale or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapyXx_NEWLINE_xXPhase I Extension and Phase II: Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapyXx_NEWLINE_xXAll patients participating in this clinical trial must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Histologically confirmed solid malignancy that is metastatic or unresectable for which\n             standard curative or palliative measures do not exist or are no longer effective (Dose\n             Escalation phase only)\n\n          -  Measurable disease according to RECIST v 1.1\n\n          -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n\n          -  Normal organ and marrow function\n\n        Dose Expansion phase specific additional inclusion criteria:\n\n          -  Patients with metastatic colorectal cancer with no available therapy options that are\n             known to provide clinical benefit per institutional standard of care. (colorectal\n             cancer cohort only)\n\n          -  Patients must have a histologically confirmed epithelial ovarian cancer, primary\n             peritoneal cancer or fallopian tube solid tumor cancer that is locally advanced or\n             metastatic with no available therapy options that are known to provide clinical\n             benefit per institutional standard of care. (ovarian cancer cohort only)\n\n          -  Patients must have histologically or cytologically confirmed cervical squamous cell\n             carcinoma that is locally advanced or metastatic with no available therapy options\n             that are known to provide clinical benefit per institutional standard of care.\n             (cervical cancer cohort only)\n\n          -  Patients must have histologically or cytologically confirmed head and neck squamous\n             cell carcinoma that is locally advanced or metastatic with no available therapy\n             options that are known to provide clinical benefit per institutional standard of care.\n             (various solid tumors cohort: head and neck squamous cell carcinoma groups only).\n\n          -  Patients must have received prior therapy with an anti-PD-1 or anti-PD-L1 antibody, or\n             previously participated in Merck MK 3475 clinical trials. Patients must have\n             experienced documented, confirmed radiographic progression of disease by iRECIST, or\n             by RECIST v1.1 (various solid tumors cohort head and neck squamous cell carcinoma,\n             Check point inhibitor experienced group only).\n\n          -  Patients must have histologically or cytologically confirmed small cell lung carcinoma\n             that is locally advanced or metastatic with no available therapy options that are\n             known to provide clinical benefit per institutional standard of care. (various solid\n             tumors cohort, SCLC group only)\n\n          -  Patients must have histologically or cytologically confirmed cholangiocarcinoma that\n             is locally advanced or metastatic with no available therapy options that are known to\n             provide clinical benefit per institutional standard of care. (various solid tumors\n             cohort, cholangiocarcinoma group only)\n\n          -  Patients must have histologically or cytologically confirmed mesothelioma that is\n             locally advanced or metastatic with no available therapy options that are known to\n             provide clinical benefit per institutional standard of care. (various solid tumors\n             cohort, mesothelioma group only)\n\n          -  Patients must have histologically or cytologically confirmed carcinoma of the\n             esophagus including the gastroesophageal junction that is locally advanced or\n             metastatic with no available therapy options that are known to provide clinical\n             benefit per institutional standard of care. (various solid tumors cohort,\n             gastroesophageal carcinoma group only)\n\n        Exclusion Criteria:\n\n        Exclusion criteria apply to all phases and cohorts in the study unless otherwise stated\n\n          -  Prior monoclonal antibody, within 4 weeks prior to first dose of study drug.\n\n          -  Prior chemotherapy, targeted small molecule therapy or radiotherapy within 2 weeks\n             prior to first dose of study drug.\n\n          -  Patients who have received any other investigational agents within 4 weeks of first\n             dose of study drug.\n\n          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic\n             T-lymphocyte-associated antigen-4 (CTLA-4) antibody. (Not applicable for various solid\n             tumors cohort, head and neck squamous cell carcinoma check-point inhibitor experienced\n             group)\n\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\n             composition to birinapant or pembrolizumab or their constituents.\n\n          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic\n             congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia,\n             autoimmune disease or inflammatory diseases, or psychiatric illness/social situations\n             that would limit compliance with study requirements.\n\n          -  Evidence of active, non-infectious pneumonitis or a history of interstitial lung\n             disease.\n\n          -  Known history of Human Immunodeficiency Virus (HIV (HIV1/2 antibodies), or Active\n             Hepatitis B (HBsAg reactive. Active Hepatitis C (HCV-RNA qualitative).\n\n          -  Currently breast feeding, pregnant or planning to conceive or father Children from\n             screening through 120 Days after last dose of study drug.\n\n          -  Patients who have received anti-PD-L2, anti-CD137, or anti-Cytotoxic\n             T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other\n             antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\n             (Various solid tumor cohort, head and neck squamous cell carcinoma check point\n             inhibitor experienced group only)Xx_NEWLINE_xXDisease status: patients with malignancy are to be referred in remission for evaluation, except in cases of virus-associated malignancy who may be referred at any time; should a patient have progressive disease or a donor becomes unavailable after enrollment, the patient will be referred back to his/her primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease under the current study, although this should only occur as a bridge to transplant; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off the study; patients receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocolXx_NEWLINE_xXCMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatmentXx_NEWLINE_xXSubject has any evidence of metastatic disease (pre-operative staging will be undertake per urologic standard of care) as deemed by the InvestigatorXx_NEWLINE_xXProgression on standard therapy, not a candidate for further chemotherapy or patient declines other optionsXx_NEWLINE_xXPatients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapyXx_NEWLINE_xXMust have received appropriate standard of careXx_NEWLINE_xXrecurrent/refractory disease after they received at least one prior standard treatment regimenXx_NEWLINE_xXPatients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not considered a standard curative optionXx_NEWLINE_xX(Part 1 only) Have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.Xx_NEWLINE_xXAdvanced stage solid tumors as documented by histological or cytological evidence, with no available approved therapies known to cure metastatic disease or extend survival, and who have received all standard therapy.Xx_NEWLINE_xXPatients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.Xx_NEWLINE_xXPhase I: histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options existXx_NEWLINE_xXPatients must have histologically confirmed solid tumors for which all standard therapy known to prolong survival have failed or for which standard therapies do not existXx_NEWLINE_xXDiagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy existsXx_NEWLINE_xXPART I: Recurrent or progressive disease on prior standard therapies with known clinical benefit with the exception of adjuvant bladder cancer populationXx_NEWLINE_xXPatient must have an advanced (metastatic or recurrent) pathologically proven solid tumor which has not responded to standard therapy or which has progressed following standard therapy for advanced disease and/or for which no standard therapy is known to be effective; patients in expansion cohort A must have accessible tumor for biopsyXx_NEWLINE_xXCOHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Patients with evidence of portal hypertension must have had an esophagogastroduodenoscopy (EGD) within last year with appropriate treatment of esophageal varices as per standard of careXx_NEWLINE_xXPatients must have disease that is no longer considered responsive to available conventional modalities or treatments (failed any known standard curative or effective therapy for that disease).Xx_NEWLINE_xXAll patients must be refractory to approved standard systemic therapy; specifically:\r\n* Metastatic colorectal patients must have received oxaliplatin or irinotecan\r\n* Hepatocellular carcinoma patients must have received sorafenib (Nexavar) since level 1 data support a survival benefit with this agent\r\n* Breast and ovarian cancer patients must be refractory to both first (1st) line and second (2nd) line treatments and must have received at least one second line chemotherapy regimen\r\n* Patients with recurrent glioblastoma that have received standard surgery, radiation therapy, and chemotherapy for their primary tumors and require resection of their tumors for palliative or other clinical indications; these patients will not undergo surgery solely for treatment on this protocolXx_NEWLINE_xXProgressive disease following at least one first line standard therapy.Xx_NEWLINE_xXRelapsed following or progressed through standard therapyXx_NEWLINE_xXHave a disease for which no standard effective therapy exists (i.e., a therapy that demonstrates a significant increase in survival)Xx_NEWLINE_xXDisease that is refractory to or relapsed from either a hypomethylating agent (e.g. decitabine or azacitidine) or a standard AML-type intensive regimenXx_NEWLINE_xXAt least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroidsXx_NEWLINE_xXFor the cohort 1, eligible patients must have a histologically, cytologically or radiographically proven metastatic or locally advanced solid tumor of any type, for which there is no curative standard therapy or standard therapy has failedXx_NEWLINE_xXCurrent use of a non-standard dialysis membraneXx_NEWLINE_xXNon-GCB of origin by standard immunohistochemical classificationXx_NEWLINE_xXSubjects must have progressed on or after standard first-line systemic chemotherapyXx_NEWLINE_xXLocally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment optionXx_NEWLINE_xXPatients for whom no standard curative therapy existsXx_NEWLINE_xXHave undergone appropriate standard of care treatment options (in the opinion of the treating investigator); participants with non-small cell lung carcinoma (NSCLC) must have undergone EGFR and ALK testing and have received appropriate initial therapyXx_NEWLINE_xXPatients must have a diagnosis of a solid tumor malignancy and is refractory to standard therapies who have relapsed after standard therapy, or whose cancers have no standard therapy.Xx_NEWLINE_xXFor the dose escalation phase: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor and have failed available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.Xx_NEWLINE_xXPart A of the study will include patients that have histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.Xx_NEWLINE_xXPreviously untreated patients who decline standard therapy for their cancer are allowed to enrollXx_NEWLINE_xXSubjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); any patient that refuses standard chemotherapy for the treatment of their disease is also considered eligible; prior adjuvant therapy will not count provided it was completed more than 6 months previouslyXx_NEWLINE_xXRefractory to approved standard systemic therapy; specifically\r\n* Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan\r\n* Patients with breast and ovarian cancer must be refractory to both 1st line and 2nd line treatments\r\n* Patients with lung cancer must have received at least one platinum-based chemotherapy regimen and at least one Food and Drug Administration (FDA) approved targeted treatment (when appropriate)\r\n* Patients with glioblastoma must have progression of disease after radiotherapy (including patients that undergo surgery for recurrent disease and are rendered no evidence of disease [NED]); this includes recurrent glioblastoma (GBM) after receiving all standard first-line treatment, including surgery (if feasible due to neurosurgical and neuro-anatomical considerations) and adjuvant radiotherapy +/- chemotherapyXx_NEWLINE_xXHistologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapyXx_NEWLINE_xXHas relapsed from or is refractory to standard treatment or for which no standard treatment is availableXx_NEWLINE_xXSubject has histologic or cytologic confirmation of metastatic NSCLC. Subjects must have a TPS score available as determined by an FDA approved test. Subject has stable disease or disease progression and is being treated with pembrolizumab therapy as standard of care by the Investigator.Xx_NEWLINE_xXMedically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physicianXx_NEWLINE_xXPathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.Xx_NEWLINE_xXPatients must have had at least two prior chemotherapeutic or biologic (e.g. rituximab alone) regimens and not currently eligible for standard curative options; steroids alone and local radiation do not count as regimensXx_NEWLINE_xXSubjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.Xx_NEWLINE_xXPatients for whom other curative or established standard-of-care therapeutic options with acceptable morbidity existXx_NEWLINE_xXPatient must have recurrent or advanced cancer (i.e., solid tumors) for whom standard therapy offers no curative potential.Xx_NEWLINE_xXSubjects must not have received any prior standard or investigational anti-tumor therapy other than surgery and must not intend to receive any standard or investigational anti-tumor therapy other than the study regimenXx_NEWLINE_xXPrior use of any standard or investigational anti-tumor therapy other than surgeryXx_NEWLINE_xXMust have refused standard of care chemotherapy for metastatic diseaseXx_NEWLINE_xXPatients must be considered candidates for prostatectomy as per standard of careXx_NEWLINE_xXSurgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiationXx_NEWLINE_xXPrior treatment with sipuleucel-T (on clinical trial or as part of standard of care)Xx_NEWLINE_xXHave evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)Xx_NEWLINE_xXAML that is refractory to or relapsed after standard induction therapy.Xx_NEWLINE_xXSubjects with histologically or cytologically proven advanced or metastatic solid malignancies for whom no effective standard therapy exists or has failed or subjects who are intolerant to established therapy known to provide clinical benefit for their condition (dose escalation cohorts; Part I).Xx_NEWLINE_xXAll patients must be refractory to approved standard systemic therapyXx_NEWLINE_xXHave had at least 1 prior line of standard therapyXx_NEWLINE_xXFor the Western safety cohort only: participants with locally advanced or metastatic solid tumor for whom no standard treatment with an established survival benefit is available or if the participant refuses other standard therapy.Xx_NEWLINE_xXSubject has received at least one prior standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy.Xx_NEWLINE_xXParticipants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimenXx_NEWLINE_xXPresence of circulating blasts (in the blood) detected by standard pathology for patients with AML, ALL or CMLXx_NEWLINE_xXFailure to respond to standard of care checkpoint blockade therapy or previously responding patients who progress on checkpoint blockade therapyXx_NEWLINE_xXOnly patients who are relapsed, refractory, or intolerant of standard AML therapy will be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy)Xx_NEWLINE_xXPatients who have received and failed, or have been intolerant to, standard first line therapies known to confer clinical benefit; patients who refuse standard therapy would also be eligible, as long as their refusal is documentedXx_NEWLINE_xXPatients must have a history of tumor progression or relapse or failure to achieve complete response following standard high-dose induction chemotherapyXx_NEWLINE_xXDiagnosis of O-AML that is refractory to or intolerant to standard therapy and is no longer likely to respond to such therapy (at least one line of therapy); or Diagnosis of MDS/CMML that is refractory to or intolerant to standard therapy and is no longer likely to respond to such therapy (at least one line of therapy)Xx_NEWLINE_xXPatients must have progressive tumor growth after having received established standard of care treatment for their diseaseXx_NEWLINE_xXPatients with advanced cancer that is refractory to standard therapy, or that has either relapsed after standard therapy or has no standard therapy that increases survival by at least three monthsXx_NEWLINE_xXAt least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2)Xx_NEWLINE_xXPrior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumorXx_NEWLINE_xXMust be refractory or intolerant to standard lines of therapyXx_NEWLINE_xXMeets standard of care to undergo embolizationXx_NEWLINE_xXAny patient not meeting institutional standard guidelines for transplant eligibilityXx_NEWLINE_xXFollow standard of care donor eligibility procedure, outlined in the standard operation procedure (SOP)Xx_NEWLINE_xXThis study will include all patients clinically suspected or histologically confirmed solid or hematological malignancy who have undergone or will undergo genetic testing of their tumor; patients may have failed first-line or standard therapy for their disease (refractory) or have no options for curative therapies; rare cancers that are metastatic at diagnosis are by definition refractory and may be included in the first line setting, at the discretion of the principal investigators; rare cancers may not have standard of care therapies - a disease/tumor is considered rare if the incidence is < 6/100,000/year using the National Cancer Institute (NCI) RareCare tumor list, or if the disease is a molecular or biologically defined subset such that the annual incidence is < 20,000 in the United StatesXx_NEWLINE_xXPatients with histologically confirmed inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have either:\r\n* Failed to respond to standard therapy or\r\n* For whom no standard therapy is available or\r\n* Refuse to receive standard therapiesXx_NEWLINE_xXCompletion of at least one standard of care IV chemotherapy course; hematologic recovery must be confirmed prior to study entry;Xx_NEWLINE_xXTo commence first-line standard nab-paclitaxel and gemcitabine chemotherapy, or gemcitabine alone, (per standard of care according to the approved prescribing schedule), within 7 to 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycleXx_NEWLINE_xXBeing considered for trabectedin as standard of careXx_NEWLINE_xXPatients must be planning to undergo standard radiation/chemotherapyXx_NEWLINE_xXPlanning to undergo additional treatment for the brain tumor other than standard of careXx_NEWLINE_xXPatients may be enrolled in any line of standard treatment (without investigational agents); the start date of current treatment should be at least two 2 weeks or more prior to registration; (Note: patients will continue to receive the planned active treatment with chemotherapy or endocrine therapy [standard of care] and initiate denosumab at the recommended dose for this protocol)Xx_NEWLINE_xXHave evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)Xx_NEWLINE_xXSubjects with advanced or metastatic solid tumors that are refractory to standard therapies known to provide clinical benefit. Subjects with hematologic malignancy including lymphoma/myeloma will not be enrolled on this study.Xx_NEWLINE_xXPatients with advanced solid tumors that are refractory to approved therapy and have had at least one line of systemic treatment with chemotherapy, immunotherapy, hormonal therapy, or other standard treatments for metastatic diseaseXx_NEWLINE_xXPatients must have disease that has relapsed after or is refractory to at least 2 lines of standard therapy; the remaining standard treatment options are unlikely to be effective in the opinion of the treating physician, or patient is felt to be ineligible for such therapies or the patient refuses such therapies; patients who have undergone autologous stem cell transplant are eligible as long as they meet all other criteriaXx_NEWLINE_xXProgression following standard combined modality treatment with radiation and temozolomide chemotherapyXx_NEWLINE_xXAny candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumorsXx_NEWLINE_xXDuring dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimenXx_NEWLINE_xXRefractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. Prior use of cisplatin (or carboplatin) is permitted.Xx_NEWLINE_xXArm A dose escalation: patients with histologically or cytologically proven advanced solid tumors for which standard treatments are not available, or for whom the current dose level of cisplatin in combination with pemetrexed is appropriate; =< 2 prior cytotoxic chemotherapy regimenXx_NEWLINE_xXPatients must have a diagnosis of advanced or metastatic malignancy that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXTumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatmentXx_NEWLINE_xXSubjects must have a histologically or cytologically proven advanced solid tumor malignancy for which palliative radiation is recommended. In solid tumors where pembrolizumab has been approved for use, patients may receive pembrolizumab as indicated, in the context of this protocol; in solid tumors where pembrolizumab has not been approved for use, the following criteria apply:\r\n* Patients must be resistant to at least 1 prior conventional chemotherapy regimen or other standard of care regimen,\r\n* Patient must have no remaining conventional treatment options proven to provide long-term disease control, and\r\n* Patient has declined other conventional treatment options\r\nPalliative radiation therapy may be recommended for primary tumor and/or any metastatic site that is accessible to biopsyXx_NEWLINE_xXHas a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently existsXx_NEWLINE_xXAll patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.Xx_NEWLINE_xXMust be eligible for treatment with nivolumab as standard of careXx_NEWLINE_xXFor Phase I portion: patient must be a candidate for nivolumab as standard of care regardless of line of therapy; for Phase II portion: patient must be a candidate for nivolumab as second-line therapy for advanced stage NSCLCXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three monthsXx_NEWLINE_xXRecurrent or refractory disease for which no further effective standard treatment is availableXx_NEWLINE_xXIf an approved first-line standard therapy for the patient’s tumor is available, subjects must have failed, be intolerant to, be ineligible for, or have refused that treatment; enrollment of patients for whom no standard therapy exists or who decline standard therapy should be discussed with the principal investigator prior to enrollment; patients must have progressive disease on study entryXx_NEWLINE_xXAll patients must have received prior first line standard therapy or declined standard therapyXx_NEWLINE_xXPatients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurredXx_NEWLINE_xXMust have received and have progressed, are refractory or intolerant to standard therapy appropriate for the specific sarcoma subtype, if there is a standard therapy for the subtype (i.e. progressing well-differentiated liposarcoma, clear cell sarcoma etc do not require prior therapy)Xx_NEWLINE_xXPatients for whom no standard curable therapy existsXx_NEWLINE_xXDiagnosis of one of the following: 1. Part 1: Histologically- or cytological-confirmed diagnosis of non-resectable or metastatic solid malignancy. At the time of enrollment, subjects either: have progressed on prior therapy (radiographic documentation of progression is adequate for study participation) AND have no standard-of-care therapy that would be expected to achieve a durable clinical response, OR refuse standard therapy, OR are not candidates for standard therapy, OR have a disease for which no generally-accepted standard-of-care exists. 2. Part 2: Histologically- or cytologically-confirmed diagnosis of metastatic or non-resectable triple-negative breast cancer (TNBC) (estrogen receptor [ER]-/ progesterone receptor [PR]-/Human Epidermal Growth Factor Receptor 2 [Her2]-, as defined by local laboratory standards); metastatic or non-resectable transitional cell carcinoma of the bladder, ureter, or renal pelvis; recurrent GBM; or non-Hodgkin's lymphoma. At the time of enrollment, subjects either: have progressed on prior therapy (radiographic documentation of progression is adequate for study participation) AND have no standard-of-care therapy that would be expected achieve a durable clinical response, OR refuse standard therapy, OR are not candidates for standard therapy.Xx_NEWLINE_xXPHASE I: Patients must have advanced solid tumor that is resistant or refractory to standard therapyXx_NEWLINE_xXRecurrence or progression of disease (confirmed by MRI and measurable by RANO criteria) following receipt of standard of care therapy, which includes maximum safe surgical resection, standard adjuvant radiation/temozolomide treatment. Participants must have completed at least 21 days of temozolomide treatment in combination with radiation therapy to be considered to have received standard of care therapy.Xx_NEWLINE_xXFailure to respond to standard therapy, or for whom standard or curative therapy does not exist, or is not tolerable. a. Subjects enrolled in the Expanded Cohort should have no more than 3 prior systemic regimens with confirmed disease progression. If the subject is refractory or has disease progression within 6 months of the adjuvant treatment, then the previous treatment should be considered as the line of treatment rather than an adjuvant therapy.Xx_NEWLINE_xXDose Escalation Cohort: Patients must have a diagnosis of a histologically confirmed solid tumor that is incurable and refractory to standard therapy or for which no standard therapy existsXx_NEWLINE_xXSubjects with solid tumor types other than TNBC may also be enrolled after discussion with the sponsor; these subjects must have a diagnosis of a histologically confirmed solid tumor that is incurable and refractory to standard therapy or for which no standard therapy existsXx_NEWLINE_xXEligible for and planning to receive standard fractionated RT with concurrent TMZXx_NEWLINE_xXBe within 6 months (+/-1 week) between last dose of an immunotherapy agent and study enrollment\r\n* Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiationXx_NEWLINE_xXPatients with HM, as previously defined, without confirmed response to standard, first-line antineoplastic therapy, and/or who do not fulfill all Inclusion Criteria as stated, will be ineligible to participate in this study.Xx_NEWLINE_xXThe patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel.Xx_NEWLINE_xXPatients must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not existXx_NEWLINE_xXHistologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three monthsXx_NEWLINE_xXSubjects must be planning to start standard of care radiation therapy and chemotherapyXx_NEWLINE_xXPatients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapyXx_NEWLINE_xXPatients must have histologically (or cytologically)-confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available.Xx_NEWLINE_xXFailed any previous front line standard of care therapy that is currently used for the patient’s initial diagnosisXx_NEWLINE_xXPatients must be irinotecan refractory; patients must have progressed on prior irinotecan therapy but must be able to tolerate standard irinotecan dosesXx_NEWLINE_xXPatients who are refusing first line standard of care chemotherapyXx_NEWLINE_xXSolid tumor specific:\r\n* Patients must have a histologically/cytologically confirmed primary solid tumor\r\n* Radiographic or clinical evidence of advanced/metastatic disease that is resistant to standard therapy or for which no standard therapy is available; lesions may be measurable or non-measurableXx_NEWLINE_xXAgree to attend study visits outside of standard of care visits, if neededXx_NEWLINE_xXPatients who have known allergic reactions to paclitaxel or IV contrast dye despite standard prophylaxisXx_NEWLINE_xXEvidence of disease by standard morphologic or by minimal residual disease (MRD) criteriaXx_NEWLINE_xXPatient has an advanced malignancy that has progressed or recurred following standard therapy for advanced disease, and for which no curative therapies are available.Xx_NEWLINE_xXHistologically or cytologically documented, locally advanced or metastatic solid malignancy that has progressed on available standard systemic therapy, and for whom no effective therapy or standard of care exists.Xx_NEWLINE_xXComplete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.Xx_NEWLINE_xXEGFR wt as per patient standard of care by a validated testXx_NEWLINE_xXAND ALK-negative rearrangement as part of the patient standard of care by a validated testXx_NEWLINE_xXRelapsed disease after standard chemotherapyXx_NEWLINE_xXCancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with REGN2810Xx_NEWLINE_xXPatients for whom there is no further standard therapy available at the time of enrollment (Part A)Xx_NEWLINE_xXHave refused standard therapyXx_NEWLINE_xXFor which there are no standard therapies available (Cohorts 1, 3, 4 and 5)Xx_NEWLINE_xXProgressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.Xx_NEWLINE_xXPHASE I COMPONENT: Histologic confirmation of relapsed/refractory solid tumors, including tumors of the central nervous system that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist; patients with diffuse pontine glioma are not required to have histologic confirmation of disease, and are eligible with radiologic confirmationXx_NEWLINE_xXPHASE I: Patients with clear cell RCC must have either declined, be ineligible to receive, have progressed on, or be intolerant to high dose interleukin (IL)-2 , or standard first and second line VEGF, or mechanistic target of rapamycin (mTOR) targeted agents; as there is no standard therapy for metastatic non-clear cell RCC, no prior therapy is requiredXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment existsXx_NEWLINE_xXELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Recurrent, refractory or relapsed advanced stage melanoma defined as progression of disease through standard therapy or patient choice to not receive standard therapy; for those that received standard systemic therapy, treatment agents may have included (but are not limited to) ipilimumab or vemurafenib (for those patients that are BRAF v600e positive)Xx_NEWLINE_xXFailure to respond to or refractory to approved/standard therapy; or for whom standard therapy does not exist, or is not tolerable; or for whom approved/standard therapy is not considered to be sufficient or appropriate by the Investigator.Xx_NEWLINE_xXCarboplatin and/or paclitaxel defined by the Investigator based on the Food and Drug Administration (FDA) approved labeling or institutional standard of care (SOC)Xx_NEWLINE_xXAdvanced solid tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available\r\n* Note: patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administeredXx_NEWLINE_xXPatients with refractory or recurrent solid tumors for which there is no standard therapy are eligible; patients must have had histologic verification of malignancy at original diagnosis or at the time of relapseXx_NEWLINE_xXPatients must have relapsed or refractory acute leukemias or high-risk MDS for which no standard therapies are anticipated to result in a durable remissionXx_NEWLINE_xXPatients must have had a previous histological verification of a solid tumor at the original diagnosis and/or recurrence including brain tumors; for patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived; the patient’s disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressiveXx_NEWLINE_xXPROCUREMENT: Cancer is:\r\n* Recurrent or persistent after standard therapy OR\r\n* Patient is unable to receive standard therapyXx_NEWLINE_xXTREATMENT: Cancer is:\r\n* Recurrent or persistent after standard therapy OR\r\n* Patient is unable to receive standard therapyXx_NEWLINE_xXPatients with a recurrent/metastatic or refractory solid tumor that has progressed or did not respond to standard therapy, or for which no standard anticancer therapy exists or is too toxicXx_NEWLINE_xXDiagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that has failed or become intolerant to standard therapyXx_NEWLINE_xXCompleted all standard of care therapy (surgery + radiation as clinically necessary) prior to vaccinationXx_NEWLINE_xXJudged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium-223 treatmentXx_NEWLINE_xXPatients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of standard chemotherapyXx_NEWLINE_xXDocumented progression of disease according to RECIST v1.1 following primary standard of care (e.g. erlotinib, gefitinib) Group 2 patients:Xx_NEWLINE_xXAutoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapyXx_NEWLINE_xXPatient is suitable to receive standard chemotherapy with radiation during weeks 2-7 (e.g. cisplatin+ etoposide or carboplatin+paclitaxel)Xx_NEWLINE_xXCandidate for known standard therapy for the patient’s disease that is potentially curativeXx_NEWLINE_xXPatients with an advanced solid tumor that is refractory to standard treatment, or for which no standard therapy is available, or the subject refuses standard therapyXx_NEWLINE_xXHave failed, or could not tolerate, other standard of care therapiesXx_NEWLINE_xXFailed at least one standard chemotherapeutic treatment for NSCLCXx_NEWLINE_xXPatients must have pathologically-confirmed solid tumors, refractory after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available.Xx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy or relapsed after standard therapy; patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effectiveXx_NEWLINE_xXPatients who have completed standard of care and recovered with mild to no residual toxicity from recent therapyXx_NEWLINE_xXPatients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurredXx_NEWLINE_xXHCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.Xx_NEWLINE_xXPatients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurredXx_NEWLINE_xXFor initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy; patients with persistent human polymavirus type II (JC) virus infection will be eligible as wellXx_NEWLINE_xXPatients may have had any number of prior systemic therapies; patients need not have exhausted standard therapy for their disease, but must be stable and must not have actively progressingXx_NEWLINE_xXPatient has received at least one prior standard chemotherapy or targeted therapy for treatment of lung cancerXx_NEWLINE_xXIf prior standard-of-care pre-treatment biopsy is inadequate for analysis by immunohistochemistry, and the patient is unwilling to undergo an additional biopsy procedureXx_NEWLINE_xXHave histologic or cytological proof of advanced cancer that has progressed and for which there is no further standard anticancer therapy available in the opinion of the investigator.Xx_NEWLINE_xXProgression by RANO criteria following all standard treatment options with known survival benefitXx_NEWLINE_xXRECIPIENT: Patients are to be referred in remission for evaluation; should a patient have progressive disease, or a donor becomes not available after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the principal investigator (PI)/lead associate investigator (LAI), then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocolXx_NEWLINE_xXFailure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any phase of standard therapy (any new lesion or an increase in size > 25% of a pre-existing lesion); patients may enter this study with or without re-induction therapy for recurrent tumorXx_NEWLINE_xXPatients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of < 10%; examples include:\r\n* Neuroblastoma or ganglioneuroblastoma\r\n** Failure to achieve at least a partial response (PR) after induction therapy with Children’s Oncology Group (COG) ANBL0532 or standard chemotherapy\r\n** Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy\r\n** Patients with high risk disease whose autologous peripheral blood stem cell product is contaminated with neuroblastoma or who do not have an autologous product available\r\n** Patients with high risk disease who do not meet eligibility requirements/organ function requirements for myeloablative conditioning\r\n** Patients with >= 5 identified lesions on the end of induction (COG ANBL0532 or standard chemotherapy) meta-iodobenzylguanidine (MIBG) scan \r\n* Stage 4 rhabdomyosarcoma\r\n* Metastatic Ewing sarcoma\r\n* Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection\r\n* Hepatoblastoma not amenable to resection\r\n* Metastatic melanoma\r\n* Desmoplastic small round cell tumor\r\n* Brain tumors such as astrocytic tumors, oligodendroglial tumors, ependymal tumors, choroid plexus tumors, other neuroepithelial tumors, neuronal and mixed neuronal-glial tumors, tumors of the pineal region, embryonic tumors\r\n* Any other solid tumor and soft tissue sarcoma with an estimated < 10% chance of survival will be considered on a case by case basis at the departmental tumor board and/or sarcoma meetingXx_NEWLINE_xXCohort B: newly diagnosed AML, failed to achieve complete remission (CR) with single standard induction chemotherapy (chemo)Xx_NEWLINE_xXRelapsed/refractory to at least one prior standard systemic treatment regimen, but no more than 4.Xx_NEWLINE_xXPatients with GI disorders who have failed standard therapyXx_NEWLINE_xXPatients who have known allergic reactions to IV contrast dye despite standard prophylaxisXx_NEWLINE_xXPatients must have had, or refused first-line standard chemotherapy for their inoperable malignanciesXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three monthsXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response of at least 10% or improves survival by at least three months; in addition, patients with disease that are “benign” by pathology, but relentlessly progressive, leading to disability, pain, and premature death in the majority of cases (including, but not limited to lymphangioleiomyomatosis [LAM], type 2 neurofibromatosis [NF], Erdheim Chester disease, and Castleman’s disease) may also be considered for enrollmentXx_NEWLINE_xXPatients with advanced or metastatic cancers and BRAF mutations that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months; patients with BRAF mutation in cell free deoxyribonucleic acid (DNA) (tested in Clinical Laboratory Improvement Amendments [CLIA] lab) are also eligibleXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXPatients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with principal investigator (PI)Xx_NEWLINE_xXPatients must have either (1) refractory or relapsed high-risk NB (including v-myc myelocytomatosis viral related oncogene [MYCN]-amplified stage 3/4/4S and MYCN-nonamplified stage 4 in patients greater than 18 months of age) resistant to standard therapy, or (2) refractory or relapsed GD2-positive tumor after receiving available life-prolonging therapies\r\n* For NB, standard therapy generally includes 5-8 cycles of high dose induction chemotherapy followed by resection of gross residual tumor, then usually myeloablative chemotherapy with peripheral blood stem cell rescue and radiation therapy to the primary site; there are also salvage chemotherapy regimens for residual disease after standard induction therapy or for relapsed NB; some examples of these chemotherapy combinations are: high-dose cyclophosphamide, topotecan and vincristine; high-dose cyclophosphamide, irinotecan and vincristine; irinotecan and temozolomide; or ifosfamide, carboplatin and etoposideXx_NEWLINE_xXPatients must have failed standard therapy and at the time of study entry have recurrent, progressive or refractory disease with no known curative optionsXx_NEWLINE_xXEvidence that the tumor MGMT promoter is unmethylated by standard of care assaysXx_NEWLINE_xXMust not be a candidate for potentially curative therapy or standard-of-care approved therapyXx_NEWLINE_xXUnresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.Xx_NEWLINE_xXPart 2: Subjects with HNSCC, NSCLC, pancreatic ductal adenocarcinoma, salivary gland cancer, and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, have been intolerant to treatment, or have refused standard treatment.Xx_NEWLINE_xXAdditional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.Xx_NEWLINE_xXFor both the extension and expansion cohorts, patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients (pancreatic and esophageal cancers) must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy; patients (breast, ovarian and gastrointestinal cancers) must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapyXx_NEWLINE_xXDiagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantationXx_NEWLINE_xXDuring the Dose Escalation Phase: only adult patients with active disease failing standard therapyXx_NEWLINE_xXPatients with malignancy are to be referred in remission for evaluation, except in the case of viral associated malignancies; should a patient have progressive disease or a donor becomes unavailable after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the principal investigator (PI)/lead associate investigator (LAI), then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocolXx_NEWLINE_xXFor tumors other than DSRCT, patients must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy or < 20% chance of long term disease-free survivalXx_NEWLINE_xXSubjects must have primary or metastatic liver malignancies for which are surgically unresectable, and exhausted all standard therapeutic options to be eligible for this studyXx_NEWLINE_xXHistologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies, or for which no standard therapies exist; disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\r\n* For the non-small cell lung cancer (NSCLC) expanded cohort only: only histologically proven adenocarcinoma that is refractory to standard therapiesXx_NEWLINE_xXPatients will undergo standard pre-transplant work-up as dictated by standard practice guidelines the results of which may be used for screening for this studyXx_NEWLINE_xXStage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapyXx_NEWLINE_xXMust have a history of tumor progression or recurrence or failure to achieve complete response with standard therapyXx_NEWLINE_xXno standard therapy optionsXx_NEWLINE_xXUnresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failedXx_NEWLINE_xXPhase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ? 1 prior line of therapy.Xx_NEWLINE_xXDisease that has progressed after standard therapies or for which standard therapy is otherwise unsuitable (example, intolerance).Xx_NEWLINE_xXProgressive disease after failure of or intolerant to all available standard systemic treatments that have shown a documented benefit in overall survival for their respective tumor type.Xx_NEWLINE_xXReceipt of all standard therapies for the tumor type:Xx_NEWLINE_xXMust have had all standard approved and unapproved therapies as deemed appropriate by the treating physician.Xx_NEWLINE_xXPatients who refuse standard therapy are excluded from the studyXx_NEWLINE_xXDose escalation: Patients with accessible tumors and with measurable disease as determined by RECIST 1.1 who have received at least one but no more than three prior lines of treatment for their disease and progressed despite standard treatment or are intolerant of standard treatment, or for whom no standard treatment existsXx_NEWLINE_xXDose expansion: Patients with advanced/metastatic solid tumors: head and neck squamous cell carcinoma (HNSCC), melanoma, accessible tumors and visceral tumors (LHC165 combination with PDR001 only). Patients must have measurable disease as determined by RECIST 1.1, and have progressed despite standard treatment or are intolerant to standard treatment, or for whom no standard treatment exists and have received at least one but no more than three prior lines of treatment for their disease.Xx_NEWLINE_xXMismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or Epstein-Barr virus positivity as determined by in situ hybridization or other institutional standardXx_NEWLINE_xXPatients must have metastatic disease that is either refractory to standard therapy or for which no effective standard therapy that confers clinical benefit is availableXx_NEWLINE_xXnewly diagnosed untreated AML in patients ? 65 years of age, if they are not candidates for standard available induction chemotherapyXx_NEWLINE_xXPatients with confirmed diagnosis of advanced malignancy, whose disease failed to respond to or progressed after standard therapy; they could not tolerate standard therapy; or such measures are not acceptable to the subject.Xx_NEWLINE_xXHas disease that is refractory to or intolerable with standard treatment, or for which no standard treatment is availableXx_NEWLINE_xXHave a histologically confirmed diagnosis of an advanced and/or metastatic solid tumor that is relapsed and/or refractory to standard therapy, as defined as progression on at least one prior line of therapy in the relapsed/metastatic setting and no existing options are felt to provide clinical benefit.Xx_NEWLINE_xXPatient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXPatients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.Xx_NEWLINE_xXPatients without confirmed progressive and/or refractory SM using standard RECIST criteria, or those with confirmed progressive and/or refractory SM using standard RECIST criteria.Xx_NEWLINE_xXHas histologically or cytologically confirmed advanced, unresectable metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit, or for which paclitaxel is considered a standard of care.Xx_NEWLINE_xXMust be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failedXx_NEWLINE_xXPatients must be refractory or intolerant to at least 1 prior standard systemic therapy, if a candidate for systemic therapyXx_NEWLINE_xXSubjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapyXx_NEWLINE_xXHistologically or cytologically confirmed malignancy or lymphoproliferative disorder known to over express CK2 which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available, including the following types: (examples)Xx_NEWLINE_xXStandard of care medical management of current prostate cancer disease status by the patient’s local oncologist, e.g. androgen deprivation therapy is allowedXx_NEWLINE_xXMust not be a candidate for potentially curative therapy or standard-of-care approved therapy.Xx_NEWLINE_xXPatient has a desire to preserve organ, understanding the risks of delaying standard of careXx_NEWLINE_xXMust have received or been intolerant to standard therapy.Xx_NEWLINE_xXFor the dose escalation part: Patients with histologically confirmed, locally advanced or metastatic solid tumors who are not candidates for or refuse standard therapy or whose disease progressed and for which standard anti-cancer treatment is no longer effective, excluding primary brain or spinal tumors.Xx_NEWLINE_xXFor the dose expansion part: Patients with histologically confirmed, locally advanced or metastatic urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra who are not candidates for or refuse standard therapy or whose disease progressed and for which standard anticancer treatment is no longer effective.Xx_NEWLINE_xXDose escalation cohort: histologically or cytologically confirmed diagnosis of a solid tumor that can be treated with either pembrolizumab or nivolumab as part of standard of care or whom no standard of therapy exists except pembrolizumab or nivolumabXx_NEWLINE_xXPatients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options existXx_NEWLINE_xXPatients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options existXx_NEWLINE_xXSubject’s current disease state must be one for which there is no known curative therapy, or in the case of a new diagnosis there must be ? 15% chance of cure if given standard-of-care chemotherapy (prognosis to be determined at the discretion of the treating physician)Xx_NEWLINE_xXFor the expansion cohort of non-small cell lung cancer (NSCLC) patients previously treated with and having progressed on immunotherapy patients must have no standard of care option available or have contraindications to such treatment (including those who decline such treatment)Xx_NEWLINE_xXEligible for checkpoint inhibitor immunotherapy (pembrolizumab) per standard of careXx_NEWLINE_xXFOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): The patient PDXs must have generated informative mouse xenograft data during Part 1 to participate in Part 2.Xx_NEWLINE_xXFOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): Patients must have adequate organ function for drugs(s) or combination being utilized (dependent on the drug (s) being given).Xx_NEWLINE_xXPatient has advanced or metastatic breast cancer that is refractory to at least one standard therapy or that has relapsed after standard therapy or that has no standard systemic therapy that increases survival by at least 3 months.Xx_NEWLINE_xXPatients are eligible if they are going to receive TMZ as part of the standard adjuvant treatment regimen following concomitant TMZ/radiation therapy (RT)Xx_NEWLINE_xXSolid tumor malignancy for which no standard of care therapy is available which has a proven overall survival benefitXx_NEWLINE_xXTreatment with bisphosphonates or denosumab is allowed and recommended per the standard of careXx_NEWLINE_xXPatient must have non-resectable disease that has progressed following standard therapy or has not adequately responded to standard therapy, or the patient must be intolerant to or have declined available standard therapies, or there must be no accepted standard therapy for their disease.Xx_NEWLINE_xXFor the dose escalation part: Patients with selected, relapsed solid tumors who have failed available standard therapy or who are not candidates for standard therapy.Xx_NEWLINE_xXFor the expansion part: Patients with relapsed, advanced and/or metastatic solid tumors who are not candidates for standard therapyXx_NEWLINE_xXPatients with T cell and natural killer (NK) cell lymphomas must be refractory to, be intolerant of, have relapsed following, or have refused all standard life-prolonging therapiesXx_NEWLINE_xXFor stratum A, patients must have local recurrent disease (defined as negative spine magnetic resonance imaging [MRI] and negative cytology within 21 days prior to study registration) and undergo resection of local recurrence as part of their standard of care; children must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapyXx_NEWLINE_xXOne of the following:\r\n* Age >= 60 years\r\n* Age < 60 years but unsuitable for standard chemotherapy because of a cardiac ejection fraction of < 50%, a pulmonary diffusion capacity < 80%, or a creatinine clearance >= 30 and < 60 mL/min, or refused standard chemotherapy despite efforts to convince them otherwiseXx_NEWLINE_xX< 60 years who are considered candidates for standard chemotherapyXx_NEWLINE_xXPhase 1: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists, or infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies, and for which no standard or available curative therapy exists, or patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection. The Phase I dose escalation cohorts are closed to enrollment. In addition to the above stated Inclusion Criteria, patients eligible for enrollment into this cohort must have a malignancy with a documented NTRK gene fusion with the exception of patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer. Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS.Xx_NEWLINE_xXPatients must have relapsed after or be refractory to effective standard therapies; for NF1 PN there is no standard medical therapy, and therefore no requirement for prior therapy; there are no limits on number of prior therapeutic regimensXx_NEWLINE_xXStandard, curative or palliative measures do not exist or are no longer effectiveXx_NEWLINE_xXTUMOR BIOPSY SEQUENCING: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survivalXx_NEWLINE_xXTREATMENT: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy or for which no standard therapy exists that has been shown to prolong survivalXx_NEWLINE_xXPHASE I: Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy definitely capable of extending life expectancy does not existXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXDOSE ESCALATION COHORT: Subjects with advanced and unresectable solid tumor who progressed on at least one line of systemic therapy, and no approved therapy or standard therapy with demonstrated clinical benefit exists; and all subjects with T790M mutation positive NSCLC have progressed on osimertinib\r\n* Note: disease measurability is not required for dose escalationXx_NEWLINE_xXSubjects must be diagnosed with a glioma, cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteinsXx_NEWLINE_xXPatients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:\r\n* Non-M3 AML refractory to standard primary induction therapy \r\n* Non-M3 AML relapsed after (i) any standard induction therapy (ii) any number of standard or experimental salvage therapies\r\n* Newly diagnosed non-M3 AML not eligible for intensive induction chemotherapyXx_NEWLINE_xXSubjects who are suitable for and willing to receive standard intensive induction therapyXx_NEWLINE_xXPatients must have had, or refused first-line standard chemotherapy for their inoperable malignanciesXx_NEWLINE_xXCohort 1 (dose escalation): histologic or cytologic proof of any solid tumor that is incurable with no standard therapy that is likely to make a major impact on clinical outcomesXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curativeXx_NEWLINE_xXAbility to tolerate intensive therapy with vosaroxin 90 mg/m^2 and standard dose of cytarabine as per investigator discretionXx_NEWLINE_xXPatients must have pathologically confirmed diagnosis of a solid tumor cancer for which there is no known standard therapy capable of extending life expectancyXx_NEWLINE_xXHistologically or cytologically proven diagnosis of hematologic malignancies for whom all standard therapy options have failedXx_NEWLINE_xXMalignancy that is incurable and for which standard (FDA approved or established standard clinical practice) curative, or palliative measures do not exist or are no longer effectiveXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy; EXCEPTION: For platinum-resistant ovarian cancer, because nab-paclitaxel has known benefit, patients who may benefit from standard single agent chemotherapy are also eligible to participateXx_NEWLINE_xXSubjects must be within 4 to 6 weeks of standard of care treatment for their particular stage of diseaseXx_NEWLINE_xXSubjects must not be more than 6 weeks from standard of care treatment for their particular stage of diseaseXx_NEWLINE_xXCOHORT I (DOSE ESCALATION): histologic proof of cancer that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapyXx_NEWLINE_xXCOHORT I (DOSE ESCALATION): known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXAdvanced or metastatic cancer for which no standard therapy exists or that has\n             progressed despite standard therapyXx_NEWLINE_xXProgression on, or intolerance of, or ineligibility for all standard therapiesXx_NEWLINE_xXSTANDARD RISK PATIENTS:Xx_NEWLINE_xXBoth patients who will and will not receive standard of care concomitant mitomycin C are eligible to enroll in this studyXx_NEWLINE_xXAdvanced (unresectable) solid tumors: patients must have failed or been intolerant to at least one line of standard therapy or refuse standard treatmentXx_NEWLINE_xXPatients must have advanced/metastatic solid malignancy or lymphoma for which no standard treatment option exists that will confer clinical benefitXx_NEWLINE_xXDOSE ESCALATION PHASE: Histological or cytopathological diagnosis of an advanced cancer that is refractory to standard therapy or for which no standard therapy existsXx_NEWLINE_xXPatients with histologically confirmed inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have either:\r\n* Failed to respond to standard therapy or\r\n* For whom no standard therapy is available or\r\n* Refuse to receive standard therapies\r\n** The study is intended to enroll patients with melanoma, renal cell, and pancreatic cancer; patients with other types of solid tumors will require approval by the principal investigatorXx_NEWLINE_xXAny standard therapy for leukemia within 14 days before enrollment (except for hydrea)Xx_NEWLINE_xXMust have prior biopsy at any time point diagnostic for confirmed MF stage IIA-IVA, and must have failed at least one standard therapy (topical or systemic); this is mandatoryXx_NEWLINE_xXPatients must have adequate TIL available as described in the Moffitt Cell Therapy Core standard operating procedures (SOP)Xx_NEWLINE_xXReceived at least one prior treatment with standard therapy (previous antibody\n             therapy is acceptable)Xx_NEWLINE_xXSubjects with advanced refractory cancer for which standard curative or palliative\n             measures do not exist or are no longer effective. There is no limitation on the\n             number or types of prior therapy.Xx_NEWLINE_xXHistologic proof of cancer which is now not amenable to alternative curative or clearly superior standard treatment optionsXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXPatients with histologically or cytologically proven advanced solid cancer and have undergone treatment with at least one regimen of standard therapy, either cytotoxic chemotherapy, a molecularly targeted agent, or immunotherapy, or have a form of cancer for which no standard therapy exists; patients with prostate cancer may continue on androgen-deprivation therapy if they are currently receiving itXx_NEWLINE_xXHistologic or cytologic confirmation of a solid malignancy with established intolerance or refractoriness to standard therapiesXx_NEWLINE_xXPatients must have histologically proven solid tumors (Phase I) with biopsiable tumor (expansion cohort) refractory to standard therapy or for whom no standard therapy exists or who decline standard therapyXx_NEWLINE_xXMedulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligibleXx_NEWLINE_xXEligibility for brachytherapy is determined per clinical standard of careXx_NEWLINE_xXPatients must have received at least one prior standard systemic therapy with documented recurrent or refractory diseaseXx_NEWLINE_xXPotential patients referred for the study may not be eligible for the experimental protocol therapy due to reasons such as uncertainty about donor HLA typing or need to control malignant disease, infection, or metabolic abnormality such as hypercalcemia on an emergent basis; should a referred patient present to us in such a scenario, the patient will be referred back to their primary hematologist-oncologist for treatment; however, if referral back to the referring physician is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease or complicating conditions (infection, metabolic problems) under the current study; in other cases, a patient may have reasonable control of malignancy but does not meet the CD4 cell cut-off of 100 cells per microliter required for cohort 3 therapy (or, absolute lymphocyte count [ALC] value of < 300); in such cases, standard care chemotherapy regimens may be administered for the specific goal of reducing the CD4 count (that is, immune depleting regimens such as the pentostatin plus cyclophosphamide combination, administered similar to the manner that we have developed on protocol 08-C-0088); if it becomes apparent that the patient will not be able to proceed to experimental therapy, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol; because such standard care therapy is not experimental, it is not necessary to complete the eligibility criteria prior to receiving such standard care; however, prior to initiation of the experimental therapy, the patient must meet each of the eligibility criteria detailed above; attempts will be made to standardize such pre-transplant chemotherapy (by administration of EPOCH-FR chemotherapy); however, other regimens using approved agents will be allowed if such regimens are thought to be in the best interest of the patientXx_NEWLINE_xXSubject did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A subject eligible for standard therapy must receive at least one cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject.Xx_NEWLINE_xXHas relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretionXx_NEWLINE_xXAdvanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.Xx_NEWLINE_xXPlan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:\r\n* Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors\r\n* Denosumab or bisphosphonates to treat metastatic bone diseaseXx_NEWLINE_xX1c. Colorectal Cancer -Enrollment Completed Metastatic or recurrent; prior treatment progression during, after, or intolerant following the last administration of approved standard therapies (required therapies apply).Xx_NEWLINE_xXLocally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatmentXx_NEWLINE_xXPatients must have recurrent/progressive high-risk neuroblastoma, refractory high-risk neuroblastoma that had less than a partial response to standard treatment or persistent high-risk neuroblastoma that had at least a partial response to standard treatment.Xx_NEWLINE_xXDuring dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimenXx_NEWLINE_xXAcute Minnesota Standard Risk GVHD requiring systemic immune suppressive therapy.Xx_NEWLINE_xXAntiviral therapy per local standard of care if active hepatitis B (HBV) infection.Xx_NEWLINE_xXSubjects who are not eligible for standard chemotherapyXx_NEWLINE_xXHistologic documentation of locally advanced, recurrent or metastatic incurable solid malignancy that has progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriateXx_NEWLINE_xXHistologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed, or in patients otherwise ineligible for standard therapy, or for an indication that anti-programmed cell death protein 1 (PD-1) therapy has been shown to be effective in studies in HIV-uninfected participants; disease-specific criteria will be applied for certain common cancers and cancers strongly associated with HIV; however, enrollment will not be confined to these tumorsXx_NEWLINE_xXSubjects must have received and have progressed, or are refractory to standard regimensXx_NEWLINE_xXEscalation Phase [Inclusion]\n\n          -  Locally advanced or metastatic adult solid tumor that has progressed or was\n             nonresponsive to available therapies, are unfit for standard chemotherapy or for which\n             no standard or available curative therapy exists;\n\n          -  ECOG score of 0, 1 or 2;\n\n          -  Adequate hematologic, hepatic, and renal function;\n\n        Expansion Phase [Inclusion]\n\n          -  Escalation Phase inclusion criteria\n\n          -  Evidence of the NTRK fusion as previously determined with prior testing from a\n             Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent certified\n             laboratory.\n\n        Exclusion (for both Escalation and Expansion)\n\n        • Current treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor or inducer (EIAEDs\n        and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed)Xx_NEWLINE_xXHas previously untreated AML and is considered to be at high risk for disease progression and/or is unlikely to derive more than transient benefit from standard therapy by having at least one of the following:Xx_NEWLINE_xXHas previously untreated AML and is considered to be at high risk for disease progression and/or is unlikely to derive more than transient benefit from standard therapy by having at least one of the following:Xx_NEWLINE_xXPhase I only: any (or no) prior therapy for metastatic disease is allowed, including cetuximab; if a patient has not received prior standard therapy, s/he must have been offered and refused prior standard therapyXx_NEWLINE_xXPart 2: *Note: Subjects must have failed available therapies that are known to confer clinical benefit as indicated below, unless they are ineligible, intolerant, or refused standard treatment.Xx_NEWLINE_xXSubjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.Xx_NEWLINE_xXSubject has HBV DNA viral load undetectable or < 100 IU/mL at screening. If subject has detectable HBsAg, HBeAg, or HBV DNA (indicating ongoing viral replication of hepatitis B, he/she must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. If not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines prior to C1D1 and must be willing to continue antiviral therapy while on study treatment.Xx_NEWLINE_xXSubjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For patients who are normocalcemic, therapy can be initiated at the time the patient initiates study drugXx_NEWLINE_xXPrimary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR.Xx_NEWLINE_xXHistologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of careXx_NEWLINE_xXHistologically or cytologically confirmed diagnosis of advanced solid tumors that have relapsed from or are refractory to standard treatment or for which no standard treatment is availableXx_NEWLINE_xXDiagnosis - Dose Escalation Phase: Histologically or cytologically confirmed diagnosis of advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available.Xx_NEWLINE_xXConfirmed diagnosis of advanced malignancies that may be controlled with p70S6K or Akt inhibition based on already identified molecular alteration known to affect the PAM pathway, such as:: such as: such as: phosphate and tensin homolog (PTEN), phosphoinositide 3-Kinase catalytic subunit alpha isoform (PIK3CA), protein kinase B 1 (Akt 1), Akt 3, mammalian target of rapamycin (mTOR), tumor sclerosis complex 1 (TSC1), tumor sclerosis complex 2 (TSC2), in subjects who have received at least all treatment options considered to be standard therapy, unless some available treatment are not acceptable to the subject. For the dose escalation portion of the trial, subjects must have received the standard therapy unless intolerant or contraindicated.Xx_NEWLINE_xXAutoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy.Xx_NEWLINE_xXPathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment.Xx_NEWLINE_xXPatients who are candidates (eligible and willing) for standard and/or potentially curative treatments are not eligibleXx_NEWLINE_xXSubjects who are eligible for further standard of care endocrine treatment.Xx_NEWLINE_xXPart A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is availableXx_NEWLINE_xXFor all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.Xx_NEWLINE_xXHistologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy existsXx_NEWLINE_xXHistologic proof of cancer which is now not amenable to curative standard treatment optionsXx_NEWLINE_xXPatient must have received at least 1 prior standard therapy for their diseaseXx_NEWLINE_xXAny evidence of metastatic disease; pre-operative staging will be undertaken per urologic standard of careXx_NEWLINE_xXPrior standard or investigational anti-cancer therapy as specified in protocolXx_NEWLINE_xXSubjects must have previously completed standard radiation therapy and been exposed to temozolomide. Patients must be in first or second relapse.Xx_NEWLINE_xXSubjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit or they must be ineligible to receive such therapy and/or have declined all such therapy. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.Xx_NEWLINE_xXMetastatic or inoperable solid tumors* (except gastrointestinal tumors or tumors that originated or metastasized to the liver) for which no standard treatment exists, or have progressed or recurred following prior therapy.Xx_NEWLINE_xXPatients in expansion cohort A will have a biopsy (which is standard of care) at the time of progression that shows evidence of MET positivityXx_NEWLINE_xXEligible to receive standard-of-care sorafenibXx_NEWLINE_xXPatients must have a histologically confirmed non-hematological malignancy established by biopsy or resection; patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligibleXx_NEWLINE_xXGroup 2: BRAFV600 positive metastatic colorectal carcinoma (CRC), or advanced non-small cell lung carcinoma (NSCLC) after failure of at least two lines of prior standard therapy or for whom no further standard therapy is indicated.Xx_NEWLINE_xXGroup 3: Advanced solid tumors with PI3K pathway alterations (PIK3CA mutation or PTEN loss) after failure of at least one line of prior standard therapy or for whom no further standard therapy is indicated. Prior treatment may not include inhibitors of the PI3K pathway.Xx_NEWLINE_xXSubjects must have no standard therapy available, or have actively refused standard therapyXx_NEWLINE_xXare, in the judgment of the investigator, appropriate candidates for experimental therapy after available standard therapies have failed to provide clinical benefitXx_NEWLINE_xXHistologically or cytologically confirmed advanced solid tumors (excluding HCC) that have progressed following standard therapy, or for which no standard therapy exists (including surgery or radiation therapy) or participants with RR-DTC.Xx_NEWLINE_xXRefractory to or intolerant of standard therapyXx_NEWLINE_xXProgression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of careXx_NEWLINE_xXStandard treatment interrupted, except if anti-HER2 therapyXx_NEWLINE_xXUse of any other standard or experimental therapy within 14 days of starting study therapyXx_NEWLINE_xXPlans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progressionXx_NEWLINE_xXEligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelinesXx_NEWLINE_xXPatients with history of hematologic malignancies who have received at least 2 lines of standard chemoimmunotherapy and have persistent diseaseXx_NEWLINE_xXHave mCRC that has been treated with currently approved standard therapiesXx_NEWLINE_xXPrior treatment with standard first line therapy in the metastatic settingXx_NEWLINE_xXSubjects >= 60 years of age with AML who are not candidates for or have refused standard chemotherapy.Xx_NEWLINE_xXFailure of at least one prior standard of care chemotherapy for advanced stage diseaseXx_NEWLINE_xXHas stable, or no evidence of, extracranial disease and not receiving systemic therapy for extracranial disease; Note: patients with stable disease must have already received standard therapy or are intolerant to standard therapyXx_NEWLINE_xXPatients must have a diagnosis with solid tumors and lymphomas, either refractory to standard therapy or for which no effective standard therapy that conveys clinical benefitXx_NEWLINE_xXPatients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. Patients must have measurable diseaseXx_NEWLINE_xXPatients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.Xx_NEWLINE_xXIn countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.Xx_NEWLINE_xXSubject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXDiagnosis - CD30+ HL or CD30+ NHL:\r\n* During the dose escalation phase: only adult patients with active disease failing standard therapy\r\n* After dose escalation: any patient (children or adults) newly diagnosed, unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantationXx_NEWLINE_xXThe participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomyXx_NEWLINE_xXPatients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapyXx_NEWLINE_xXKnown standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXPatients with no prior therapy for WM, must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimenXx_NEWLINE_xXHistological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.Xx_NEWLINE_xXPatients enrolled in the dose escalation stages must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the physician's judgment likely to result in clinical benefit or if such therapy has been refused by the patient. Documentation of the reason must be provided for patients who have not received a standard therapy likely to result in clinical benefit.Xx_NEWLINE_xXPatients with advanced/metastatic cancer, with measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant to SOC, or for whom no standard therapy exists. Patients must fit into one of the following groups: • CRC •NSCLC • TNBC• RCCXx_NEWLINE_xXSCCHN that has progressed during or following at least 1 and up to 5 prior systemic treatments for metastatic or recurrent disease deemed to be incurable. Patient who refuse radical resection for recurrent disease or are intolerant of or refused standard first line therapy are eligible to enrollXx_NEWLINE_xXHas progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)Xx_NEWLINE_xXPatients undergoing Surefire DEB-TACE procedure as clinically determined to be part of their standard of care treatment planXx_NEWLINE_xXParticipants must have relapsed disease despite standard therapyXx_NEWLINE_xXAt least one tumor for which palliative RT is considered appropriate standard therapyXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curativeXx_NEWLINE_xXDiagnosis of advanced or recurrent, histologically or cytologically confirmed, solid malignancy that is either metastatic or unresectable. At time of enrollment, subjects either refuse standard curative or palliative therapy, are not candidates for standard curative or palliative therapy, have a disease for which no non-investigational therapy exists, OR have progressed on prior therapy (up to three lines of prior cytotoxic agents are permitted).Xx_NEWLINE_xXPatients must have histologically confirmed solid tumor malignancy (excluding primary brain tumor) that is metastatic or unresectable and have failed standard therapies; patients are also eligible patients declined (or if their physicians determined them unsuitable for) standard therapy options.Xx_NEWLINE_xXPatients who declined standard therapies or whose physicians determined they were not suitable for standard therapy options are eligibleXx_NEWLINE_xXDocumented objective radiographic or clinical disease progression on two previous lines of standard therapyXx_NEWLINE_xXHas been previously treated with standard therapies, which must include, for Cohort A, fluoropyrimidine, oxaliplatin, and irinotecan, and for Cohort B, at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/- anti-VEGF/EGFR monoclonal antibody (mAb).Xx_NEWLINE_xXSubjects have received two or more standard available therapies known to prolong survival and for which they would be considered eligible; such therapies should include regimens containing oxaliplatin and irinotecan in combination with a fluoropyrimidine if appropriate (e.g., FOLFOX and FOLFIRI or their variants)Xx_NEWLINE_xXAt least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2)Xx_NEWLINE_xXPatients must have received standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapyXx_NEWLINE_xXStandard chemotherapy/trastuzumab declined by patient OR patient is deemed by physician for any reason to not be a candidate for standard therapy (i.e. patient and/or provider choose not to pursue standard trastuzumab-based chemotherapy regimen because of concerns related to toxicity or patient preference)Xx_NEWLINE_xXHave histological or cytological diagnosis of locally advanced/metastatic HER2 solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXSubject is a candidate for high-dose therapy and autologous SCT based on standard criteria at the institution where this treatment will be administeredXx_NEWLINE_xXAdvanced or metastatic colorectal cancer with no curative options available and progression on previous standard therapy, including an EGFR inhibitor if KRAS wild-typeXx_NEWLINE_xXFor the dose-escalation cohorts: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy availableXx_NEWLINE_xXFor the expansion cohort: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer (TNBC), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically acceptable.Xx_NEWLINE_xXDose expansion cohort only: Histological or cytological confirmation of advanced unresectable solid tumors for which no standard therapy is available in patients with a known BRCA germline mutation or those with metastatic triple negative breast cancer without known BRCA mutation; for the paclitaxel cohorts, any solid tumors with potential benefit from this combination and paclitaxelXx_NEWLINE_xXMust have failed at least 1 standard of care systemic therapy for their malignancyXx_NEWLINE_xXProgression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumabXx_NEWLINE_xXPatients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative optionXx_NEWLINE_xXPatient with histologically-confirmed Stage IV malignant metastatic adenocarcinoma of the pancreas; (a) who has relapsed from or is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit or (b) who are intolerant to or refuse standard chemotherapy and, therefore, for whom experimental therapy is a reasonable option.Xx_NEWLINE_xXDose Escalation Cohort only: Confirmed advanced solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective; subjects with progressive brain metastases are also eligible. OR Confirmed Histological/cytological hematological malignancy that is refractory to/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists. OR Confirmed high grade glioma (grade 3and4) that is relapsed/refractory to standard therapies and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.Xx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or proven capable of extending life expectancyXx_NEWLINE_xXHad received standard treatment (no limitations for prior therapies), and in treating physician’s opinion, no suitable standard treatment is available, or for those subjects who decline chemotherapyXx_NEWLINE_xXSubject must have histological confirmation of AML and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.Xx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy or has relapsed after standard therapyXx_NEWLINE_xXPatients must have biopsy-proven metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapyXx_NEWLINE_xXPatients with locoregional disease that have not received appropriate standard locoregional therapy with surgery and/or radiation therapyXx_NEWLINE_xXMust have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 5 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapiesXx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancyXx_NEWLINE_xXPrior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapyXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXSubjects must have histologically or cytologically confirmed, IDH1 gene-mutated advanced solid tumors, including glioma, that have recurred or progressed following standard therapy, or that have not responded to standard therapy.Xx_NEWLINE_xXHistologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriateXx_NEWLINE_xXAny standard contraindications to myeloablative HSCT per standard of care practices at COHXx_NEWLINE_xXHistologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failedXx_NEWLINE_xXSubjects have already undergone all standard of care surgery appropriate for stage of disease.Xx_NEWLINE_xXRefractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival at least 3 monthsXx_NEWLINE_xXZometa or denosumab can be continued as per standard of care as long as started before the study treatment is startedXx_NEWLINE_xXHave a plan by treating physician to receive FOLFOX or FOLFOX-Avastin standard therapy for colorectal cancer as a first-line chemotherapy treatmentXx_NEWLINE_xXFailed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment.Xx_NEWLINE_xXPatient has a confirmed solid tumor diagnosis according to the following: a. Phase 1: patient has a recurrent or refractory solid tumor that has progressed or did not respond to standard therapy, or for which no standard anticancer therapy exists b. Phase 2: patient has radiologically documented measurable disease by RECIST 1.1 (for neuroblastoma, evaluable disease by MIBG/Curie score is also acceptable) in one of the following tumor types and has failed up to three lines of treatment i. Group 1: neuroblastoma ii. Group 2: rhabdomyosarcoma iii. Group 3: Ewing's sarcoma Phase 1 portion or in preclinical studiesXx_NEWLINE_xXPart A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.Xx_NEWLINE_xXPart A2 only: Patients with histological or cytological diagnosis of HCC who have had 0 to 2 prior lines of systemic therapy (progressed or intolerant to approved HCC standard of care treatment).Xx_NEWLINE_xXPart B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.Xx_NEWLINE_xXHave documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:Xx_NEWLINE_xXMust have advanced disease and no standard treatment options as determined by locally/regionally available standards of care and treating physician's discretionXx_NEWLINE_xXPatients must have histologically documented solid tumors whose disease has progressed on standard therapy that is known to be associated with a survival advantage or have disease for which there is no known standard therapyXx_NEWLINE_xXPatient must require a new pre-treatment biopsy as part of their standard of care work-upXx_NEWLINE_xXPatient does not require a pre-treatment biopsy as part of their standard of care work- upXx_NEWLINE_xXother solid tumors (all comers) for which there is no standard systemic therapy and there is a rationale for use of pexidartinib at the Investigator's discretionXx_NEWLINE_xXFor dose escalation part: Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failedXx_NEWLINE_xXEligibility for dose escalation cohort: Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective OR solid tumor for which irinotecan monotherapy is considered standardXx_NEWLINE_xXPatients must continue HER2-targeted monoclonal antibody therapy dosing per standard of care through the entire study period (one year)\r\n* HER2-targeted monoclonal antibody therapy is defined as either trastuzumab monotherapy, or trastuzumab and pertuzumab combination therapy administered per standard of careXx_NEWLINE_xXFailed standard front-line therapyXx_NEWLINE_xXSolid malignancy that is refractory to at least one prior line of treatment, or for which no standard therapy exists, is required; one prior line of treatment with irinotecan is allowedXx_NEWLINE_xXMust have received or been previously offered standard first-line chemotherapy for advanced non-small cell lung cancerXx_NEWLINE_xXPhase I patients: Histologic documentation of a solid malignancy and who have exhausted available standard medical treatments or for whom no standard treatments are currently available; this includes primary brain tumorsXx_NEWLINE_xXPatient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy existsXx_NEWLINE_xXPatients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative optionXx_NEWLINE_xXFailure to respond to standard therapy, or for whom standard therapy does not exist.Xx_NEWLINE_xXPatients with advanced or metastatic cancers with no available standard therapy are eligible to enter the phase 1 portion of this studyXx_NEWLINE_xXSTEP 2 ENROLLMENT AND RANDOMIZATION: concurrent chemoradiation is permitted as consolidative therapy; the following concurrent therapies are permitted: tyrosine kinase inhibitors (i.e. erlotinib) - can be delivered with both hypofractionated (>= 3 Gray [Gy] per fraction) and standard fractionated radiation therapy (< 3 Gy per fraction); platinum-based chemotherapy - standard fractionated radiation therapy (< 3 Gy per fraction)Xx_NEWLINE_xXProgression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimensXx_NEWLINE_xXPatients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible.Xx_NEWLINE_xXIn the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.Xx_NEWLINE_xXRelapsed or refractory after ? 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received Rituximab and alkylating agents.Xx_NEWLINE_xXPatient must have histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma harboring a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation, for which no standard therapy is available, is resistant/refractory to standard therapy, has relapsed after standard therapy, or has no standard therapy that improves survival by at least three monthsXx_NEWLINE_xXPatients with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the patient refuses standard therapy.Xx_NEWLINE_xXPatients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy available that improves survival by at least three monthsXx_NEWLINE_xXThe participant has a histologic or cytologic diagnosis of a solid tumor (non-prostate, non-breast) that is metastatic and is refractory to or progressed (or relapsed) following standard therapies, or has disease for which no standard therapy exists; presence of metastatic bone lesion(s) is requiredXx_NEWLINE_xXProgressive Disease (PD) following standard chemoradiationXx_NEWLINE_xXPatients must have histologically confirmed (by the National Cancer Institute [NCI] Pathology Department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are associated with minimal patient survival benefit (as defined the Lymphoid Malignancies Branch physicians or if the patient refuses standard of care treatment); enrollment of patients with tumors that can be safely biopsied is encouragedXx_NEWLINE_xXPatients with advanced cancer, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least 3 months is availableXx_NEWLINE_xXSubjects must have failed at least one previous chemotherapy regimen for metastatic disease if standard therapies existXx_NEWLINE_xXThe patient is using an effective contraceptive (per the institutional standard), if procreative potential existsXx_NEWLINE_xXPatient is starting standard of care Gemcitabine treatmentXx_NEWLINE_xXPatients must have completed standard radiation therapy with concurrent TMZ and must not have evidence of progressive disease on post treatment imagingXx_NEWLINE_xXDose Escalation phase: Patients with solid tumors (including melanoma) who have failed or are not candidates for standard therapies of for whom no approved therapy is availableXx_NEWLINE_xXHistologically or cytologically confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy; patients with tumor types in which carboplatin and paclitaxel is appropriate as a first-line regimen for advanced disease are eligibleXx_NEWLINE_xXFor all Parts (Dose escalation and expansion): The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy either after available standard therapies have ceased to provide clinical benefit (Parts A, B, C, D, E and F) or in combination with fulvestrant (Part G only)Xx_NEWLINE_xXRelapsed AML or secondary AML (from myelodysplastic syndromes [MDS] or treatment related): not in CR after 1 or more cycles of standard re-induction therapyXx_NEWLINE_xXProgressed or not tolerated standard therapy, and no further standard therapy is availableXx_NEWLINE_xX(Arm A) relapsed or refractory CLL/SLL and require treatment in the opinion of the Investigator. Subject must have relapsed following or be refractory to standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or alkylator (chlorambucil, bendamustine) based regimens. In addition, there are no other curative options, and the subject has exhausted options that would be considered standard of care, orXx_NEWLINE_xX(Arm B) relapsed or refractory NHL and require treatment in the opinion of the Investigator. Subject must have histologically documented diagnosis of NHL as defined in the World Health Organization classification scheme, except as noted in the exclusion criteria. Subject must have relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. In addition, there are no other curative options, and the subject has exhausted options that would be considered standard of care. Subjects with other lymphoproliferative diseases can be considered in consultation with the Abbott medical monitor.Xx_NEWLINE_xXKnown standard therapy for the patient’s disease that is potentially curative or proven capable of extending life expectancyXx_NEWLINE_xXPatients who have known allergic reactions to paclitaxel or IV contrast dye despite standard prophylaxisXx_NEWLINE_xXPatients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three monthsXx_NEWLINE_xXCandidate for known standard therapy for the patient’s disease that is potentially curativeXx_NEWLINE_xXEvidence of CRPC indicated by history of progression despite standard hormonal therapy (by PSA and/or imaging studies)Xx_NEWLINE_xXPatients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXAdvanced solid tumor for which, in the opinion of the Investigator, no other standard or investigational therapy offers greater benefit.Xx_NEWLINE_xXHistologically or cytologically proven metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for subjects in dose escalation.Xx_NEWLINE_xXShow objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability (excluding ASPS subjects who have not received prior therapy) within 6 months of enrollment.Xx_NEWLINE_xXProgression on or following, or intolerant of, at least one prior line of standard systemic therapy for advanced or metastatic gastric or pancreatic cancers.Xx_NEWLINE_xXProgression on or following, or intolerant of, at least two prior lines of standard systemic therapy for advanced or metastatic colorectal cancers.Xx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three monthsXx_NEWLINE_xXPatients must have a histologically-confirmed metastatic or locally advanced cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy that increases survival by at least three months does not existXx_NEWLINE_xXCompleted all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.Xx_NEWLINE_xXSubjects must have a pathologic diagnosis of advanced or recurrent endometrial adenocarcinoma and must have failed at least 1 prior line of standard chemotherapyXx_NEWLINE_xXPatients in whom surgical excision of the tumor is part of standard of care managementXx_NEWLINE_xXSolid tumors refractory to standard therapyXx_NEWLINE_xXAny available standard line of therapy known to be life-prolonging or life-savingXx_NEWLINE_xXPatients must be planning to undergo standard of care treatment with surgery and radiation therapy.Xx_NEWLINE_xXELIGIBILITY CRITERIA – RECIPIENT ON STANDARD CARE THERAPYXx_NEWLINE_xXIn investigators opinion, no curative standard therapy existsXx_NEWLINE_xXProgression following at least 6 weeks of standard doses of Herceptin (Arm A only)Xx_NEWLINE_xXPatients with histologically confirmed solid tumors who: o Part 1: have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapyXx_NEWLINE_xXPatients must have histologically or cytologically confirmed AML, other than acute promyelocytic leukemia, as defined by the 2008 World Health Organization (WHO) criteria that have relapsed or refractory to standard chemotherapy; unsuitable for standard chemotherapy or unwilling to undergo standard chemotherapy; subjects >= 60 years of age with newly diagnosed AML who are not candidates for or have refused standard chemotherapy are eligibleXx_NEWLINE_xXPatient is expected to undergo autologous HPC transplantation that is consistent with standard of careXx_NEWLINE_xXHistological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.Xx_NEWLINE_xXSubjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and during the trial, unless there is a contraindication or subject intolerance to these therapiesXx_NEWLINE_xXHas a histologically- or cytologically-confirmed advanced malignancy that has progressed after standard-of-care therapy/treatments and there is no available therapy likely to convey clinical benefitXx_NEWLINE_xXRefractory B-ALL, defined by not having achieved a CR or CRi after two attempts at remission induction using standard regimens, orXx_NEWLINE_xXSubjects must have no alternate therapy of proven benefit or have refused standard therapy.Xx_NEWLINE_xXPatients must have histologic or cytologic confirmation of cancer for which there is no known standard therapy capable of extending life expectancyXx_NEWLINE_xXDiagnosis of one of the following advanced solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the participant: NMC;TNBC; NSCLC; or CRPCXx_NEWLINE_xXPart 1: Subjects with solid tumors that are refractory to, relapsed after or intolerant to standard therapy, or for whom no standard therapy exists or who are considered by the investigator to be inappropriate for standard therapy.Xx_NEWLINE_xXTumor progression following at least one prior standard therapyXx_NEWLINE_xXEligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in 28-day cycles as standard therapyXx_NEWLINE_xXStage IIB-IV mycosis fungoides and Sezary syndrome who have failed at least one standard systemic therapy or are not candidates for standard therapy; (pathology should be reviewed and diagnosis confirmed at Thomas Jefferson University Sidney Kimmel Cancer Center)Xx_NEWLINE_xXConfirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable.Xx_NEWLINE_xXSubjects must have histologically or cytologically confirmed locally advanced or metastatic solid tumors and must be refractory to any standard therapy, or have no standard therapy available, or have actively refused any standard therapy or, in the investigator's opinion, experimental treatment in this study is clinically and ethically acceptable for the subject.Xx_NEWLINE_xXPatients with CNS refractory small cell lung cancer having received standard recommended dosing for either of the two therapies:\r\n* Whole brain radiation therapy (WBRT)\r\n* Prophylactic cranial irradiation (PCI)Xx_NEWLINE_xXSubjects with advanced, histologically or cytologically confirmed tumor, refractory to any standard treatment, with no standard therapy available, in whom standard therapy is not a therapeutic option or the subject actively refuses use of chemotherapy which would be regarded standard and/or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.Xx_NEWLINE_xXSubjects with pathologically documented AML that has failed standard treatment, or subjects without prior therapy who refuse standard treatment optionsXx_NEWLINE_xXPatients for whom no standard curable therapy existsXx_NEWLINE_xXPatient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty scoreXx_NEWLINE_xXAdvanced or metastatic solid tumor that has progressed or was not responsive to standard therapyXx_NEWLINE_xXDose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the 2008 World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit. MM Dose Expansion Cohort:Xx_NEWLINE_xXHistologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A and B)Xx_NEWLINE_xXPhase I: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by modified RECIST version 1.1 who have progressed despite standard therapy or be intolerant of standard therapy, or for whom no standard therapy exists, who have tumors harboring one of the following: confirmed PIK3CA mutation or amplification, PTEN loss of function, EGFR mutation, cMET activation and/or HER2 overexpression. Endometrial carcinoma will not be selected for any molecular status.Xx_NEWLINE_xXPhase II: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by modified RECIST version 1.1, who progressed despite standard therapy or be intolerant of standard therapy, or for whom no standard therapy exists, fitting in one of the following groups: Group 1: patients with PIK3CA mutated or amplified ER positive (ER+) breast cancer ; Group 2: patients with endometrial carcinoma (not selected for any molecular status); Group 3: patients with solid tumors (with the exception of PIK3CA mutant/amplified ER+ breast cancer and endometrial carcinoma) harboring PIK3CA mutation or amplification/any PTEN status; Group 4: patients with solid tumors (with the exception of endometrial carcinoma) harboring PTEN loss of function/ PIK3CA wild type; Group 5: non-small cell lung cancer harboring cMET activation and/or EGFR mutation. Up to 3 lines of chemotherapy allowed in advanced/metastatic setting.Xx_NEWLINE_xXPatients with locally advanced or metastatic solid tumors who have either relapsed following, or progressed through, standard therapy; have a current disease state for which there is no standard effective therapy; is not a candidate for, or is unwilling to undergo, standard therapy in cases where no curative option exists.Xx_NEWLINE_xXDiagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is availableXx_NEWLINE_xXIn addition to inclusion criteria listed for Part 1, Part 2 will enroll GCB-DLBCL tFL and MM subjects only. Relapsed and/or refractory MM or tFL that have failed prior standard therapy and for which there is no standard salvage regimenXx_NEWLINE_xXPathologically proven diagnosis of breast cancer with clinical evidence of recurrent disease on the chest wall following treatment that included radiotherapy, and for which there is no current standard of care or curative resection able to be performedXx_NEWLINE_xXAbility to undergo standard induction chemotherapyXx_NEWLINE_xXAdvanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo, standard therapy.Xx_NEWLINE_xXare eligible for any standard therapy known to be life prolonging or life savingXx_NEWLINE_xXPatients who are not eligible for standard induction chemotherapy (or any standard therapy known to be life prolonging) because of poor performance status, significant tissue comorbidities, or unfavorable risk of diseaseXx_NEWLINE_xXPathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapyXx_NEWLINE_xXWilling to receive their standard multimodality therapy at Mayo Clinic, RochesterXx_NEWLINE_xXDiagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.Xx_NEWLINE_xXSubjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.Xx_NEWLINE_xXSCREENING: Patients must have received or refused first line standard systemic therapy for their metastasesXx_NEWLINE_xXStage IIIc or IV histologically proven melanoma (confirmed by Vanderbilt pathologists), that is not curable by standard surgery, radiation therapy, or chemotherapy; no available effective therapy (i.e.; therapy known to be curative); non-biopsied (resected) tumor sites must be measurable for therapyXx_NEWLINE_xXMale or female patient with Glypican 3 positive advanced solid tumor not amenable to standard therapy or for which standard therapy is not available or not indicatedXx_NEWLINE_xXAdvanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Part 2a:Xx_NEWLINE_xXAdvanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.Xx_NEWLINE_xXAdvanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.Xx_NEWLINE_xXAdvanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Part 2d:Xx_NEWLINE_xXAdvanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.Xx_NEWLINE_xXAdvanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Part 2e:Xx_NEWLINE_xXAdvanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.Xx_NEWLINE_xXCandidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (Cohort 2 preferred over Cohort 1)Xx_NEWLINE_xXPatients must have either progressed on least one standard therapy or there must be no standard treatment exists that has been shown to prolong survival for the patient’s disease; patients may have received any number of prior cytotoxic agentsXx_NEWLINE_xXInclusion Criteria:\n\n        Phase I part:\n\n        - Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease\n        as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite\n        standard therapy or are intolerant of standard therapy, or for whom no standard therapy\n        exists\n\n        Phase II part:\n\n          -  Patients with advanced/metastatic solid tumors, with at least one measurable lesion as\n             determined by RECIST version 1.1, who have had disease progression following their\n             last prior therapy and fit into one of the following groups:\n\n          -  Group 1: NSCLC\n\n          -  Group 2: Melanoma\n\n          -  Group 3: Renal cancer\n\n          -  Group 4: Mesothelioma\n\n          -  Group 5: TNBC\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status ? 1\n\n          -  Patient must have a site of disease amenable to biopsy, and be a candidate for tumor\n             biopsy.\n\n        Exclusion Criteria:\n\n          -  History of severe hypersensitivity reactions to study treatment ingredients or other\n             mAbs\n\n          -  Active, known or suspected autoimmune disease\n\n          -  Active infection requiring systemic antibiotic therapy\n\n          -  HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n\n          -  Patients receiving chronic treatment with systemic steroid therapy, other than\n             replacement-dose corticosteroids in the setting of adrenal insufficiency\n\n          -  Patients receiving systemic treatment with any immunosuppressive medication\n\n          -  Use of live vaccines against infectious disease within 4 weeks of initiation of study\n             treatment\n\n          -  Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.\n\n          -  Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that\n             require local CNS-directed therapy or increasing doses of corticosteroids within the\n             prior 2 weeks\n\n          -  History of drug-induced pneumonitis or current pneumonitis.Xx_NEWLINE_xXEnrollment into Arm B will be permitted if ibrutinib is considered the standard of care in the clinical practice. EXPANSION COHORT 2 OF ARM C:Xx_NEWLINE_xXPart 1, Part 2b, Part 2d, and Part 2e: Patients with advanced solid tumors who have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy.Xx_NEWLINE_xXPatients with a diagnosis of advanced unresectable non-hematological malignancy that has no known standard of care or for which the use of gemcitabine plus cisplatin constitutes a reasonable optionXx_NEWLINE_xXPatients must have prostate cancer that is advanced or recurrent and for which standard curative or reliable palliative therapies do not exist or are no longer effectiveXx_NEWLINE_xXSubjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.Xx_NEWLINE_xXSubjects with advanced, histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.Xx_NEWLINE_xXParticipants for whom no further standard of care therapy exists, must have received standard of care chemotherapy in the adjuvant or advanced/metastatic settingXx_NEWLINE_xXDisease progression despite standard therapiesXx_NEWLINE_xXProgressive disease without any standard therapies establishedXx_NEWLINE_xXStandard therapies are considered intolerableXx_NEWLINE_xXStandard (i.e., includes at least taxane + anthracycline) NAC and definitive surgery planned; (NOTE: NAC chemotherapy will be per standard of care, and not dictated by this clinical trial)Xx_NEWLINE_xXOperable tumor >= 1 cm by standard two dimensional (2D) ultrasound (largest unidimensional measurement) and less than 9 weeks after completion of standard NACXx_NEWLINE_xXNo standard care availableXx_NEWLINE_xXPLD at the dose and schedule being used might be considered standard of careXx_NEWLINE_xXDiagnosis of teratoma for which no additional standard surgical or medical therapy existsXx_NEWLINE_xXPatients with recurrent metastatic or locally advanced disease considered refractory or intolerant to all standard treatment available for their tumor, or those tumors for which no standard treatment is availableXx_NEWLINE_xXAdvanced/metastatic solid tumor refractory to standard therapyXx_NEWLINE_xXPathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapyXx_NEWLINE_xXprogressed or recurred despite standard therapyXx_NEWLINE_xXno standard therapy existsXx_NEWLINE_xXpatient is intolerant of standard therapyXx_NEWLINE_xXpatient is not a candidate for standard therapyXx_NEWLINE_xXHistologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not existXx_NEWLINE_xXAt least two-weeks since receipt of prior standard or investigational therapyXx_NEWLINE_xXSubjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;Xx_NEWLINE_xXPatients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. Patients must have measurable diseaseXx_NEWLINE_xXHemodynamically stable, consistent with standard of care values for patients undergoing elective tumor resectionXx_NEWLINE_xXPatient willing to undergo scheduled standard of care TRUS guided biopsyXx_NEWLINE_xXPatients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies existsXx_NEWLINE_xXRelapsed or refractory disease after at least one line of prior therapy. Subjects must have previously received appropriate line(s) of standard of care (SOC) treatment.Xx_NEWLINE_xXGroup 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is availableXx_NEWLINE_xXSubject must have advanced and/or metastatic, histologically or cytologically documented cancer or lymphomas, for whom there is no available standard therapy shown to provide clinical benefit.Xx_NEWLINE_xXFor those receiving bevacizumab, standard medical exclusionary conditions applyXx_NEWLINE_xXAll patients must have received prior first line standard therapy or declined standard therapy, and have been either non-responders (progressive disease) or have recurredXx_NEWLINE_xXProgression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimensXx_NEWLINE_xXRefractory to or intolerant of standard systemic therapy, including having received two or more standard available therapies known to prolong survival for which s/he was eligible, including leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) or leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) with or without bevacizumab, aflibercept, cetuximab or panitumumabXx_NEWLINE_xXHistologically or cytologically confirmed advanced solid tumor, including glioma, or angioimmunoblastic T-cell lymphoma (AITL) that has recurred or progressed following standard therapy, or that has not responded to standard therapyXx_NEWLINE_xXUse of any other standard or experimental therapy within 14 days of starting study therapyXx_NEWLINE_xXHistological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.Xx_NEWLINE_xXProgression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:Xx_NEWLINE_xX- The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards)Xx_NEWLINE_xXDiagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is availableXx_NEWLINE_xXMust have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is deemed appropriate for treatment with 1 of the 2 chemotherapy regimens in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable or measurable.Xx_NEWLINE_xXDiagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is availableXx_NEWLINE_xXHas a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, and for whom no standard treatment is available.Xx_NEWLINE_xXPatients must have experienced disease recurrence or progression during or after prior treatment with one or more prior standard systemic therapies;Xx_NEWLINE_xXHistologically- or cytologically-confirmed melanoma or clear-cell RCC that are refractory to standard therapy or for which no standard therapy existsXx_NEWLINE_xXHave advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapyXx_NEWLINE_xXAdvanced or metastatic solid tumor refractory to standard therapyXx_NEWLINE_xXPatients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.Xx_NEWLINE_xXHistologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy existsXx_NEWLINE_xXHistologically or cytologically confirmed gastrointestinal (GI) carcinoma, which has progressed on standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy), for which effective therapy is not available or for which patients are not a candidate for or intolerant of such therapies.Xx_NEWLINE_xXPatients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.Xx_NEWLINE_xXFor dose escalation cohorts: Subjects with advanced, histologically or cytologically confirmed solid tumors are eligible. Subjects' tumors (all comers) must be refractory to standard treatment with no standard therapy available, or subjects actively refuse any treatment, which would be regarded standard. In addition, the investigator must judge the experimental treatment as clinically and ethically acceptableXx_NEWLINE_xXPatients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.Xx_NEWLINE_xXPatients must have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with 1 of the 3 chemotherapy regimens in this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurableXx_NEWLINE_xXPart 1 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available. Part 2 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available, or docetaxel-naive patients who have failed standard treatment and have tumors for which a docetaxel-based regimen would be appropriate.Xx_NEWLINE_xXPatients with WHO-defined AML, 60 years of age or older, who are unlikely to benefit from standard induction therapy, defined as having at least 1 of the following:Xx_NEWLINE_xXProgressed or refractory to at least 1 prior line of standard therapyXx_NEWLINE_xXPatients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy.Xx_NEWLINE_xXArm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatmentXx_NEWLINE_xXArm 2 only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatmentXx_NEWLINE_xXAdvanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapyXx_NEWLINE_xXPathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myelomaXx_NEWLINE_xXNot a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care)Xx_NEWLINE_xXHistologically or cytologically confirmed solid tumors known to express C4.4a (eg, carcinomas of the lung, head & neck SCC, esophagus SCC (squamous cell carcinoma),colon, ovary, prostate, and breast) that are refractory to any standard therapy, or have no standard therapy available, or for which subjects actively refuse any treatment that would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial.Xx_NEWLINE_xXMust have a disease that is relapsed/refractory to all potentially curative standard treatment regimens or must have a current disease for which there is no known curative therapy, or therapy proven to prolong survival with an acceptable quality of life.Xx_NEWLINE_xXProgressed, or been intolerant to, at least one standard treatment regimenXx_NEWLINE_xXNot eligible for or declined transplantation or any standard therapy known to be life prolonging or life savingXx_NEWLINE_xXParts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.Xx_NEWLINE_xXRelapsed or refractory disease (as defined below) for which patients are ineligible for or have exhausted standard therapeutic options that would be considered standard of careXx_NEWLINE_xXHistologically- or cytologically-confirmed advanced/metastatic solid tumor or lymphoma that is refractory to standard therapies, or the patient refuses standard therapyXx_NEWLINE_xXParticipants with histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of careXx_NEWLINE_xXAll patients must have received at least one standard chemotherapy or chemoradiotherapyXx_NEWLINE_xXHistologically or cytologically confirmed solid tumors that are refractory to standard therapy or for which no standard therapy existXx_NEWLINE_xXTumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy existsXx_NEWLINE_xXPatients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three monthsXx_NEWLINE_xXPatients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapyXx_NEWLINE_xXHistologic proof of cancer for which no standard therapy is available, and which shows no staining for RB by IHC.Xx_NEWLINE_xXSubjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapyXx_NEWLINE_xXRCC patients only: Tumor progression after receiving standard/approved chemotherapy and/or targeted agent, where there is no approved therapy or for tumors where sorafenib based therapy would be standard therapy (Phase I)Xx_NEWLINE_xXHistologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable.Xx_NEWLINE_xXHave either relapsed or refractory AML, or who have newly diagnosed Flt3-ITD positive AML but either refuse or are considered by the Investigator not to be an appropriate candidate for standard chemotherapy.Xx_NEWLINE_xXRefractory disease is defined by the failure to obtain a complete remission (CR) with a HDAC-containing or a standard induction regimen. Patients who require two cycles of induction therapy to attain a first CR are not considered to have refractory disease.Xx_NEWLINE_xXPatients with advanced cancer, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least 3 months if availableXx_NEWLINE_xXSubjects should have received at least two standard systematic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline (unless contraindicated).Xx_NEWLINE_xXSubjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalationXx_NEWLINE_xXPart B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:Xx_NEWLINE_xXDiagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.Xx_NEWLINE_xXPatients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy existsXx_NEWLINE_xXPhase I: Diagnosis of recurrent, metastatic or primary unresectable solid tumor that does not have curative standard treatmentXx_NEWLINE_xXDiagnosed with advanced refractory solid malignancies or intolerant of standard therapy for the stage of the disease (because there is currently no standard approved therapy for adenoid cystic carcinoma, therefore there is no requirement of prior therapy for this patient population)Xx_NEWLINE_xXDose-escalation stage: Participants with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy existsXx_NEWLINE_xXExpansion stage: Participants with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: CRC, NSCLC, HNSCC, or pancreatic cancerXx_NEWLINE_xX65+ yrs with AML not eligible for standard frontline chemoXx_NEWLINE_xXPatients with metastatic renal cell carcinoma referred for the study may not be eligible for the experimental protocol therapy due to reasons such as uncertainty about donor HLA typing or need to control malignant disease, infection, or metabolic abnormality such as hypercalcemia on an emergent basis; should a referred patient present to us in such a scenario, the patient will be referred back to their primary hematologist-oncologist for treatment; however, if referral back to the referring physician is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease or complicating conditions (infection, metabolic problems) under the current study; if it becomes apparent that the patient will not be able to proceed to experimental therapy, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol; it is not necessary to complete the eligibility criteria prior to receiving such standard care; however, prior to initiation of the experimental therapy (starting with the pentostatin-cyclophosphamide [PC] regimen), the patient must meet each of the eligibility criteriaXx_NEWLINE_xXPatients must have completed standard frontline therapy for newly diagnosed metastatic disease; lung, bone, bone marrow or other metastases are sufficient to qualify as metastatic disease; standard frontline therapy is comprised of a regimen that includes (but is not limited to) multiple cycles of vincristine, adriamycin, ifosfamide, and etoposide; local therapy as dictated by the treating institutions; patients may have received autologous stem cell transplantation or other investigational agents as part of their primary therapyXx_NEWLINE_xXDisease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:Xx_NEWLINE_xXStandard safety inclusion for serum creatinine, AST, ALT, bilirubinXx_NEWLINE_xXPatients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three monthsXx_NEWLINE_xXSolid tumor, including central nervous tumors, that is recurrent or refractory to standard therapy or for which standard therapy is not available; all research participants must have a pathologic diagnosis either from their initial presentation, or at the time of recurrence or progression; the requirement for histologic verification may be waived for patients with brainstem glioma and optic pathway gliomaXx_NEWLINE_xXAll patients in both group 1 and 2 will also be referred to radiation and medical oncology for standard of care adjuvant therapy with or without PDT therapyXx_NEWLINE_xXPatient had recurrence of osteosarcoma in the lung following standard therapy including: adriamycin, cisplatin, ifosfamide and methotrexate.Xx_NEWLINE_xXThe patient received induction and consolidation therapy according to the Institution's standard of care.Xx_NEWLINE_xXHistologically or cytologically confirmed solid tumor that has recurred after standard therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO NOT need histologic proof of the diagnosis.Xx_NEWLINE_xXMust be planning to undergo standard radiation therapy.Xx_NEWLINE_xXBy standard clinical criteria, be medically appropriate to receive rituximab and anthracycline-containing induction therapy and high-dose chemotherapy with AHCTXx_NEWLINE_xXPatients with bilateral pulmonary metastases from sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura who can be rendered no clinical evidence of active disease (NED) or minimal residual disease (MRD) by standard of care metastasectomy where NED refers to diagnostic tests failing to detect presence of disease and MRD refers to low-volume, subclinical disease which is not amenable to standard of care biopsy for histologic confirmation and poses no immediate threat to patient health and would not otherwise warrant standard of care treatment but surveillance insteadXx_NEWLINE_xXPatients must have received first line standard systemic therapy for their metastases (if applicable)Xx_NEWLINE_xXPatients with locally advanced or metastatic HPV associate malignancy (cervical, vaginal, vulvar, penile, anal, or oropharyngeal carcinoma), either refractory to standard therapy or for which no effective standard therapy that confers clinical benefit is availableXx_NEWLINE_xXPatients must have previously received standard systemic therapy for advanced thyroid cancer (to include radioactive iodine for iodine-avid tumors and surgery [if indicated]) and have been either non-responders (progressive disease) or have recurredXx_NEWLINE_xXCOHORT C SPECIFIC INCLUSION: Histologically confirmed IDH mutant glioma, meningioma, or ependymoma that has recurred despite previous standard of care therapy; because this cohort is, in part, meant to allow patients access to therapy who might not otherwise be eligible for other clinical trials - deviations from standard of care treatment can be presented to and approved by the principal investigator for inclusion in the studyXx_NEWLINE_xXNo other investigational or standard anti-tumor therapy allowedXx_NEWLINE_xXon maintenance standard-of-care chemotherapies or on treatment holidayXx_NEWLINE_xXRelapsed or refractory to greater than or equal to (>=) 2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.Xx_NEWLINE_xXConfirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.Xx_NEWLINE_xXParticipants who are refractory or relapsed after at least 1 prior line of therapy and for whom no effective standard therapy is available per the investigator's assessment.Xx_NEWLINE_xXParticipants must have disease that is relapsed or refractory and for which standard curative or palliative measures do not exist or are no longer effectiveXx_NEWLINE_xXCompleted curative intent therapy, without additional standard of care curative intent therapy feasible within 20 weeks prior to study enrollmentXx_NEWLINE_xXMeasurable disease that is amenable to curative intent therapy, or amenable to standard of care systemic/palliative therapy (e.g. platinum containing chemotherapy, cetuximab, pembrolizumab or other approved options)Xx_NEWLINE_xXDisease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists; exceptions: NSCLC, head and neck squamous cell cancer (HNSCC), bladder cancer, MSI-H/dMMR cancers and melanoma expansion cohorts in Part 2B pembrolizumab combination. 1) Subjects must not have received more than 5 prior lines of therapy for advanced disease including both standards of care and investigational therapies. 2) Subjects who received prior anti-Programmed cell death protein 1(PD-1)/ Ligand-1 (L1) therapy must have received at least 4 months of treatment (Part 1B and Part 2B).Xx_NEWLINE_xXEstimated intelligence at least 80 (standard score)Xx_NEWLINE_xXDiagnosis of glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 gray (Gy) of radiation given over 30 treatmentsXx_NEWLINE_xXWilling to be randomized to either standard care or intervention groupXx_NEWLINE_xXUnwilling to be randomized to either standard care or intervention groupXx_NEWLINE_xXPatients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment planXx_NEWLINE_xXHistologic proof of HCC reviewed and confirmed per the local standard of careXx_NEWLINE_xXTumor for which prior treatment has proven to be ineffective or intolerable or for which no standard therapy existsXx_NEWLINE_xXPhase I-Ib part (including dose ranging part): Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST v1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists and who did not receive prior anti-PD-1/PD-L1 treatment.Xx_NEWLINE_xXPhase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in the indication in which at least one confirmed PR or CR was seen during the dose escalation phase I part. Patients must have measurable disease as determined by RECIST v1.1, have progressed despite standard therapy or be intolerant to standard therapy.Xx_NEWLINE_xXPhase II part (MBG453 in combination PDR001): Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1, who have received standard therapy and are intolerant of standard therapy or have progressed following their last prior therapy.:Xx_NEWLINE_xX(Part A only) Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which no standard therapy exists, or who are not eligible for standard treatment. Subjects must have received at least one prior therapy for their malignancy;Xx_NEWLINE_xXFor all arms except Arm L (pembrolizumab) and Arm M (nivolumab), patients must have failed prior standard curative chemotherapy for their disease; subjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapyXx_NEWLINE_xXParticipant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.Xx_NEWLINE_xXParticipants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.Xx_NEWLINE_xXPatients will receive standard of care systemic treatment for underlying solid malignancy as deemed necessary by treating physicianXx_NEWLINE_xXPatients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insuranceXx_NEWLINE_xXScheduled to undergo bronchoscopy for malignant airway obstruction as standard medical careXx_NEWLINE_xXIs pregnant (confirmed by the patient as imaging clinic standard of care) or nursing motherXx_NEWLINE_xXEligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intentXx_NEWLINE_xXFor the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined.Xx_NEWLINE_xXFor the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 1 prior standard treatment regimen or standard therapy was declined.Xx_NEWLINE_xXIntolerance to at least 2 prior standard therapy regimensXx_NEWLINE_xXAdvanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. Newly diagnosed patients who refuse standard treatment regimens are also eligibleXx_NEWLINE_xXEvidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy.Xx_NEWLINE_xXPrevious standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows:Xx_NEWLINE_xXThe Ewing’s sarcoma must have progressed following at least one standard prior chemotherapy regimenXx_NEWLINE_xXCompletion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)Xx_NEWLINE_xXIs pregnant (confirmed by the patient as imaging clinic standard of care) or nursing motherXx_NEWLINE_xXPatients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancerXx_NEWLINE_xXWomen who have already had their standard of care post-NAT mammogram and/or breast MRIXx_NEWLINE_xXLung cancer patients receiving definitive radiation therapy defined as 45-75 Gy as part of  standard of care for their diseaseXx_NEWLINE_xXPatient must be expected to undergo therapy with bevacizumab in combination with paclitaxel at recommended standard of care doses if suspected recurrence is confirmed with imagingXx_NEWLINE_xXMust be patients undergoing standard of care EGD for the confirmation of dysplasia in Barrett's esophagus (BE) or endoscopic eradication therapy (EET) for dysplasia in BEXx_NEWLINE_xXPatients scheduled for 90Y radioembolization for HCC as part of their standard of careXx_NEWLINE_xXInadequate tumor sites or volume to allow for biopsy per standard of careXx_NEWLINE_xXEligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved irinotecan-containing regimensXx_NEWLINE_xXSubjects for whom participating would significantly delay the scheduled standard of care therapyXx_NEWLINE_xXSubjects for whom participating would significantly delay the scheduled standard of care therapyXx_NEWLINE_xXSevere claustrophobia not relieved by oral anxiolytics per institutional standard practiceXx_NEWLINE_xXContraindications for MRI or GBCA (standard of care)Xx_NEWLINE_xXPatients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocolXx_NEWLINE_xXParticipating would significantly delay the scheduled standard of care therapyXx_NEWLINE_xXScheduled for contrast CT (standard of care)Xx_NEWLINE_xXAny condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)Xx_NEWLINE_xXCompletion of treatment with standard radiation (with or without concurrent therapy)Xx_NEWLINE_xXPatients whose lung tumors are being monitored by magnetic resonance (MR) imaging as part of standard clinical careXx_NEWLINE_xXConcurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed)Xx_NEWLINE_xXIs pregnant (confirmed by the patient as imaging clinic standard of care) or nursing motherXx_NEWLINE_xXfMRI and/or DTI required for preoperative imaging as part of the standard of careXx_NEWLINE_xXScheduled to receive therapy with trastuzumab plus chemotherapy as part of standard careXx_NEWLINE_xXScheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard careXx_NEWLINE_xXDeclined all standard treatment optionsXx_NEWLINE_xXKnown lung lesion(s) based on standard of care (SOC) non-contrast CTXx_NEWLINE_xXRelapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimenXx_NEWLINE_xXHistologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:Xx_NEWLINE_xXProgressive disease following or intolerant of or refuses standard of care systemic therapyXx_NEWLINE_xXRelapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase).Xx_NEWLINE_xXPatients must have had prior central nervous system (CNS) radiotherapy for their glioma, including standard doses for low-grade or high-grade glioma as well as non-standard dose and fractionation, including hypofractionated regimens, stereotactic radiosurgery, etcXx_NEWLINE_xXPatients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitorsXx_NEWLINE_xXAdvanced low or intermediate grade gastroenteropancreatic or lung or thymus neuroendocrine tumor (NET), or NET of unknown primary, progressed after at least 1 line of anticancer therapy (unless no standard treatments available or such treatments are deemed not appropriate)Xx_NEWLINE_xXPatients must have been referred for repeat tumor biopsy as part of standard care and the biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery); such approval includes review of medical history and laboratory parameters as per standard careXx_NEWLINE_xXPatients must be scheduled to receive: 1) standard chemotherapy with/without radiation therapy; OR 2) single-agent bevacizumab (Avastin)Xx_NEWLINE_xXARM II ONLY: Nonspecific or no evidence for disease on standard imaging modalityXx_NEWLINE_xXSubjects for whom participating would significantly delay the scheduled standard of care therapyXx_NEWLINE_xXParticipation would significantly delay the scheduled standard of care therapyXx_NEWLINE_xXPhysicians determine that OCT investigation will not alter standard of care for the patientXx_NEWLINE_xXPatient who will undergo standard of care clinical staging for UTUCXx_NEWLINE_xXParticipants with hepatocellular carcinoma or Intrahepatic Cholangiocarcinoma (ICC) who have progressed despite standard therapy or are intolerant of standard therapyXx_NEWLINE_xXPlan to begin trabectedin as standard of careXx_NEWLINE_xXConfirmed locally advanced and/or metastatic solid tumor in participants who have progressed on a standard therapy, are intolerant to standard therapy, and/or are non-amenable to standard therapyXx_NEWLINE_xXHas undergone ? 2 prior standard therapiesXx_NEWLINE_xXHas failed standard treatmentXx_NEWLINE_xXParticipants must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor(s) appropriate for treatment with one of the 2 combination therapies in Part B of this study, have progressed despite standard therapy, or for whom conventional therapy is not considered effective.Xx_NEWLINE_xXCriteria 3, Participants had disease progression during or after one or more prior standard of care systemic anti-cancer therapy (eg chemotherapy, targeted therapy) for metastatic diseaseXx_NEWLINE_xXPatients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors that progressed to standard therapy or for whom no standard therapy exists:Xx_NEWLINE_xXAdult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable.Xx_NEWLINE_xXIn the Dose Escalation Segment, patients who are refractory, relapsed, or unresponsive to standard treatment.Xx_NEWLINE_xXHistologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or stage IV NSCLC demonstrated ALK-positive or an advanced tumor, other than NSCLC, that carries an ALK genetic alteration (mutation, translocation or amplification) and/or ALK overexpression that has progressed despite standard therapy, or for which no effective standard therapy exists.Xx_NEWLINE_xXPatient is willing and able to undergo standard of care imaging studies (same\n             imaging/staging modality being used at each evaluation), which are anticipated to be\n             performed prior to the initiation of therapy and subsequently every 3 months.Xx_NEWLINE_xXThe participant has histologically or cytologically advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.Xx_NEWLINE_xXThe participant has histologically or cytologically confirmed advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.Xx_NEWLINE_xXSubjects will be screened and excluded per standard clinical protocolXx_NEWLINE_xXIneligible for or have exhausted standard therapeutic optionsXx_NEWLINE_xXMust have received and progressed on or failed one standard/approved treatment for cancer type, if availableXx_NEWLINE_xXHistologically or cytologically confirmed non-CNS solid tumor that recurred after standard/frontline therapy, or for which there is no standard/frontline therapy available.Xx_NEWLINE_xXPatients with advanced cancer who are refractory to, have demonstrated intolerance to, or have refused access to, available standard therapiesXx_NEWLINE_xXPatients with relapsed or refractory disease with no available standard therapyXx_NEWLINE_xXPatients must have histologically confirmed solid tumors for which standard therapy known to prolong survival has failed in the metastatic setting or for which standard therapies do not existXx_NEWLINE_xXHistologically documented, metastatic NSCLC that has failed at least one standard therapyXx_NEWLINE_xXSubject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remissionXx_NEWLINE_xX