Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physicianXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXNervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) resulting from prior therapy must be =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligibleXx_NEWLINE_xXResolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) grade ? 1 or to that patient's pre-study baseline (except alopecia or neuropathy)Xx_NEWLINE_xXAny pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events version 4.03) unless the symptom is not considered medically significant by the treating investigator (e.g., alopecia)Xx_NEWLINE_xXNo ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msecXx_NEWLINE_xXPatients must not have any unresolved toxicity greater than National Cancer Institute (NCI)-CTCAE version (v) 4.0 grade 1 from previous anti-cancer therapy except alopecia within 7 days prior to registrationXx_NEWLINE_xXPatients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or lessXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXDiarrhea >= grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) categorization within 14 days of registrationXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXPatients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1Xx_NEWLINE_xXEligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of InductionXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXPatients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met: minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose, and no history of severe immune-related adverse effects from anti-CTLA-4 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baselineXx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXAny ongoing toxicity from prior anti-cancer treatment that, in the judgment of the investigator, may interfere with study treatment; all toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4) or baseline prior to registrationXx_NEWLINE_xXDiarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v] 4.0)Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, radiotherapy, surgery to =< grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAEv4) except neuropathy which may be =< grade 2Xx_NEWLINE_xXRecovered from all toxicities associated with prior treatment, to acceptable baseline status or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4, grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligoXx_NEWLINE_xXRecovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (eg, alopecia or vitiligo).Xx_NEWLINE_xXResidual toxicity from prior therapy grade > 1 (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) that could interfere with study endpoints or put patient safety at riskXx_NEWLINE_xXSubjects with >= grade 2 peripheral neuropathy at enrollment per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)Xx_NEWLINE_xXFailure to recover from all adverse events/toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; NOTE: Exception: patients with any grade of alopecia are allowed to enter the studyXx_NEWLINE_xXClinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (</=) 2 (according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) prior to Day 1 of Cycle 1Xx_NEWLINE_xXNational Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medicationXx_NEWLINE_xXResolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.Xx_NEWLINE_xXEXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXEXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXPatients who have received prior treatment with anti-CTLA-4 antibody may be enrolled, provided the following requirements are met:\r\n* > 6 weeks from the last dose\r\n* No history of severe immune-related adverse effects from anti-CTLA-4 antibody (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)Xx_NEWLINE_xXPersistent diarrhea or malabsorption National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical managementXx_NEWLINE_xXSubject has any peripheral neuropathy >= National Cancer Institute (NCI) CTCAE grade 2 at enrollmentXx_NEWLINE_xXModerate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXPersistent proteinuria >= grade 3 NCI-CTCAE v4.0Xx_NEWLINE_xXParticipants who have had chemotherapy within 14 days prior registration or those who have not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study); there is no washout period required for trastuzumab or for endocrine therapy; however subjects who received fulvestrant immediately prior to this trial should wait at least 28 days before receiving their first dose of fulvestrant on studyXx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-CTCAE version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 to less than or equal to grade 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXNeuropathy >= grade 3 or painful neuropathy >= grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v]4.03)Xx_NEWLINE_xXPresence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ?Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v. 5.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomizationXx_NEWLINE_xXFor patients with newly diagnosed ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:\r\n* Decline in serum cancer antigen (CA) 125 level\r\n* At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging\r\n* Improvement of ascites volume\r\n* Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery\r\n* Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as definedXx_NEWLINE_xXSignificant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1Xx_NEWLINE_xXPeripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 or 4.0, as utilized in the parent studyXx_NEWLINE_xXHas sensory or motor neuropathy of >= National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Grade 3.Xx_NEWLINE_xXAny ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade > 2, NCI CTCAE grade 4 atrial fibrillation, or corrected QC interval per Fridericia's formula (QTcF) interval > 470 msec, except for documented right bundle branch block, at screeningXx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXPersistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 days before registrationXx_NEWLINE_xXAt least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (4 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy); any number of prior therapies for recurrent/metastatic ACC are allowed, with the exception of previous treatment with PD-1 pathway inhibitorsXx_NEWLINE_xXNot recovered from side effects of prior therapy to ? Grade 1 (according to National Cancer Institute [NCI] CTCAE version 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > GradeXx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, or peripheral neuropathy must have resolved to grade 1 (National Cancer Institute [NCI] CTCAE version 4) or baseline before administration of study drugXx_NEWLINE_xXAll non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (</=) 2 prior to starting therapy AlectinibXx_NEWLINE_xXPersisting toxicity related to prior therapy > Grade 1 National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); however, sensory neuropathy ? Grade 2 is acceptable.Xx_NEWLINE_xXHave discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.0 grade 1 or less at the time of signing the informed consent form (ICF) except for alopeciaXx_NEWLINE_xXDiarrhea > grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03Xx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrhealsXx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1, in the opinion of the treating physicianXx_NEWLINE_xXSubject has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [v] 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without interventionXx_NEWLINE_xXPatients with >= grade III or grade II with pain peripheral neuropathy (National Cancer Institute [NCI] CTCAE version [v.] 4.03 criteria)Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE version (v) 4.0Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXPatients must have histopathological confirmation of pancreatic adenocarcinoma prior to entering this study by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this studyXx_NEWLINE_xXConfirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)Xx_NEWLINE_xXHistory of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias > Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.Xx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrhealsXx_NEWLINE_xXPatient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as >= grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0 (CTCAE)Xx_NEWLINE_xXConfirmed histopathologic diagnosis by National Cancer Institute (NCI) Laboratory of PathologyXx_NEWLINE_xXAny abnormality that would be scored as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (v 3.0) grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation onlyXx_NEWLINE_xXInadequate recovery from toxicity attributed to prior anti-cancer therapy.\r\n* With the exception of alopecia, fatigue, or peripheral neuropathy, patients must have recovered to =< grade 1 (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] 4.03) residual toxicity prior to first dose of protocol-indicated treatment.Xx_NEWLINE_xXConcurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug.\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders non-healing wound, ulcer, or bone fracture.Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 or lessXx_NEWLINE_xXTREATMENT WITH SJCAR19: Has recovered from all National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade III-IV, non-hematologic acute toxicities from prior therapyXx_NEWLINE_xXPersisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 5.0); however, alopecia and sensory neuropathy grade =< 2 is acceptable.Xx_NEWLINE_xXConfirmation of diagnosis of metastatic gastrointestinal epithelial cancer by the National Cancer Institute (NCI) Laboratory of Pathology.Xx_NEWLINE_xXHistory of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ? 3 drug-related CNS toxicityXx_NEWLINE_xXUnstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), New York Association class III or IV heart failureXx_NEWLINE_xXSubject has not fully recovered to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ? Grade 1 from toxicity due to all prior therapies, except alopecia and other non-clinically significant AEs.Xx_NEWLINE_xXDiarrhea > grade 1 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) in the absence of antidiarrhealsXx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician.Xx_NEWLINE_xXResolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ? 1Xx_NEWLINE_xXSignificant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment. Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3.Xx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] 5.0), any history of anaphylaxis or history of uncontrolled asthmaXx_NEWLINE_xXGrade >= 2 neuropathy (National Cancer Institute [NCI] CTCAE version 4)Xx_NEWLINE_xXPersisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]. 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator's judgement are acceptableXx_NEWLINE_xXNational Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatmentXx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] v4.03), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 grade 1Xx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: -- Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.-- Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the principal investigator.Xx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03)Xx_NEWLINE_xXPeripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXPatients with a known allergy or hypersensitivity to the protocol therapies or any of their components to be used in the arm the patient is to be enrolled on. Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).Xx_NEWLINE_xXSubjects must have recovered to =< grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 or stabilized from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks or 5 half-lives earlier, whichever is shorterXx_NEWLINE_xXToxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; patients with long-standing stable grade 2 neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)Xx_NEWLINE_xXKnown severe (National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXNot recovered from adverse events (AE)s or toxicities due to previous treatments to a grade 1 or less specified in National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 excepting, albumin (< 2.5 g/dL), AST and ALT in patients with liver metastases (> 5 x ULN) alkaline phosphatase (ALP) in patients with bone metastases (> 5 x ULN) and alopeciaXx_NEWLINE_xXKnown prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade ? 3)Xx_NEWLINE_xXConfirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of National Cancer Institute (NCI)Xx_NEWLINE_xXPersisting toxicity from prior therapy (National Cancer Institute [NCI] CTCAE v4.03 grade >1); however alopecia or other grade =< 2 adverse events (AEs) not constituting a safety risk, based on investigator’s judgement, are acceptableXx_NEWLINE_xXHave resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ?Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.Xx_NEWLINE_xXPatients may have received any number of prior lines of therapy. All prior systemic anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0; National Cancer Institute [NCI], 2009) at the time of enrollment. This does not include alopecia and grade 1 or less peripheral neuropathy.Xx_NEWLINE_xXResolution of all acute toxic effects of any prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) CTCAE version 4.0 grade 1Xx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or baseline prior to administration of first dose of study drug; subjects with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long-lasting sequelae, such as chronic neuropathy after platinum based therapy, are permitted to enrollXx_NEWLINE_xXSubjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events\r\n[CTCAE] version 4.03) or baseline before administration of study drug.Xx_NEWLINE_xXActive uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to 3).Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1Xx_NEWLINE_xXSubject has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v 4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria.Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) CTCAE version 4.0 grade 1Xx_NEWLINE_xXClinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.0) as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXPatients must have histopathological confirmation of colorectal carcinoma (CRC) by the laboratory of pathology of the National Cancer Institute (NCI) prior to entering this studyXx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grading, in the absence of antidiarrhealsXx_NEWLINE_xXAbsence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade 3 or 4 according to National Cancer Institute (NCI) Common TerminologyXx_NEWLINE_xXKnown prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade ? 3)Xx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria; subjects with grade ? 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physicianXx_NEWLINE_xXNo dehydration of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade >= 1Xx_NEWLINE_xXGrade >= 3 peripheral neuropathy according to (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) version 4.0Xx_NEWLINE_xXConfirmation of G12V mutated KRAS, NRAS or HRAS by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXHaematological and liver function test results ? grade 2 toxicity (according to US National Cancer Institute's Common Terminology) Criteria for Adverse Events v4.03 [CTCAEXx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ? 1 or baseline (except alopecia or neuropathy)Xx_NEWLINE_xXPersisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, grade 2 anemia, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptableXx_NEWLINE_xXSTUDY TREATMENT: All toxicities attributed to prior anti-cancer therapy other than nephropathy, neuropathy, hearing loss, alopecia and fatigue must have resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enrollXx_NEWLINE_xXPeripheral neuropathy of grade >= per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, at the time of or within 3 weeks prior to the first study therapyXx_NEWLINE_xXActive known clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)Xx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXPrior treatment toxicities have not resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (except for alopecia and neuropathy)Xx_NEWLINE_xXserum potassium NCI-CTCAE version 4.03 Grade <2;Xx_NEWLINE_xXserum calcium NCI-CTCAE version 4.03 Grade <2;Xx_NEWLINE_xXserum magnesium NCI-CTCAE version 4.03 Grade <2;Xx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to grade 1 (National Cancer institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll; neuropathy must have resolved to grade 2 (NCI CTCAE version 4)Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXSignificant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)Xx_NEWLINE_xXPatients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 or to the baseline laboratory values as defined in the inclusion criteriaXx_NEWLINE_xXPresence of toxicities attributed to prior therapy other than alopecia that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drugXx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXPresence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) or baseline before administration of study drugXx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXPersisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 [v4.03] grade > 1); however alopecia, sensory neuropathy grade =< 2, or other grade =< 2 adverse events (AEs) not constituting a safety risk based on investigator's judgment are acceptableXx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXAny hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medicationXx_NEWLINE_xXNot recovered to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drugXx_NEWLINE_xXPresence of peripheral neuropathy >= grade 3 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v 4.0)Xx_NEWLINE_xXAny previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3Xx_NEWLINE_xXOngoing or active infection (bacterial, fungal, or viral) of National Cancer Institute (NCI)-CTCAE version 4.03 grade > 2Xx_NEWLINE_xXPresence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0) or baseline before administration of study drugXx_NEWLINE_xXToxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study principal investigator (PI)Xx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis and may be included after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with their assigned investigational product (IP) (e.g., hearing loss) may be included after consultation with the study physicianXx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrhealsXx_NEWLINE_xXPersisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 4.03); however, alopecia and sensory neuropathy grade =< 2 is acceptableXx_NEWLINE_xXPresence of ? CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03)Xx_NEWLINE_xXPatients with a known allergy or hypersensitivity to avelumab, 5-azacytidine, or any of their components; known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXLack of recovery of prior adverse events to grade =< 1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] 4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing; stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the investigatorXx_NEWLINE_xXSymptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4Xx_NEWLINE_xXSymptomatic altered hearing > grade 2 by NCI-CTC version (v)4 criteriaXx_NEWLINE_xXSignificant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)Xx_NEWLINE_xXAll prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).Xx_NEWLINE_xXPeripheral neuropathy National Cancer Institute (NCI) CTCAE >= grade 2 at baselineXx_NEWLINE_xXUnresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE version [v]4.03) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by nivolumab may be included (eg, hearing loss) after consultation with the principal investigatorXx_NEWLINE_xXRecovery from toxicity from any prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.03) to grade 1 or better (except for =< grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis)Xx_NEWLINE_xXPatients with ongoing toxicities > grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (excluding alopecia) due to prior anti-cancer therapyXx_NEWLINE_xXPatients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1Xx_NEWLINE_xXPatients are ineligible if they have unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) CTCAE version 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria\r\n* Note: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI and Northwestern University (NU) Quality Assurance Monitor (QAM)Xx_NEWLINE_xXPeripheral sensory neuropathy or peripheral motor neuropathy >= grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0Xx_NEWLINE_xXUnresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the study chairXx_NEWLINE_xXUnresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g. hearing loss) after consultation with the principal investigatorXx_NEWLINE_xXAll prior treatment-related toxicities must be National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4 =< Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be =< Grade 2]) at the time of treatment allocation.Xx_NEWLINE_xXOngoing >= grade 3 cardiac, pulmonary, renal, gastrointestinal or hepatic toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity criteriaXx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: a) patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; b) patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physicianXx_NEWLINE_xXAny active grade 3 or higher (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03) viral, bacterial, or fungal) infection within two weeks prior to the first dose of study treatmentXx_NEWLINE_xXPeripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03Xx_NEWLINE_xXActive known clinically serious infections (> grade 2 National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)Xx_NEWLINE_xXPrior treatment toxicities not resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except alopecia and neuropathyXx_NEWLINE_xXAll AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version [v.]4.0) grade =< 2Xx_NEWLINE_xXFull recovery from the acute effects of prior cancer treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as listed above; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by MEDI4736 and tremelimumab may be included (eg, hearing loss, neuropathy) upon approval of the principal investigator (PI)Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1 or less at the time of signing the informed consent form (ICF) except for alopeciaXx_NEWLINE_xXConfirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)Xx_NEWLINE_xXPatients who have not had resolution of clinically significant toxic effects of prior anticancer therapy to =< grade 1 as per by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v. 4.0)Xx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any degree of alopecia are allowed to enter the study)Xx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0), any history of anaphylaxis, or uncontrolled asthmaXx_NEWLINE_xXAny unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician and/or PI\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the treating physician and/or PIXx_NEWLINE_xXConcurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders\r\n* Non-healing wound, ulcer, or bone fractureXx_NEWLINE_xXNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.0) grade 3 or higher toxicities due to any prior therapy (e.g. radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medicationXx_NEWLINE_xXResolution of acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 (except alopecia)Xx_NEWLINE_xXOngoing infection > Grade 2 NCI-CTCAE v 4.03Xx_NEWLINE_xXHave recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 grade ?1.Xx_NEWLINE_xXSubjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)Xx_NEWLINE_xXSubject has unresolved toxicities from prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (National Cancer Institute [NCI] CTCAE version [v] 4.0) grade 2 or higher clinically significant toxicity (excluding alopecia)Xx_NEWLINE_xXSubject has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without interventionXx_NEWLINE_xXToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that armXx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade =< 1 or baseline (except alopecia or neuropathy)Xx_NEWLINE_xXCardiac dysrhythmias of NCI CTCAE grade >= 2 within the last 28 daysXx_NEWLINE_xXUnstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03), New York Association class III or IV heart failureXx_NEWLINE_xXConcurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 or requiring the use of parenteral anti-microbial agents within 7 days before day 1 of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disordersXx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.0 grade 1 or less at the time of signing the informed consent form (ICF)Xx_NEWLINE_xXAny other serious illness or medical condition, such as but not limited to:\r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Known bone marrow dysplasiaXx_NEWLINE_xXPersistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v4.03).Xx_NEWLINE_xXPeripheral neuropathy of National Cancer Institute (NCI)- Common Terminology Criteria (CTC) grade >= 2Xx_NEWLINE_xXPrior non-hematologic treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of the following grade 2 toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests international normalized ratio (INR) and/or activated partial thromboplastin time (aPTT); weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertensionXx_NEWLINE_xXReceipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).Xx_NEWLINE_xXAll prior anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE version 5.0; National Cancer Institute [NCI], 2017) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents)Xx_NEWLINE_xXPatients who meet any of the National Cancer Institute (NCI) Working Group criteria to initiate treatment for CLL are NOT eligible for participationXx_NEWLINE_xXConfirmation of diagnosis of metastatic cancer including melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXPeripheral neuropathy of grade 2 or greater severity as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; patients with grade 2 or higher (NCI-Common Toxicity Criteria [CTC]) neuropathyXx_NEWLINE_xXThe subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade =< 1 from adverse events (AEs) (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to studyXx_NEWLINE_xXContraindication to antiangiogenic agents, including:\r\n* Bronchopulmonary hemorrhage/bleeding event >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) within 4 weeks or less prior to first dose of study drug\r\n* Any other hemorrhage/bleeding event >= grade 3 (CTCAE version [v]4.0) within 4 weeks or less prior to first dose of study treatment\r\n* Radiological evidence of any intracranial hemorrhage within the 4 weeks or less prior to first dose of study treatment \r\n* History of significant intratumoral, intracerebral, or subarachnoid hemorrhage\r\n* Serious non-healing wound, ulcer, or bone fracture\r\n* Documented bowel perforation within 6 months of the start of study treatmentXx_NEWLINE_xXHistologic confirmation of disease in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH)Xx_NEWLINE_xXResolution of any effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 and to baseline laboratory values as defined belowXx_NEWLINE_xXClinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXNot recovered from side effects of prior therapy to ? Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.Xx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, or currently taking antidiarrhealsXx_NEWLINE_xXPotassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade 1Xx_NEWLINE_xXPresence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ? grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade 3) due to prior cancer therapyXx_NEWLINE_xXAll Institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXSevere major organ toxicity; renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 1 or less (per National Cancer Institute [NCI] Common Toxicity Criteria [CTC] version 3 criteria) with the following exceptions:\r\n* Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase should be =< 5 x upper limit of normal (ULN)\r\n* Serum bilirubin =< 3 x ULN and nausea and vomiting should be =< grade 2\r\n* Patients with myelosuppression are not excluded if absolute neutrophil count (ANC) >= 500/uLXx_NEWLINE_xXPatients with grade 3 toxicities or less using the Common Toxicity Criteria (version 3.0) developed by the National Cancer Institute of the United States of America (USA) (Common Terminology Criteria for Adverse Events version 3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical examXx_NEWLINE_xXPatients must have a tissue diagnosis of grade 1, 2 and/or 3 A/B LYG (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI); final histopathologic classification and pathologic grade will be determined by Stefania Pittaluga, M.D. or her designeeXx_NEWLINE_xXDiagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI)Xx_NEWLINE_xXActive or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ? 2).Xx_NEWLINE_xXUnresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidismXx_NEWLINE_xXAny unresolved toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, including electrolyte abnormalities, from previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physicianXx_NEWLINE_xXKnown severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v]4.0), any history of anaphylaxis or uncontrolled asthmaXx_NEWLINE_xXPresence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v4.0)Xx_NEWLINE_xXSymptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4Xx_NEWLINE_xXAll prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, must be <=Grade 1 at the time of enrolment except for alopecia and Grade 2 peripheral neuropathy.Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be <= Grade 1 at the time of enrollment, except for alopecia and Grade 2 neuropathy.Xx_NEWLINE_xXResolution of any clinically significant toxic effects of prior therapy to grade 0 or 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 (exception of alopecia and grade 2 peripheral neuropathy).Xx_NEWLINE_xXResolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE 4.03 grade =< 1Xx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] 5.0) or baseline before administration of study treatment. Participants with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enrollXx_NEWLINE_xXAny unresolved toxicity (non-immune mediated) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia\r\n* However, patients with irreversible toxicity not reasonably expected to be exacerbated by the treatment with durvalumab + trabectedin may be included only after consultation with the study physicianXx_NEWLINE_xXFull recovery from the acute effects of prior treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as outlined below; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g., hearing loss, neuropathy) upon approval of the principal investigator (PI)Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF); exceptions to this include alopeciaXx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v 4.0) grade 2 or higher from previous anti-cancer therapy, except alopeciaXx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy must have been resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug(s) other than:\r\n* Patients with toxicities attributed to prior anti-cancer therapy that either are not expected to resolve and/or result in long-lasting sequelae, such as neuropathy after platinum-based therapy, or are not expected to interfere with treatment on study, such as fatigue, alopecia, or grade 2 hematologic toxicity are eligibleXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAny > grade 1 (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.03) adverse reaction unresolved from previous treatments or not readily managed and controlled with supportive care; the presence of alopecia of any grade and peripheral neuropathy ? grade 2 without pain is allowedXx_NEWLINE_xXHistologic confirmation of disease in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomizationXx_NEWLINE_xXRecovered from toxic effects of prior therapy to < Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy and Day 1 is:Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXPeripheral neuropathy of any etiology > grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0)Xx_NEWLINE_xXSubject must be also enrolled on an National Cancer Institute (NCI) allogeneic transplant protocolXx_NEWLINE_xXDiagnosis must be confirmed by the National Cancer Institute (NCI) Laboratory of PathologyXx_NEWLINE_xXTotal calcium (corrected for serum albumin) within institutional normal limits, or =< grade 1 according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 if judged clinically not significant by the investigator (bisphosphonate use for malignant hypercalcemia control is not allowed)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXNo pre-existing neuropathy grade > 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) for human studies must be metXx_NEWLINE_xXPatients must have histologically confirmed B-cell CLL/SLL according to World Health Organization (WHO) criteria with at least one of the following indications for treatment:\r\n* Progressive disease or marked splenomegaly or hepatomegaly\r\n* Anemia (hemoglobin [Hgb] < 11 mg/dL) or thrombocytopenia (platelets < 100,000 /mm^3)\r\n* Unexplained weight loss exceeding 10% of body weight over the preceding 6 months\r\n* Fevers > 100.5 degrees F or night sweats for greater than 2 weeks without evidence of infection\r\n* Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months\r\n* Significant fatigue (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03 grade 2 or higher)Xx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)Xx_NEWLINE_xXPeripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXElectrolytes =< grade 1 severity according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or if judged clinically not significant by the investigatorXx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia; in specific cases, will be allowed with permission from the principal investigatorXx_NEWLINE_xXConfirmation of diagnosis of metastatic ocular melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXNo evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version [v]4.0)Xx_NEWLINE_xXPatients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be > 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0Xx_NEWLINE_xXNo evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v 4.0)Xx_NEWLINE_xXPatient must not have ongoing ventricular cardiac dysrhythmias of grade >= 2 as described by the Cancer Therapy Evaluation Program (CTEP) version 4.0 of the National Cancer Institute (NCI) CTCAEXx_NEWLINE_xXNo clinically significant (equivalent to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3-4) bleeding episodes within the past 3 monthsXx_NEWLINE_xXHistory of severe (defined as ? grade 3, using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent.Xx_NEWLINE_xXSubject has any peripheral neuropathy ? NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events ) Grade 2 at randomization/enrollment.Xx_NEWLINE_xXSignificant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade ?2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)Xx_NEWLINE_xXResolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator’s discretion)Xx_NEWLINE_xXOngoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade >= 2Xx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline (except alopecia or neuropathy)Xx_NEWLINE_xXPatients must not currently have a > grade 1 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)Xx_NEWLINE_xXOngoing clinical adverse events NCI CTCAE Grade >2 resulting from prior cancer therapiesXx_NEWLINE_xXResolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.Xx_NEWLINE_xXHave side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)Xx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade < 3 (exception to this criterion: patients with any grade of alopecia or neuropathy are allowed to enter the study)Xx_NEWLINE_xXAny non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screeningXx_NEWLINE_xXClinically significant toxicity from prior therapy that has not resolved to Grade <=2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v 4.0Xx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline (except alopecia)Xx_NEWLINE_xXAny peripheral neuropathy ? National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2.Xx_NEWLINE_xXAt least 14 days since the end of prior systemic VEGF-targeted treatment (ie, sunitinib, pazopanib, axitinib, or sorafenib), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity (except alopecia and hypothyroidism) either to Grade 0 or 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) or to baseline.Xx_NEWLINE_xXUnresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteriaXx_NEWLINE_xXPatients meeting any of the following consensus criteria for initiating treatment for their CLL:\r\n* Progressive symptomatic splenomegaly and/or lymphadenopathy identified by physical examination\r\n* Anemia ( < 11g/dL) or thrombocytopenia ( < 100,000/uL) due to bone marrow involvement\r\n* Presence of unintentional weight loss > 10% over the preceding 6 months\r\n* National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 fatigue\r\n* Fevers > 100.5°F or night sweats for > 2 weeks without evidence of infectionXx_NEWLINE_xXNational Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before ScreeningXx_NEWLINE_xXOngoing infection > Grade 2 NCI-CTCAE v4.03.Xx_NEWLINE_xXDehydration Grade ? 1 NCI-CTCAE v4.03.Xx_NEWLINE_xXPersistent diarrhea or malabsorption >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical managementXx_NEWLINE_xXDiarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v.] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacementXx_NEWLINE_xXConcurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug \r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders \r\n* Non-healing wound, ulcer, or bone fractureXx_NEWLINE_xXAll prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).Xx_NEWLINE_xXCurrent National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0Xx_NEWLINE_xXNational cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)Xx_NEWLINE_xXPrior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXSubject has resolution to grade ?1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatmentXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXParticipant has resolution to grade ? 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ? 2Xx_NEWLINE_xXOngoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACE) version 4.0 grade >= 2; however, stable atrial fibrillation controlled medically or with a device (e.g. pacemaker) or prior ablation is allowedXx_NEWLINE_xXRecovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).Xx_NEWLINE_xXAny unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapyXx_NEWLINE_xXSignificant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.0 diarrhea of any etiology at baseline)Xx_NEWLINE_xXPotassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade 1Xx_NEWLINE_xXPresence of NCI CTCAE ? grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade 3) due to prior cancer therapyXx_NEWLINE_xXResolution of clinically significant side effects of prior chemotherapy, radiotherapy, immunotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 or grade =< 2 for neuropathyXx_NEWLINE_xXPrior treatment toxicities have not resolved to =< grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (except clinically insignificant toxicities such as alopecia)Xx_NEWLINE_xXPatient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study).Xx_NEWLINE_xXAny previous National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 4 venous thromboembolismXx_NEWLINE_xXHistory of severe hypersensitivity reaction to any monoclonal antibody (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade less than/equal to 1 or baseline (except alopecia)Xx_NEWLINE_xXHave resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.Xx_NEWLINE_xXAt least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab-containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowedXx_NEWLINE_xXAll prior treatment- related toxicities must be National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 <=Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be <= Grade 2]) at the time of treatment allocation.Xx_NEWLINE_xXOngoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.Xx_NEWLINE_xXNational Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatmentXx_NEWLINE_xXPersistent diarrhea or malabsorption > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical managementXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXsignificant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.Xx_NEWLINE_xXSubjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drugXx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF)Xx_NEWLINE_xXDehydration grade >= 1 NCI-CTCAE v4.0Xx_NEWLINE_xXOngoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF)Xx_NEWLINE_xXFollowing medical conditions are not eligible:\r\n* Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer or cervical dysplasia)\r\n* Any other serious illness or medical condition, such as but not limited to: \r\n** Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade 2\r\n** Cardiac failure New York Heart Association (NYHA) III or IV\r\n** Crohn’s disease or ulcerative colitis\r\n** Bone marrow dysplasia or myelodysplastic syndromeXx_NEWLINE_xXThe subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drugXx_NEWLINE_xXInadequate liver function: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >5× upper limit of normal [ULN] for >2 weeks; bilirubin >3× ULN) unless due to underlying diseaseXx_NEWLINE_xXGrade II or greater peripheral vascular disease based on National Cancer Institute (NCI) Common Toxicity Criteria (CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangreneXx_NEWLINE_xXPeripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXAll toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 4.03) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long-lasting sequelae, such as neuropathy after chemotherapy, are permitted to enrollXx_NEWLINE_xXAny hemorrhage or bleeding event >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4 grade 3 =< 4 weeks prior to registrationXx_NEWLINE_xXPersistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 days before study enrollment with the exception of alopeciaXx_NEWLINE_xXAny other serious illness or medical condition in the opinion of the investigator, such as but not limited to:\r\n* Any grade >= 2 infection as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 \r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Fecal incontinenceXx_NEWLINE_xXParticipant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 4Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) grade 1 or less at the time of signing the Informed Consent Form (ICF)Xx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXAt least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowedXx_NEWLINE_xXRecovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0) grade ?2.Xx_NEWLINE_xXHas not recovered (recovery is defined as National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version (v)4.03] grade =< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterionXx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1, in the opinion of the Treating PhysicianXx_NEWLINE_xXAny acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) (version 4) grade of =< 1; chemotherapy induced alopecia and grade 2 peripheral neuropathy are allowedXx_NEWLINE_xXHave resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to National Cancer Institute Common Terminology Criteria (NCI CTC) grade =< 1 prior to study registrationXx_NEWLINE_xXThe patient has ? Grade 2 peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) at screeningXx_NEWLINE_xXKnown prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)Xx_NEWLINE_xXParticipant has significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0] diarrhea of any etiology at screening)Xx_NEWLINE_xXAny acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4) grade of =< 1; chemotherapy induced alopecia and grade 2 peripheral neuropathy are allowedXx_NEWLINE_xXPre-existing neuropathy >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopeciaXx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 grade 1 or less at the time of signing the informed consent form (ICF)Xx_NEWLINE_xXSignificant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)Xx_NEWLINE_xXSubjects who have not recovered from toxicities as a result of prior anticancer therapy to less than Grade 2 severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0, except alopecia and infertility.Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1, except for diarrhea (which must be grade 0 without supportive antidiarrheal medications) and alopecia (any grade)Xx_NEWLINE_xXOngoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)Xx_NEWLINE_xXAny other serious illness or medical condition, such as but not limited to: Any active infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2; Cardiac failure New York Heart Association (NYHA) III or IV; Fecal incontinence (this is because of Ra-223 elimination in feces).Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 or less at the time of signing the informed consent form (ICF)Xx_NEWLINE_xXClinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])Xx_NEWLINE_xXOngoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 4.0. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.Xx_NEWLINE_xXResolution of chemotherapy and radiation therapy related toxicities to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 1 or lower severity, except for diarrhea (which must be Grade 0 without a supportive antidiarrheal medications) and alopecia (any grade)Xx_NEWLINE_xXResolution of all clinically significant toxic effects of prior cancer therapy to grade ?1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)Xx_NEWLINE_xXPrior anti-cancer treatment related toxicities except alopecia and lab values as outlined above must be =< grade 1 as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4Xx_NEWLINE_xXSymptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4Xx_NEWLINE_xXUnresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)Xx_NEWLINE_xXDiarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v.] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacementXx_NEWLINE_xXHas recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)Xx_NEWLINE_xXOngoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade >= 2Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXResolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v.)3.0 grade =< 1 and to baseline laboratory values as defined in the inclusion criterion immediately belowXx_NEWLINE_xXAny unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.Xx_NEWLINE_xXResolution of all toxic side effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) grade =< 1 (with the exception of grade 2 alopecia, grade 2 neuropathy and grade 2 fatigue)Xx_NEWLINE_xXHistory of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0Xx_NEWLINE_xXPrevious radiation allowed provided the patient has recovered from the acute and chronic side effects to =< grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events v. 4.0 [CTCAE v 4.0])Xx_NEWLINE_xXDiarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrhealsXx_NEWLINE_xXResolution of all acute toxic effects of prior radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia;Xx_NEWLINE_xXE 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.Xx_NEWLINE_xXE 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).Xx_NEWLINE_xXOngoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)Xx_NEWLINE_xXDehydration according to NCI-Common Toxicity Criteria (CTC) v 4.0 grade >= 1Xx_NEWLINE_xXAny unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical MonitorXx_NEWLINE_xXResolution of any pre-existing toxicity from prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 =< grade 1 except neuropathy (=< grade 2) and tinnitus (=< grade 2), and hearing loss (=< grade 4)Xx_NEWLINE_xXAt least 2 weeks must have elapsed since the end of prior systemic treatment and/or 4 weeks since completion of radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment; any number of prior therapies for recurrent/metastatic salivary gland cancer are allowedXx_NEWLINE_xXKnown prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)Xx_NEWLINE_xXPrior anti-PD-L1 therapies are excluded\r\n* Patients who have received prior treatment with immunotherapy including anti-PD-1 anti-CTLA-4 may be enrolled, provided that there was no history of severe immune-related adverse effects (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grade 3 and 4)Xx_NEWLINE_xXAny unresolved clinically significant treatment related toxicity of >= grade 1 intensity, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), from previous anti-cancer therapy; patients with irreversible toxicity (eg, hearing loss, peripherally neuropathy) or reversible toxicity (eg, alopecia) that is not reasonably expected to be exacerbated by the investigational product and is not expected to interfere with study participation may be includedXx_NEWLINE_xXToxicities of prior therapy (except alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI)Xx_NEWLINE_xXConfirmed pathological diagnosis by the Laboratory of Pathology, National Cancer Institute (NCI)Xx_NEWLINE_xXAny toxicity from prior chemotherapy has resolved or Grade 1 (NCI-CTCAE, Version 4.0)Xx_NEWLINE_xXOngoing infection > Grade 2 NCI-CTCAE v4.0.Xx_NEWLINE_xXDehydration Grade > 2 NCI CTCAE v4 within 7 days prior to registration.Xx_NEWLINE_xXClinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXAll prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)Xx_NEWLINE_xXHas persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia). Stable sensory neuropathy ? grade 2 National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 is acceptedXx_NEWLINE_xXPersistent proteinuria >= grade 3 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (> 3.5 g/24 hours [hrs], measured by urine protein: creatinine ratio on a random urine sample)Xx_NEWLINE_xXTreatment with any anticancer therapy (standard or investigational) within the 14 days prior to the first dose of study drug. In addition, subjects must have fully recovered (i.e., National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] Grade 1 [exception: subjects with prior bortezomib may have CTCAE Grade 2 neuropathy]) from the clinically significant toxic effects of that treatmentXx_NEWLINE_xXAny hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3 within 4 weeks prior to start of study medicationXx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 or less at the time of signing the informed consent form (ICF); alopecia (any grade) and peripheral neuropathy < grade 2 is allowedXx_NEWLINE_xXResolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.Xx_NEWLINE_xXResolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.Xx_NEWLINE_xXAcute toxic effects of all prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 =< grade 1 or baseline prior to beginning treatment; alopecia (any grade) is allowed; peripheral neuropathy =< grade 2 is allowedXx_NEWLINE_xXLack of recovery of prior adverse events to Grade ?1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.Xx_NEWLINE_xXConfirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXUnresolved toxicity greater than Grade 1 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 from previous anti-cancer therapy, with the exception of alopecia and peripheral neuropathy. Lymphoma subjects with <= Grade 3 lymphopenia can be enrolled at the discretion of the investigator.Xx_NEWLINE_xXConfirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXRecovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy & Day 1 is:Xx_NEWLINE_xXActive clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]Xx_NEWLINE_xXResolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, grade =< 1 (with the exception of alopecia and =< grade 2 neuropathy); subject must have recovered from significant surgery-related complicationsXx_NEWLINE_xXPrior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0Xx_NEWLINE_xXPatients must have recovered from toxicity related to prior therapy (chemotherapy, surgery or radiation) to grade =< 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE]); the National Cancer Institute (NCI) CTCAE version 4 will be used for toxicity and adverse event reportingXx_NEWLINE_xXPatients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1Xx_NEWLINE_xXPre-existing peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ?2)Xx_NEWLINE_xXPatients with baseline neurologic symptoms at National Cancer Institute (NCI) Common Toxicity Criteria (CTC) level 3 are not eligibleXx_NEWLINE_xXHave not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.Xx_NEWLINE_xXHave discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0).Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXHas recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)Xx_NEWLINE_xXClinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)Xx_NEWLINE_xXIneligible for cisplatin-based chemotherapy as defined by any one of the following criteria: Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (of 25 Decibel at two contiguous frequencies or more severe); NCI CTCAE v 4.0 Grade >= 2 peripheral neuropathy; ECOG Performance Status of 2Xx_NEWLINE_xXAcute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1Xx_NEWLINE_xXSubject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ? Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia.Xx_NEWLINE_xXAdverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.Xx_NEWLINE_xXResolution to grade =< 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03) of all clinically significant toxic effects of prior anti-cancer therapy (with the exception neuropathy, which may be =< grade 2 within 14 days prior to cycle 1 day 1)Xx_NEWLINE_xXPrior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to =< grade 1 according to National Cancer Institute (NCI) CTCAE version 4.0 (except alopecia)Xx_NEWLINE_xXPatients must have histopathological confirmation of colorectal carcinoma (CRC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this studyXx_NEWLINE_xXAny acute toxicities due to prior anti-cancer treatments and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade of =< 1 (except alopecia)Xx_NEWLINE_xXActive, clinically serious infections defined as ?Grade 2 according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE), version 4.0Xx_NEWLINE_xXRecovery from all reversible AEs of previous medical therapies to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1, except for alopecia (any grade)Xx_NEWLINE_xXAdverse events (with exception of alopecia, peripheral sensory neuropathy and those listed in specific exclusion criteria) from any prior anti cancer therapy of grade > 1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] version [v.]4.0)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXHas gastrointestinal bleeding or any other hemorrhage/bleeding event National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) >Grade 3 within 6 months of start of study drug.Xx_NEWLINE_xXPeripheral neuropathy of grade >= 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, at the time of or within 3 weeks prior to the first study therapyXx_NEWLINE_xXHistory of severe (using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current minor version ? grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipientsXx_NEWLINE_xXHave peripheral neuropathy of grade 3 or grade 4 at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03, 14 June 2010 scale; or Total Neuropathy Score–clinical (TNSc) score greater than 4Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopeciaXx_NEWLINE_xXOngoing cardiac dysrhythmia >= 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE, v4.0])Xx_NEWLINE_xXThe subject has not recovered from toxicity due to prior therapy to Baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (<=) 2 is permitted.Xx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI CTCAE version 4.03) Grade 2 or higher from previous anti-cancer therapy, except alopecia.Xx_NEWLINE_xXPART II: Utilizing the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4, values for the following laboratory tests should be no more than grade two levels: ANC, hemoglobin, platelet count, total bilirubin, creatinine, transaminase (AST/ALT), PT, PTT, urine uric acid, urine pH, urine oxalateXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXCurrent peripheral neuropathy of grade >= 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0Xx_NEWLINE_xXAll non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (</=) 2 prior to starting therapyXx_NEWLINE_xXAntitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ? 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.Xx_NEWLINE_xXPatients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy and radiation) =< 3 weeks prior to starting study drug, or who have side effects (except alopecia, lymphopenia and hyperglycemia) that have not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or lessXx_NEWLINE_xXUnresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.Xx_NEWLINE_xXAll acute toxic effects of any prior treatment have resolved to grade 1 or less (by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v 4.0) at the time of registration; NOTE: exceptions to this criterion will include alopecia and fatigueXx_NEWLINE_xXPulmonary hemorrhage/bleeding event > National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0) grade 2 within 4 weeks of enrollmentXx_NEWLINE_xXActive clinically serious infection > NCI-CTCAE grade 2Xx_NEWLINE_xXUnresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).Xx_NEWLINE_xXParticipants with evidence of electrolyte imbalance such as hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, and hypermagnesemia of Grade > 1 intensity, as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, prior to dosing on Cycle 1 Day 1. Treatment for correction of electrolyte imbalances is permitted to meet eligibilityXx_NEWLINE_xXHistory of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapyXx_NEWLINE_xXAdequate recovery from prior therapy, all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 4.0Xx_NEWLINE_xXPatients must have histopathological confirmation of hepatocellular carcinoma (HCC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study ORXx_NEWLINE_xXPathologic confirmation of cancer by the Laboratory of Pathology, National Cancer Institute (NCI)Xx_NEWLINE_xXHas AEs that have resolved to Grade ? 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapyXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXUnresolved toxicity greater than National Cancer Institute-Common Terminology Criteria for Adverse Events version 4 Grade 1 from previous anti-cancer therapy except alopecia.Xx_NEWLINE_xXPrior chemotherapy and/or radiation are allowed; at least 3 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (with the exception of alopecia and radiation-induced taste changes); prior temozolomide treatment is not restrictedXx_NEWLINE_xXNeuropathy ? Grade 3 or painful neuropathy ? Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0).Xx_NEWLINE_xXNot recovered from side effects of prior therapy to ? grade 1 (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [NCI CTCAE v. 4.03]). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > grade 1Xx_NEWLINE_xXResolution to grade =< 1 by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) of all clinically significant toxic effects of prior anti-cancer therapy (with the exception neuropathy, which may be =< grade 2 within 14 days prior to cycle 1 day 1)Xx_NEWLINE_xXConfirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)Xx_NEWLINE_xXConfirmation of diagnosis of thyroid cancer by the Laboratory of Pathology of the National Cancer Institute (NCI)Xx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll acute toxicities as a result of any prior treatment must have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 or less at the time of signing the Informed Consent Form (ICF) (Note: ongoing grade 2 neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted)Xx_NEWLINE_xXAny other serious illness or medical condition, such as but not limited to: \r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV \r\n* Crohn’s disease or ulcerative colitis \r\n* Bone marrow dysplasia \r\n* Fecal incontinenceXx_NEWLINE_xXToxicities of prior therapy (excepting alopecia and sensory neuropathy) should be resolved to < grade 2 per the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4; all appropriate treatment areas should have access to a copy of the CTCAE version 4Xx_NEWLINE_xXModerate-to-severe bone pain (i.e., National Cancer Institute’s Common Terminology Criteria for Adverse Events grade 2-3 bone pain)Xx_NEWLINE_xXAny vomiting, retching or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea 24 hours preceding chemotherapyXx_NEWLINE_xXClinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAEXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXOngoing infection > grade 2 NCI-CTCAE v4.0Xx_NEWLINE_xXDehydration grade > 1 NCI-CTCAE v4.0Xx_NEWLINE_xXHistory of persistent proteinuria >= grade 3 NCI-CTCAE v4.0Xx_NEWLINE_xXKnown history of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade >= 2 symptomatic chronic heart failure (CHF), myocardial infarction within 12 months prior to randomization, significant symptoms (grade >= 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade >= 3)Xx_NEWLINE_xXPeripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0Xx_NEWLINE_xXThe patient has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia; the exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteriaXx_NEWLINE_xXPatients with a National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (v) 4 sensory neuropathy score of 0Xx_NEWLINE_xXPatients who are considered to be moderately or severely anemic as per the National Cancer Institute (NCI) classification will not be included in the study, i.e. patients with hemoglobin level less than 8 g/dlXx_NEWLINE_xXAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metXx_NEWLINE_xXAny vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours(hrs.) preceding radiation and chemotherapyXx_NEWLINE_xXNormal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged Grade 0-1 by per National Cancer Institute Common Toxicity Criteria (NCI-CTC)Xx_NEWLINE_xXAll prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events, version 4) must be <=Grade 1 at the time of enrollment except for alopecia, and grade 2 neuropathy.Xx_NEWLINE_xXComplete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapyXx_NEWLINE_xXPresence of neuropathy > Grade 1 per NCI CTCAE version 5.0Xx_NEWLINE_xXAcute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade of =< 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowedXx_NEWLINE_xXPatients must not have persistent diarrhea greater than National Cancer Institute (NCI) CTCAE grade 2 at the time of study registration, despite medical managementXx_NEWLINE_xXKnown severe (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)Xx_NEWLINE_xXResolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2Xx_NEWLINE_xXRecovery from toxic effects of prior therapies to grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (NCI-CTCAE), version (v) 4Xx_NEWLINE_xXResolution of all toxic effects of prior treatments (except alopecia) to Grade <=1 NCI CTCAE, Version 4.03.Xx_NEWLINE_xXSensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=3.Xx_NEWLINE_xXThe participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.Xx_NEWLINE_xXThe participant has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.Xx_NEWLINE_xXPatients who have an active clinically significant infection of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ? 2Xx_NEWLINE_xXResolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baselineXx_NEWLINE_xX