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+CT or MRI within 14 days prior to start of study drug
+Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease\r\n* NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist\r\n* NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment\r\n* NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
+No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
+Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start
+Obtained within 14 days prior to treatment start: Platelets (UNVPLT) >= 100 × 10^9/L
+Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of treatment start
+Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of treatment start or unrecovered adverse events (AEs) due to agents administered more than 4 weeks of treatment start
+Prior or concomitant treatments:\r\n* Prior treatment with ibrutinib\r\n* The following cancer treatments:\r\n** Chemotherapy or biological therapy within 14 days prior to start of treatment\r\n** Immunological therapy, radiation therapy, or hormonal therapy within 7 days prior to start of treatment\r\n** Major surgery within 15 days prior to start of treatment\r\n** Subjects who have unresolved toxicity (>= grade 2) from prior anti-cancer therapy, unless that event is thought to be due to disease progression\r\n* Any investigational agent, including small molecule agents, within 30 days prior to start of study treatment\r\n* Any of the following with 7 days prior to start of study treatment:\r\n** B-cell receptor pathway inhibitor;\r\n** CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin);\r\n** Potent CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine or St. John's wort);\r\n** Warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect);\r\n** Antiretroviral medications\r\n** Antibiotics, antifungals, or antivirals to treat an active infection (prophylactic antibiotics allowed)\r\n* Subjects who are unable or unwilling to discontinue use of prohibited medications, including medications with CYP450 interactions\r\n* Subject has received prior treatment with allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
+Systemic corticosteroid use within 7 days before planned start of study therapy
+Participants may not be receiving any other non-Food and Drug Administration (FDA) approved study agents at the start of conditioning for stem cell transplantation; patients may receive non-FDA approved agents at the time of screening/enrollment as long as such agent(s) will be discontinued by the start of conditioning for transplantation
+Live vaccination is not allowed for at least 4 weeks prior to the start of AMG 757 treatment, during treatment, and until end of last study dose
+Has received prior radiotherapy within 2 weeks of start of study treatment.
+Must start the study treatment no more than 60 days from the last dose of RT (if administered) and no more than 120 days from the date of surgical removal of nodal metastases
+Radiation therapy within 2 weeks of study treatment start
+Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy); or use of any investigational drug within 28 days before the start of trial treatment.
+Autologous HSCT within six weeks prior to start of AMG 673 treatment.
+Allogeneic HSCT within three months prior to start of AMG 673 treatment.
+Patients cannot have received radiotherapy to lung fields within 6 months of study treatment start.
+Patients with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e. D1 of cycle 1); however, prior surgery or radiation therapy aimed at local palliation or attempted local disease control (except in case of thoracic radiotherapy) is permitted but has to be completed one week before treatment start
+Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e. D1 of cycle 1)
+Receipt of a stable ART regimen for at least 3 weeks prior to start of trial
+Prior radiation within 14 days before start of study registration
+For Parts A, B, and C, eligibility of participants who require blood transfusion before and after the start of the study treatment should be discussed by the Sponsor and investigator
+Patients may not have received any other investigational agents within the last 14 days at the time of treatment start
+Use of any other experimental medication(s) within 14 days prior to start of the study treatment.
+All radiology studies (study requiring staging) must be performed within 35 days prior to the start of therapy
+Radiotherapy to multiple sites or immunotherapy within 3 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
+Patients must be able to start treatment within 56 days of randomization.
+Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
+Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
+Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
+Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
+Have had significant active cardiac disease within 6 months prior to the start of study treatment, including any of the following:
+Has received prior radiotherapy within 2 weeks of start of trial treatment.
+Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start
+Has received prior radiotherapy within 2 weeks of start of study therapy
+Has received prior radiotherapy within 2 weeks of start of study treatment.
+Subjects using agents known to inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 7 days prior to study start
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+Participation in other therapeutic clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Prior radiation therapy within 21 days prior to the start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start
+Patients can continue taking what they are taking at the time they start on the study, but agree not to start any new (over the counter) herbal supplement on regular basis during study duration
+Participants must be willing and able to undergo a biopsy at the start of this study and an on-treatment biopsy if safe and feasible
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
+Prior radiotherapy within 2 weeks of start of study treatment
+Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment
+Previous radiation therapy completed =< 7 days prior to the start of study drugs
+Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Participation in other clinical trials, including those with other investigational agents not included in this trial, such as monoclonal antibodies, within 30 days of the start of this trial and throughout the duration of this trial
+Measurable disease before start of pre-study nivolumab treatment
+Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
+Receipt of therapy on a clinical trial, including investigational and non-investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial; participation on non-therapeutic clinical studies is allowed, and patients who participated on a clinical trial for induction and/or transplant but who have completed the prescribed therapy course for that study and have been off therapy for at least 30 days are eligible
+Patients receiving proton pump inhibitors which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
+Autologous HSCT within six weeks prior to start of AMG 330 treatment
+Allogeneic HSCT within three months prior to start of AMG 330 treatment
+Participation in other clinical treatment trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+Radiotherapy within the last 4 weeks before start of study drug treatment with the exception of limited field palliative radiotherapy for bone pain relief
+Other anti-neoplastic investigational agents currently or within 2 weeks prior to apheresis (i.e. start of protocol therapy)
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21days of the start of this trial and throughout induction and consolidation 1 portions of this trial (while on MLN 9708); patients may enroll in transplant and post transplant studies after consolidation 1 treatment
+Must have discontinued radiotherapy at least 14 days with resolution of any toxicity to Grade 1 or better prior to the start of treatment.
+Hematologic inclusion within 2 weeks of start of treatment
+< 24 days from prior temozolomide, < 6 weeks from nitrosourea, < 4 weeks from other chemotherapy or investigational agents prior to start of treatment within study.
+Concomitant therapies that cannot be discontinued or switched to a different medication prior to study entry that are known to increase serum phosphate levels are not permitted within 4 weeks prior to start of study treatment)
+Patients who have received high doses of systemic corticosteroids for the treatment of their ATL within 4 weeks prior to the start of therapy
+Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study
+Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start
+Patients must be able to start treatment within 56 days of randomization.
+History of bowel obstruction within 28 days from proposed start of treatment
+Patients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registration
+Major surgery as determined by the investigator within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted).
+Systemic therapy with immunosuppressive agents within 7 days before the start of treatment; or use of any investigational drug within 28 days before the start of trial treatment.
+Potassium, magnesium, phosphate must be corrected to at least lower limit of laboratory normal prior to start of treatment
+Subjects with concurrent cytotoxic chemotherapy or radiation therapy; there must be at least 28 days between any other prior chemotherapy (or radiotherapy) and study treatment; prior antibody therapy must be discontinued 8 weeks prior to start of study treatment
+Patients who develop acute GVHD prior to start of study drug.
+Other anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)
+Cohort #2: prior treatment with ibrutinib is allowed; patients should not have received any anti-lymphoma therapy within 3 weeks from start of study treatment, with the exception of ibrutinib
+Received treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001.
+Within 28 days prior to treatment start: Potassium within institutional normal range
+Administration of an investigational therapeutic within 30 days of treatment start
+Major surgery as determined by the investigator within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted).
+Systemic therapy with immunosuppressive agents within 7 days before the start of treatment; or use of any investigational drug within 28 days before the start of trial treatment.
+Leukemic blast cell count >50 × 109/L before the start of study therapy and despite the use hydroxyurea.
+Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
+Has received prior RT within 2 weeks of start of study treatment
+Patients should be off any prior treatment or line of therapy for 2 weeks prior to start study with the exception of hydrea (hydroxyurea)
+Has a history of arterial thromboembolism within 12 months of start of study drug
+Patients must start therapy within 7 calendar days of registration
+PART A DOSE ESCALATION\n\n        Inclusion Criteria: PART A Dose Escalation\n\n          1. 18-70 years of age\n\n          2. Histologically confirmed WHO grade IV glioblastoma\n\n          3. Unequivocal evidence of a tumor recurrence (any number of recurrences) or progression\n             after an initial treatment regimen (prior to enrollment on this study) consisting of\n             surgical intervention (tumor resection), radiation, and temozolomide chemotherapy (per\n             Stupp protocol), as assessed by MRI of the brain with and without contrast within 30\n             days prior to the initiation of injections of VBI-1901.\n\n          4. Recovery from the effects of surgery.\n\n          5. Corticosteroid (dexamethasone or equivalent) dosage ? 4mg daily that has been stable\n             or decreasing for at least 5 days.\n\n          6. Recovery from prior therapy toxicity defined as resolution of all treatment-related\n             adverse events (AEs) to Grade ? 1 or pre-treatment baseline (except alopecia).\n\n          7. Karnofsky performance status (KPS) score ? 70%.\n\n          8. Adequate organ function, including the following:\n\n               1. Absolute neutrophil count (ANC) ? 1,000/?L, platelets ? 100,000/?L\n\n               2. Serum creatinine < 1.5 × the upper limit of normal (ULN)\n\n               3. Bilirubin < 1.5 × ULN\n\n               4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN\n\n          9. Women of childbearing potential: negative urine pregnancy test within 14 days prior to\n             the start of VBI-1901 treatment.\n\n         10. Female subjects of childbearing potential and sexually active male subjects must agree\n             to use an acceptable form of contraception for heterosexual activity (i.e., oral\n             contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted\n             contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 30 days\n             before Screening, during the study, and for 60 days after the last dose of study\n             drug).\n\n         11. Female subjects without childbearing potential (spontaneous amenorrhea for > 12 months\n             or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy >\n             6 months before Screening) are eligible for inclusion without contraceptive use\n             restriction.\n\n         12. Able and willing to comply with protocol requirements, including being able to have an\n             MRI in the opinion of the Investigator.\n\n         13. Written consent has been obtained.\n\n         14. Tumor specimen available for central pathological review.\n\n        Exclusion Criteria: PART A Dose Escalation\n\n          1. Contrast-enhancing residual tumor that is associated with either diffuse sub-\n             ependymal or leptomeningeal dissemination.\n\n          2. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or\n             equivalent or requirement of increasing dose of systemic corticosteroids during the 7\n             days prior to the start of VBI-1901 treatment.\n\n          3. Evidence of HCMV viremia in serum of > 18,200 (4.3Log10) IU/mL using FDA approved\n             COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).\n\n          4. Surgical resection or major surgical procedure within 4 days prior to the start of\n             VBI- 1901, or stereotactic biopsy within 7 days prior to the start of VBI-1901.\n\n          5. Active infection requiring intravenous antibiotics or antiviral.\n\n          6. History of cancer (other than GBM or prostate) within the past 2 years that could\n             negatively impact survival and/or potentially confound tumor response assessments\n             within this study.\n\n          7. Known immunosuppressive disease or active systemic autoimmune disease such as systemic\n             lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or\n             Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus,\n             hypothyroidism due to autoimmune condition only requiring hormone replacement therapy,\n             psoriasis not requiring systemic therapy, or conditions not expected to recur in the\n             absence of an external trigger are permitted to enroll.\n\n          8. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.\n\n          9. Evidence of intra-tumoral or peri-tumoral hemorrhage on baseline, other than those\n             that are ?Grade 1 and either post-operative or stable on at least 2 consecutive MRI\n             scans.\n\n         10. Any condition which in the investigator's opinion makes the subject unsuitable for\n             study participation.\n\n         11. Lack of family or social support structure that would preclude continued participation\n             in the study.\n\n        PART B\n\n        Inclusion Criteria: Part B\n\n          1. 18-70 years of age.\n\n          2. Histologically confirmed WHO grade IV glioblastoma.\n\n          3. Unequivocal evidence of a first tumor recurrence with measurable disease, defined as 1\n             cm but no greater than 3 cm of enhancing tissue measured in 2 planes (axial, coronal,\n             or sagittal) after an initial treatment regimen (prior to enrollment on this study)\n             consisting of surgical intervention (tumor resection), radiation, and temozolomide\n             chemotherapy (per Stupp protocol), as assessed by MRI of the brain with and without\n             contrast within 30 days prior to the initiation of injections of VBI-\n\n        1901.\n\n        4. At least 12 weeks since treatment per Stupp protocol prior to first dose of VBI-1901.\n\n        5. Recovery from the effects of surgery.\n\n        6. Corticosteroid (dexamethasone or equivalent) dosage ? 4mg daily that has been stable or\n        decreasing for at least 5 days.\n\n        7. Recovery from prior therapy toxicity, defined as resolution of all treatment-related\n        adverse events (AEs) to Grade ? 1 or pre-treatment baseline (except alopecia).\n\n        8. Karnofsky performance status (KPS) score ? 70%.\n\n        9. Adequate organ function, including the following:\n\n          1. Absolute neutrophil count (ANC) ? 1,000/?L, platelets ? 100,000/?L;\n\n          2. Serum creatinine < 1.5 × the upper limit of normal (ULN);\n\n          3. Bilirubin < 1.5 × ULN;\n\n          4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.\n\n             10. Women of childbearing potential must have a negative urine pregnancy test within\n             14 days prior to the start of VBI-1901 treatment.\n\n             11. Female subjects of childbearing potential and sexually active male subjects must\n             agree to use an acceptable form of contraception for heterosexual activity (i.e., oral\n             contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted\n             contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 30 days\n             before Screening, during the study, and for 60 days after the last dose of study\n             drug).\n\n             12. Female subjects without childbearing potential (spontaneous amenorrhea for > 12\n             months or surgically sterilized by tubal ligation, hysterectomy, or bilateral\n             oophorectomy > 6 months before Screening) are eligible for inclusion without\n             contraceptive use restriction.\n\n             13. Able and willing to comply with protocol requirements, in the opinion of the\n             Investigator.\n\n             14. Written consent has been obtained.\n\n             15. Tumor specimen available for central pathological review.\n\n        Exclusion Criteria: Part B\n\n          1. Contrast-enhancing residual tumor that is any of the following:\n\n               1. Greater than 3 cm in 2 planes (axial, coronal, or sagittal);\n\n               2. Multi-focal (defined as two separate areas of contrast enhancement measuring at\n                  least 1 cm in 2 planes that are not contiguous on either fluid-attenuated\n                  inversion recovery (FLAIR) or T2 sequences);\n\n               3. Associated with either diffuse sub-ependymal or leptomeningeal dissemination.\n\n          2. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or\n             equivalent or requirement of increasing dose of systemic corticosteroids during the 7\n             days prior to the start of VBI-1901 treatment.\n\n          3. Evidence of HCMV viremia in plasma of >18,200 (4.3log10) IU/mL using FDA approved\n             COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).\n\n          4. Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic\n             vaccination, or biologics (e.g. monoclonal antibodies) presumed to have\n             immunomodulatory effects.\n\n          5. Surgical resection or major surgical procedure within 14 days prior to the start of\n             VBI- 1901, or stereotactic biopsy within 14 days prior to the start of VBI-1901.\n\n          6. Radiation therapy, local therapy (except for surgical re-resection), or systemic\n             therapy following first recurrence/progressive disease. Excluded local therapies\n             include stereotactic radiation boost, implantation of carmustine biodegradable wafers\n             (Gliadel), intratumoral or convection- enhanced delivery administered agents, etc.\n\n          7. Active infection requiring intravenous antibiotics or antivirals.\n\n          8. History of cancer (other than GBM or prostate) within the past 2 years that has\n             metastatic or local recurrence potential and could negatively impact survival and/or\n             potentially confound tumor response assessments within this study.\n\n          9. Known immunosuppressive disease or active systemic autoimmune disease such as systemic\n             lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or\n             Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus,\n             hypothyroidism due to autoimmune condition only requiring hormone replacement therapy,\n             psoriasis not requiring systemic therapy, or conditions not expected to recur in the\n             absence of an external trigger are permitted to enroll.\n\n         10. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.\n\n         11. Evidence of intra- or peri-tumoral hemorrhage on baseline MRI scan, other than those\n             that are ?Grade 1 and either post-operative or stable on at least 2 consecutive MRI\n             scans.\n\n         12. Any condition which in the investigator's opinion makes the subject unsuitable for\n             study participation.\n\n         13. Lack of family or social support structure that would preclude continued participation\n             in the study.
+Concurrent use of other investigational drugs or treatment in another clinical trial with a non-FDA-approved medication within the past 4 weeks before start of therapy
+Subjects must start study agent within 6 weeks from the first diagnostic surgery for glioblastoma
+Chemotherapy or immunotherapy within 3 weeks prior to start of hu3F8
+PSA >= 0.2 prior to start of androgen deprivation treatment
+Prior radiation therapy is permitted, provided it is completed at least 28 days prior to the start of study drug
+Recent or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment within 2 weeks prior to the start of study drug
+Anticancer therapy, including but not limited to chemotherapy, hormonal therapy, or radiotherapy, within 4 weeks prior to start of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives.\r\n* Herbal therapy > 1 week prior to start of study treatment (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to start of study treatment).\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to start of study treatment.
+Signs or symptoms of infection within 2 weeks prior to start of study treatment.
+Baseline pulmonary function tests (PFTs) available or will be obtained prior to treatment start
+Prior chemotherapy or radiation must have concluded >= 21 days prior to the start of study treatment
+Change in chemotherapy or hormone therapy within 8 weeks of the start of the study
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Prior chemotherapy, monoclonal antibody therapy, must have been completed at least 4 weeks prior to start. Radiotherapy or radiosurgery must have been completed at least 2 weeks prior to start.
+Have peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 mcg/mL as determined by an ELISA test within 90 days prior to start of study treatment
+Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:
+Had a prior anti-cancer monoclonal antibody (other than pembrolizumab) within 30 days prior to start of study treatment, or failure to recover to CTCAE Grade 1 or better from the adverse events of prior therapies
+Washout period of at least 14 days after any approved or experimental tumor directed therapy prior to start of cyclophosphamide and fludarabine
+Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment
+A 4 weeks interval from any investigational agents or cytotoxic chemotherapy to start of study is required
+Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study treatment.
+STUDY TREATMENT: Able to start study treatment in less than or equal to 90 days after completion of chemoradiation
+Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events (AEs) before completion of the planned treatment course) without PD before the start of the next regimen.
+Subjects must be scheduled for surgery at Medical University of South Carolina (MUSC) no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1
+FOR ALL PHASES (Ib AND II): Blood or platelet transfusion within 7 days prior to treatment start
+Radiotherapy within 2 weeks before the start of protocol-specified therapy.
+Agreement to use adequate contraception from 2 weeks before the start of treatment with Minnelide and until 90 days after completion of treatment.
+(For cohort B only): Patients must have at least 3 and no more than 5 weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine
+Prior experimental therapy within 4 weeks of planned start of this trial
+Treatment with other investigational agents including chemotherapy, immunotherapy, or radiation therapy within a month prior to the start of this clinical trial
+Prior radiation treatment less than 6 months from the planned start of reirradiation of any part of the intended treatment volume
+Concurrent anticancer treatment within 28 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin); major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy); concurrent systemic therapy with immunosuppressive agents within 28 days before the start of trial treatment; use of hormonal agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment; Note: subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab
+Cancer chemotherapy within 2 weeks prior to start of daratumumab treatment (exception hydroxyurea). Use of hydroxyurea to control proliferative disease will be allowed prior to starting therapy on study and for 7 days during cycle 1-3 (maximum daily dose of 7 gm)
+Surgery, radiation or chemotherapy within 4 weeks of proposed step 1 start date
+Investigational drug within 4 weeks of proposed step 1 start date
+Long-acting somatostatin analogue treatment within 14 days of proposed step 1 start date
+Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:
+Non-leukocyte depleted whole blood transfusion within 120 days of the date of patient's start on the study
+Any investigational therapy within 28 days prior to the start of Cycle 1
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 5 half lives of those investigational agents before the start of this trial and throughout the duration of this trial
+Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
+Myocardial infarction, stroke, coronary artery bypass surgery, coronary stent, or unstable angina within one year are excluded; Note: A subject may enroll in the study and have a start date set in the near future in a way that meets the timelines for exclusion items by the treatment start date
+Platelets (plt) >= 100 x 10^9/L, within 14 days start of study start
+Potassium within normal range, or correctable with supplements; within 14 days start of study start
+Serum total bilirubin =< 1.5 x ULN, within 14 days start of study start
+Subjects who have received therapy for HCV =< 4 weeks from the start of pembrolizumab; Note: those with untreated HCV and those who completed HCV therapy >= 4 weeks of study treatment start are eligible
+Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication.
+Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.
+Serious persistent infection within 14 days prior to the start of study medication.
+Prior experimental therapy within 30 days of planned start of this trial
+Treatment with intravenous (systemic antibiotics, antivirals, or antifungals) within 14 days prior to start of treatment
+Radiation therapy within 4 weeks prior to start of olaparib treatment (includes radiation targeting bone metastases) or radionuclide treatment within 6 weeks of treatment start.
+INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients must be off chemotherapy for a minimum of 3 weeks prior to start of treatment; targeted therapies must be stopped at least 3 days prior to start of lymphodepletion
+Current or anticipated use of other investigational agents; NOTE the following clarification for this study:\r\n* Prohibited concurrent therapy: \r\n** Participation in clinical trials with other investigational agents, not included in this trial, within 14 days of the start of this trial until 2 weeks after subject has received the last dose of bortezomib for mobilization\r\n** Hypersensitivity to bortezomib, boron or mannitol or G-CSF
+Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other investigational agent) within 4 weeks prior to start of study treatment (corticosteroid treatment at doses of ?20 mg/day, G-CSF or GM CSF are permitted up to 2 weeks prior to start of study treatment.). Note: excluding pre-treatment with rituximab as part of this study
+Patients must not have received an investigational anti-cancer drug within two weeks of start of protocol treatment
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period
+Has received external radiotherapy within the last 4 weeks prior to start of study treatment
+Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment
+If an accessible lesion is present, a biopsy will be performed within 6 weeks of the start of study intervention; the results of the biopsy must be obtained prior to initiation of study intervention
+Participation in other clinical trials involving investigational agents within 21days of the start of this trial and throughout the duration of this trial
+Any ongoing infection whether receiving or not receiving antibiotics or have received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug.
+The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days prior to start of study treatment and throughout the duration of this trial
+Inclusion Criteria: All subjects\n\n          1. Age ? 18 years old.\n\n          2. Confirmed diagnosis of glioblastoma (WHO Grade IV).\n\n          3. Ability to undergo serial MRIs.\n\n          4. ECOG status ? 1.\n\n          5. Adequate bone marrow function.\n\n          6. Adequate renal and hepatic function.\n\n          7. Females of childbearing potential and non-sterile males must agree to use highly\n             effective methods of birth control throughout the course of study and at least up to\n             90 days after last dosing.\n\n          8. Ability to swallow whole capsules.\n\n             Subjects in Arms A and B (not Arm C) must also meet inclusion criteria 8 - 10:\n\n          9. No previous treatment for GB except surgery.\n\n         10. Able to start radiation therapy ? 49 days after surgery but ? 14 days after a biopsy\n             or ?28 days after an open biopsy or craniotomy with adequate wound healing.\n\n         11. Documented unmethylated MGMT promoter status.\n\n             Subjects in Arm C must also meet inclusion criteria # 12 - 14:\n\n         12. No prior systemic chemotherapy other than TMZ for GB.\n\n         13. Progressive disease > 2 months after completion of first line therapy.\n\n         14. At least one measurable lesion by mRANO.\n\n             Subjects in Arm C Phase 2, Cohort C1 must also meet criteria # 15. This is not\n             applicable to subjects enrolled in Arm C, Ph 1b.\n\n         15. Documentation of unmethylated MGMT promoter status.\n\n             Subjects in Arm C Phase 2, Cohort C2 must also meet Criteria #16. This is not\n             applicable to subjects enrolled in Arm C Phase 1b.\n\n         16. Documentation of methylated MGMT promoter status.\n\n        Exclusion Criteria: All subjects\n\n          1. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents ?21 days\n             prior to start of study treatment.\n\n          2. Toxicity of ? Grade 2 from prior therapy.\n\n          3. Major surgery or significant other injury ? 4 weeks prior to start of study treatment.\n\n          4. History of other active malignancies within 2 years with exception of (i) adequately\n             treated in situ cancer of the cervix, (ii) non-melanoma skin cancer, or (iii)\n             localized adequately treated cancer with curative intent or malignancy diagnosed > 2\n             years ago with no evidence of disease and no treatment ? 2 years prior to study\n             treatment.\n\n          5. Uncontrolled seizure disorder.\n\n          6. Active infection requiring systemic treatment.\n\n          7. Known human immunodeficiency virus (HIV) or active viral hepatitis.\n\n          8. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease,\n             ventricular arrhythmia or CVA ? 6 months prior to start of treatment.\n\n          9. Active clinically significant gastrointestinal disease.\n\n         10. Active bleeding disorder ? 6 months prior to start of treatment.\n\n         11. Need for therapeutic anti-coagulation with heparin, warfarin or other anticoagulants.\n\n         12. Use of any medications or food known to be strong or moderate cytochrome P450, family\n             3, subfamily A (CYP3A) inhibitors or strong inducers.\n\n         13. Pregnant or nursing females.\n\n         14. Significant intercurrent illness that may result in subject's death prior to death\n             from glioblastoma.\n\n         15. Known hypersensitivity to any component of TMZ or decarbazine (DTIC). [Subjects in\n             Arms B and C only.]
+Prior treatment with chemotherapy or immunotherapy within 14 days prior to enrollment. Subjects receiving palliative radiation to CNS disease within 7 days may be eligible with PI approval. If the most recent treatment line is an EGFR-TKI, the washout period is a minimum of 3 days before the start of paclitaxel/selumetinib (i.e. treatment with the EGFR-TKI may continue until 3 days before start of study treatment). For other targeted therapy agents, the washout period will be 5 half-lives, prior to start of treatment on study.
+Study treatment both planned and able to start within 7 days of randomisation.
+Participation in other clinical trials with investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy; for patients receiving ALL maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs; for patients on oral targeted therapies (such as imatinib, dasatinib, ponatinib), - these agents should be discontinued at least 48 hours prior to start of study drugs
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial or throughout the duration of this trial
+Hormonal treatment within 2 weeks prior to start of study treatment
+Patients must be registered prior to the start of treatment
+The date protocol therapy is projected to start must be no later than 7 days after the date of study registration
+Participation in other clinical trials with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the start of study drugs with the following exceptions: \r\n* To reduce the circulating lymphoblast count or palliation: steroids, hydroxyurea; no washout necessary for these agents \r\n* For ALL maintenance/CML treatment: mercaptopurine, methotrexate, vincristine, single-agent, single-dose of cytarabine and/or tyrosine kinase inhibitors; these agents should be discontinued at least 48 hours prior to start of study drugs; (Note: the interval of time from last dose of any approved tyrosine kinase inhibitor [TKI] to start of protocol treatment is 48 hours regardless of the indication for treatment with the TKI)
+Prior treatment of cancer (chemotherapy, radiation therapy, and surgery) is allowed if completed at least 3 weeks prior to start of treatment with nintedanib and if all treatment-related toxicities are resolved
+History of cardiac infarction within the past 12 months prior to the start of study treatment
+Ongoing GI adverse events > grade 2 (e.g., nausea, vomiting, or diarrhea) at the start of the study
+Platelets >= 100,000/uL obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy
+Medical oncology examination to evaluate medical contraindications prior to start chemotherapy
+Dental evaluation with management prior to start of radiation
+Use of drugs known to inhibit UGT1A1, such as atazanir, gemfibrozil, indinavir, or ketoconazole, within 2 weeks prior to start of study treatment
+Flucytosine within 2 weeks prior to start of study treatment
+The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment; Note: Subjects with a history of early stage or locally advanced non-metastatic prostate cancer within 2 years of the start of study treatment may be included in the study
+For patients receiving treatment of their AML, MDS or ALL prior to transplantation:\r\n* Interval between the start of a cycle of conventional cytotoxic chemotherapy and the start of conditioning regimen must be at least 30 days\r\n* Interval between completing treatment with a hypomethylating agent or other non-cytotoxic chemotherapy and the start of conditioning regimen must be at least 10 days
+Patients must not have received prior chemotherapy or radiation for < 4 weeks prior to start of study treatment
+Patients may be entered if they have received prior radiation therapy involving =< 30% of the bone marrow; any prior radiation therapy must have been administered >= 4 weeks prior to start of study treatment and the patient must be recovered from the acute toxic effects of the treatment prior to start of study treatment
+Leukocytes >= 3,000 cells/uL (to be performed within 7 days prior to start of study treatment)
+Platelets >= 100,000 cells/uL (to be performed within 7 days prior to start of study treatment)
+At least 2 weeks from prior MF-directed treatment (till the start of study drug)
+Participation in another clinical trial with drug intervention within 21 days prior to start of cycle 1 and during the study
+Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that: \r\n* Chemotherapy was administered > 28 days before the start of HD IL-2\r\n* Surgery, radiation, immunotherapy or any targeted agents was administered > 14 days before the start of HD IL-2
+Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy.
+No chemotherapy or immunotherapy for a minimum of three weeks prior to start of hu3F8
+Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen (Turnstile II)
+Patients must have been off all prior therapy for CML for 2 weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, and bosutinib) which should be discontinued >= 24 hours prior to the start of therapy; patients who are receiving dasatinib prior to enrollment do not have to discontinue this agent prior to start of study therapy
+A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
+A minimum of 2 weeks elapsed off of sipuleucel-T and radiation therapy prior to start of study drug
+Participants who have had chemotherapy or radiotherapy within 2 weeks prior to treatment start or those who have not recovered from adverse events due to agents administered more than 2 weeks prior to treatment start; hydroxyurea is allowed for symptomatic leukocytosis during screening, lead in, and cycle 1 only if clinically necessary; a total white blood cell (WBC) count < 25 x 10^9/L prior to first dose of decitabine on trial is required; prior leukapheresis and/or prior or concurrent treatment with hydroxyurea to achieve this level are allowed
+Donor lymphocyte infusion within 8 weeks prior to treatment start if post-transplant
+Any previous BMT must have occurred at least 3 months prior to start of conditioning
+Patients must be registered prior to the start of treatment
+The date protocol therapy is projected to start must be no later than 7 days after the date of study registration
+Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume
+Normal left ventricular function as evaluated by echocardiograph within 4 weeks of start of protocol therapy
+Evidence of suspicious microcalcifications in the breast prior to the start of radiation
+Patient has to start gefitinib within 6 weeks of hepatic resection with full recovery
+Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol
+Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol
+Must be willing to provide blood samples prior to the start of treatment on this study for exploratory tumor molecular profiling analyses.
+Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed within28 days prior to start of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases ?14 days prior to start of study treatment and has recovered from all acute toxicities is allowed.
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Concurrent anticancer treatment within 28 days before the start of trial treatment
+Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. Non-interventional trials (that is, observational trials) are permitted at any time point.
+Cancer chemotherapy within four weeks prior to start of MCLA-117;
+Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
+Concurrent anti-cancer chemotherapy, except TACE (transarterial chemoembolization), during or within 30 days prior to start of study drug
+Concurrent immunotherapy (including monoclonal antibodies),during or within 30 days prior to start of study drug
+Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug
+Radiotherapy during study or within 3 weeks of start of study drug. [Palliative radiotherapy will be allowed]
+Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment, with the following exceptions:
+Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment
+Previous radiation therapy completed =< 7 days prior to the start of study drugs
+Patients with proliferative disease can be cytoreduced with cytotoxic chemotherapy at investigator’s discretion, but there should be at least a 14 day window between start of cytoreductive therapy and start of daratumumab
+Has received prior radiotherapy within 3 weeks of start of study treatment
+Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 28 days prior to start of this study
+Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Patients must have recovered from all radiotherapy-related toxicities.
+Willingness and ability to schedule mastectomy 21-28 days following start of study agent; women with breast implants may participate
+Study treatment both planned and able to start within 14 days of randomisation
+Last dose of any myelosuppressive or biologic therapy was given at least 2 weeks before the start date for vorinostat on this protocol
+Patients who have received chemo-, hormone-, radio or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 14 days prior to start of treatment or those who have not recovered from adverse events attributed to the agent to grade 1 or baseline\r\n* Exceptions for prior treatments are:\r\n** Hydroxyurea for increased blast count (no washout period required; it can be continued throughout the first cycle of therapy)\r\n** Leukapheresis for leukocytosis (no wash out period required; it can be continued during the study)\r\n*** Note: If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration; please see assigned quality assurance monitor (QAM) with questions
+Therapy for underlying malignancy within 2 weeks prior to start of study treatment
+Cancer chemotherapy within 2 weeks prior to start of daratumumab treatment (steroid or hydroxyurea can be used up to 24 hours prior to first daratumumab infusion for control of high white cell counts)
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents; exceptions are 1) hydroxyurea that requires no washout prior to the start of Hu8F4, and 2) up to 2 doses of single-agent cytarabine (up to 3 grams/m^2) given for palliative purposes for which a washout of >= 48 hours (hrs) is required
+Chemotherapy or surgery within 4 weeks prior to treatment start
+Radiation treatment within 3 weeks prior to treatment start
+Chemotherapy or surgery within 4 weeks prior to treatment start
+Radiation treatment within 3 weeks prior to treatment start
+Have a prior history of cancer other than MDS or myeloproliferative disorder, unless the subject has been free of the disease for ? 1 year prior to the start of study treatment.
+Have had significant active cardiac disease within 6 months prior to the start of study treatment
+If the subject is on continuous dosing with enzalutamide prior to dosing start with GSK525762 plus enzalutamide on trial, then subject can start on combined dosing at end of screening period; Lead-in dosing period for abiraterone only will be required: if the subject has abiraterone discontinuation for more than 3 days prior to dosing start with GSK525762 plus abiraterone on trial, then abiraterone only lead-in dosing of 7 days is required.
+No active symptoms related to carcinoid syndrome during the last 3 months prior to start of study treatment.
+Pretreatment with interferon as last treatment prior to start of study treatment.
+Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to the start of the study treatment
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
+Cohort 1a & 1b patients only: an interval of at least 3 weeks between prior surgical resection to start of study therapy, or one week for stereotactic biopsy to start of study treatment
+Platelets >= 100 000/uL, specimens must be collected within 10 days prior to the start of study treatment
+Use of a protease inhibitor for any indication within three months prior to start of study treatment
+Subjects who have received systemic anticancer therapy within 3 weeks before the start of study treatment; mitomycin C or nitrosoureas must be excluded within 6 weeks before the start of study treatment
+Use of drugs that inhibit renal tubular secretion (e.g. probenecid and cimetidine) within 2 weeks before the start of study treatment
+No brain radiation therapy > 4 weeks before planned start of protocol treatment
+No chemotherapy for > 3 weeks before planned start of protocol treatment
+Hyperleukocytosis with > 50,000 blasts/ul; hydroxyurea for blast count control is permitted before starting treatment and up to maximum of 4 days after starting treatment on the study; the white blood cell (WBC) need not reach 50,000/ul to start hydroxyurea during protocol; the decision to start hydroxyurea during this time is at the discretion of the treating physician; patients will be withdrawn from the study if > 50,000 blasts/ul persists on hydroxyurea or recur >= 5 days after starting treatment on the study
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of the trial and throughout the duration of this trial
+History of any of the following within 6 months prior to start of MLN0128:
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy
+Other anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)
+Platelets >= 100,000/mcL assessed within seven (7) days prior to the start of therapy
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
+More than one relapse, secondary glioblastoma and prior treatment with bevacizumab are excluded. An interval of at least 12 weeks from the completion of radiation therapy to start of study treatment is required.
+Receipt of anti-CTLA-4 or anti-CD27 antibody within 3 months prior to the planned start of study treatment.
+Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).
+If PET-negative based on the returned results from centralized review, patients must be planning to begin further treatment within 35 days of the start of cycle 3 of R-CHOP; if PET-positive based on the returned results from centralized review, it is important for patients to start IFRT as soon as possible after the end of cycle 3 of R-CHOP; they should be planning to initiate IFRT followed by yttrium-90 ibritumomab tiuxetan within 35 days of the start of cycle 3 of R-CHOP
+Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Prior exposure to bevacizumab or other VEGF- or VEGF-receptor-targeted agent within 8 weeks of study start.
+Central review of pathology is required for study participation, but not required prior to enrollment or start of treatment in order to avoid delay. If the results of central pathology review are not available prior to the start of study treatment, the confirmation of diagnosis of ATC at the local laboratory is mandatory prior to scheduled start of treatment with lenvatinib.
+Radiotherapy within 4 weeks prior to start of study treatment, except as follows:
+Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
+Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
+Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment
+Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start
+Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
+Received other investigational agents within 30 days prior to the start of the conditioning regimen
+Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
+Radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
+Chemotherapy within 21 days or at least 5 half-lives prior to the planned start of study treatment; radiation outside the thorax within 14 days prior to the planned start of study treatment or thoracic radiation; antibody based therapy or investigational therapy within 28 days prior to the planned start of study treatment.
+No anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start
+Last dose of therapeutic glucocorticosteroids given greater than 14 days prior to start of study treatment.
+serious persistent infection within 14 days prior to the start of study medication;
+Pregnant or lactating females; serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start)
+Palliative radiotherapy completed =< 7 days from treatment start
+Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
+Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment:
+In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of 5-azacytidine and lirilumab will be at least 2 weeks OR at least 5 half-lives for cytotoxic/noncytotoxic agents; use of one dose of cytarabine (up to 2 g/m^2) is allowed prior to the start of study therapy or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and while the patient is on active study treatment, as needed, for clinical benefit and after discussion with the principal investigator (PI); concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted
+Within 14 days of study start: Platelets (plt) >= 100 x 10^9/L
+Within 14 days of study start: Potassium within normal range, or correctable with supplements
+Subject is taking warfarin at start of treatment or within 6 months prior to start of study treatment
+Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
+Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
+Patients who have received a taxane based treatment or abiraterone, within 4 weeks before start of study treatment.
+Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+Treatment with Coumadin; patients who recently received Coumadin must be off Coumadin for at least 7 days prior to start of the study
+Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+The subject has had within 2 years before the start of study treatment evidence of another malignancy which required systemic treatment
+Radiation therapy within four weeks prior to start of study treatment (day -1)
+Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy
+Received chemotherapy or biologic therapy =< 3 weeks prior to the start of neratinib
+The interval between last PD-(L)1 directed treatment and start of study treatment should be at least 21 days.
+Major surgery within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted)
+Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
+Receipt of any other investigational agents within 4 weeks preceding the start of study treatment
+Patients receiving prohibited concomitant medications at the start of the study
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
+History of prior or concomitant malignancies within 3 years of study start
+Participation in a clinical trial involving an investigational drug within 30 days of study start
+Participation in other clinical trials, including those with other investigational agents not included in this trial and throughout the duration of this trial; within at least 5 half-lives of previous therapy for smoldering myeloma at start of this trial
+Subjects who have started oral or parenteral anticoagulation therapy within 2 weeks before the start of anetumab ravtansine until end of treatment visit.
+No major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
+Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered.
+Signs or symptoms of severe infection (sepsis) within 2 weeks prior to treatment start
+Study treatment both planned and able to start within 7 days after randomisation.
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to start
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+Has a history of arterial thromboembolism within 12 months of start of study drug
+Radiation therapy planned to start =< 8 weeks after surgery and at least 7 days after the start of minocycline
+Patients with a history of prior intratumoral bleeding must be evaluated with a non-contrast head CT to exclude acute blood prior to start of treatment
+Patients who have required a blood transfusion within 28 days prior to study start
+Patients who have received any hemopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) within 2 weeks prior to study start
+Participants who received any investigational treatment within 4 weeks of study start
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial (for all other standard therapies, no treatment within 14 days of the start of this trial)
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+Cytoreduction allowed: \r\n* Hydroxyurea, corticosteroids, leukapheresis can be used prior to start of induction chemotherapy\r\n* Cyclophosphamide up to dose 50-60 mg/kg is allowed for cytoreduction, but must be given at least 7+/- 2 days before start of induction chemotherapy
+The patient has received therapeutic dose chemotherapy or radiotherapy ? 21 days prior to start of Investigational Product.
+The patient has had minor surgery ? 7 days from the start of study treatment (excluding the placement of central/peripheral lines, skin biopsy).
+Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment:
+Subjects must have platelet count greater than 25,000 per microliter at baseline and at the start of study (day 1, cycle 1) visit
+Completion of previous chemotherapy regimen >= 2 weeks prior to the start of study treatment
+Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy and biologic therapy at least 2 weeks prior to the start of RT.
+A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
+A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
+Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less; any prior radiation must have been completed at least 2 weeks prior to start of therapy
+Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 4 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less; any prior radiation must have been completed at least 2 weeks prior to start of therapy
+Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+Subjects may not initiate a new form of cancer therapy, non-steroidal or steroid anti-inflammatory agents, or antibiotics during the study period or for 4 weeks prior to the start of study agents
+Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of bortezomib treatment on day +7; exceptions require approval of the study PI; and notifying Millennium Pharmaceuticals Incorporated (Inc.) within 72 hours
+Prior treatment with anti-cluster of differentiation (CD)20 monoclonal antibody or alemtuzumab within 2 months prior to start of therapy
+Administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment.
+The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Prior treatment with anti-cluster of differentiation (CD)20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 3 weeks of the start of study drug or patients receiving prior treatment with investigational drugs 4 weeks of the start of study drug
+Prior radiotherapy within 4 weeks of the start of study drug
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+The participant has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines, monoclonal antibodies or major surgery in the 4 weeks prior to the start of the study
+Laboratory evaluations;\r\n* Semen analysis (patients will not be excluded if they do not wish to have an analysis or their insurance denies the claim) (prior to start of radiation)\r\n* Follicle-stimulating hormone (prior to start of radiation\r\n* Luteinizing Hormone (prior to start of radiation)\r\n* Lactate Dehydrogenase (prior to start of radiation)\r\n* Human chorionic gonadotropin (prior to start of radiation)\r\n* Complete blood count (prior to start of radiation)\r\n* Alpha-fetoprotein (prior to start of radiation)
+Patients may not have had prior radiotherapy to > 25% of bone marrow; standard rectal cancer chemoradiation will not exclude subject from study protocol; any radiation must have concluded >= 4 weeks prior to start of protocol treatment
+Patients expected to survive longer than 3 months from the start date of the protocol treatment
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+Time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. Patients must have recovered from any acute toxicity produced by previous therapy.
+Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 4 weeks prior to start of therapy
+Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible; one week must have lapsed since last date of radiotherapy, which is recommended to be a limited field and from start of protocol therapy; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and one week have passed since the last date of therapy and from start of protocol therapy
+Patients who had radiation therapy within 28 days prior to start of study treatment (palliative radiotherapy to bone lesions allowed if completed 2 weeks prior to study treatment start)
+No prior radiation treatment to the affected spine, or sacral region; prior chemotherapy is allowed within 30 days of start of treatment
+Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
+Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study
+Participants may not be receiving any other study agents during the study or within 4 weeks of the start of the trial
+EXPANSION COHORT ONLY: Participants may not be receiving any other study agents during the study or within 4 weeks of the start of the study
+Evidence of suspicious microcalcifications in the breast prior to start of radiation
+Use of any other experimental drug or therapy other than carfilzomib and pomalidomide within 28 days of treatment start on this protocol
+Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy except for palliative bone-directed radiotherapy, immune therapy, or cytokine therapy except for erythropoietin) within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy); use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration-resistant prostate cancer (CRPC), who may remain on treatment with luteinizing hormone-releasing hormone agonists or antagonists; or use of any investigational drug within 28 days before start of trial treatment. Note: Small molecule or antibody targeted therapy is permissible <14 days from start of trial treatment.
+For patients previously treated with other agents approved for the treatment of prostate cancer (5-? reductase inhibitors, estrogens, others), discontinuation of therapy must have occurred ?4 weeks prior to start of study drug.
+Palliative radiotherapy (to bone or soft tissue lesions) must be completed >2 weeks prior to start of study drug.
+Have peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 mcg/mL as determined by an ELISA test within 28 days prior to start of study treatment
+Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:
+Chemotherapy within 14 days of the start of this trial
+Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start
+Interval of at least 2 weeks from any prior neurosurgical resection (1 week for intracranial biopsy) to start of study drug; and patient must have adequate wound healing
+For patients with no prior chemotherapy, treatment must start within 35 days of\r\ndefinitive surgery or as indicated if enrolled on therapeutic study
+Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
+Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
+Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
+Specific anti-cancer therapy within 3 weeks of study start
+Must be able to start treatment with radiation therapy (RT) within 2 weeks or 10 working days at a qualified center (to be defined by the Radiation Oncology chair) and to start TMZ prescribed at a participating center within 2 weeks or 10 working days of randomization
+Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.
+Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol
+Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol
+Any investigational treatments for any condition within 4 weeks prior to the start of study treatment.
+Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication
+Eligible for and agree to BM aspirate prior to treatment start
+No prior treatment for ALL, except steroids or hydroxyurea (stopped within 24 hours before start of protocol treatment)
+Ongoing immunosuppressive therapy within 14 days prior to the start of study therapy;
+Treatment must start not more than 15 days from diagnosis of metastatic retinoblastoma
+Inclusion Criteria (TNBC Cohort Only):\n\n          -  Women ?18 years of age\n\n          -  Pathologically documented diagnosis of TNBC that is metastatic or locally advanced and\n             unresectable\n\n          -  Adequate hepatic function and coagulation profile\n\n          -  Negative HIV, HBV and HCV\n\n        Inclusion Criteria (HCC Cohort Only):\n\n          -  Men or Women ?18 years of age\n\n          -  Histological or cytological confirmed diagnosis of HCC with Barcelona Clinic Liver\n             Cancer Stage B or C who cannot benefit from resection, local ablation, or\n             chemoembolization\n\n          -  ECOG performance status of 0 or 1\n\n          -  Has at least 1 measurable lesion based on irRECIST 1.1.\n\n          -  Negative HIV tests\n\n        Inclusion Criteria (Either Cohort):\n\n          -  subject agrees to undergo a pre-treatment and an on-treatment biopsy of the tumor\n\n          -  Completion of all previous therapy for the treatment of cancer ?3 weeks before the\n             start of study drug\n\n          -  All acute toxic effects of any prior antitumor therapy resolved to Grade ?1 before the\n             start of study drug\n\n          -  Adequate bone marrow and renal function\n\n          -  Life expectancy of ?3 months\n\n        Exclusion Criteria (Either Cohort):\n\n          -  Pregnant or breastfeeding\n\n          -  History of another malignancy except for the following: adequately treated local basal\n             cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately\n             treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2\n             cancers currently in complete remission; or any other cancer that has been in complete\n             remission for ?2 years.\n\n          -  Gastrointestinal disease that may interfere with drug absorption or with\n             interpretation of GI AEs.\n\n          -  Known symptomatic brain metastases requiring ?10 mg/day of prednisolone (or its\n             equivalent).\n\n          -  Significant cardiovascular disease within 6 months prior to start of study drug\n\n          -  Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or\n             requirement for systemic anticoagulation with unfractionated heparin,\n             low-molecular-weight heparin or heparin fractions, or oral anticoagulants.\n\n          -  Evidence of an ongoing systemic bacterial, fungal, or viral infection\n\n          -  Has received a live vaccine within 30 days of planned start of study drug\n\n          -  Major surgery within 4 weeks before the start of study drug\n\n          -  Prior solid organ or bone marrow progenitor cell transplantation\n\n          -  Prior therapy with any known inhibitor of MNK1 or MNK2\n\n          -  Prior high dose chemotherapy requiring stem cell rescue\n\n          -  History of or active autoimmune disorders or other conditions that might impair or\n             compromise the immune system\n\n          -  Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids\n\n          -  Use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4 within 7 days prior\n             to the start of study drug or expected requirement for use of a strong CYP3A4\n             inhibitor or inducer during study participation\n\n          -  Need for proton pump inhibitors and histamine H2 blockers\n\n          -  Previously received investigational product in a clinical trial within 30 days or\n             within 5 elimination half lives (whichever is longer) prior to the start of study\n             drug, or is planning to take part in another clinical trial while participating in\n             this study\n\n          -  HCC Cohort Only: Portal vein invasion at the main portal (Vp4), inferior vena cava, or\n             cardiac involvement of HCC based on imaging.
+History of prior or concomitant malignancies within 3 years of study start
+Participation in another clinical trial or treatment with any investigational drug (excluding anticancer treatments) within 30 days of study start
+At least 4 months from prior anti-EGFR therapy prior to start of study treatment
+Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
+Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
+Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study
+Patients must have been off all prior therapy for CML for 2 weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, dasatinib, ponatinib and bosutinib), which should be discontinued 48 hours (hrs) prior to the start of therapy; patients who are receiving nilotinib prior to enrollment do not have to discontinue this agent prior to start of study therapy
+No response or disease progression ? 24 months from start of last previous therapy
+Radiotherapy within 3 weeks prior to start of treatment
+Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
+Participation in other clinical trials with other investigational agents not included in this trial, within 21days of the start of this trial and throughout the duration of this trial
+Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial
+Systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
+Investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
+Receiving treatment with long acting proton pump inhibitors, and cannot be discontinued 3 days prior to the start of INC280 treatment and during the course of the study.
+Patients with previous anti-cancer chemotherapy, immunotherapy or investigational agents =< 3 weeks prior to the first day of study defined treatment; NSCLC patients with EGFR mutation can enroll within 7 days of discontinuing EGFR-TKI; palliative radiation < 1 week before the start of treatment (lesions subjected to radiotherapy may not be used as target lesions); patients who receive gamma knife radiosurgery for brain metastases within 1 week prior to treatment start
+For disease specific studies: the subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment (i.e., D1 of Cycle 1)
+Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1)
+Inclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject is ? 60 years of age at the time of signing the ICF\n\n          2. Subject has primary (ie, de novo) or secondary (progression of MDS or\n             myeloproliferative neoplasms ([MPN], or therapy-related) AML according to WHO\n             classification (Appendix B)\n\n          3. Subject has received second- or third-line of AML therapy (see Appendix G for the\n             definition of prior AML line; note that, for subjects having AML secondary to prior\n             higher risk [Intermediate-2 or High risk according to the International Prognostic\n             Scoring System] MDS treated with a hypomethylating agent [eg, azacitidine or\n             decitabine], the hypomethylating therapy can be counted as a line if there is disease\n             progression to AML during or shortly [eg, within 60 days] after the hypomethylating\n             therapy.)\n\n          4. Subject has the following disease status:\n\n               1. Refractory to or relapsed after second- or third-line of intensive therapy for\n                  AML (eg, the \7 + 3\ regimen):\n\n                  at least 5% leukemic blasts in bone marrow (the minimum number of treatment\n                  cycles of the intensive therapy is per the investigator's discretion); or\n\n               2. Refractory to or relapsed after second- or third-line low-intensity AML therapy\n                  (eg, LDAC, azacitidine or decitabine):\n\n             at least 5% leukemic blasts in bone marrow after at least 2 treatment cycles\n\n          5. Subject is eligible for and willing to receive the pre-selected CCR treatment option,\n             according to the investigator's assessment (Note: Subjects with degenerative and toxic\n             encephalopathies, especially after the use of methotrexate or treatment with ionizing\n             radiation, should not receive cytarabine.)\n\n          6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n             (Appendix D)\n\n          7. Subject has IDH2 gene mutations tested centrally (using the \investigational use\n             only\PCR assay, Abbott RealTime IDH2) in samples of bone marrow aspirate and\n             peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral\n             blood. (Note: in the event that the central laboratory result is delayed and precludes\n             acute clinical management of a subject who has confirmed IDH2 gene mutation by local\n             evaluation, the subject may be eligible for randomization with approval by the Medical\n             Monitor.)\n\n          8. Subject has adequate organ function defined as:\n\n               -  Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)\n                  and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ? 3\n                  x upper limit of normal (ULN), unless considered due to leukemic organ\n                  involvement, following review by the Medical Monitor; and\n\n               -  Serum total bilirubin ? 1.5 x ULN, unless considered due to Gilbert's syndrome\n                  (eg, a gene mutation in UGT1A1) or leukemic organ involvement, following review\n                  by the Medical Monitor; and\n\n               -  Creatinine clearance > 30 mL/min based on the Modification of Diet in Renal\n                  Disease (MDRD) glomerular filtration rate (GFR):\n\n             GFR (mL/min/1.73 m2) = 175 × (serum creatinine)-1.154 × (Age)-0.203 × (0.742 if\n             female) × (1.212 if African American)\n\n          9. Females of childbearing potential (FCBP)* may participate, providing they meet the\n             following conditions:\n\n               -  Agree to practice true abstinence from sexual intercourse or to use highly\n                  effective contraceptive methods (eg, combined [containing estrogen and\n                  progestogen] or progestogen-only associated with inhibition of ovulation, oral,\n                  injectable, intravaginal, patch, or implantable hormonal contraceptive; bilateral\n                  tubal occlusion; intra-uterine device; intrauterine hormone-releasing system; or\n                  male partner sterilization [note that vasectomized partner is a highly effective\n                  birth control method provided that partner is the sole sexual partner of the FCBP\n                  trial participant and that the vasectomized partner has received medical\n                  assessment of the surgical success]) at screening and throughout the study, and\n                  for 4 months following the last study treatment (6 months following the last dose\n                  of cytarabine); and\n\n               -  Have a negative serum ?-subunit of human chorionic gonadotropin (?-hCG) pregnancy\n                  test (sensitivity of at least 25 mIU/mL) at screening; and\n\n               -  Have a negative serum or urine (investigator's discretion under local\n                  regulations) ?-hCG pregnancy test (sensitivity of at least 25 mIU/mL) within 72\n                  hours prior to the start of study treatment in the Treatment Phase (note that the\n                  screening serum pregnancy test can be used as the test prior to the start of\n                  study treatment in the Treatment Phase if it is performed within the 72-hour\n                  timeframe).\n\n         10. Male subjects must agree to practice true abstinence from sexual intercourse or to the\n             use of highly effective contraceptive methods (as described above) with non-pregnant\n             female partners of childbearing potential at screening and throughout the course of\n             the study, and should avoid conception with their partners during the course of the\n             study and for 4 months following the last study treatment (6 months following the last\n             dose of cytarabine; 6 months following the last dose of azacitidine in Canada)\n\n         11. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted\n\n         12. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject is suspected or proven to have acute promyelocytic leukemia based on\n             morphology, immunophenotype, molecular assay, or karyotype\n\n          2. Subject has AML secondary to chronic myelogenous leukemia\n\n          3. Subject has received a targeted agent against an IDH2 mutation\n\n          4. Subject has received systemic anticancer therapy or radiotherapy < 14 days prior to\n             the start of study treatment. Note that hydroxyurea is allowed prior to the start of\n             study treatment for the control of leukocytosis (however, hydroxyurea should not be\n             given within 72 hours prior to and after administration of azacitidine).\n\n          5. Subject has received non-cytotoxic or investigational agents < 14 days or 5\n             half-lives, whichever is longer, prior to the start of study treatment\n\n          6. Subject has undergone HSCT within 60 days prior to the start of study treatment, or on\n             immunosuppressive therapy post HSCT at the time of screening, or with clinically\n             significant graft-versus-host disease (GVHD). The use of a stable dose of oral steroid\n             post-HSCT and/or topical steroids for ongoing skin GVHD is permitted.\n\n          7. Subject has persistent, clinically significant non-hematologic toxicities from prior\n             therapies\n\n          8. Subject has or is suspected of having central nervous system (CNS) leukemia.\n             Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is\n             suspected during screening.\n\n          9. Subject has active uncontrolled systemic fungal, bacterial, or viral infection\n             (defined as ongoing signs/symptoms related to the infection without improvement\n             despite appropriate antibiotics, antiviral therapy, and/or other treatment)\n\n         10. Subject has immediately life-threatening, severe complications of leukemia such as\n             uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated\n             intravascular coagulation\n\n         11. Subject has significant active cardiac disease within 6 months prior to the start of\n             study treatment, including New York Heart Association (NYHA) class III or IV\n             congestive heart failure (Appendix E); acute coronary syndrome (ACS); and/or stroke;\n             or left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or\n             multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of\n             study treatment\n\n         12. Subject has prior history of malignancy, other than MDS, MPN or AML, unless the\n             subject has been free of the disease for ? 1 year prior to the start of study\n             treatment.\n\n             However, subjects with the following history/concurrent conditions are allowed:\n\n               -  Basal or squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix\n\n               -  Carcinoma in situ of the breast\n\n               -  Incidental histologic finding of prostate cancer (T1a or T1b using the tumor,\n                  node, metastasis clinical staging system)\n\n         13. Subject is known seropositive or active infection with human immunodeficiency virus\n             (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n\n         14. Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other\n             conditions that limit the ingestion or gastrointestinal absorption of drugs\n             administered orally\n\n         15. Subjects has uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or\n             diastolic BP > 100 mmHg)\n\n         16. Subject is a pregnant or lactating female\n\n         17. Subject has known or suspected to have hypersensitivity to any of the components of\n             study treatment\n\n         18. Subject is taking those medications (listed in Section 8.2) that are known to prolong\n             QT interval unless the subject can be transferred to other medications at least 5\n             half-lives prior to the start of study treatment\n\n         19. Subject has QTc interval (ie, Fridericia's correction [QTcF]) ? 450 ms or other\n             factors that increase the risk of QT prolongation or arrhythmic events (eg, heart\n             failure, hypokalemia, family history of long QT interval syndrome) at screening\n\n         20. Subject is taking the following sensitive CYP substrate medications that have a narrow\n             therapeutic range are excluded from the study unless the subject can be transferred to\n             other medications at least 5 half-lives prior to the start of study treatment:\n             paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19),\n             thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2)\n\n         21. Subject is taking the breast cancer resistance protein (BCRP) transporter-sensitive\n             substrate rosuvastatin should be excluded from the study unless the subject can be\n             transferred to other medications at least 5 half-lives prior to the start of study\n             treatment\n\n         22. Subject has any significant medical condition, laboratory abnormality, or psychiatric\n             illness that would prevent the subject from participating in the study\n\n         23. Subject has any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study\n\n         24. Subject has any condition that confounds the ability to interpret data from the study
+For disease specific studies: the subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+Exposure to another investigational drug within 3 weeks prior to start of study treatment.
+The patients may start any Food and Drug Administration (FDA) approved endocrine therapy (with which they have not been previously treated) at week 4 of the trial except for tamoxifen
+Previously untreated AML (except: emergency leukopheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy)
+Radiotherapy within 4 weeks prior to the start of study treatment
+Patients who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment:
+Inclusion Criteria:\n\n        Cohort 0 and Arm A\n\n          -  Patient must have histologically or cytologically confirmed advanced cancer for which\n             standard cures or relieving measures either do not exist, are ineffective or are not\n             acceptable to the patient.\n\n          -  Measureable disease according to RECIST criteria version 1.1.\n\n          -  ECOG performance status of 0 to 1.\n\n          -  Adequate bone marrow function.\n\n        Arm B\n\n          -  Patients with documented acute myeloid leukemia (AML), except for acute promyelocytic\n             leukemia.\n\n          -  Patients with relapsed/refractory AML or patients who have not received prior therapy\n             who are high risk according to European LeukemiaNet (ELN) criteria.\n\n          -  ECOG performance status of 0 to 2.\n\n        For Cohort 0, Arms A and B\n\n          -  Life expectancy of >/= 12 weeks.\n\n          -  Age >/= 18 years or older.\n\n          -  All patients must be willing to use effective methods of contraception until 10 days\n             after the last dose; women must not be pregnant or breast-feeding.\n\n          -  Adequate renal and hepatic function.\n\n          -  Patients with stable central nervous system (CNS) tumors are eligible.\n\n          -  There are no requirements or limitations on the amount or type of prior\n             anti-tumor/anti-leukemia therapy.\n\n        Exclusion Criteria:\n\n        Cohort 0 and Arm A\n\n          -  Patients with a history of any form of leukemia except for Stage 0 and 1 chronic\n             lymphocytic leukemia (CLL) not requiring treatment.\n\n          -  Patients receiving any cancer treatment within 21 days of start of study medication.\n             Patients must also have recovered from severe side effects due to prior treatment\n             before study start.\n\n          -  Patients with known bone marrow disorders that may interfere with bone marrow\n             recovery, or patients with delayed recovery from prior chemoradiotherapy.\n\n          -  Patients with known bleeding or clotting disorders or non-drug-induced low platelet\n             count.\n\n        Arm B\n\n        - Patients receiving any cancer treatment within 14 days of start of study medication.\n        Hydroxyurea may be taken until first administration of the study drug. Patients must also\n        have recovered from severe side effects due to prior treatment before study start.\n\n        For Cohort 0, Arms A and B\n\n          -  Patients receiving any other test drugs within 30 days of start of study medication\n\n          -  Patients receiving the cytochrome P450 inhibitors, substrates or inducers specified in\n             the protocol.\n\n          -  Anticoagulation or antiplatelet treatment must be discontinued 7 days prior to start\n             of study medication.\n\n          -  Patients who have received hormonal therapy (except for prostate cancer treatment and\n             hormone replacement therapy) within the 2 weeks prior to start of study medication.\n\n          -  Patients with evidence of electrolyte imbalance, which may be treated to meet\n             eligibility.\n\n          -  Serum albumin < 2.8 g/dL.\n\n          -  HIV-positive patients who are currently receiving combination antiretroviral therapy.\n\n          -  Patients who have any severe and/or uncontrolled medical conditions or other\n             conditions that could affect their participation in the study.
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+History of heart problems or thrombosis within 6 months prior to study start.
+Platelets ? 100 x 109/L (in case of transfusion stable for ?14 days prior to treatment start)
+Treatment with other investigational agents, chemotherapy, or immunotherapy within 14 days of the start of this trial and throughout the duration of this trial
+Investigational agents within 4 weeks before start of study therapy
+Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment.
+Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment).
+Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
+Receipt of an investigational drug within 28 days prior to study start
+Radiotherapy within 4 weeks before start of study treatment
+Inclusion criteria:\n\n        Part A only:\n\n          1. Patients with histologically confirmed advanced solid tumours that are metastatic or\n             unresectable and for which standard curative or palliative measures do not exist or\n             are no longer effective. Patients who refuse standard therapy are also eligible.\n\n             Part B only:\n\n          2. Pathologically confirmed diagnosis of Stage IV (M1a or b) non-small cell lung cancer\n\n          3. Documented Epidermal Growth Factor Receptor (EGFR) T790M mutation\n\n          4. Progression of disease on a reversible tyrosine kinase inhibitor within 30 days of\n             starting study drug. Loss of exposure to prior EGFR TKI should not be >30 days; any\n             procedural delay in confirmation of progression is to be discussed with the BI\n             Clinical Monitor.\n\n             Parts A and B:\n\n          5. Evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n\n          6. Age >/= to 18 years\n\n          7. Eastern Cooperative Group (ECOG) performance status 0-1\n\n          8. Adequate organ function\n\n          9. Recovered from any previous therapy-related toxicity to </= to Grade 1 at study entry\n             (except for stable sensory neuropathy </= Grade 2 and alopecia)\n\n         10. Written informed consent\n\n         11. Ability to take oral medication\n\n        Exclusion criteria:\n\n        Parts A and B:\n\n          1. Chemotherapy, biological therapy, or investigational agents (except erlotinib or\n             gefitinib) within 4 weeks prior to the start of study treatment\n\n          2. Hormonal treatment within 2 weeks prior to the start of study treatment (continued use\n             of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer is\n             permitted)\n\n          3. Radiotherapy within two weeks prior to the start of study treatment (except palliative\n             radiotherapy given for symptom control)\n\n          4. Less than 3 days from prior treatment with gefitinib or erlotinib. Patients with\n             adverse events related to gefitinib or erlotinib must recover to Grade 1 or less to be\n             eligible.\n\n          5. Major surgery within 4 weeks before starting study treatment or scheduled for surgery\n             during the projected course of the study\n\n          6. Known hypersensitivity to afatinib or the excipients of any of the trial drugs\n\n          7. History or presence of clinically relevant cardiovascular abnormalities such as\n             uncontrolled hypertension, congestive heart failure New York Heart Association\n             classification of 3, unstable angina or poorly controlled arrhythmia as determined by\n             the investigator. Myocardial infarction within 6 months prior to starting study\n             treatment\n\n          8. Women of childbearing potential and men who are able to father a child, unwilling to\n             be abstinent or use adequate contraception prior to study entry, for the duration of\n             study participation and for at least 2 months after treatment has ended.\n\n          9. Female patients of childbearing potential who are nursing; are pregnant; are not using\n             an acceptable method of birth control, or do not plan to continue using this method\n             throughout the study; and do not agree to submit to pregnancy testing required by this\n             protocol\n\n         10. Any history of or concomitant condition that, in the opinion of the investigator,\n             would compromise the patient's ability to comply with the study or interfere with the\n             evaluation of the efficacy and safety of the test drug\n\n         11. Previous or concomitant malignancies at other sites, except effectively treated\n             non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ\n             or effectively treated malignancy that has been in remission for more than 3 years and\n             is considered to be cured\n\n         12. Required treatment with any of the prohibited medications listed in this protocol that\n             cannot be stopped for the duration of trial participation\n\n         13. Known pre-existing Interstitial Lung Disease\n\n         14. Any history or presence of poorly controlled gastrointestinal disorders that could\n             affect the absorption of the study drug (for example, Crohn's disease, ulcerative\n             colitis, chronic diarrhea, malabsorption) in the opinion of the investigator\n\n         15. Active hepatitis B infection (defined as the presence of Hepatitis B DNA), active\n             hepatitis C infection (defined as the presence of Hepatitis C RNA) and/or known Human\n             Immunodeficiency Virus carrier\n\n         16. Prior participation in a blinded afatinib clinical study, unless permission to unblind\n             was granted in consultation with the Clinical Monitor of the blinded study\n\n         17. Meningeal carcinomatosis\n\n         18. Patients with brain or subdural metastases are not eligible, unless they have\n             completed local therapy and have discontinued use of corticosteroids or have been on\n             stable doses of corticosteroids for at least 4 weeks before starting study treatment.\n             Any symptoms attributed to brain metastases must be stable for at least 4 weeks before\n             starting study treatment\n\n         19. QTc interval > 0.47 seconds as measured during screening procedures
+3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
+Myelosuppressive chemotherapy: Last dose was given at least 14 days before the start date for protocol therapy.
+Biologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.
+The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
+Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days prior to start of CA-4948
+Treatment with any chemotherapy or investigational agents within 4 weeks of the start of study treatment; subjects must have recovered from toxicities of prior therapy
+No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
+One of the following:\r\n* Cytotoxic chemotherapy, alemtuzumab, or an adequate course of 5-azacitidine or decitabine within 3 months prior to start of conditioning; or\r\n* Previous BMT within 6 months prior to start of conditioning\r\n** Note: Patients who have received treatment outside of these windows may be eligible if it is deemed sufficient to reduce graft rejection risk; this will be decided on a case-by-case basis by the PI or co-PI
+Any previous BMT must have occurred at least 3 months prior to start of conditioning
+Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.
+Patients must not have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study
+Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
+Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
+Participation in a study with an investigational drug from 4 weeks prior to study start until study end
+Any treatment with investigational drugs within 30 days before the start of the study
+Patients who are currently receiving other anti-cancer agents are not eligible except for hydroxyurea (which may be continued until 24 hours prior to start of protocol therapy)
+Patients with clinically significant ascites requiring paracentesis on 2 or more occasions within 4 weeks prior to start of study treatment
+Patients who are currently receiving or consuming\r\n* Medications that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 14 days of starting study treatment\r\n• Medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes =< 7 days prior to start of study treatment\r\n* Amiodarone =< 180 days prior to start of study treatment\r\n* Grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products =< 7 days prior to start of study treatment\r\n* Warfarin (or derivatives)
+Evidence of recurrence of rectal cancer prior to the start of study treatment
+Inability to start study treatment within 12 weeks following the completion of curative intent therapy for rectal adenocarcinoma
+PRIOR TO START OF TREATMENT:
+Be planning to start yoga on their own during the time they are enrolled in the study
+Participation in any other clinical study within the last 4 weeks prior to the start of the study
+Platelets >= 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start
+Prior systemic treatment with an azole drug within two weeks of start of treatment
+Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.
+Will not start treatment for at least 2 weeks AND
+Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning
+Whole-brain radiotherapy (WBRT) < 14 days from the anticipated start of nintedanib/placebo administration
+Unable to start nintedanib/placebo treatment between 4 - 6 weeks after completing the last dose of thoracic radiation
+Patients planning to start any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study
+An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
+Participation in any investigational drug study within 4 weeks preceding the start of study treatment
+Received any investigational treatment within 4 weeks prior to the start of study medication;
+Have had an infection requiring the use of parenteral antibiotics within 14 days prior to the start of Day 1;
+Currently on or expected to start cytotoxic chemotherapy within 1 week of study enrollment
+Cancer diagnosis between 6 months and 3 years at the start of the study
+Patients who have been treated with chemotherapy or radiation within two weeks of planned study enrollment; this does not include hydroxyurea or ruxolitinib, which may be continued until start of conditioning therapy
+Patient has hemodynamic instability within 24 hours before the start of study treatment.
+Patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment.
+Willingness to be randomized to an immediate or delayed (by 8 weeks) start date
+Patient has taken phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.) for any indication within the last 48 hours prior to the start of treatment with study drug
+In patients without cGVHD, transplant must have occurred 80-150 days before the start of study drug
+Previous treatment with denosumab or use of bisphosphonate within 3 months of start of study
+Participants take supplements or foods that are labelled as containing green tea for 8 weeks before start of treatment
+Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study agent
+Certain medicines and herbal remedies taken during the 7 days before the start of study drug
+Potassium within institutional range, obtained within 14 days prior to treatment start
+Bilirubin =< ULN (unless documented Gilbert's disease), obtained within 14 days prior to treatment start
+No prior chemotherapy regimen; prior isotope therapy with strontium-89, samarium or radium-223 (RAD223) should be completed at least three months (12 weeks) prior to treatment start
+No gross disease visible on imaging at the start of radiotherapy
+Patients who have received targeted agents or systemic potentially radiosensitizing chemotherapy within 2 weeks of lung SBRT start
+Recommended to start lenalidomide
+Intention to start therapy
+testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
+No gross disease visible on imaging at the start of radiotherapy
+Has received prior radiotherapy within 2 weeks of start of study treatment for any other condition.
+Received treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001 dosing on W1D1.
+Bilirubin =< 1.5 x ULN, completed within 2 weeks prior to start of protocol therapy
+Platelets >= 100,000/L, within 2 weeks prior to study start
+Alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0 x in case of liver mets), within 2 weeks prior to study start
+Treatment with long-acting proton pump inhibitors that cannot be discontinued 3 days prior to the start of study drug and during the course of the study
+Participation in other clinical trials utilizing other therapeutic investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
+The patient has received radiotherapy within 30 days prior to the start of study drug, or has not recovered from the acute toxicities associated with prior approved therapies including investigational drugs.
+Patients are eligible to be treated with RT and plan to start treatment
+Patients are eligible to be treated with RT or CRT and plan to start treatment
+Treatment with investigational or approved anti-cancer drugs within 4 weeks before the start of BAY1436032 treatment and during the study (glioma patients must have completed chemoradiotherapy at least 12 weeks prior to screening and their baseline scan; see inclusion criteria #2)