Received prior radiotherapy to any portion of the abdominal cavity or pelvis
Must not have received therapy with anti-CD20 monoclonal antibodies within 90 days of entry onto this study
Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study
Must not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this study
Parts C, D, and E: patients who have received prior ipilimumab are not eligible
Has received more than 1 allo-HSCT.
Has received more than 2 days of systemic corticosteroids for aGVHD.
Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:\r\n* Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible\r\n* Patients who have received prior therapy with ABI-009 are not eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible\r\n* Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible
Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment
Must have received first-line multimodal therapy with surgery followed by temozolomide (unless MGMT promoter unmethylated) and radiation (subjects with GBM must have received temozolomide and radiation concurrently)
Patients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollment
Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment
Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration
Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen\r\n* NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll\r\n* NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician
Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registration
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; patients must not have received any radiation therapy within 14 days prior to sub-study registration
Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registration
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)
Patients may not have received any of the protocol agents within 5 years prior to randomization
There is no limit to the number of prior lines of treatment a patient has received
Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
There is no limit to the number of prior lines of treatment a patient has received
Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Patients must not have received prior systemic treatment for this melanoma
Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration
Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine
Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib
Patients must not have received any prior radiation to the bladder for bladder cancer
Patients must not have received prior intravesical BCG or intradermal BCG
Patient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step 1
Patients must not have received any prior chemotherapy, radiation therapy, or other therapy for the treatment of ALL (other than those noted below) and must not be receiving any immunosuppressive therapy; patients may not have received any prior investigational therapy within 28 days prior to registration; patients must not have received any monoclonal antibody therapy within 42 days of registration; patients may have received the following within any time prior to registration: low dose chemotherapy-including: cyclophosphamide 1 g/m^2, oral 6-mercaptopurine, or oral methotrexate (other low dose chemotherapy may be allowable, however any other options not listed here should be confirmed with the study chairs), TKI therapy, steroids, hydroxyurea, leukapheresis, intrathecal chemotherapy or vincristine (vincristine sulfate)
Patients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration, with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1); IV cyclophosphamide may be administered at doses of 1 g/m^2 or less until up to 7 days prior to registration
Patients must not have received enzyme–inducing anticonvulsants within 14 days prior to enrollment
Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis
Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
Prior treatment. Patients must have received:
Patients are not required to have received or progressed on a prior therapy.
Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
Subject has received bevacizumab (Avastin).
Patients may have received prior radiotherapy
Patient received prior treatment with a CD33 antibody.
Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
Subjects who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).
Must have previously received first line treatment regimen
Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration; Food and Drug Administration (FDA)-approved tyrosine kinase inhibitors may also be administered until 1 day prior to start of study therapy (cycle 1 [C1], day 1 [D1])\r\n* All drug-related toxicities must have resolved to =< grade 2
Subjects who have received prior therapy with any hypomethylating agents
May have received treatment with abiraterone acetate, enzalutamide and/or one prior chemotherapy (docetaxel)
Participant must have received at least one prior line of treatment of multiple myeloma; for pomalidomide-containing arm(s), patients must have received at least one prior line of treatment and must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor (either in separate regimens or within the same regimen) unless not a candidate
Patients who have received prior therapy with bevacizumab, or related drugs (previous therapy with carboplatin is allowed)
Must not have received any biological modifier within 14 days of entry on to this study
Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study
Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study
Patients who have received systemic interferon (IFN)? within the previous 6 months prior to enrollment to the study.
Patients in dose escalation and all expansion cohorts except first relapse AML may have received up to three prior lines of therapy.
Has received at least 2 prior regimens of standard treatment
For Arm B: must have received at least 2 but not more than 4 prior lines of therapy.
Prior receipt of any investigational immunotherapy. Subjects may have received agents that have local health authority approval for the disease indication
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
Has received pegzilarginase as part of any previous therapy
The most recent cytotoxic, biologic or non-hormonal targeted therapy received must have been completed at least 21 days prior to study treatment
Received small molecule targeted therapy such as TKIs within 2 weeks prior to study enrollment
Participants cannot have received more than two prior regimens Specifically for participants in Arm B:
Received >6 cycles lifetime exposure to Lenalidomide.
Received >2 cycles of alkylating agent combinations.
Received 3-bis(2-chloroethyl)-1nitrosourea (BCNU or Carmustine) within 6 weeks prior to anticipated first dose of G-CSF.
Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).
Received marrow stimulating factors:
Received G-CSF within 14 days prior to anticipated first dose of G-CSF.
Received Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated first dose of G-CSF.
Received erythrocyte of platelet stimulating agents within 30 days prior to anticipated first dose of G-CSF
Patients must not have received prior anti-VEGF therapy including bevacizumab (i.e. patients must be bevacizumab naive)
Inclusion Criteria:\n\n        Male or female patients ?18 years of age. For Japan only: written consent is necessary both\n        from the patient and his/her legal representative if he/she is under the age of 20 years.\n\n        Histologically documented advanced or metastatic solid tumors or lymphomas\n\n          -  Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer,\n             urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL),\n             microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or\n             melanoma\n\n          -  Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those\n             with mixed histology, there must be a predominant histology\n\n          -  Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one\n             additional tumor type based on emerging data from part 1 of the study.\n\n        Patient (except for those participating in Japanese safety run-in) must have a site of\n        disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating\n        institution's guidelines. Patient must be willing to undergo a new tumor biopsy at\n        screening, and again during therapy on this study.\n\n        o Part 4: Safety run-in part in Japanese patients can enroll any tumor type included in\n        part 1 and 2.\n\n        The collection of recent sample is permitted under the following conditions (both must be\n        met):\n\n          -  Biopsy was collected ? 3 months before 1st dose of study treatment and available at\n             the site.\n\n          -  No immunotherapy was given to the patient since collection of biopsy.\n\n        Part 1 - 3 only: Patients (other than those with DLBCL) must previously have received at\n        least 1 and no more than 3 prior lines of therapy for their disease, specifically including\n        the following, unless considered inappropriate for the patient (e.g. safety concern, label\n        contraindication):\n\n          -  Patients with NSCLC must have received a prior platinum-based combination.\n\n          -  Patients with EGFR positive NSCLC with a T790M mutation must have progressed on\n             osimertinib or discontinued due to toxicity.\n\n          -  Patients with head and neck cancer must have received a prior platinum-containing\n             regimen.\n\n          -  Patients with bladder cancer must have received a prior platinum-containing regimen or\n             be ineligible for cisplatin.\n\n          -  Patients with renal cell carcinoma must have received a prior VEGF tyrosine kinase\n             inhibitor (TKI).\n\n          -  Patients with MSS colorectal cancer must have received (or be intolerant to) prior\n             therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens.\n\n          -  Patients with triple negative breast cancer must have received a prior\n             taxane-containing regimen.\n\n        Patients with DLBCL should be limited to those with no available therapies of proven\n        clinical benefit\n\n        o Patients should have had prior autologous hematopoietic stem cell transplantation\n        (auto-HSCT) or determined to be ineligible for auto-HSCT.\n\n        Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors;\n        single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except\n        for NSCLC patients enrolled in part 3 and Japanese safety run-in part.\n\n        Patients must have measurable disease, defined as at least one lesion that can be\n        accurately measured in at least one dimension (longest diameter to be recorded for\n        non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques\n        or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI),\n        or calipers by clinical exam.\n\n        Other protocol-defined inclusion criteria may apply.\n\n        Exclusion Criteria:\n\n        Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR\n        inhibitors for non-oncologic indications (e.g. Parkinson's disease) may be considered for\n        enrollment on a case by case basis.\n\n        Current or prior use of immunosuppressive medication within 28 days before the first dose\n        of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic\n        corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of\n        prednisone) History of another primary malignancy except for:\n\n          -  Malignancy treated with curative intent and with no known active disease ?2 years\n             before the first dose of study drug and of low potential risk for recurrence\n\n          -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of\n             disease\n\n          -  Adequately treated carcinoma in situ without evidence of disease Active or prior\n             documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave's\n             disease, or psoriasis not requiring systemic treatment (within the past 2 years) are\n             not excluded.\n\n        More than 3 prior lines of therapy except for Japanese safety run-in part. History of\n        interstitial lung disease or non-infectious pneumonitis Participation in another clinical\n        study with an investigational product during the last 21 days prior to starting on\n        treatment.\n\n        Other protocol-defined exclusion criteria may apply.
Subject has received or plans to receive the following excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy. Required Wash-out periods:
Phase 1: Subjects with a RET rearrangement must have had disease progression after at least one prior line of systemic therapy; subjects with an ALK rearrangement may be either treatment naive or may have received prior treatment, and must have CNS disease present at baseline; subjects cannot have received more than one prior RET TKI (such as, but not limited to, vandetanib, sorafenib, sunitinib, ponatinib, or cabozantinib); subjects enrolling to the phase 1 portion of the trial must not have received prior alectinib therapy
Phase 2:\r\n* Cohort A: RET-positive NSCLC subjects must have received at least one prior line of therapy, but must be RET TKI-naive\r\n* Cohort B: RET-positive NSCLC that has previously been treated with one RET TKI; subjects cannot have received more than one prior RET TKI and must not have received prior alectinib\r\n* Cohort C: RET-positive thyroid cancer, must be radioactive iodine refractory
LVEF within normal limits if patient received prior anthracycline therapy [Period 1].
Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously.
Participants in all combination therapy arms must have recurrent or metastatic NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy.
Prior treatment specifics:\r\n* Participants must have radiological or objective evidence of progression to a CDK4/6 inhibitor regimen in the metastatic setting AND relapse/progression on an nonsteroidal anti-inflammatory drug (NSAI) (defined as either relapsed =< 12 months after completing adjuvant NSAI or progressed through an NSAI for metastatic or locally advanced breast cancer)\r\n* Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long none of them were exemestane-based and the last dose is >= 14 days prior to registration\r\n* Participants may have received any CDK4/6 inhibitor (i.e. palbociclib, ribociclib, abemacicliclib, etc) as long as the last dose is >= 14 days prior to registration\r\n* Participants may have received up to one prior chemotherapy line for advanced breast cancer as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received prior biologic treatments or investigational drugs as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing > grade 1 treatment related toxicities and have completed treatment >= 14 days prior to registration
COHORT 2: Have received NO prior treatment for AML with the exception of hydroxyurea / leukapheresis\r\n* NOTE: Subjects may have been treated for pre-existent myeloid disorder such as myelodysplastic syndrome or myeloproliferative neoplasm including hypomethylating agents
SAFETY RUN-IN: Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
Have previously received TB-403
Has received previous treatment with another agent targeting the lymphocyte-activation gene 3 (LAG-3) receptor.
Received previous therapy for malignancy within 21 days
Patients with only non-measurable bone lesions must have disease progression based on PCWG3 with 2 or more new lesions or have prostate-specific antigen (PSA) progression before enrollment. Arm 4: Patients with extensive-stage disease small cell lung cancer (SCLC) must meet the following criterion: i. Patients received ? 2 prior lines of therapy. Arm 5: Patients with HER2-negative gastric or gastroesophageal junction cancer must meet the following criterion: i. Patients received ? 2 prior lines of therapy. Arm 6: Patients with locally advanced or metastatic urothelial (muscle-invasive bladder, ureter, urethra or renal pelvis) cancer must meet the following criterion: i. Patients received ? 2 prior lines of therapy in the advanced or metastatic disease setting. ii. Patients must have received prior platinum-based systemic chemotherapy. Arm 7: Patients with advanced or metastatic pancreatic adenocarcinoma must meet the following criteria: i. Patients must have received at least one line of platinum containing regimens in either an advanced or metastatic setting, unless the patient has known deleterious germline or somatic BRCA1/2 mutation prior to being screened (in which case they can be considered for the study if the patient has never received platinum-containing regimen), AND ii. Patients received ? 1 prior lines of therapy in the advanced or metastatic disease setting. Arm 8: Patients with advanced or metastatic solid tumor malignancies must meet the following criterion: i. Patients with at least 1 prior platinum-containing treatment in any treatment setting.
Patients who have already started or received post-transplant maintenance or consolidation regimen
Patients must have received at least one prior line of targeted therapy
Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least 21 days prior to study registration or at least six weeks if nitrosourea; at least two weeks must have lapsed if patients received lower dose oral etoposide (50 mg/2) without experiencing evidence of myelosuppression (i.e. neutropenia or requiring transfusion with blood products)
Patient has received radiation therapy prior to study registration; patients must have had their last fraction of local irradiation to the primary tumor >= 3 months prior to registration, their last fraction of craniospinal irradiation (>= 24 Gy) or total body irradiation >= 3 months prior to registration or >= 6 weeks (wks) for the therapeutic doses of MIBG; patient has not received focal irradiation for symptomatic metastatic sites within 14 days prior to registration
Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
Prior whole-lung or hemi-thorax irradiation of greater than 12 gray (Gy) received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion)
Patients who received any of the following within the 14 days before initiating study treatment:
Patients may not have received enzalutamide or ARN-509 (another androgen receptor antagonist) in the past
Patients may not have received cabazitaxel in the past
Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer
Patients may have received prior trastuzumab therapy alone or in combination with chemotherapy; a 2 week washout period is required between trastuzumab treatment and first dose of afatinib
Participants who have received prior treatment with interstitial brachytherapy, stereotactic radiosurgery, or implanted chemotherapy sources, such as wafers of polifeprosan 20 with carmustine
Received prior treatment with AZD9291 (osimertinib) or CO1686 (rociletinib) and experienced disease progression.
Received at least one prior line of therapy for incurable or metastatic NSCLC. Up to one prior line of checkpoint inhibitor therapy is permitted (must have received at least 6 months of treatment).
Received systemic anticancer therapy within the previous 21 days
ARM 1: Must have prior exposure to an immunomodulatory drug (IMiD) and proteasome inhibitor (PI) and have had 2 prior regimens/lines of therapy; but there is no maximum number of prior regimens, and prior autologous bone marrow transplant is acceptable if > 12 weeks from transplantation; patients may have received prior carfilzomib (sensitive, relapsed and refractory [having progressed while receiving carfilzomib or within 60 days of stopping carfilzomib] are all eligible), but must be > 4 weeks from last dosing of carfilzomib
Patients may have received prior carfilzomib (sensitive, relapsed and refractory all eligible);  response and duration of prior carfilzomib therapy must be known
Have previously received at least 2 but no more than 5 previous systemic regimens for the treatment of DLBCL
BRAF mutation-positive and has received prior systemic therapy with ipilimumab or other anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies. The BRAF exclusion criterion does not apply to participants with solid tumor in Parts 4 and 5 (dose confirmation only).
PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression
Patients who have received prior radiotherapy to all areas of current active disease are ineligible
Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol.
Patients who have received radiation to more than 25% of marrow-bearing areas
Relapsed or refractory to the most recently received therapy.
All pts must have received prior lenalidomide therapy and been determined to be refractory, relapsed, or intolerant.
Growth factor(s): Must not have received within 1 week of entry onto this study.
>= 6 months must have elapsed if the patient has received involved field XRT or gamma knife that includes all target lesions (i.e., there is no restriction if a new lesion arises outside the radiation field or a non-irradiated lesion progresses); >= 6 months must have elapsed if the patient has received craniospinal XRT; >= 6 weeks must have elapsed if patient has received radiation to areas outside optic glioma
Subjects with MSI-H pancreatic cancer who have not previously received pembrolizumab.
Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecean, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the locally advanced or metastatic setting.
Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the recurrent/metastatic setting.
Have received radioimmunotherapy (eg, 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of AG-270.
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
Patients can have received any number of prior therapies for treatment of their uveal melanoma excluding prior treatment with an ERK inhibitor; patients who have received prior MEK inhibition or other MAPK targeted agents will be allowed on study
Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.
Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.
Cohort 3: Are BRCA positive and have previously received a PARP.
Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
During Phase 2, subjects with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study
Patients who have previously received gemcitabine plus oxaliplatin therapy
Has received prior radiotherapy within 2 weeks of start of study therapy or received lung radiation therapy of >30 Gray (Gy) within 6 months of the first dose of study therapy
Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
Received any previous treatment for AML
Received >100 mg/m2 equivalents of daunorubicin (see Appendix G for conversion table)
Have received at least 1 prior line of therapy and meets at least one of the following criteria:
Have received no more than 2 prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens.
Evidence of tumor progression on or after the last treatment regimen received and within 6 months prior to study enrollment
Received corticosteroids within the past 1 week
Patients may be newly diagnosed or have received any number of lines of prior anticancer therapy; however, patients are required to have received available therapies for their primary disease, as deemed appropriate by the treating investigator
Subjects must not have received any previous androgen deprivation therapy (LHRH agonist or LHRH antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting\r\n* Exceptions\r\n** Patients may have received no more than 30 days of anti-androgen (e.g. bicalutamide) in the metastatic setting prior to the start of study treatment.
Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer: systemic or IT) must have been completed at least 4 weeks prior to enrollment and all adverse events have either returned to baseline (or resolved to < grade 1); note: subjects who have received prior platinum therapy are eligible irrespective of their response.
Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis
Patients may have received 0-1 prior chemotherapeutic regimen for metastatic breast cancer and must have been off treatment with chemotherapy for at least 21 days before enrollment in the study; the number of patients with 0 prior chemotherapeutic regimen will be limited to a maximum of n = 20
Patients must not have received prior exposure to VX15/2503
Patients may have had treatment (chemotherapy and/or radiotherapy) or no treatment for any number of relapses prior to this recurrence\r\n* Patients must have received their last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks of nitrosourea\r\n* Patients must have received their last dose of other investigational or biological agent > 7 days prior to study entry\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period should be extended beyond the time during which adverse events are known to occur; this should be discussed with the study chair\r\n* If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation; these patients should also be discussed with the study chair\r\n* Patients must have received their last fraction of craniospinal or focal radiation to primary tumor or other sites > 12 weeks (3 months) prior to registration
Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
Received prior anticancer therapy within 21 days of first dose
All NF-1 patients with a LGG are eligible for Stratum 2, with or without histologic confirmation, provided they have never previously received adjuvant therapy with the exception of surgery
Patients must have received no previous therapy for the tumor with the exception of corticosteroids and surgery; patients with a gross total resection will not be eligible
Part A) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
Part B) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
Part D) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
Part E) ER-positive and/or PR-positive/HER2- disease and received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting.
Treatment with targeted agents, immunotherapy, or hormones is allowed; patients are only eligible if they have received and failed, or have been intolerant to standard treatments known to confer clinical benefit
Cohort A: Patients with TNBC must have received no more than 4 lines of systemic cytotoxic chemotherapy; patients must have received and failed, or have been intolerant to anthracycline, taxanes, capecitabine, eribulin or other agents known to confer clinical benefit; patients are not required to fail all these agents if, in the investigator’s opinion, patients would benefit from treatment on current protocol
Patients who have received radiation within 14 days before the first dose of study treatment
Must have received at least one prior systemic therapy
Patients who have received acute, low-dose, systemic immunosuppressant medications may be enrolled
TREATMENT EXCLUSION: Received anti-CD30 antibody-based therapy within the previous 4 weeks
HER2 IHC 3+ or IHC 2+/FISH+ breast cancer patients who have received prior therapy with trastuzumab, pertuzumab, and T-DM1, at least 1 and no more than 3 prior systemic chemotherapy regimens
Patients with HGG: Have previously received radiotherapy and temozolomide with a maximum of 2 prior relapses on treatment
Patients who have received G-CSF since the time of diagnosis of the current disease
Must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
Has not received prior systemic treatment for metastatic NSCLC.
Have received vaccination against Neisseria meningitidis at least 2 weeks prior to beginning study protocol (only for cohorts where patients receive eculizumab treatment) in accordance with the most current Advisory Committee on Immunization Practices (ACIP) recommendations
Participants may have received prior cranial irradiation
The patient has undergone at least one prior, but no more than 2 prior standard, therapies for pancreatic cancer.If the patient has had prior gemcitabine treatment, the last date of gemcitabine administration-should be > 3 months prior to screening for the study. All patients who have previously received gemcitabine should be discussed with the medical monitor during screening
Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity, or if a patient with a surgical option refuses surgery\r\n* Since there is no standard effective chemotherapy for patients with NF1 and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, or other VEGFR inhibitors are eligible for enrollment\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and no prior radiation therapy should have been directed at the target PN\r\n* At least 4 weeks must have elapsed since receiving medical therapy directed at the PN\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing\r\n* Patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) before entering this study
Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of MLA treatment
Patients who have received anti-thymocyte globulin (ATG), Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days
Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
Patients will be excluded from Arms A and C if they have received a previous myeloablative transplant; patients who have received a prior HCT at least 6 months prior may be considered for inclusion on Arms B or D after discussion with the principal investigator (PI)
Patients may have received previous NY-ESO-1 vaccine therapy; patients who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy (at least 4 weeks for prior taxane or prior bevacizumab) prior to randomization and recovered from toxicities to less than grade 2
Received prior treatment targeting the signaling pathway of TGF-?.
Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment
Prior melanoma vaccinations may be an exclusion criterion in the following circumstances:\r\n* Patients who have received, within the prior 5 years, melanoma vaccines or other vaccines containing an incomplete Freund’s adjuvant (IFA; such as montanide ISA-51).\r\n* Patients who have received any melanoma vaccine within the past 12 months.\r\n* Patients who have been vaccinated in the past with any of the melanoma peptides in the LPV7 vaccine included in this study.
Patients who have previously received PGG-Betafectin (Betafectin) or Imprime PGG
ER+ and/or PR+ (Note: This group of patients must have received at least 1 and up to 3 prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER2+ patients in this group must have received a minimum of 2 lines of HER2-directed therapy in the advanced setting.) This group of patients may be pre-menopausal with ovarian suppression or post-menopausal. LHRH agonists maybe used to render ovarian suppression with post-menopausal ranges of estradiol or FSH per institutional guidelines.
Patients must have received prior temozolomide or an alkylating agent (ex. lomustine [CCNU]/carmustine [BCNU])
Participants who have already received anti-VEGF or experimental antiangiogenic therapy for glioblastoma
Patients who have received prior radiation of osseous lesions
Patients who have received any prior immunotherapy
Patients must not have received prior therapy with lenalidomide (for more than 2 months) nor eltrombopag
Patients who have received targeted prior VEGFR or FGFR-targeted agents (i.e. sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, etc.)
Patients who have received prior systemic therapy for metastatic RCC or have previously received IL-2 are not eligible; patients on hydroxychloroquine (HCQ) in neoadjuvant protocols or in the past for clinical indications ARE eligible
Patients who have previously received recombinant (r)IL-12
All patients must be refractory to approved standard systemic therapy; specifically:\r\n* Metastatic colorectal patients must have received oxaliplatin or irinotecan\r\n* Hepatocellular carcinoma patients must have received sorafenib (Nexavar) since level 1 data support a survival benefit with this agent\r\n* Breast and ovarian cancer patients must be refractory to both first (1st) line and second (2nd) line treatments and must have received at least one second line chemotherapy regimen\r\n* Patients with recurrent glioblastoma that have received standard surgery, radiation therapy, and chemotherapy for their primary tumors and require resection of their tumors for palliative or other clinical indications; these patients will not undergo surgery solely for treatment on this protocol
Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tositumomab (Bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplant
Has received any systemic bone-seeking radiopharmaceutical in the past
Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel
Has received four or more systemic anticancer regimens for mCRPC. Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC. A ‘line’ is a regimen. Combinations of hormones and other types of therapies count as single lines
Has received blood transfusions or growth factors within the last 4 weeks prior to randomization
TREATMENT WITH SJCAR19: Prior to planned SJCAR19 infusion, patients with a history of prior allogeneic HCT must be at least 3 months from HCT, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion
Patients who have received prior taxanes, including weekly taxanes are allowed
Patients must have received treatment with prior enzalutamide for greater than three 28-day cycles and must have had evidence of disease progression while on enzalutamide.
Has received no more than 5 previous lines of chemotherapy and has received at least one line of therapy with an endocrine therapy or endocrine therapy combination.
Has received prior therapy with an anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
At least 2 weeks must have elapsed since local radiation therapy (XRT) (small port); ? 3 months must have elapsed if prior cranial or craniospinal XRT was received, if ? 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; ? 6 weeks must have elapsed if other substantial bone marrow irradiation was given
Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment
Received at least one systemic therapy for advanced disease, with no further approved treatment options that provide proven clinical benefit.
Subject has received:
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Has received prior chemotherapy (including investigational agents) for any malignant disorder, thoracic radiation therapy or prior surgical resection of an esophagogastric tumor\r\n* Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
Subjects who have received prior PSA, MUC1, and/or brachyury-targeted immunotherapy (e.g. vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment
Patients who have previously received either AG120 or venetoclax.
Any patient with the diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except GIST and Kaposi’s) from any site. A minimum of 1 prior chemotherapy regimen, including adjuvant or neo-adjuvant therapy for the treatment of sarcoma. Patients eligible for an anthracycline should have received a prior anthracycline containing regimen. Patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment. Patients with a diagnosis of liposarcoma should also have received eribulin if they received anthracycline-based therapy prior to eribulin. Patients with a diagnosis of myxoid liposarcoma should have received trabectedin. Patients with angiosarcoma should have received either taxol or docetaxel. Patients must have measurable disease defined as at least 1 lesion >= 1 cm in the greatest dimension
Patients who have received prior treatment with avapritinib or regorafenib.
Patients who have received more than 3 different prior TKI treatment regimens.
Patients who received any systemic anticancer therapy within 2 weeks before randomization.
Patients who have received neutrophil growth factor support within 14 days of randomization.
Has received prior sunitinib or pembrolizumab therapy for the treatment of malignancy
Has received prior therapy with an indoleamine-pyrrole 2,3-dioxygenase (IDO) inhibiting agent
Received ADT for more than 6 months prior to randomization
The patient has previously been enrolled in the study or received ESK981
Osteosarcoma cohort only: Subjects with osteosarcomas must have relapsed or become refractory to conventional therapy and have received a regimen including some combination of high-dose methotrexate, doxorubicin, cisplatin, and/or ifosfamide.
Received prior treatment with enzalutamide, or
Received prior 2nd generation anti-androgen and require urgent disease response or stabilization
Received bupivacaine or any other local anesthetic within 7 days of screening.
Patient shouldn’t have received any anti-cancer therapy for glioblastoma in past
Prior therapy: Patients must have been receiving single agent ibrutinib therapy at the time of disease progression. Patient may have received other therapy in combination with ibrutinib earlier in the treatment course. Patients may have received other therapies after ibrutinib but stopped based on the defined wash-out periods and still meet iwCLL criteria for treatment
The subject has received therapeutic radiation:\r\n* To the bladder/prostate/rectum pelvis\r\n* To any other site(s) within 28 days of the first dose of study treatment
Patients may not have received prior cell therapy
Has not received any prior therapy for the disease
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: HR+BC patients must have received prior treatment with at least 2 lines of hormonal treatment (selective estrogen receptor modulator [SERM], adriamycin-ifosfamide [AI], or fulvestrant) and deemed ineligible for further hormonal therapy; patients may have received prior chemotherapy and there is no limit to the number of prior chemotherapy
Patient received BCG treatment for UC during the 6 months prior to Visit 1.
Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.
The most recent dose of olaratumab must have been received within 180 days of randomization in this study.
For the CPI-Treated Expansion Cohort: Subject must have received prior treatment with a CPI in the metastatic setting.
Has received no prior systemic therapy for advanced RCC.
Has received prior radiotherapy for RCC.
Patients must have received < 2 cycles of systemic anti-myeloma therapy.
Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.
Patients who previously received lenalidomide and have experienced toxicities resulting in treatment discontinuation.
Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.
Received prior treatment for cancer with a camptothecin-derived agent.
Must have received 4 or more prior lines or therapy in the metastatic setting
Must have received prior trastuzumab, pertuzumab, and T-DM1
Subject who have received ferumoxytol within 3 weeks of study entry
Have received a T cell-depleted allogeneic (i.e., non-autologous) HCT within the previous 100 days.
Participation in another interventional clinical trial unless prior approval has been received from the Chimerix Medical Monitor (or designee).
Received any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.
Patients must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab; if RAS wild type, patients should have received and progressed or become intolerant to the above as well as cetuximab or panitumumab containing therapies; prior therapy with regorafenib and/or TAS 102 is allowed
Subject who have received ferumoxytol within 3 weeks of study entry
Has received prior approved radiotherapy within 14 days of study therapy.
Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC\r\n* Note: prior surgical resection with recurrence, or palliative local therapy (including transcatheter arterial chemoembolization [TACE], Y-90 resin microspheres, etc.) would not exclude trial participation, but must have been performed at least 6 months prior to enrollment
Phase 2a: Patients with various solid tumors or NHL who have received prior therapy.
High microsatellite instability (MSI-H) colorectal cancer patients must have received an approved PD-1 targeted agent prior to enrolling in this trial
Patient may not have received definitive salvage therapy for their post-transplant relapse; use of hydroxyurea is permitted
Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ?3 weeks (21 days) prior to the first dose of study treatment.
Have received prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
Patients may have received one prior depot injection of LHRH agonist or LHRH antagonist (degarelix) within 30 days prior to study entry. Patients who have received any other prior hormonal therapy or any chemotherapy for prostate cancer will be excluded. (Patients who have discontinued finasteride or dutasteride or testosterone supplement for at least 2 weeks will be allowed to enroll).
Received a monoclonal antibody or immunoglobulin -based agent within 1 year of Screening, or has documented immunogenicity to a prior biologic.
Patients must have received last BCG dose within a year of enrollment
Subject has received colony-stimulating growth factor(s) within 7 days prior to screening (or within 14 days if subject received polyethylene glycol formulations).
Have received prior abiraterone and/or enzalutamide
Must not have received an antineoplastic targeted therapy within 14 days.
Patients who have received no prior systemic treatment
Participants who have previously received TAS-102
Docetaxel appropriate\r\n* Patients who have not received prior docetaxel (or other taxane therapy) in the advanced setting are eligible for all cohorts\r\n* Patients who have previously received docetaxel (or other taxane therapy) in the advanced setting are eligible for the dose escalation cohort only, if anticipated to have maintained taxane sensitivity and in the opinion of the investigator would still benefit from further docetaxel therapy
Patients must not have received growth factor(s) within 1 week of entry onto this study
For the expansion cohort: patients must have had disease progression on alectinib (including patients who received alectinib as first-line treatment); subsequent anti-neoplastic therapy (including other ALK inhibitors or chemotherapy) after progression on alectinib is not permitted; Note: patients in the dose-finding portion of the study may have received other anti-neoplastic therapy after progression on alectinib
Patients can either be chemotherapy-naive or have received platinum-based chemotherapy for locally advanced or metastatic disease; acute effects of therapy must have resolved to baseline severity or to CTCAE grade =< 1 except for AEs that in the investigator’s judgment do not constitute a safety risk for the patient; patients who have received prior treatment with checkpoint inhibitors are eligible
Prior therapy for lymphoma including chemotherapy or immunotherapy including ibrutinib/anti-CD20 agents; patient may have received corticosteroids, but should be off them 2 weeks prior to study entry; known prior significant hypersensitivity to obinutuzumab (not including infusion reactions) or ibrutinib
Patients may have received any previous therapy, including surgical excision, but must have histologically documented recurrence on new biopsy and a measurable lesion that meets the above criteria
Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients in the dose escalation component may have received a taxane in the peri-operative setting, provided they developed disease recurrence >6 months after the completion of this therapy
must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
Has received prior therapy with an immunomodulatory agent.
Patients should have received at least one line of approved chemotherapy and/or hormonal therapy
Patients may have received prior immunotherapy
Patients with known ROS1 mutations who have not received prior targeted therapy
Patients must not have received zoledronic acid (ZA) for any reason prior to the study
Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:
Patients with R/R PTCL who have received at least one and no more than three previous lines of therapy are eligible to be enrolled in this study
Patients who have previously received systemic topotecan for their tumor
Patients who have received any monoclonal antibody therapy within 4 weeks prior to entering the study
Patients may be treated on this trial without having received prior medical therapy directed at their GIST, patients who have had prior GIST-directed surgery may enroll provided they have measurable disease
Patients can or cannot have receive prior therapy with hypomethylating agent but will be allocated to specific patient cohorts based on their prior exposure. Patients that had received prior hypomethylating agent therapy should have at least received 6 cycles of therapy and not achieved any response or had progressed after any given number of cycles
Subjects who received GCB systemically previously are eligible for participation
Received prior treatment with nab-paclitaxel.
Cetuximab-naive patients may not have received cetuximab therapy in the recurrent/metastatic setting (treatment in curative setting permitted)
Patients may not be receiving or have received Zometa during/or within 3 weeks prior to treatment with Zometa
Received any investigational drugs within the 14 days prior to CIML NK cell infusion date
The patient must have received a boost immunization with trivalent inactivated poliomyelitis vaccine (IPOL) (Sanofi-Pasteur) >= 1 week prior to administration of the study agent
Patients enrolling in this trail should have received either Enzalutamide or Abiraterone
Received prior obinutuzumab.
Patients who received prior local therapy (e.g., transarterial chemoembolization [TACE]) are eligible
Subject has received treatment with a systemic therapeutic radioisotope (89Sr, 223Ra dichloride, 153Sm-lexidronam) or has received prior external beam radiation therapy (EBRT) of the head and/or neck
Received systemic multiple myeloma therapy post-relapse/progression; patients that received 1-2 cycles of salvage therapy, local radiation, and/or corticosteroids post-relapse/progression are eligible if there was no further disease progression following administration
Has received prior therapy with pembrolizumab
Concurrent treatment with other anti-cancer systemic therapies is not allowed. No other concomitant intrathecal therapy with another agent will be allowed. For patients that have received other systemic therapies, the minimum wash out period is as follows:\r\n* Patients that received previous IT therapy must have received their last treatment >= 14 days prior to the start of treatment\r\n* Patients who have received systemic chemotherapy must have received their last treatment >= 21 days prior to the start of treatment\r\n* Patients who have received an approved biologic therapy (e.g. anti-PD-1, anti-CTLA4, IL2, interferon) must have received their last treatment >= 4 weeks prior to the start of treatment\r\n* Patients who have been treated with an approved targeted therapy (BRAF inhibitor and/or MEK inhibitor) must have received their last treatment >= 28 days or 5 half-lives (whichever is shorter) prior to the start of treatment\r\n* Patients who have received any other investigational agents must have received their last treatment >= 28 days or 5 half-lives (whichever is shorter) prior to the start of treatment
Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Patients must not have received prior treatment with bevacizumab.
Receiving, or received during the four weeks prior to first dose, cytotoxic treatment for their malignancy Receiving, or received during the week prior to first dose, corticosteroids for any reason
Subjects must have received adequate first-line therapy including at a minimum:
Received more than one line of therapy for DLBCL
Participants who have previously received ibrutinib for another indication
Have received any unapproved agent or device within 30 days before initiation of study treatment.
Have previously received maribavir.
During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
Has previously received treatment with bevacizumab
Received any prior treatment with a CPI.
Has evidence of progression on or after the last regimen received:
Clear cell subject: must have received at least 2 prior systemic regimens, one of which is an anti-VEGF agent.
Non-clear cell subject: must have received at least one prior anti-VEGF regimen
Received more than 1 prior systemic chemotherapy in the unresectable or metastatic setting; if the patient received 1 prior systemic chemotherapy, the patient is eligible; having received prior therapies for breast cancer (such as everolimus or experimental agents) does not affect eligibility for this study
Subject has received at least one line of prior therapy
Received any previous gene therapy using an integrating vector within 6 months
LYMPHODEPLETION: Subjects who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to lymphodepletion on this study
There must be evidence of progression on or after last treatment regimen received and within 6 months of enrollment
Patients may have received treatment (e.g. azacitidine/decitabine, lenalidomide, growth factors) for antecedent low-grade myeloid neoplasm
Patients with steroid refractory cGVHD typically have received salvage with multiple lines of therapy; hence in this trial there will be no restriction in terms of prior lines of therapy received; prior ECP exposure is allowed, however prior IL-2 use is excluded
The patient must have received a boost immunization with trivalent inactivated poliomyelitis (IPOL) (Sanofi-Pasteur) at least 1 week prior to administration of the study agent
Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (at least 59 Gy)\r\n* If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\r\n* If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial
Patients who have received pleurectomy with decortication (P/D) or EPP for mesothelioma
Has received prior bisphosphonate therapy
Patients with prior bevacizumab use for tumor treatment; patients who received bevacizumab for symptom management, including but not limited to cerebral edema, pseudoprogression can be included in the study
Patients who received ? 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
Has received sorafenib within 14 days of first dose of study medication
All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of adverse reaction to the vaccine
Has received more than one systemic treatment for steroid refractory aGvHD.
Received more than 1 line of systemic treatment for advanced/metastatic CRC and/or a patient whose first line therapy did not contain oxaliplatin and bevacizumab
Insurance pre-authorization must be received
Subjects who have received cabozantinib or have an allergy to cabozantinib are excluded; subjects who have previously received tyrosine kinase inhibitors are allowed
Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy); patients who received neoadjuvant therapy are included
Has received prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment
Disease status defined as:\r\n* Patients with relapsed or refractory DLBCL that has relapsed post-transplant or that has been determined to be ineligible or unsuitable for transplant; patients must have to have received at least one prior systemic therapy
Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimens previously received for NF1 related; or other tumor manifestations
Patients who have received prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed
Patients must have received prior radiation therapy and standard temozolomide; patients who have received additional therapies for previous progressions will be considered eligible
Histologically confirmed CD30-positive (defined in this study as >= 1% expression) MF (including large cell transformation variant) or SS who have either:\r\n* Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR\r\n* Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
Any investigational anticancer therapy received within 28 days prior to the first dose of durvalumab and tremelimumab
Patients must have received one course of induction treatment with BCG (4-6 weekly doses), irrespective of the interval since last treatment; patients are allowed to have received any number of prior chemotherapy instillations\r\n* NOTE: Patients may have received prior intravesical interferon
Patients who have received a prior monoclonal antibody =< 28 days prior to study day -14 are not eligible
Subjects must not have received paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy
Subjects must have received or be receiving, at time of enrollment, “RVD” therapy (combination therapy with lenalidomide, bortezomib, and dexamethasone); patients must have received =< 6 cycles of RVD at time of enrollment and must not have progressed (by IMWG criteria) on RVD; patients may have received other regimens prior to RVD if such therapy was limited to =< 3 cycles; patients may have received radiation therapy prior to enrollment; patients must not have received infusional chemotherapy (e.g., bortezomib/thalidomide/dexamethasone-cisplatin/doxorubicin/cyclophosphamide/etoposide [VTD-PACE] or similar regimen) prior to enrollment
Have received prior gene therapy or gene-modified cellular immunotherapy
Patients must have received prior treatment with a platinum containing regimen and may have received an unlimited number of prior regimens (including prior taxanes)
Patients may have received prior targeted therapy such as bevacizumab
Received 3 or more prior myelotoxic treatment regimens
Prior treatment:\r\n* Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks prior to the start of study drug; however, if they have received nitrosourea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received\r\n* No limitations to number of prior therapies\r\n* Prior treatment with volasertib or any PLK1 inhibitor\r\n* Prior treatment with a histone deacetylase inhibitor (anti-epileptics ok)
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, aside from hydroxyurea for count control, within three weeks of beginning the trial, and should have recovered from all toxicities of prior therapy (to grade 0 or 1)
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration; patients who received prior radiotherapy to >= 25% of bone marrow are not eligible independent of when it was received
Patients who have received experimental agents within 4 weeks of study entry
Patients who have received organ transplantations.
Subject has received > 6 months of lenalidomide (Revlimid) therapy prior to stem cell collection
Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day
Patients must have received at least 1 prior regimen
Patients who have received any non-anti-folate containing neoadjuvant or systemic chemotherapy are eligible; any prior intravesical therapy, or immunotherapy is allowed
Patients who received previous anti-folate-containing chemotherapy
PRIOR TO LYMPHODEPLETION: Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
PRIOR TO LYMPHODEPLETION: Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
Patients who have previously received alemtuzumab are ineligible
Prior treatment with paclitaxel in the metastatic setting is not allowed (patients who received neoadjuvant paclitaxel can be included)
Subjects must not have received capecitabine or bevacizumab for this disease
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery; prior treatment with Gliadel wafers will be excluded
Received at least one prior line of therapy including immuno-chemotherapy.
Patients may have received prior systemic chemotherapy; such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present disease
Patients who have received chemotherapy and/or radiation therapy within 2 weeks unless there is evidence of rapidly progressive disease; in the event that subjects have received chemotherapy < 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to less than or equal to grade 1; hydroxyurea is allowed up to 24 hours prior to starting therapy in the setting of rapidly proliferating disease
Patient has received intervening therapy for lymphoma after CTL019 infusion
Patients with solid tumors as described below:\r\n* Inoperable or metastatic (advanced) melanoma:\r\n** Has received, is intolerant, or refused a CTLA-4 inhibitor (ipilimumab) or a PD-1 inhibitor (nivolumab or pembrolizumab) as monotherapy and/or a combination of ipilimumab and nivolumab\r\n** Has received or is intolerant of a BRAF inhibitor or the combination of BRAF and MEK inhibitors for BRAFv600 mutant melanoma and a PD-1 inhibitor as monotherapy or in combination\r\n* Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma:\r\n** Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy\r\n** If platinum sensitive disease, should have received >= 2 lines of chemotherapy\r\n** May have received PARP inhibitors, bevacizumab or other targeted VEGF inhibitor therapy\r\n* Inoperable or metastatic (advanced) synovial sarcoma:\r\n** Should have received and progressed on >= two lines of systemic therapy\r\n* Subjects with other histologies:\r\n** Must have previously received two lines of systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been deemed either non-responders (progressive disease) or have recurred
Patient must have completed a frontline induction therapy (minimum of 2 treatment cycles); NOTE: Standard therapies/therapeutic agents are defined as those listed in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of CLL; also, patients who received induction regimen as part of a clinical trial and is not necessarily mentioned in the NCCN guidelines, will also be eligible as long as the patient has completed at least 2 treatment cycles of induction regimen, achieved a clinical response (PR or CR) and is able to meet all other criteria for the study; however, patients who have previously received ibrutinib or have been randomized to ibrutinib containing arms in a clinical trial will not be eligible for this study
Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have \2\ prior therapies
Patients must have received last dose of either fluorouracil, oxaliplatin, leucovorin calcium, and irinotecan hydrochloride (FOLFIRINOX) based or gemcitabine/abraxane based chemotherapy for 4-8 cycles with last dose of therapy between 2-5 weeks of study enrollment, with no evidence of metastatic disease
Patients who have only received single agent gemcitabine chemotherapy; abraxane component may be reduced or modified but must be included for a minimum of two cycles
Has received systemic therapy within 4 weeks of the first dose of pembrolizumab
Patients who have received thoracic radiation > 30 gray (Gy) within six months of the first dose of pembrolizumab
Patients must have received at least one prior therapy for metastatic melanoma
Patients who have received prior histone deacetylase (HDAC) inhibitors, or brentuximab vedotin, may be permitted to enter the study unless they have received an HDAC inhibitor or brentuximab within the last 6 months
Patient must have received =< 3 prior cytotoxic regimens in the metastatic setting
Patients must have received at least one dose of an anthracycline based neoadjuvant regimen; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
Patients who have received up to two previous lines of systemic chemotherapy are eligible for this trial
PHASE II:\r\n* Patients must have received at least one course of platinum-based chemotherapy for the management of primary disease including carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted agents, or extended therapy administered after surgical or non-surgical assessment\r\n* There are no restrictions on the total number of prior regimens patients may have received
PHASE I: Patients who have previously received anti-cytotoxic T-lymphocyte antigen (CTLA)-4 antibody therapy
Received any treatments prohibited in this trial
Received prior treatment of TAS3681
Prior therapy with abiraterone, enzalutamide and/or docetaxel; if a patient has not received docetaxel or cabazitaxel chemotherapy, the patient must be informed of this treatment choice as an alternative; if the patient has received docetaxel or cabazitaxel chemotherapy or refuses one of both of these therapies, this rationale must be documented and the patient is then eligible; patient must be offered and made aware of all Food and Drug Administration (FDA)?approved treatment options; patients with bone only disease may not have received radium-223
Subjects who have received prior Doxil and progressed on this therapy are not eligible, but subjects may have received prior doxorubicin.
Subjects must not have received prior gene therapy or gene-modified cellular immunotherapy; subject may have received, however, non-gene-modified autologous T-cells in association with an anti-myeloma vaccine (e.g., human telomerase reverse transcriptase [hTERT] or melanoma-associated antigen 3 [MAGEA3]) or vaccination against infectious agents (e.g., influenza or pneumococcus) as was performed on our previous studies
Participants who have received allogeneic HSCT within 90 days prior to randomization
Patients who have received previous anti-angiogenic treatment (experimental or marketed: bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib or others)
Any number of lines of prior hormone therapy are allowed\r\n* Patients with clear progression on either tamoxifen or fulvestrant should receive the alternate agent if feasible; if a patient has received both agents in the past, the drug received while on study is at the discretion of the treating physician
Patients with non-clear cell histology must have received at least one prior anti-cancer therapy; prior rapalogues are allowed
Received prior hemibody external radiotherapy
Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;
Have received CAR-T therapy;
Have received targeted small molecule therapy < 14 days prior to C1D1;
Patients may not have previously received alisertib
Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
For the combination cohorts (cohorts 5 and 6 in Part 1) and Part 2, subjects with metastatic melanoma or NSCLC do not need to have received prior therapy
Newly diagnosed Philadelphia chromosome-positive (Ph+) ALL, previously untreated, except for the below allowances:\r\n* Previously received hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone (HyperCVAD) cycle 1A +/- cycle 1B\r\n* Previously received induction phase I +/- induction phase II of Berlin-Frankfurt-Munster (BFM)-modeled (pediatric or pediatric-inspired) ALL regimen\r\n* Previously received other representative (modified from HyperCVAD, BFM, or AML-like) ALL induction course, including ABL tyrosine-kinase inhibitor (TKI) plus corticosteroid\r\n* If the patient has received any of the above prior therapy, they may be enrolled, regardless of remission status
Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
Must not have received any tumor vaccines within previous six weeks
Absence of human anti?mouse monoclonal antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Patients who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to enrollment on this study
Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
For the phase II portion of the study, patients must be chemo-naive, i.e. not have received any prior chemotherapy (except hydrea or one dose of ara-C [cytarabine] =< 2 g) for AML or MDS; they could have received hypomethylator agents, transfusions, hematopoietic growth factors or vitamins; temporary prior measures such as apheresis or hydrea or one dose of ara-C =< 2 g in order to safely control hyperleucocytosis prior to enrollment
Received at least one dose of an anthracycline-based NACT; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
Patients with newly diagnosed DIPG who have received vorinostat previously will not be eligible for stratum I; patients with progressive DIPG will be eligible if they have received either one of the two drugs vorinostat or temsirolimus but will not be eligible for stratum II if have received both the drugs before
Patients must previously have received at least one prior line of therapy for their disease
Biologic therapy (anti-neoplastic)\r\n* Must not have received oral tyrosine kinase inhibitors (other than dasatinib) or other similar agents within 3 weeks of the study entry and all toxicities must have resolved to < grade 2 prior to enrollment\r\n* Must not have received bevacizumab or other monoclonal antibody therapy within 4 weeks of study the entry
Patients must not have received prior therapy with dasatinib and temsirolimus for any indication
Patients must not have received systemic chemotherapy for at least 4 weeks, and must not have received prior radiation therapy to the tumor site being irradiated on this study
Patients who have received radiation to the spleen within 3 months prior to registration
Patients may not have received radiation to the index lesion within 1 year of enrollment
Patients may not have had prior SGT-53. Patient who have received prior topotecan, cyclophosphamide, or both are eligible.
Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma
Patients who have received a vaccine for HIV-1 or any prior gene modified cell product, at any time
Study specific limitations on prior therapy:\r\n* Patients who have received poly-ICLC are eligible for this trial if all acute poly-ICLC -related toxicity has resolved\r\n* Patients must not have received pegylated interferon previously
Growth factor(s): must not have received within 2 weeks of entry onto this study
Presence of antibody against basiliximab in serum (only required for patients who have received prior antibody)
Patients who have received prior everolimus or ceritinib
Patients who have not completed standard of care treatment prior to participation in this trial, i.e. surgical procedure and radiation therapy (at least 59 Gy); Note: If tumor is unmethylated, patients are not mandated to have received chemotherapy prior to participation in this trial; however, if tumor is methylated, patients must have received at least one chemotherapy regimen prior to participation in this trial
Inclusion:\n\n          1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a\n             candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.\n\n          2. Patients may have received one prior treatment regimen with crizotinib (all other ALK\n             inhibitors are excluded).\n\n          3. Patients may have received prior chemotherapy, biologic therapy, or other\n             investigational agents. ALK inhibitors other than crizotinib are excluded.\n\n          4. Patient has a World Health Organization (WHO) performance status 0-2.\n\n        Exclusion:\n\n          1. Prior treatment with an ALK inhibitor other than crizotinib.\n\n          2. History of carcinomatous meningitis.\n\n          3. Presence or history of a malignant disease other than an ALK-positive advanced tumor\n             that has been diagnosed and/or required therapy within the past 3 years.\n\n        5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6\n        months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis,\n        including clinically significant radiation pneumonitis (i.e., affecting activities of daily\n        living or requiring therapeutic intervention).\n\n        7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently\n        receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative\n        anticoagulants.
Patients who have received other investigational drugs within 28 days of Viralym-A infusion.
Patients who have not received any prior treatment
Patients who have received prior FGFR targeted therapy
Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment; steroid use for management of refractory pain or for contrast induced allergy is allowed
Prior BRAF or mitogen-activated protein kinase kinase (MEK) directed therapy; patients who have received prior interferon are eligible
Patient are eligible if they have received one or more prior treatment
Patients are allowed to consent to PANGEA as long as they have received 2 months (4 doses) or less of FOLFOX (plus trastuzumab if HER2 amplified) chemotherapy
Patients must have received a taxane as part of their prior treatment
Patients must not have received previous irradiation to the brain
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Must not have received any hematopoietic growth factors within 7 days/
Research participants who received memory-enriched CD19R(EQ):CD28:zeta/EGFRt+ on IRB#13277
Subject has received any treatment for the treating renal mass; such as radiofrequency ablation (RFA) or cryoablation\r\n* If other renal masses received RFA or cryoablation or surgery, then these patients are eligible
Subjects received previous abdominal radiation
Patients must not have received other investigational agents within 14 days of initiation of the conditioning regimen
Have previously received any anthracycline outside the protocol
Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
Participants must have received at least one line of prior systemic chemotherapy and must have experienced documented radiographic progression or intolerance on this therapy
Patients must not have received prior bone seeking radionuclides
Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study
Patient has received at least one prior standard chemotherapy or targeted therapy for treatment of lung cancer
The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC
Patients who have received growth factors within 14 days prior to initiation of dosing of CFI-400945 fumarate.
Received no more than 1 prior treatment for ALL/LBL
Note: Patients who have received transplant during 1st remission are excluded since this would be considered a 2nd treatment
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
Patients who have received the combination of gemcitabine and docetaxel in the metastatic setting are excluded
Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible
Patients must not be currently receiving any chemotherapy agents (except hydroxyurea)\r\n* Intrathecal cytarabine (ARA-C) and intrathecal methotrexate are permissible (as they are not systemic and only isolated to the central nervous system)\r\n* Patients cannot have received more than 3 prior lines of therapy for their hematologic malignancy; patient may have previously had azacitidine or decitabine and still be eligible
Patients who have received prior anti-cancer treatment within the following time frames:\r\n* Received systemic therapies less than 14 days prior to starting on treatment\r\n* Received radiation therapy less than 14 days prior to starting on treatment\r\n* Received biologic therapy less than 14 days prior to starting on treatment
Patients with a history of non-breast malignancies are eligible as long as they have not received prior radiotherapy to the thoracic region, and have a greater than 2 year interval without evidence of recurrence
Cohort A: patients who have received prior cytotoxic chemotherapy, such as anthracyclines and cytarabine not permitted; but prior treatment with demethylating agents (azacytidine or decitabine), lenalidomide etc ALLOWED
Cohort B: patients who have received prior fludarabine , clofarabine or drugs known to target T cells not permitted; but prior standard induction with anthracyclines and cytarabine ALLOWED including after demethylating agents
Subjects must not have received medical therapy for any cancer within ONE year prior to registration
Patients must have previously received standard initial therapy, including attempted gross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non- metastatic tumors and at least microscopic residual disease) involved field fractionated radiation therapy (RT); patients may have received re-irradiation but not to the index lesion within 4 weeks
Patients who have received prior immunotherapy
Patients who have received immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received alemtuzumab or ATG within 8 weeks of the transplant admission
All patients must have received prior lenalidomide therapy and been determined to be refractory; refractory will be defined as a history of progression on a regimen containing full or maximally tolerated dose of lenalidomide administered for a minimum of at least two completed cycles of therapy
Patients having received anti-CD20 therapy ? 4 weeks prior to the first study dose.
Patients having received alemtuzumab (anti-CD52) therapy ? 6 months prior to the first study dose.
Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
Received 3 or more prior myelotoxic treatment regimens
Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
COHORT 3: ATOPIC DERMATITIS PATIENTS: Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months
Patients who received previous radiotherapy to the brain
Patients who received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, analgesics, and other drugs to treat symptoms or prevent complications
Patients are eligible whether they have received or not prior tyrosine kinase inhibitor (TKI) therapy; for the phase I portion of the study, patients who had received prior therapy with dasatinib should have been able to tolerate the dose equivalent to the starting dose of dasatinib in the dose level at which the patient is being entered; patients who previously received dasatinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3-4 toxicity not responding to optimal management
Presence of antibody against basiliximab (only required for patients who have received prior antibody)
Immunomodulatory treatment - patient must have received last dose > 21 days prior to enrollment
Received >360 mg/m2 equivalents of daunorubicin
Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.
Patient must not have received: cimetidine within 48 hours prior and for the duration of the study
Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an anti-thymocyte globulin level of >= 2 ugm/ml
For both the extension and expansion cohorts, patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients (pancreatic and esophageal cancers) must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy; patients (breast, ovarian and gastrointestinal cancers) must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy
Must not have received any biological modifier within 14 days of entry on to this study
Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study
Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study
Received anti-CD30 antibody-based therapy within the previous 4 weeks
Patients in Stratum F must have received craniospinal radiation
Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy; patients enrolled on Stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment; patients on Strata A, B, E, and F cannot have received chemotherapy after radiation therapy was completed
Patients who have received prior immunotherapy
Received the last anti-cancer therapy at least 28 days ago
Subjects with hepatocellular carcinoma must have received sorafenib as one of the standard treatment options prior to being enrolled into the study
Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy
Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis).
Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
Patients who have received < 2 cycles of multiagent chemotherapy and patients who have received no multiagent chemotherapy within the 3 months previous to umbilical cord blood transplant (UCBT) as well as patients experiencing graft failure following previous allogeneic transplant
Patients may have received prior hormonal therapy; the hormonal treatment must have been discontinued for > 6 months prior to study entry
Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
Patients who have received Y-90 ibritumomab (zevalin) or I-131 tostumomab (bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplant
Patients who received > 450 mg/m^2 doxorubicin and have a cardiac ejection fraction on echocardiogram =< 40% on protocol entry are not eligible to received DA-EPOCH-R
Received prior therapy with eribulin mesylate
Has received autologous SCT within 12 weeks before the date of study treatment.
Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted > 6 months; refractory is no response or relapse within 6 months; previous biopsies < 6 months prior to treatment on this protocol will be acceptable\r\n* NOTE: Arms A/B – relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\r\n* NOTE: Arm C patients include relapsed lymphoma patients of any type, other than those eligible for Arms A/B, for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed double-hit high grade lymphoma patients and relapsed Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding
Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ? 25% of bone marrow are not eligible, irrespective of when it was received.
Patients must not have received any other anti-cancer treatment (including surgery, radiation or systemic chemotherapy) since the base trial.
Patients who have received prior treatment with PTK7-ADC (PF-06647020)
Patients who have received prior immunotherapies
Patients with genomic tumor aberrations should have received prior treatment with an FDA-approved targeted therapy (if available)
Subjects who have received prior immunotherapy may be eligible
Patients must have received prior systemic sorafenib treatment for HCC with documented progression during or after discontinuation of sorafenib treatment (for France only: patients must have received at least 8 weeks of prior sorafenib treatment), or are intolerant to sorafenib (defined as documented Grade 3 or 4 adverse events that led to sorafenib discontinuation),.
Patients who have received organ transplants.
Prior history of standard dose focal RT to 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower doses; patients who have received prior treatment with non-standard RT dose and fractionation schemes are still eligible, provided they have only received a single course of RT; however, subjects treated with interstitial brachytherapy or single-fraction stereotactic radiosurgery are not eligible for this trial
Has received any treatments prohibited in this trial within specified time frames
Patients who have received no less than 20 transfusions of RBCs;
Patients must have received prior external beam radiotherapy and temozolomide.
Patient received nitrosureas within 6 weeks prior to the first dose.
Patient received corticosteroids within 2 weeks prior to the first dose.
Patient received plasmapheresis within 4 weeks prior to the first dose.
Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
Patient who received bortezomib within 6 months of randomization to this study
\Study entry\ is defined as the date of informed consent. Patients who received investigational therapy (agents that are not FDA approved), monoclonal antibody such as bevacizumab or cetuximab, or who received radiotherapy to the skull, spine, thorax or pelvis within 30 days of entry into the protocol. Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site, and provided skull, spine, thorax or pelvis were not in the radiotherapy field.
Patients who have received standard chemotherapy with FDA approved agents within 21 days of entry into the protocol.
Received prior systemic anti-cancer therapy for NSCLC
Received and failed potentially curative chemotherapeutic regimens (e.g., ABVD, Stanford V, or BEACOPP)
Completed autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entry
Received allogeneic BMT
Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.
Subjects who have received prior taxane therapy in the metastatic setting
Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
Has received systemic anti-cancer therapy within the 3 weeks prior to starting the trial.
Carcinoma patients in Arm A or Arm B must have received at least 1 prior regimen of standard of care systemic antitumor therapy for their metastatic disease and experienced tumor progression within 3 months after the last prior administration of the therapy or experienced unacceptable toxicity to these treatments.
Has FLT3-ITD mutant (> 3% FLT3-ITD/total FLT3) AML (primary AML or secondary to myelodysplastic syndrome [MDS]) that have failed any prior induction therapy regimen or have relapsed after prior induction/consolidation therapy, have not received more than one salvage therapy, and have not received more than one FLT3 inhibitor during prior AML treatment(s)
Has received at least 2 prior lines of therapy as described in the protocol.
Has received at least 2 consecutive cycles of lenalidomide and be refractory to lenalidomide, as defined per protocol.
Subjects have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide containing systemic anti-cancer therapy regimen
Have received prior NY-ESO-1 therapy
Have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide
Has received previous treatment with another agent targeting the Lymphocyte-activation gene 3 (LAG-3) receptor
Has received previous treatment with another agent targeting endothelial growth factor (VEGF) or the VEGF receptor
received the transplant < 6 months prior to study Day 1
(Dose levels 1 and 2) - may have received one or more systemic treatments or regimens for metastatic RCC; (dose level 3) - cannot have received prior systemic treatment for RCC
Patients who have received any therapy other than hydroxyurea with the purpose of treating their AML are not eligible
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Patients are excluded if they have received total body irradiation (TBI)
Patients must not have received valproic acid within 30 days of study entry
Has received a T-cell product within 6 weeks prior to planned infusion of genetically modified T cells.
Histological confirmation of WM for which the patient has received at least one prior treatment; patients may have relapsed or refractory disease;(definition: relapse; patients who have received prior treatment for WM and now have disease recurrence; refractory; patients who have received anti-WM therapy and are noted to have progressive disease while on therapy, or those patients who demonstrated disease progression within 6 months of the last anti-WM treatment)
Patients who have received RAI within 8 weeks
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Concomitant use of the Optune device will also be excluded.
May have received 1 prior biologic regimen (i.e. avastin) but not within 4 weeks of enrollment
Has received prior therapy with an anti-IDO-1 agent
Patients must have never received any prior systemic therapy for their disease.
Received any systemic treatment for pancreatic cancer =< 14 days prior to first dose of rucaparib
Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy; patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. breast cancer prevention trial or for other past indications (including previous breast cancer) are eligible; tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study
The subject must have recovered (=< grade 1) from the acute toxic effects of prior therapy\r\n* NOTES: Subjects may have received a single platinum-based cytotoxic chemotherapy regimen; subjects having received prior cytotoxic chemotherapy must have completed their treatment more than 6 months prior to registration; subjects may have received prior therapy with hormones or biologic agents, but such therapies must be discontinued at least 28 days prior to registration for protocol therapy
Patients who have received bevacizumab, Gliadel, or are on active therapy with Optune are not eligible
Have received any prior treatment for AML with the exception of hydroxyurea.
Subjects who had previously received an experimental agent for MDS may not be randomized until a washout period has elapsed since the last dose of that agent.
Received any of the following within the specified time frame prior to administration of study medication:
Have previously received maribavir.
Have received any unapproved agent or device within 30 days before initiation of study treatment.
Subject received HMA for at least 6 cycles and was still transfusion dependent (as defined in 5b below).
Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
Have received either of the study drugs
Has received prior therapy with an anti-CTLA4 agent
Have received prior treatment with trastuzumab.
Received the following within 7 days prior to the initiation of study treatment:
Specifically, for participants in Cohorts A1 and A2: Age greater than or equal to (>=) 18 years, disease progression or failure to achieve complete or partial response after intensive cytotoxic therapy, participants cannot have received more than two prior intensive regimens (e.g., induction + consolidation and one salvage therapy + consolidation)
Patients who have received previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine will be excluded
Patient must not have received pegfilgrastim within 14 days of enrollment
Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment
Patients who have received prior anti-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigen
Patients may have received previous NY ESO 1 vaccine therapy; patients who received bevacizumab or other experimental therapies are eligible for enrollment provided they have discontinued therapy (at least 4 weeks) prior to randomization and recovered from toxicities to less than grade 2
Subjects who have received prior therapy with hypomethylating agents (5-azacytidine, decitabine, SGI-110)
Must not have received prior treatment for MDS with any hypomethylating agent
TREATMENT: Patients who have received prior carboplatin or AZD1775 (MK-1775) would not be excluded unless the two drugs were administered in combination; patients who have received prior carboplatin in combination with AZD1775 (MK-1775) would still be eligible to receive other study treatment regimens based on identified genetic mutation(s), other than carboplatin plus AZD1775 (MK-1775)
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible
Prior therapy with TEW-7197 or received any investigational drug within the prior 28 days
Patients who have received any tumor-directed therapy prior to biopsy are not eligible; concurrent treatment with corticosteroids is allowed
Recurrent tumors near the brainstem and optic chiasm must not have received prior radiation therapy
Participants may have received prior treatment with weekly paclitaxel; however, participants who have had progression on or within 8 weeks of their last dose of weekly paclitaxel will not be eligible
Growth factors:\r\n* Patients must not have received growth factors for 7 days prior to CPX-351\r\n* Patients must not have received pegfilgrastim for 14 days prior to CPX-351
Patients who have received > 450 mg/m^2 daunorubicin equivalents; patients who relapse after receiving AAML0531/AAML1031 therapy will be eligible for this study, provided they have not received any additional anthracyclines; NOTE: for the purposes of determining eligibility for this protocol, the following cardiotoxicity multipliers will be used to determine daunorubicin equivalents:\r\n* Doxorubicin (doxorubicin hydrochloride): 1\r\n* Mitoxantrone: 3\r\n* Idarubicin: 3\r\n* Epirubicin: 0.5
Patient must have received 2 or more prior lines of systemic therapy for myeloma; patients must be off last treatment for at least 2 weeks (wks) by the beginning of treatment on this protocol
Patients may have received prior interferon alpha (IFN-alpha), but must not have received IFN-alpha in the 4-week period prior to enrollment on the trial; patients who have not received prior adjuvant therapy should be informed of the potential therapeutic benefit of IFN-alpha; previous radiation therapy, including after the surgical resection, is allowed as long as 14 days have elapsed between the radiation and initiation of first vaccination with NeoVax
Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, the dose counts against the total dose limit.
Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy
Participants who have received any chemotherapy or radiotherapy for previous malignancy are not eligible; participants who have ever previously received any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (e.g., rheumatologic or autoimmune condition) are not eligible
Patients who have received previous radiation therapy to critical organs exceeding any of the limits shown below, are excluded:
Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study\r\n* Myelosuppressive chemotherapy: must have received last dose at least 2 weeks prior to protocol therapy; this includes cytotoxic agents given on a low dose metronomic regimen\r\n* Biologic (anti-neoplastic agent) (includes retinoids): must have received last dose at least 7 days prior to protocol therapy\r\n* Monoclonal antibodies: must have received last dose at least 7 days or 3 half-lives, whichever is longer, prior to protocol therapy
Prior anti-disialoganglioside (GD2) antibody, isotretinoin, or lenalidomide therapy:\r\n* Patients who have received prior anti-GD2 antibody therapy are eligible if they did not have tumor relapse/progression while receiving this therapy\r\n* Patients who have received either isotretinoin or lenalidomide are eligible, but not if they have received the two agents concomitantly
Participants are allowed to have received, but are not required to have received, one\n             additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the\n             management of ovarian cancer.
Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment
Patients who have received hepatotoxic drugs less than 7 days prior to enrollment
Patients who have received prior biologic agents less than 30 days prior to enrollment
Arm 2 patients may have an unlimited number of prior therapy regimens but may not have received prior antiangiogenesis therapy except for bevacizumab (patients may not have received aflibercept, ramucirumab, cediranib, cabozantinib, or XL184)
Arm 1 patients must have not received bevacizumab previously
All patients must have previously received trastuzumab and a taxane, separately or in combination and have received prior therapy for metastatic disease
Patients must not have received nitrosourea or mitomycin C within 42 days prior to sub-study registration
Subjects who have previously received anetumab ravtansine
Patients with acute or lymphoma forms must have received at least one cycle of combination chemotherapy (with or without mogamulizumab) or interferon (with or without zidovudine and/or arsenic); individuals with chronic or smoldering acute T-cell lymphoma (ATL) are not required to have had prior treatment or could have received any number of previous courses of therapy
Must have received prior anthracyline and taxane compound therapy unless clinically contraindicated
No limitations to number of prior chemotherapies for metastatic disease; treatment with prior taxanes (except nab-paclitaxel) is allowed as long as it has been 6 months or more since exposure to prior taxane; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment
Patients who have received prior therapy with eribulin mesylate are not eligible
Patient who has received investigation agent within 30 days prior to enrollment
Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy; patient should not have received gemcitabine within 6 months of starting the study treatment; 5-flourouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug
Patients who have received one prior regimen must have a GOG performance status of 0, 1 or 2; patients who have received two or more prior regimens must have GOG performance status of 0 or 1
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Patients may not have received any prior carfilzomib treatment
Patients must have begun cycle 2 (carfilzomib – 27 mg/m^2) and must not have received any dose reduction for toxicity in the last cycle of treatment, immediately preceding progression
Re-enrollment: Received at least 3 intravenous doses of ALT-803 with no dose-limiting toxicity (DLT)
Patients who have received radiation therapy as part of their leukemia treatment may be ineligible and individual cases must be presented to the study principal investigator (PI) for determination of eligibility
Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
Patients may have received prior bortezomib therapy.
Patients who have never received trastuzumab
Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
Patient who has received any prior anthracyclines
Patients who have received ipilimumab in the past are excluded
Patients that have received prior radioimmunotherapy
Patients must have received and completed first line therapy
Please note: prior intensive induction therapy for acute leukemia is allowed only in the phase I portion of this study\r\n* PHASE I PORTION ONLY: Patients of any age who have received no more than one prior attempt at induction chemotherapy (and may have received treatment consolidation), must have recovered from acute toxicities of therapy and be >= 4 weeks from last dose of cytotoxic treatment; patients who have received prior autologous or allogeneic stem cell transplantation are not eligible; patients may have received 1 or 2 cycles of cytarabine-based therapy as attempted induction
Patients may have received prior radiation therapy provided at least 28 days have elapsed since the last treatment and patients have recovered from all associated toxicities at the time of registration
Patients must not have received prior therapy with PF-02341066
Off all myelofibrosis (MF)-directed therapy including investigational agents for at least 2 weeks prior to study enrollment and recovered from all toxicities; patient who has been on stable dose of ruxolitinib and has received ruxolitinib =< 6 months prior to the study entry will be considered potentially eligible for the study with the caveat that there is no evidence of loss of response (> 5 cm increase in spleen size from the nadir)
Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
Patients with recurrent disease may not have received more than three prior chemotherapies for treatment of their uterine cancer
Patients who have received prior therapy with trastuzumab or any other anti-epidermal growth factor type II receptor antibody
Subject is in second or later hematologic relapse or has received salvage therapy for refractory disease
Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or abiraterone acetate, or enzalutamide (MDV3100); concurrent megestrol for hot flashes is allowed
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Patients must not have received previous systemic anthracycline (intravesical anthracycline is allowed)
Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Has received more than 1 allo-HSCT.
Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.
For participants who are ineligible for auto-SCT, has received at least ?2 lines of prior therapy and has failed to respond to or relapsed after their last line of treatment. For participants who received consolidative local radiotherapy after systemic therapy, local radiotherapy will not be considered as a separate line of treatment.
Relapsed or refractory Richter syndrome and has received ?1 previous treatment for RS.
Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
Must have received > or = 1 prior treatment regimen.
Subjects must have received prior antiangiogenic therapy.
Subjects may have received no more than 2 lines of prior therapy for advanced disease.
Subjects may have received no more than 2 lines of prior therapy for advanced disease.
Subjects may have received no more than 2 lines of prior therapy for the advanced disease
During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
previously received:
must have received a taxane in any disease setting
may have received any endocrine therapy (excluding fulvestrant)
received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
Subject must have received no prior treatment for AML with the exception of hydroxyurea
HER2+ patients must have received pertuzumab and TDM-1 (ado-trastuzumab emtansine) prior to trial enrollment; unless deemed ineligible for these therapies, and with the exceptions listed below:\r\n* Patients with metastatic breast cancer who have not received prior pertuzumab are eligible if: heavily pretreated prior to Food and Drug Administration (FDA) approval of pertuzumab (6/8/2012) for first-line treatment of HER2+ metastatic breast cancer (MBC)\r\n* Patients with metastatic breast cancer who have not received ado-trastuzumab emtansine are eligible if: heavily pretreated prior to FDA approval of ado-trastuzumab emtansine (2/22/2013) for the treatment of patients with HER2+ MBC who previously received trastuzumab and a taxane separately or in combination
Received prior sorafenib.
Has received previous therapy with pomalidomide
Have received more than one prior antiangiogenic agent (that is, bevacizumab, sorafenib, sunitinib) for TCC of the urothelium.
Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents
previously received at least 1 but no more than 4 lines of therapy, one therapy must have included a VEGF TKI
previously received at least 1 but no more than 3 lines of therapy, one therapy must have included a fluoropyrimidine based regimen
previously received at least 2 but no more than 4 lines of therapy, which must have included both an irinotecan and an oxaliplatin based regimen
Patients must not have received any prior treatment for AML
The patient has previously received treatment with SL-401.
All patients must have received at least one prior therapy - 1 cycle of cytarabine containing regimen or 2 cycles of hypomethylating agent - before determination of refractory status (defined as response duration less than 3 months or no response)
Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)
Patients must have received as a minimum a first line chemotherapy regimen consisting of at least 2 of the following agents: doxorubicin, cyclophosphamide, ifosfamide, etoposide.
Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:
Previously received X4P-001
Received prior treatment with at least 1, but no more than 3, prior lines of therapy for MM.
Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration
Subject must have received sorafenib treatment and either:
Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day 1;
Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose)
Received any anticancer medication or therapy in the 21 days prior to study Day 1
Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
Has previously received TAS-102.
Patients who previously received gemcitabine for the treatment of recurrent disease
Part C (CPI-Treated Expansion): Subject must have received prior treatment with a CPI in the metastatic setting
Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide ( for lenalidomide : unless the last dose received is >= 8 weeks prior to inclusion into the study).
Patients must have received at least one prior salvage regimen for recurrent ovarian cancer
Patients must not have received prior irinotecan-based chemotherapy (e.g. irinotecan hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin [FOLFIRINOX] or FOLFIRI)
Has received no prior systemic therapy for advanced RCC.
Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin (mTOR) targeting agents.
Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
Has received previous therapy with pomalidomide and did not achieve at least a stable disease
Patients who have received prior administration of an Aurora A kinase targeted agent (including alisertib) are not eligible
Inclusion Criteria:\n\n        Among other criteria, patients must meet all of the following conditions to be eligible for\n        the study:\n\n          -  Unresectable, histologically-confirmed advanced (Stage III or Stage IV) melanoma\n\n          -  Disease progression during or after the last anticancer therapy received. For Cohort\n             3, progression must have occurred during the PD-1 targeted CPI (checkpoint inhibitor)\n             treatment and the investigator has deemed it appropriate to continue treatment with\n             the PD-1 targeted CPI beyond confirmed disease progression\n\n          -  No more than one prior chemotherapy-containing regimen for advanced disease.\n\n          -  Prior treatments received must include at least one CPI inhibitor (e.g., anti-CTLA-4,\n             PD-1-, PD-L1-targeted immunotherapy) and for patients with a BRAF mutation at least\n             one BRAF- or MEK-targeted therapy, unless patients are not candidates for, or refused,\n             these therapies. For cohort 3, prior treatment received must include a PD-1 targeted\n             CPI administered during the most recent disease progression and for patients with BRAF\n             mutation at least one BRAF- or MEK-targeted therapy when appropriate\n\n          -  The study site will submit paraffin-embedded tumor tissue obtained from the patient\n             for gpNMB analysis. Patients may require a biopsy if recent tumor tissue is not\n             available. Patients in cohort 2 and 3 must submit a recently obtained biopsy of the\n             skin fold for gpNMB analysis. Patients in Cohort 4 will submit a tumor tissue sample\n             while on study.\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n\n          -  Adequate bone marrow, liver and renal function.\n\n        Exclusion Criteria:\n\n        Among other criteria, patients who meet any of the following conditions are NOT eligible\n        for the study:\n\n          -  Previously received glembatumumab vedotin (CR011-vcMMAE, CDX-011) or other\n             MMAE-containing agents\n\n          -  Treatment with the following therapies before the planned start of study treatment:\n\n               1. BRAF or MEK inhibitors within 2 weeks\n\n               2. Monoclonal based therapies within 4 weeks except for the PD-1 targeted checkpoint\n                  inhibitor in cohort 3\n\n               3. Immunotherapy (tumor vaccine, cytokine, or growth factor given to control the\n                  cancer) within 2 weeks\n\n               4. Chemotherapy within 21 days or at least 5 half-lives (whichever is longer)\n\n               5. Investigational therapy within 2 weeks (or at least 5 half-lives, whichever is\n                  longer)\n\n          -  Patients with ocular melanoma\n\n          -  Neuropathy that is moderate (Grade 2) or worse.\n\n          -  Cancer that has spread to the brain or spine will be discussed with the study sponsor\n             and may exclude patients from the trial.\n\n          -  History of another cancer except:\n\n               1. Patients with adequately treated and cured non-melanoma skin cancer or in situ\n                  cancer\n\n               2. Patients with any other cancer from which the patient has been disease-free for ?\n                  3 years\n\n          -  Significant cardiovascular disease\n\n          -  Previously received varlilumab or any other anti-CD27 mAb (Cohort 2 only)\n\n          -  Active systemic infection requiring treatment\n\n          -  Treatment with immunosuppressive medications within 4 weeks or corticosteroids within\n             two weeks\n\n          -  Patients with interstitial lung disease (Cohort 3 only)\n\n          -  Patients with active diverticulitis (Cohort 3 only)\n\n          -  Any non-study vaccination within 4 weeks, or influenza vaccine within 2 weeks, prior\n             to CDX-301 dosing (Cohort 4 only)
Subjects must have received at least one line of hormonal therapy in the metastatic setting
Subject has received no prior systemic therapy
Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
Previously received any prior TKI, including ALK-targeted TKIs.
Received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other MMAE-containing agents previously.
Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
Has received ?3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ?4 lines for NSCLC or urothelial cancer.
Patients who will be enrolled under protocol amendment # 2 must have previously received bevacizumab, either discontinued due to intolerability, or progressed after at least 2 cycles of bevacizumab
Subjects who have received an anti-DLL4 antibody, or an anti-DLL4/VEGF bispecific antibody Subjects who have received prior anti-VEGF therapy are eligible, unless they have residual serious adverse events related to their anti-VEGF therapy.
Carmustine ? 600 mg/m² received as part of the pre-transplant conditioning regimen
Patients may have received prior lenalidomide as long as it has been at least two years since exposure and the patient may not have experienced a progression while receiving lenalidomide previously
Hgb < 100 g/L, have received ? 2 units PRBC in the 12 weeks prior to study entry, and be intolerant of or had inadequate response to ruxolitinib;
Patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers who have received up to two prior treatment regimens
Must not have received systemic antineoplastic therapy, including radiotherapy within 7 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =< 14 days and total treatment dose was =< 360 mg
Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
Must not have received any prior systemic therapy for their mRCC.
Patients who have previously received systemic, radiation or other treatment for uterine cancer
Received other treatments for MDS within 28 days prior to first dose (example [eg], azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks for long-acting ESAs)
have received prior second-line treatment with oxaliplatin and/or irinotecan, and no other licensed/standard-of-care therapies are available. If the participant has RAS wild type colorectal cancer, he or she also must have received prior treatment with an epidermal growth factor receptor monoclonal antibody
Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
Has received prior therapy with vorinostat or other epigenetic agent
Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer; they must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment; patients are allowed to have received, but are not required to have received, one to two cytotoxic regimens for management of recurrent or persistent disease; (for the purposes of this study poly adenosine diphosphate [ADP] ribose polymerase [PARP] inhibitors given for recurrent or progressive disease will be considered cytotoxic; PARP inhibitors given as maintenance therapy in continuation with management of primary disease will not be considered as a separate cytotoxic regimen); if two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, and the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued; patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Have not received prior treatment with docetaxel.
Received FOLFOX within 6 weeks before starting regorafenib
Patients who have received any treatment with ibrutinib prior to study entry
Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Patients who received only one cycle of antineoplastic therapy in the advanced setting are allowed).
Received more than 3 prior systemic treatment regimens with chemotherapy , hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting
Patients with metastatic malignant solid tumors who received treatment in the past 6 months are excluded
Recurrent tumors near the brainstem and optic chiasm must not have received prior radiation therapy
Patients with history of hematologic malignancies who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease
Hb < 10 g/dL at screening OR have received at least one transfusion within 12 months prior to screening
Have received prior treatment with everolimus
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
Patients who have previously received hormonal therapy for endometrial cancer.
In Part B-AZD9291 LM expansion (sub-cohort of T790M+ LM patients), patients must have central confirmation of T790M+ mutation status from a sample taken after documented progression on the last treatment administered prior to enrolling in the study. Patients must have received prior therapy with an EGFR TKI and may also have received additional lines of treatment. Stable extracranial disease is not required.
MEL subjects may be treatment naïve or may have received prior lines of therapy for metastatic disease (Parts 1A and 1B)
Received 3 or more prior myelotoxic treatment regimens
Participants must have never received previous R-CHOP treatment
Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen Expansion Portion of the Study:
For patients with relapsed/refractory disease: patients may have previously received chemotherapy with a mitoxantrone- or cladribine-based regimen for MDS or AML; if that patient has received G-CLAM before and has been sensitive to this regimen, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)
Subject must have received ? 1 prior treatment regimen(s)
Patients who have received hematopoietic growth factor support within 14 days of day 1 of SGN-35
Patients who have received any treatment with SGN-35 prior to study entry
Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible
Subjects who have received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Subjects who have received local hepatic injection chemotherapy are eligible.
Patients may have received one or more lines of prior chemotherapy with/without rituximab (including high dose therapy plus stem cell transplant which is counted as one regimen); prior bortezomib is allowed; patients must not have received bortezomib in the past 6 months
Received alemtuzumab or other anti-Tcell antibody within 28 days
Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent
Received anti-CD30 antibody-based therapy within the previous 4 weeks
Patients who received PDGFR inhibitors (imatinib, sunitinib, nilotinib, etc.) previously are excluded (patients who received PDGFR antibody based treatment however are allowed)
The patient must have received no more than 1 prior line of therapy for extensive disease.
The patient must have received at least 1 and no more than 2 prior lines of treatment in the metastatic setting.
Received therapy with any immunotherapeutic agents including, but not limited to, any anti-PD1 or anti-PDL1 antibody therapy, with these exceptions: Melanoma patients having received and progressed on anti-CTLA4 (cyctotoxic T lymphocyte-associated antigen 4) may participate in the trial; Bladder cancer patients having received intra-vesical BCG may participate in the trial.
Received systemic anti-cancer therapy within 30 days of Week 0, Day 11 of study treatment.
Subject has received previous therapy for AML, with the exception of the following:
Have received prior radiation to maximally tolerated levels to any critical normal organ
Have previously received HCT
Have received an antibody therapy within 3 weeks
Patients who have received prior therapy with a TLR agonist, excluding topical agents. Patients who have received experimental vaccines or other investigational immune therapies should be discussed with the Medical Monitor to confirm eligibility.
Patients who have received systemic treatment with IFN-? within the previous 6 months prior to enrolling into this study.
Prior CD19 directed therapy, including CAR+ T cell, BiTE, and antibody drug conjugate (ADC), with the exception of subjects who received KTE-C19 in this study and are eligible for re-treatment
Participants cannot have received any anti-neoplastic therapy (including radiotherapy, chemotherapy or immunotherapy) after ASCT
Patients must have not received previous treatment with any of the study medications or similar drugs
Subjects who have received prior CEA, MUC1, and/or brachyury-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 4 weeks prior to enrollment
Patients who have received prior capecitabine therapy are not eligible
Participants who have received prior bevacizumab are eligible unless there is evidence of unacceptable toxicity due to prior bevacizumab exposure
Received 1 or 2 prior lines of therapy.
Has participated in a previous trial and received pembrolizumab therapy
Patients must not have received any drug that is a moderate or strong inhibitor of 2B6, 2C9, 3A4, and 2C19 within 1 week prior to receiving cyclophosphamide dosing through 72 hours after cyclophosphamide dosing; patients must not have received any drug that is a moderate or strong inducer of 3A4 within 2 weeks prior to cyclophosphamide dosing
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
AML participants ? 60 years old in first relapse with a disease-free interval < 12 months, or further relapse. First relapse is also applicable to AML post-MDS patients who have received prior treatment for MDS, but have not received prior treatment for AML.
Patients may not have received eribulin or lenvatinib previously
Have received previous systemic therapy with ramucirumab
Subject received prior systemic treatment for HCC with sorafenib or other anti-VEGF therapy and had confirmed disease progression or discontinued treatment due to a drug-related toxicity. Subject may have received 1 line of systemic therapy before or after sorafenib/anti-VEGF treatment.
Received double-blind enzalutamide study treatment during the main study.
Subject has received chemotherapy, immunotherapy or any other systemic anticancer therapy (including sorafenib) or any other investigational drug within 14 days prior to the Day 1 visit.
Received double-blind placebo during the main study.
Patients who have received prior treatment with GEN-1.
Patients who have previously received denosumab
Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment
Patients who have received Gliadel wafers or alternating electrical field therapy are not eligible for this study
For stratum A, patients must not have received prior anthracycline-based therapy (prior treatment with non-anthracyclines is permitted)
For stratum B patients must have received prior anthracycline-based therapy (or have a contraindication to receiving this treatment) and must not have received prior gemcitabine (gemcitabine hydrochloride)
Have received at least one prior therapy for WM
ELIGIBILITY FOR TREATMENT ON ARM 1: Patients must have received at least one line of therapy for NSCLC or mesothelioma or previously documented to have declined therapy
Received prior hemibody external radiotherapy
Patients that have received systemic treatments within four weeks prior to the beginning of treatment
Subject has received prior treatment with fulvestrant.
Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.
Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
Patients may have received but may not have progressed on prior anti-angiogenic therapy in the upfront setting
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery
All patients need to have received at least one prior CNS directed therapy; there is no restriction on the number of recurrences
Patients who have received allogenic stem cell transplants
For Phase I part: o Patients who have not previously received at least one line of therapy for ALK-positive NSCLC
Prior systemic chemotherapy allowed; it is anticipated and suggested that most patients enrolled on study will have received a minimum of approximately 2 months of systemic therapy according to routine institutional practices; the patient must also be felt by the treating medical oncologist and radiation oncologist to be a candidate for treatment with gemcitabine/nab-paclitaxel chemoradiotherapy
MCL patients must have:\r\n* At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma\r\n* Received at least 1 prior standard therapy for MCL
Must not have received systemic anti-neoplastic therapy, including radiotherapy within 14 days of study treatment
=< 3 prior chemotherapies in the metastatic setting; prior anthracycline, taxane, gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, TDM-1, etc.) are allowed; if patients received prior gemcitabine, it could not have been combined with pertuzumab; patients should have progression of disease on current therapy
Patients must have received prior radiotherapy and prior temozolomide as treatment for the malignant glioma
There is no limit on the number or type of prior chemotherapies except:\r\n* Patients must not have received prior treatment with convection enhanced delivery, other catheter based intra-tumoral treatment, or carmustine (BCNU)/Gliadel wafers\r\n* Patients with prior therapy that included stereotactic radiosurgery (including gamma-knife or cyber-knife) during therapy for newly diagnosed or recurrent disease, or re-irradiation of any type, must have confirmation of true progressive disease rather than radiation necrosis based upon surgical documentation of recurrent/progressive disease; imaging with magnetic resonance (MR)Spectroscopy, MRPerfusion, positron emission tomography (PET), or other techniques is not adequate to exclude radiation necrosis for this study\r\n* Patients may not have received prior treatment with an agent designed to inhibit mTOR or PI3K/AKT including, but not limited to, temsirolimus, rapamycin (sirolimus), RAD001 (everolimus), other rapalogs, BKM120, or perifosine; any question regarding the definition of an agent designed to inhibit mTOR or PI3K/AKT targeting should be discussed with the sponsor\r\n* Patients may not have received prior treatment with direct VEGF/VEGFR inhibitors such as bevacizumab (Avastin), aflibercept (VEGF-Trap), cediranib (AZD2171), trebananib (AMG 386), or XL-184 (Cabozantinib)
Patients enrolled in other clinical trials must have received their last treatment at least 6 weeks prior to enrollment
Previously received docetaxel or are not healthy enough per clinical judgment or declined to receive it
Must have not received post-ASCT consolidation therapy.
Patients who have received no more than 1 prior cytotoxic treatment regimen.
Subjects must have received at least one prior treatment regimen\r\n* Subjects that have received a prior Bruton’s agammaglobulinemia tyrosine kinase (BTK) inhibitor or cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition are ineligible\r\n* Subjects that have undergone prior allogeneic stem cell transplantation will only be eligible if the transplant occurred at least 1 year prior to study entry, the patient is no longer taking any immunosuppressive therapy, and there are no significant ongoing transplant-related adverse effects\r\n* Subjects must not have received chemotherapy =< 21 days prior to first administration of study treatment, monoclonal antibody =< 6 weeks prior to first administration of study treatment, and/or radiotherapy or other investigational agents =< 4 weeks prior to first administration study treatment unless the subjects’ tumor has progressed on the previous therapy and the investigator believes that the patient should not postpone further therapy and, all treatment-related toxicities have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 =< grade 1; subjects may be receiving equivalent to prednisone at a maximum dose of 20 mg/day orally
Patients may have received unlimited lines of prior therapy
Received more than 3 lines of prior conventional therapy for advanced disease
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
Have received recent (within 28 days prior to randomization) yellow fever vaccination
Inclusion Criteria.\n\n          -  Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor\n             Receptor 2 Negative (HER2-) breast cancer.\n\n          -  Recurrent, locally advanced, unresectable or metastatic breast cancer with disease\n             progression following anti-estrogen therapy.\n\n          -  Prior treatment with at least 2 chemotherapy regimens:\n\n               -  At least 1 of these regimens must have been administered in the metastatic\n                  setting.\n\n               -  At least 1 of these regimens must have contained a taxane.\n\n               -  No more than 2 prior chemotherapy regimens in the metastatic setting.\n\n          -  Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group\n             scale.\n\n          -  Have discontinued all previous therapies for cancer.\n\n          -  Have the presence of measureable disease as defined by Response Evaluation Criteria in\n             Solid Tumors Version 1.1.\n\n        Exclusion Criteria:\n\n          -  Have either a history of central nervous system (CNS) metastasis or evidence of CNS\n             metastasis on the magnetic resonance image of brain obtained at baseline.\n\n          -  Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6)\n             inhibitor.\n\n          -  Have received treatment with a drug that has not received regulatory approval for any\n             indication within 14 or 21 days of the initial dose of study drug.\n\n          -  Have had major surgery within 14 days of the initial dose of study drug.\n\n          -  Have a history of any other cancer (except non-melanoma skin cancer or carcinoma\n             in-situ of the cervix).
Subjects who have received radiation to the orbit at any time previously
Subject has previously received regorafenib;
Patients should not have received any platelet transfusions in the last 4 weeks before screening date
Received any prior ALK-targeted TKI other than crizotinib.
Received crizotinib within 3 days of the first dose of brigatinib (Day 1, Cycle 1).
Patients must have received treatment with either enzalutamide and/or abiraterone prior to study entry
Patients with therapy-related AML or MDS should have not received prior cumulative anthracycline (daunorubicin equivalent) lifetime dose > 450 mg/m^2
Patients may be treatment naïve, or may have received standard chemotherapy; including regimens containing a fluoropyrimidine, or oxaliplatin, or irinotecan, or regorafenib, or bevacizumab.
Patients may not have received prior interferon, either systemic or intra-cystic
The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ? 7 days from the first dose of Investigational Product.
Patients must have had at least one prior treatment for metastatic disease with standard chemotherapy and cetuximab in combination or as monotherapy. [Note: patients who received panitumumab instead of cetuximab are eligible.]
Patients who received ? 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.
Patients must not have received prior treatment with pazopanib or topotecan
Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation
Subject has received previous therapy for AML, with the exception of the following:
Patients must have received primary treatment with radical prostatectomy
Patients with colon cancer (cohort A and B) must have received at least 2 prior cancer therapy regimens; patients with other cancer types (cohort C) must have received at least 1 prior cancer therapy regimen; patients in cohort D must have received at least 1 prior cancer therapy regimen; patients must have progressive disease on study entry
Patients who have received =< 1 cycle of therapy after most recent progression/relapse are eligible to enroll on study\r\n* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted\r\n* Bisphosphonates are permitted\r\n* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted\r\n* Prior treatment with radiotherapy is permitted\r\n* Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 4 weeks from last dose (on a trial or outside a trial) are eligible
Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received previous treatment as follows:
COHORT I: Patients must have received at least one and no more than two prior systemic therapy regimens; at least one of the regimens must have included pemetrexed and a platinum
COHORT II: Patients must not have previously received treatment with chemotherapy for MM
Participants who have received previous therapy with neratinib or fulvestrant
Patients that have received the study medication (Xgeva/Prolia)
The patient has received =< 5 lines of prior therapy
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Patients may have received up to 3 prior cycles of hypomethylator therapy (i.e. decitabine or azacitidine) prior to enrollment and may have received supportive care measures (growth factors, erythropoietin stimulating agents, transfusion, etc)
Patients who have received yttrium-90 microspheres are not eligible
Patients who have received previous treatment with bevacizumab for CNS disease are not eligible for participation
Patients must have received prior radiotherapy for meningioma; patients may have received standard external beam radiation, interstitial brachytherapy, or radiosurgery in any combination; an interval of >= 4 weeks (28 days) must have elapsed from the completion of radiotherapy to study entry and there must be subsequent evidence of tumor progression; patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progression disease rather than radiation necrosis based on positron emission tomography (PET), MR-perfusion, MR-spectroscopy, or surgical documentation of disease; if there is any question, investigators should discuss with the MSKCC principal investigator (PI)
Patients may have not received treatment for 28 days before the first day of the study protocol (dose escalation only)
Received prior salvage therapy, including radiotherapy
Patients may have received therapy for other malignancies, as long as they have completed therapy at least 6 months prior to study entry and be deemed to have a life expectancy of at least 2 years with regard to that malignancy
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Previously received eribulin.
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Having received systemic immune suppressive therapy within 30 days prior to leukapheresis
Patient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
Patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies (ipilimumab) or pharmaceutical compounds are excluded.
Patients who have received radiation therapy =< 2 weeks prior to study entry; patients who have received prior radiotherapy must have recovered from toxicity (=< grade 1) induced by this treatment
Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
Subjects who received any prior treatment with docetaxel are excluded. Subjects who have received gemcitabine in first line therapy but do not have squamous cell carcinoma, will be eligible as they can receive pemetrexed for the salvage regimen.
Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Participants who have previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
Patients who are post auto-SCT as primary therapy must have received maintenance therapy with lenalidomide
All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel
Have received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entry
Patients must not have received any chemotherapy within 21 days of enrollment, and any acute treatment-related toxicities must have returned to baseline; patients may be receiving Hydrea at time of enrollment
Patient must not have previously received nab-paclitaxel
Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
Patents who received an anthracycline prior to enrollment must have an ejection fraction ? 50%
Prior treatment with brentuximab vedotin and bendamustine in combination; may have received prior therapy with brentuximab vedotin or bendamustine separately
Received either brentuximab vedotin or bendamustine within 3 months of receiving their first dose of protocol based therapy
Participants may not have received any prior camptothecin, including but not limited to: topotecan, irinotecan
Secretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2).
Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapy
Patients must have been treated with at least one prior treatment regimen that included carboplatin; patients who have received prior radiation therapy for this tumor are eligible
Growth factor(s): must not have received within 2 weeks of entry onto this study
One of the following subgroups of patients with HER2 overexpression as follows: \r\n* Histologically-confirmed breast cancer that is metastatic or locally recurrent (7th Edition of the American Joint Committee on Cancer [AJCC] Tumor, Lymph Node, Metastasis [TNM] System) and measurable and/or evaluable or non-measurable by RECIST 1.1 criteria with HER2/neu overexpression by immunohistochemistry (2+,3+) or fluorescent in situ hybridization (FISH)+ and progressive disease despite having received at least 1 prior Food and Drug Administration (FDA) approved HER2 targeted therapy (e.g. trastuzumab, trastuzumab plus pertuzumab, T-DM1, or lapatinib) (determined by their physician); prior therapy has at least one of the following stipulations: \r\n** Patients may have received neoadjuvant or adjuvant treatment with prior trastuzumab or lapatinib treatment \r\n** Patients have received a trastuzumab, trastuzumab + pertuzumab, or T-DM1-based therapy for locally advanced or metastatic disease for a minimum of 9 weeks duration; patients may have received more than 1 trastuzumab-based combination therapy\r\n** Patients have received a lapatinib-based therapy for locally advanced or metastatic disease for a minimum of 9 weeks duration; patients may have received more than 1 lapatinib-based combination therapy\r\n* Histologically-confirmed gastric, esophageal, or gastroesophageal adenocarcinoma that is metastatic or locally recurrent (7th Edition of the AJCC TNM System) and measurable or non-measurable by RECIST 1.1 criteria with HER2/neu overexpression by immunohistochemistry (2+,3+) or FISH+ and progressive disease despite having received at least 1 prior HER2 targeted therapy for a minimum of 9 weeks duration) (determined by their physician) or with previously documented HER2 over-expressing disease not being currently treated on a HER2 targeted therapy\r\n* Other histologically confirmed metastatic (stage IV) or locally recurrent (stage III) (7th Edition of the AJCC TNM System) malignancy with HER2/neu overexpression by immunohistochemistry (2+,3+) or FISH+; no prior HER2 directed therapy will be required for this subgroup; however, patients will been required to have at least 1 line of therapy with a known survival benefit for their malignancy
The patient has not received an investigational chemotherapy within the last 28 days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL-2 or IFN?) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy
The patient must have received a boost immunization with trivalent inactivated poliovirus vaccine (IPOL) (Sanofi-Pasteur) at least 1 week prior to administration of the study agent
Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions:
For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib
Subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ?10 days prior to initiation of study treatment
Must have received at least one prior systemic anticancer therapy for NSCLC
Patients are eligible even if they have not received prior treatment; they are also eligible if they have received prior treatment, and any number of treatments is allowed
Participants may have received prior hydroxyurea but may not be currently being treated with hydroxyurea at the time of study initiation
Patients may have received lenalidomide and/or dexamethasone
Patients must not have received prior Gliadel wafers
Patients who have received prior treatment with implanted radiotherapy or chemotherapy sources such as wafers of polifeprosan 20 with carmustine
Received platelet transfusion within 14 days prior to Screening evaluations.
Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with Navelbine within prior 12 months
Received other recent antitumor therapy
Inclusion Criteria: Each patient MUST:\n\n          -  Have histologically confirmed cancer of the colon or rectum with radiologically\n             documented and measurable metastases (high CEA alone is insufficient for study entry).\n\n          -  Have received an oxaliplatin-based chemotherapy regimen in the metastatic setting or\n             relapsed within 6 months of completion of adjuvant therapy containing oxaliplatin.\n\n          -  Not have received prior FOLFIRI or irinotecan in the metastatic setting.\n\n          -  Have his/her tumor assessed for KRAS status and found to be mutation positive.\n\n          -  Have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy,\n             chemotherapy, or surgical procedures, i.e., all such effects must have been resolved.\n\n          -  Be at least 18 years of age.\n\n          -  Have an ECOG Performance Score of ? 2.\n\n          -  Have a life expectancy of at least 3 months.\n\n          -  Have baseline laboratory results as follows:\n\n               -  Absolute neutrophil count (ANC) ? 1.5 x 10^9 [SI unit 10^9/L]\n\n               -  Platelets ? 100 x10^9 [SI units 10^9/L] (without platelet transfusion)\n\n               -  Hemoglobin ? 9.0 g/dL [SI units gm/L] (with or without RBC transfusion)\n\n               -  Serum creatinine ? 1.5 x upper limit of normal (ULN)\n\n               -  Bilirubin ? ULN\n\n               -  AST/ALT ? 2.5 x ULN (? 5 x ULN if liver metastases)\n\n               -  Negative pregnancy test for females with childbearing potential.\n\n               -  Proteinuria < grade 2.\n\n          -  Have signed an informed consent indicating that the patient is aware of the neoplastic\n             nature of their disease and have been informed of the procedures of the protocol, the\n             experimental nature of the therapy, alternatives, potential benefits, side effects,\n             risks, and discomforts.\n\n          -  Be willing and able to comply with scheduled visits, the treatment plan, and\n             laboratory tests.\n\n          -  Be medically eligible to receive bevacizumab\n\n        Exclusion Criteria: No patient may:\n\n          -  Receive concurrent therapy with any other investigational anticancer agent while on\n             study.\n\n          -  Have previously received irinotecan or FOLFIRI in the metastatic setting (patient is\n             eligible if he/she had received irinotecan or FOLFIRI as adjuvant therapy more than 6\n             months before entry into the study)\n\n          -  Have brain metastases.\n\n          -  Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or\n             C.\n\n          -  Have received >20 Gy of radiation to the pelvis.\n\n          -  Have received chemotherapy, immunotherapy, hormonal therapy or had major surgery\n             within 28 days; or received radiotherapy within 14 days; or minor surgery within 7\n             days prior to receiving the study drug.\n\n          -  Be a pregnant or breast-feeding woman. Female patients of childbearing potential must\n             agree to use effective contraception, be surgically sterile, or be postmenopausal.\n             Male patients must agree to use effective contraception or be surgically sterile.\n             Barrier methods are a recommended form of contraception.\n\n          -  Have clinically significant cardiac disease (New York Heart Association, Class III or\n             IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial\n             infarction within 1 year prior to study entry, or Grade 2 or higher compromised left\n             ventricular ejection fraction.\n\n          -  Have dementia or altered mental status that would prohibit informed consent.\n\n          -  Have any other acute, or chronic medical or psychiatric condition or laboratory\n             abnormality that may increase the risk associated with study participation or study\n             drug administration or may interfere with the interpretation of study results and, in\n             the judgment of the Principal Investigator, would make the patient inappropriate for\n             this study.\n\n          -  Have uncontrolled hypertension, proteinuria, or recent major surgery (all clinical\n             parameters related to bevacizumab use). Any other clinical parameter considered\n             important should be discussed with the medical monitor.
Patients who have received prior therapy with ADXS11-001
For Parts A & B: Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment. For Part C: not received previous systemic treatment. For Part D: have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment or have not received prior systemic treatment.
Have received more than 1 line of systemic treatment in Parts A, B and D
Received randomized double-blind treatment in PREVAIL;
Received prior TKI treatment within 7 days prior to receiving the first dose of ponatinib, or have not recovered from adverse events (except alopecia) due to agents previously administered.
For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.
Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
Must not have received an excessive cumulative dose of anthracycline
Glioblastoma disease-specific concerns: Patients must not have received previous or concurrent radiotherapy to the brain
Glioblastoma disease-specific concerns: Patients must have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, AED's, analgesics, and other drugs to treat symptoms or prevent complications
Subject may have received prior hormonal therapy
If the subject received at least 4 cycles of systemic therapy and no measurable tumor reduction compared to the previous scan is observed, such subject can be enrolled
Follicular lymphoma patients must have received at least 3 prior lines of therapy; patients are eligible regardless of whether they have received an autologous transplant
Expansion Cohort 1: Subjects with RCC with clear cell histology who have not received prior systemic anticancer therapy
Received prior treatment with a hypomethylating agent, except as allowed in Exclusion Criterion 7.b
Patients must have received at least 2 prior regimens and have received or be deemed ineligible for autologous stem cell transplant, and must have received prior brentuximab vedotin
Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within 6 months of the last dose of previous systemic therapy
Has received prior systemic therapy for the treatment of SCLC
Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility. Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
Patients who have received treatment with IFN-? within the previous 6 months prior to enrollment.
Participants may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks; subjects may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway in the recurrent setting, including thalidomide, bevacizumab, sunitinib, or sorafenib; in the Phase I portion of the trial, subjects may not have received prior treatment with oregovomab (OvaRex) or any other antibodies that may interfere with CA-125 measurements
Patients must not have received prior Gliadel wafers
Patients with HL who have received ASCT in the previous 30-45 days
Patients who have received prior therapy with any anti-VEGF drug, including bevacizumab.
Patients must not have received systemic chemotherapy or monoclonal antibody therapy within 2 weeks of study enrollment; patients who have previously received bolus nelarabine are still eligible; hydroxyurea or corticosteroids for control of blood counts is allowed, but must be discontinued 24 hours prior to initiating nelarabine
Patients who have received a prior allogeneic HCT must have no active GVHD requiring immunosuppressive therapy for at least 21 days prior to start of conditioning
Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible; patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration; patients must have recovered from adverse events from any previous therapy
Patients who have received previous docetaxel or cisplatin
Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.
Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
Subjects who received previous systemic treatment for acute GVHD, except for a maximum of 3 days (72 hours) of 2 mg/kg corticosteroid therapy.
Patients must have received at least one but no more than 4 prior lines of systemic therapy
Received more than one treatment course of enzalutamide or abiraterone
Patients who have received radiation to more than 25% of marrow-bearing areas
Subject has received previous systemic therapy for Hepatocellular carcinoma including sorafenib, chemotherapy and investigational agents 2. Subject has received any local anticancer therapy ? 4 weeks prior to baseline tumor evaluation 3. Subject has undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks prior to signing the Informed Consent Form or who have not recovered from surgery 4. Subject has received an investigational drug or therapy for disease other than Hepatocellular carcinoma within the last 4 weeks or 5 half-lives, whichever is shorter, prior to signing the Informed Consent Form 5. Subject has completed any radiation treatment less than 2 weeks prior to signing the Informed Consent Form 6. Subject has received the last dose of ?-interferon, ribavirin, sofobuvir and/or other antiviral therapies for Hepatitis C Virus (HCV) less than 4 weeks prior to signing the Informed Consent Form 7. Subject has any clinically significant bleeding, including bleeding from esophageal/gastric varices within ? 3 months of signing the informed consent form, which required transfusion, surgical procedure or hospitalization. Esophageal varices should be treated according to local standard practice (eg, ligation or banding and procedure completed ? 3 months prior to signing the informed consent form). See Inclusion Criterion 10 8. Subjects requiring therapeutic anticoagulation with either warfarin or low molecular weight heparin. Low dose low molecular weight heparin for catheter maintenance are permitted 9. Subject has tumor invasion of stomach or duodenum 10. Subject has histologic proof of fibrolamellar carcinoma 11. Subjects with known symptomatic brain metastasis 12. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) malabsorption ? National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of either study drug 13. Subject has history of concurrent second cancers requiring active, ongoing systemic treatment. 14. Subject has a known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory) 15. Subject has peripheral neuropathy of at least NCI CTCAE Grade 2 16. Subject has a history of persistent skin rash of at least NCI CTCAE Grade 2 17. Subject has impaired cardiac function or clinically significant cardiac disease including any of the following:
Relapse patients should have NOT received chemotherapy for 4 weeks, and no patient should have received nitrosoureas (melphalan, lomustine [CCNU] or mustard); no patient should have received radiation therapy in the previous 42 days
Must have received at least one (1) line of prior systemic therapy that may NOT have included VELCADE (bortezomib)
Patients may not have received more than 2 prior cytotoxic regimens
Has received systemic anti-cancer therapy within the 14 days prior to randomization
Patients who have received prior treatment with antiCTLA-4 may be enrolled, provided the following requirements are met:
Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
Received >24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before
Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin (ATG) and have ATG levels of >= 2 ugm/ml
Received the last dose of previous treatment / therapy before Day 1 of cycle 1:
Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
Subject has received ASP2215 previously.
Patients who have previously received treatment with ibrutinib (modified by amendment 1), including:
Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately
Must have previously received at least one prior chemotherapeutic regimen for RT.
Patients who have received > 500 cGy radiation to the kidneys will be excluded from the study
No systemic antineoplastic therapy may have been received between the time of biopsy and the first administration of study treatment.
Patients must not have received any non-cytotoxic therapy for management of recurrent or persistent disease, except hormonal based therapy is allowed; patients are allowed to have previously received, but are not required to have received non-cytotoxic therapy as part of their primary treatment regimen
Received prior treatment with docetaxel.
For the phase I portion of the study, patients who had received prior therapy with nilotinib should have been able to tolerate the dose equivalent to the starting dose of nilotinib in the dose level at which the patient is being entered; patients who previously received nilotinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3 or 4 toxicity not responding to optimal management
Subjects who received radiotherapy for DCIS may enroll
Subjects who received prior anthracycline therapy
Any chemotherapy and/or radiation therapy received =< 3 months of study entry and any immunotherapy received =< 6 months of study entry (with the execption of Bacillus Calmette-Guerin [BCG] treatment)
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received systemic steroids within 4 weeks prior to starting study treatment
Patients who have received prior immunotherapies
Received any hematopoietic growth factors within 14 days prior to screening.
Must have received at lease one agent known to impact survival (abiraterone, enzalutamide, ect.)
Patients who have received previous abdominal radiation
Patients must have received prior fluoropyrimidine, oxaliplatin and irinotecan-based therapy for their disease and had progression or intolerance to these agents that resulted in treatment discontinuation
Pts who have received prior mantle or extensive mediastinal radiation
Patients may not have received more than 4 prior regimens of therapy
Previously received photodynamic therapy for cholangiocarcinoma
Patients must have received at least two lines of systemic therapy for breast cancer in the metastatic setting; patients who are hormone receptor positive must have received at least one line of hormonal therapy AND one line of chemotherapy in the metastatic setting
Patients are permitted to have received prior therapy, but must have received a minimum of 30 Gy to the chest wall with a minimal interval since completion of radiation therapy equal to or greater than 6 months; patients who have previously received more than one course of radiotherapy to the breast and/or chest wall OR have received a cumulative dose to the chest wall in excess of 70 Gy will not be considered eligible
Patients who have received prior chemotherapy are allowed, provided they have been off systemic therapy for 21 days and all acute toxicities have resolved to less than grade 2; patients who have received paclitaxel within 3 months of study entry and have developed documented progressive disease despite therapy
Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.
Patients who have received any previous carfilzomib treatment
Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
Patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient’s last prior therapy before initiation of treatment on clinical trial
Received prior HD IL-2 therapy.
Received concomitant Temozolomide
Received maintenance Temozolomide
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Received systemic steroids within 30 days of study enrollment
Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
Have received experimental therapy within 2 weeks of enrollment
Has never received cetuximab or panitumumab, and has not received any treatment for colorectal cancer within 30 days prior to the first dose of study treatment under this protocol;
Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;
NON-PROGRESSED DIPG (STRATUM 2): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must not have received any other prior therapy for treatment of their central nervous system (CNS) malignancy besides standard radiation therapy
Patients who have previously received enzalutamide; patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
Has previously received X4P-001.
Parts A and B only: Has received a prior course of axitinib.
Has received other anti-cancer therapy within the following specified intervals prior to Day 1:
Has, within 2 weeks prior to Day 1, received a medication prohibited based on CYP3A4 interaction
Patients who have received prior anti-androgen therapy
For Part 3, the patient has not received prior treatment with a TKI.
Subjects must have received adequate prior therapy including at a minimum:
Prior therapy with bortezomib is allowed; patients who have received prior bortezomib therapy must have received bortezomib > 6 months ago, and must have shown some response; patients that did not respond to prior bortezomib therapy are not eligible
Patient has received any second line therapy to treat aGVHD prior to screening.
Patient has received systemic agents other than steroids and prophylactic agents for primary treatment of acute GVHD.
Patient has received any stem cell agents (other than hematopoietic graft) during study participation or within 30 days prior to study entry.
Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll. o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
Patients must not previously have received the Prevnar 13 pneumococcal vaccination; NOTE: previous vaccination with Pneumovax (PCV23) is permitted but must have been at least 365 days prior to registration
Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
Have received previous treatment with ramucirumab or LY2875358, except for participants enrolled in cohort B1 (Gastric or GEJ adenocarcinoma) and B4 (non- small cell lung cancer) who may have received previous ramucirumab treatment.
The subject has received systemic antineoplastic therapy within 14 days of study treatment, (however, hydroxyurea or 6-mercaptopurine can be given for the purposes of cytoreduction up to one day prior to enrollment, with the exceptions noted above in the inclusion criteria)
Patients who have previously received CDX-011 (glembatumumab vedotin) or other monomethyl auristatin E (MMAE)-containing agents
Patients who have received other investigational drugs within 28 days of Viralym-C infusion
Have received at least one prior therapy. Patients who are over age 65 and have not received therapy for AML are also eligible, if they are not candidates for induction chemotherapy
Patient has received 6 cycles of DI-Leu16-IL2 on Protocol AO-101
Received AT treatment within the last 3 months prior to Screening visit.
Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed)
Patients must have already received or refused 1st-line treatment
Patient has received any of the following treatments within the specified timeframe prior to dosing:
Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
Documentation of lesion response during the course of therapy received prior to randomization (i.e., improvement or no worsening of tumor burden; the absence of new lesions)
Patients must have received >= 2 daratumumab infusions and be scheduled to receive another dose
Patients must not have received systemic therapy or radiotherapy within the preceding 3 weeks; patients must have recovered from adverse events from previous therapy by the time of registration
Patients must have received one prior approved therapy for metastatic disease and have not curable options, with the exception of HER2+ breast or gastric patients for whom this can be the first line of treatment (no prior therapy)
Must have at least one FDA approved endocrine therapy option with which the patient has not received prior treatment
Participants who received prior treatment with a hypomethylating agent
Subject has received more than 5 prior cytotoxic agent-containing regimens.
Received monoclonal antibodies (for any reason), chemotherapy, surgery, investigational therapy, or radiotherapy within 14 days of the first dose of mogamulizumab;
Subject has not received fosbretabulin treatment in the study OX4218s
Have received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entry
Patients who have received any hormonal therapy directed at the malignancy within 2 weeks prior to entering the study
Patients must have received crenolanib on RELHEM2 prior to HSCT to continue on to maintenance
Subject has received either:
Participants must have received at least one prior therapy for FL
Patients has received prior treatment with LEE011.
Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
Patient has received prior treatment with ceritinib.
Received Tivantinib as prior therapy
Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy and are refractory to their most recent line of therapy, as defined as relapse while on therapy or within 60 days from their last line of therapy. If patient has not received either an immunomodulatory drug (IMID) or proteasome inhibitor as a prior therapy then Investigator must notify Novartis prior to the patient enrollment. Patients who have received a prior bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study
Patients may have received azacitidine, decitabine, or lenalidomide but no “cytotoxic therapy” such as ara-C or anthracyclines; data suggest that failure to respond to azacitidine reduces probability of response to 3+7; hence in the interest of having a relatively homogeneous population, while patients who have received and failed azacitidine or decitabine will be eligible for this study, they will be analyzed separately from patients who have not received these drugs
Any number of prior chemotherapies or biological therapies are allowed, patients are required to have prior treatment with pertuzumab and ado-trastuzumab emtansine with the exceptions listed below: \r\n* Metastatic patients who have not received prior pertuzumab are eligible if: heavily pretreated prior to Food and Drug Administration (FDA) approval of pertuzumab (08-June-2012) for first line treatment of HER2+ MBC\r\n* Metastatic patients who have not received ado-trastuzumab emtansine are eligible if: heavily pretreated prior to FDA approval of ado-trastuzumab emtansine (22-Feb-2013) for the treatment of patients with HER2+ MBC who previously received trastuzumab and a taxane, separately or in combination
May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.
Received prior GVAX pancreas vaccine or CRS-207
Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
Has the subject received Avastin® (bevacizumab) for this recurrence/progression, or within the 4 weeks prior to planned Visit 1?
Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen
Last received ONT-10 a maximum of 6 months (unless approved by the medical monitor) prior to receiving the first dose of maintenance or retreatment cohort therapy
Bevacizumab-naïve patients: these patients may not have more than one prior relapse not counting the current relapse being treated by this protocol and must have received at least one prior chemotherapy regimen, which must have included temozolomide
Bevacizumab-refractory patients: these patients may not have more than 2 prior relapses not counting the current relapse being treated by this protocol and must have received multiple chemotherapy regimens, including a temozolomide regimen and a bevacizumab regimen
Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen)
Patients who have previously received romidepsin or Abraxane
Patients must have received at least one prior therapy for MDS; patients could have received transplant for MDS
Received prior abiraterone acetate, but not within the 3 months prior to study drug dosing
Subject has received rifampin within 4 days prior to first dose of ABT-263
Patient must not have received definitive treatment for AML, defined as any prior chemotherapy with antileukemic activity
Patients may not have received more than 1 prior line of endocrine therapy in the metastatic setting
Patients should not have received radiotherapy within 14 days prior to the first dose of orteronel
Patients must be chemo-naïve, i.e., not have received any prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; prior anthracycline therapy is allowed, but must not exceed a dose of 200 mg/m^2 daunorubicin or equivalent; prior all-trans retinoic acid (ATRA) for suspected APL is allowed; prior methotrexate for central nervous system (CNS) involvement is allowed; patients with prior history of MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat
Patients who are receiving or have received any other investigational agents within 30 days of study day 1, or who have previously received MK-2206 at any time
For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
Received one prior cycle of fulvestrant within 28 days of randomization are eligible.
Subjects must have received prior treatment with bortezomib, and either thalidomide or lenalidomide
Subjects must have received an alkylating agent unless contraindicated; subjects may have received these agents alone or in combination with other myeloma treatments
Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at any time posttransplant.
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, within three weeks of beginning the trial, and should have recovered from all toxicities of prior therapy (to grade 0 or 1)
Received at least 4 weeks of one prior sorafenib containing systemic therapy and then experienced documented radiographic disease progression; or inability to tolerate prior therapy received for at least a minimum period of time.
Received other recent antitumor therapy
Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
May have previously received monotherapy with demethylating agents for MDS or AML
May have previously received chemotherapy with MEC for MDS or AML
Patients who have received prior biologic agents less than 4 weeks prior to enrollment
Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment
Must have been receiving or have received crizotinib
Received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with DKN-01
Received bisphosphonates (e.g., etidronate, clodronate, tiludronate, pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate) within 2 weeks prior to study entry
Patient has relapsed or refractory disease and received at least one prior therapy.
Patients must have received at least one prior line of therapy and also must have received at least one proteasome inhibitor and one immunomodulatory agent (IMiD); for example; one prior line of therapy may consist of all predetermined components of induction followed by autologous stem cell transplantation and maintenance
Patients who have received prior treatment with cyclophosphamide and topotecan are eligible if they did not have tumor relapse/progression while receiving this combination.
The patient received any induction chemotherapy regimen and may have received post-remission consolidation therapy prior to screening.
The patient previously received treatment with SL-401.
Most recent enzalutamide dose received is 160 mg once daily with no change in dose for at least 2 weeks prior to Screening.
Patients may have received, but are not required to have received, one or two additional cytotoxic regimens for management of recurrent or persistent disease
Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity\r\n* Patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* There will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, peginterferon alfa-2b (Peg-Intron), sorafenib, imatinib, or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the PN; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 before entering this study\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healing
Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent <14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ?5 half-lives of the investigational agent has elapsed.
Have received any prior treatment with bevacizumab (Avastin).
Has received a transfusion (platelets or red blood cells) within 3 weeks before the first dose of niraparib
Has received a transfusion (platelets or red blood cells) within 3 weeks of the first dose of niraparib
Received prior bevacizumab therapy or had clinically documented reason why not administered
Received prior paclitaxel therapy or had clinically documented reason why not administered
Up to 12 patients with metastatic colorectal cancer with a history of progression or recurrence following prior fluoropyrimidine, irinotecan and platinum containing regimens as well as bevacizumab. In addition, patients with Kras wild type tumor must have received at least one EGFR blocker.
Arm A: Patients with AML who are 65 years of age or older with refractory or relapsed disease, or who have not received prior therapy but are not eligible to receive intensive frontline chemotherapy (i.e., Acute Group patients);
Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib
Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine
Prior therapy against VEGF or VEGFRs including, but not limited to bevacizumab, sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is permitted so long as the agent does not have any known activity against DLL4 and the last dose received s at least 6 weeks prior to first dose of MEDI0639.
Patients must have not received any prior therapy other than surgery and/or steroids
Patients may have received secondary hormonal manipulations (excluding prior abiraterone acetate, MDV3100 or TAK700) or up to two lines of chemotherapy; all prior therapy except Lupron must have been discontinued for more than 4 weeks before enrollment
Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to the first study dose
Patient may have received initial treatment for GBM as follows:
Patient has received previous treatment with PI3K and/or mTOR inhibitors for GBM or for pre-existing neoplasm transformed to GBM. Patient has received any prior anti-neoplastic therapy for BKM, except for the treatment allowed in inclusion criteria
Patients must not have received systemic therapy for RCC within four weeks prior to registration
Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
Patient received at least 2 prior regimens for MM.
All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
Patients must have received adequate prior alkylator therapy
Received previous treatment with any c-MET experimental therapeutic.
Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy
Part E - Diagnosed with cholangiocarcinoma, either intrahepatic or extrahepatic, that is unresectable, recurrent, or metastatic. Participants must not have received prior systemic front line therapy for metastatic or resectable disease (i.e. participants may have received adjuvant gemcitabine but have not yet received gemcitabine/cisplatin for recurrent metastatic disease). Participants must be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Participants should be evaluated for the need to undergo biliary drainage by stent placement prior to study participation. Participants should have adequate biliary drainage with no unresolved biliary obstruction.
Previously received mapatumumab or sorafenib.
Has received prior anthracycline therapy
Has received prior taxane therapy
Has received bevacizumab within 4 weeks prior to randomization
Participants who have received prior Pemetrexed treatment.
Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
Patients who have previously received treatment with LY2940680
received Avastin
Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
Patients who have previously received radiation therapy to areas of the lung or mediastinum near target(s)
The subject must have received intravenous fluid resuscitation
Patients may not have received more than 2 prior cytotoxic regimens
Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting
Patients must have received at least one prior line of therapy and their disease has relapsed..
Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy
Patients who have received prior Yttrium-90 radioembolization
Subject who received any other systemic anticancer treatment after parent study entry (radiation to local areas such as bone or brain if received in the parent ASP8273 study is permitted).
Patients may have received previous NY-ESO-1 vaccine therapy
Patients may have received prior chemotherapy for advanced disease including either capecitabine or temozolomide single agent as long as it did not include combination of capecitabine and temozolomide
Patients who have received any treatment of ponatinib prior to study entry
Patients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollment
Patients who have tested positive for a v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation may have received prior BRAF inhibitor therapy as a prior line of systemic therapy; patients may have received up to 2 prior lines of therapy with a checkpoint inhibitor (CPI), which may have included pembrolizumab, nivolumab, or ipilimumab; these agents may have been administered as single-agent treatment, in combination with each other, or in combination with other agents; patients who have received prior treatment with ipilimumab must have relapsed after achieving a response to prior ipilimumab treatment; this response may have been achieved with ipilimumab administered as single-agent therapy or in combination with another treatment; patients who have received prior treatment with pembrolizumab or nivolumab must have progression of disease after at least 4 doses of either drug alone or in combination with other agents
Patients who have previously received anti CD40 (agonistic) therapy prior adjuvant interferon (IFN), is allowed if last dose was received at least 6 months from enrolling to protocol
Subjects who have received prior oncolytic therapy or prior therapy with and toll-like receptor (TLR) agonist including topical agents; subjects that have received experimental vaccines or other immune therapies should be discussed with the medical monitor or the primary investigator (PI) to confirm eligibility
Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and
Patients with persistent or recurrent disease must have received definitive chemoradiation therapy as first line therapy; patients with advanced (stage IVB) disease may have received palliative radiation therapy
Prior therapy:\r\n* Patients must have received at least one prior standard cytotoxic regimen such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) or doxorubicin hydrochloride, etoposide phosphate, vincristine sulfate, cyclophosphamide, and prednisone (EPOCH) - unless they were not candidates for this therapy\r\n* Patients must have received prior brentuximab vedotin - unless they were not candidates for this therapy\r\n* Patients must have received prior autologous stem cell transplant unless they refused or were not candidates for stem cell transplant
Prior treatment:\r\n* Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks prior to the start of study drug; however, if they have received nitrosourea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received\r\n* No limitations to number of prior therapies\r\n* Prior therapy with other ALK inhibitor investigational agents with the exception of crizotinib (i.e., prior treatment with crizotinib is allowed)
Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months; these patients can have received any amount of prior chemotherapy to enter this trial
CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
Other investigational therapy received within 8 weeks prior to screening visit
Received an investigational therapy within the 4 weeks prior to registration, or is scheduled to receive one during the treatment period
Received a new anti-cancer agent within 4 weeks prior to registration
Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician
Subject has previously been enrolled in this study and received at least 1 per protocol PLT transfusion
Have received more than 3 prior CTX regimens
Subject has received prior therapy with a BH3 mimetic.
Patients must not have received prior treatment with talimogene laherparepvec (T-VEC) or other oncolytic virus agents
Patients who have received previous treatment with ionizing radiation
Having received Ayurvedic treatment within 6 months of study enrollment.
Primary malignancy for which the patient received transplant has been stable for 3 months prior to enrollment on study
Survivors must not have previously received an SCP or are unwilling to receive one
Has received voriconazole within 5 days prior to starting study therapy
All gastrointestinal malignancies where the patient received oxaliplatin for cancer treatment or breast malignancies where patients have received docetaxel or paclitaxel for cancer treatment
No prior chemotherapy or radiation therapy for osteosarcoma; subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTX
Patients who may have previously received SP-SAP on the study
Has received the full dose of CTX over the course of their treatment
Previous psychological counseling received in supportive care department.
Received >= 2000 centigray (cGy) radiation to the heart/chest
Have received prior investigational anti-androgen therapy, including ARN-509
Have received at least one prior therapy for WM
Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than one line of systemic therapy in the recurrent/metastatic setting.
Untreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents or hypomethylating agents for this diagnosis. Patients with other prior cancer diagnoses are allowed as long as they have no measurable disease, are not undergoing active therapy, and have a life expectancy of ? 4 months.
Untreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents for this diagnosis.
Patient has received prior radiotherapy to the involved breast
Patients who have received chemotherapy within 3 weeks of first fenretinide treatment, or who have received investigational drugs within 6 weeks of first fenretinide treatment. Patients must have otherwise recovered from toxicities of prior therapy.
Subjects who have received radiotherapy to the pelvis and/or sternum within one year of first Investigational Product administration
Subjects who have previously received or have planned Total Body Irradiation (TBI)
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Patient may have received more than one HCT
Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
Patients who have received any systemic agents in addition to steroids for treatment of GVHD
Participants who have received endocrine therapy within 1 year prior to screening breast MRI
Patients who have received prior cytotoxic chemotherapy are ineligible; patients may have received prior adjuvant hormonal therapy for localized breast cancer, provided that it was completed prior to registration, and that the patient remains free of recurrent or metastatic disease
Women who self-report having received a hysterectomy
Received colposcopy of cervix within TWO years
Received Pap test within ONE year
Myeloid or lymphoid hematologic malignancy treated with a reduced intensity (RI) or non-myeloablative (NMA) conditioning HSCT who received calcineurin inhibitor based drug (for example: tacrolimus or cyclosporin) and methotrexate as part of their initial GVHD prophylaxis; patients who received sirolimus as part of their GVHD prophylaxis will be eligible
Received post-transplant cyclophosphamide
Received rolapitant within 21 days prior to study enrollment
Received a negative mammography screening result in the previous four weeks
Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
Prior malignancy in which they received any thoracic radiotherapy unless the treating physician considers it unlikely to impact the clinical outcome of the patient
At screening has received any listed prohibited prior and concomitant treatments and procedures
Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins.
Has not received any doses of HPV vaccine
Has received any formulation of POS within prior 10 days
having received at least 6 consecutive 4-week treatment cycles with azacitidine for injection, or
Subjects must have received at least one line of hormonal therapy in the metastatic setting.
Patients who have received prior romidepsin use are eligible
Patients who have previously received SCH727965
Patient has not received any previous brain RT.
Not having received any doses of the HPV vaccine
Received a previous allogeneic HSCT (previous autologous HSCT is acceptable)
Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day 1
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients who have not previously received a bevacizumab-containing regimen (i.e., this must be the first bevacizumab-containing therapy administered to the patient)
Subject who have received ferumoxytol within 3 weeks of study entry
Participants who have already received anti-vascular endothelial growth factor (VEGF) or experimental anti-angiogenic therapy for glioblastoma
Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial chemoembolization [TACE])
Subject has previously received VM110, or any other investigational product in the past thirty days
Subject who have received ferumoxytol within 3 weeks of study entry
Subject who have received ferumoxytol within 4 weeks of study entry
Participants who have already received anti-VEGF or investigational anti-angiogenic therapy for glioblastoma
Undergoing current therapy for organ confined or systemic disease; this does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting
Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
Have received orthodontic work involving ferromagnetic materials
Patients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatment
Patients who have not received an allogeneic HCT
Subjects with myelodysplastic syndrome who have not been treated previously with 5-azacytidine or decitabine are eligible, regardless of International Prognostic Scoring System risk score; subjects may have received transfusion support, growth factor support, or lenalidomide as previous therapy; however, they shall not have received growth factor support or lenalidomide within 4 weeks of study enrollment
Patients who have received no prior therapy are eligible, as well as those who have received prior treatment
Patient has previously received [18F]NaF in the last thirty days
Patients who may not have received trastuzumab within the prior 6 months for any other reason
Participants who have received trastuzumab within the prior 36 days
Patient must not have received any growth factors =< 7 days of entry onto this study
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
Inclusion Criteria:\n\n        Subjects will be eligible for the study if they:\n\n          1. Are of or older than the legal age in the respective countries at the time when\n             written informed consent is obtained\n\n          2. Have histologically or cytologically confirmed advanced (unresectable) or metastatic\n             biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma (CCA),\n             gallbladder cancer and carcinoma of Ampulla of Vater. This includes clinical diagnosis\n             of biliary tract cancer with histological confirmation of adenocarcinoma.\n\n          3. Have received and failed one and only one prior line of systemic treatment for\n             advanced or metastatic disease with radiologic evidence of disease progression. This\n             prior line of systemic treatment must also contain gemcitabine\n\n          4. Have received at least 6 doses of gemcitabine containing treatment in first line\n             (Adjuvant therapy is not regarded as 1st line therapy)\n\n          5. Have radiographically measurable disease based on Response Evaluation Criteria in\n             Solid Tumours (RECIST) v1.1 as assessed by Independent Central Review (ICR) (For Part\n             1)\n\n          6. Have no evidence of biliary duct obstruction, unless obstruction is controlled by\n             local treatment or, in whom the biliary tree can be decompressed by endoscopic or\n             percutaneous stenting with subsequent reduction in bilirubin to below or equal to 1.5\n             × upper level of normal (ULN)\n\n          7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          8. Are able to understand and willing to sign the informed consent form\n\n          9. Have adequate organ and hematological function:\n\n               1. Hematological function, as follows:\n\n                    -  Absolute neutrophil count (ANC) ? 1.5 × 109/L\n\n                    -  Platelet count ? 100 × 109/L\n\n               2. Renal functions, as follows:\n\n                  • Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73m2\n\n               3. Hepatic function, as follows:\n\n                    -  Albumin ? 3 g/dL\n\n                    -  Total bilirubin ? 1.5 × ULN\n\n                    -  Aspartate aminotransferase and alanine aminotransferase ? 5 × ULN\n\n        Exclusion Criteria:\n\n        Subjects will be ineligible for the study if they:\n\n          1. Are currently on or have received anti-cancer therapy within the past 3 weeks before\n             receiving the first dose of study medication\n\n          2. Are currently on or have received radiation or local treatment within the past 3 weeks\n             for the target lesion(s) before receiving the first dose of study medication\n\n          3. Have evidence of multiple (? 2) peritoneal metastases or ascites at baseline as\n             assessed by ICR (For Part 1). (Ascites which can be attributed by non-malignant causes\n             is not excluded.)\n\n          4. Have had major surgical procedures within 14 days prior to first dose of study\n             medication\n\n          5. Have a known metastatic brain lesion(s), including asymptomatic and well controlled\n             lesion(s)\n\n          6. Have malabsorption syndrome, diseases significantly affecting gastrointestinal\n             function, resection of the stomach or small bowel, or difficulty in swallowing and\n             retaining oral medications which in the opinion of the Investigator could jeopardize\n             the validity of the study results\n\n          7. Have uncontrolled intercurrent illness including, but not limited to, ongoing or\n             active infection, unstable angina pectoris, cardiac arrhythmia, diabetes,\n             hypertension, or psychiatric illness/social situations that would limit compliance\n             with study requirements\n\n          8. Have any history of other malignancy unless in remission for more than 1 year\n             (non-melanoma skin carcinoma and carcinoma-in-site of uterine cervix treated with\n             curative intent is not exclusionary)\n\n          9. Are female patients who are pregnant or breast feeding\n\n         10. Have been previously treated with varlitinib or have been previously treated with\n             capecitabine as first line therapy for advanced or metastatic disease. For patients\n             who have previously received capecitabine as a radiosensitizer or as part of their\n             adjuvant therapy and their disease has relapsed for more than 6 months after their\n             last dose of capecitabine adjuvant therapy, their capecitabine therapy will not be\n             considered as a line of systemic chemotherapy for metastatic/advanced disease, and\n             thus they can participate in the study\n\n         11. Have received any investigational drug (or have used an investigational device) within\n             the last 14 days before receiving the first dose of study medication\n\n         12. Have unresolved or unstable serious toxicity (? common terminology criteria for\n             adverse events [CTCAE] 4.03 Grade 2), with the exception of anemia, asthenia, and\n             alopecia, from prior administration of another investigational drug and/or prior\n             cancer treatment\n\n         13. Have a known positive test for human immunodeficiency virus, hepatitis C (treatment\n             naïve or after treatment without sustained virologic response), or hepatitis B\n             infection with hepatitis B virus deoxyribonucleic acid exceeding 2000 IU/mL\n\n         14. Have a known history of drug addiction within last 1 year which, in the opinion of the\n             Investigator, could increase the risk of non-compliance to investigational product\n\n         15. Need continuous treatment with proton pump inhibitors during the study period\n\n         16. Have a history of (non-infectious) pneumonitis that required steroids or current\n             pneumonitis, or have a history of interstitial lung disease or current interstitial\n             lung disease\n\n         17. Have any history or presence of clinically significant cardiovascular, respiratory,\n             hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,\n             neurologic or psychiatric disease or any other condition which in the opinion of the\n             Investigator could jeopardize the safety of the patient or the validity of the study\n             results\n\n         18. Have a baseline corrected QT interval (Fridericia's formula) (QTcF) > 450 ms or\n             patients with known long QT syndrome; torsade de pointes; symptomatic ventricular\n             tachycardia; an unstable cardiac syndrome in the past 3 months before screening visit;\n             > class 2 New York Heart Association heart failure; or > class 2 angina pectoris; or\n             receiving quinidine, procainamide, disopyramide, amiodarone, dronedarone, arsenic,\n             dofetilide, sotalol, or methadone. Please also see prohibited medication/therapy\n             (Section 5.4.10.1)
Participants who received biopsy only or have received more than 2 prior courses of radiation for meningioma
Patient who has received vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines
Has received previous treatment with another agent targeting the T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (TIGIT) receptor
INCLUSION:\n\n        All Patients\n\n          1. Male or female aged ?18 years.\n\n          2. ECOG PS score of 0-1.\n\n          3. Adequate organ function.\n\n          4. Ability to understand and willingness to sign informed consent form prior to\n             initiation of study procedures.\n\n          5. Measurable disease per RECIST, OR for patients with a primary diagnosis of castration\n             resistant prostate cancer, progressive disease (PD) by prostate surface antigen (PSA)\n             or imaging in the setting of medical or surgical castration.\n\n          6. Documented BRCA mutation, with the following exceptions: a) Patient is intended to be\n             enrolled in a Single-patient Cohort; b) Patient has an advanced DNA repair\n             mutation-positive solid tumor and is intended to be enrolled in Expansion Cohort 5.\n\n             Patients in the Dose-escalation Phase:\n\n          7. Locally advanced solid tumor other than a primary central nervous system (CNS) tumor\n             for which the patient has received ?3 prior lines\n\n          8. Confirmed solid tumor in one of the following categories:\n\n               -  BRCA mutation-positive pancreatic cancer for which the patient received up to 1\n                  prior line of cytotoxic chemotherapy in the advanced disease setting.\n\n               -  Advanced BRCA mutation-positive castration-resistant prostate cancer (CRPC) for\n                  which the patient received up to 2 prior lines of cytotoxic chemotherapy in the\n                  advanced disease setting.\n\n               -  Advanced BRCA mutation-positive ovarian cancer for which the patient received up\n                  to 3 prior lines of cytotoxic chemotherapy in the advanced disease setting.\n\n               -  Advanced BRCA mutation-positive triple-negative breast cancer (TNBC) for which\n                  the patient received up to 3 prior lines of cytotoxic chemotherapy in the\n                  advanced disease setting.\n\n               -  Advanced DNA repair mutation-positive solid tumors, including, but not limited to\n                  BRCA and non-BRCA DNA mutations, who have received up to 3 prior lines of\n                  cytotoxic chemotherapy in the advanced disease setting. DNA-repair mutations may\n                  include, but are not limited to ATM, CHEK2, PALB2, and RAD51D. Abnormal\n                  homologous repair deficiency (HRD) tests will also be allowed.\n\n        Note that in both dose escalation and dose expansion portions of the study, prior targeted\n        therapy including prior poly ADP ribose polymerase (PARP) inhibitor therapy, prior\n        immunotherapy, or prior hormonal therapy is permissible. Patients with castration resistant\n        prostate cancer may have received unlimited prior hormonal therapies.\n\n        EXCLUSION:\n\n          1. History of leptomeningeal disease or spinal cord compression.\n\n          2. Underwent major surgery within 4 weeks before first treatment.\n\n          3. Received cancer-directed therapy 14 days (6 weeks for mitomycin C and nitrosoureas)\n             before start of treatment.\n\n          4. Grade 2 or greater peripheral neuropathy at start of treatment.\n\n          5. If female, pregnant or breast-feeding.\n\n          6. Known human immunodeficiency virus (HIV) infection or hepatitis B or C infection\n\n          7. Any primary brain tumor (e.g., astrocytoma, glioblastoma).\n\n          8. Hypersensitivity or history of anaphylactic reaction to any platinum-containing\n             agents.
Well differentiated, low, intermediate, or high-grade, gastrointestinal mid-gut (arising from the lower jejunum, ileum, appendix, cecum, and proximal colon) NET with documented disease progression within 6 months prior to start of study treatment and evidence of radiographic disease progression based on scans performed not more than 15 months apart. Patients may have received 1 or more prior lines of anticancer therapy, such as somatostatin analogues, targeted agents, or liver-directed intra-arterial therapy, but are NOT eligible if they have received prior systemic cytotoxic chemotherapy or peptide receptor radionuclide therapy (PRRT).
Well differentiated, low, intermediate, or high-grade, pancreatic NET with documented disease progression within 6 months prior to start of study treatment and evidence of radiographic disease progression based on scans performed not more than 15 months apart. Patients may have received 1 or more prior lines of anticancer therapy, such as somatostatin analogues, targeted agents, or liverdirected intra-arterial therapy, and up to 1 prior line of systemic cytotoxic chemotherapy, but are NOT eligible if they have received more than 1 prior line of systemic cytotoxic chemotherapy or if they have received prior peptide receptor radionuclide therapy (PRRT)
Have received orthodontic work involving ferromagnetic materials
Women should have received no prior therapy for their disease
Patients who received radiation to the chest within the past 6 months
Previously received cryotherapy of RCC
Participants with HCC must have received prior sorafenib therapy. ICC participants must have received prior platinum (cisplatin or oxaliplatin) based therapy unless contraindicated.
Have either received prior anthracycline treatment or have a reason not to receive anthracycline in the judgment of their treating physician
Must have received at least 1 prior approved immunotherapy or chemotherapy; however, not within 28 days of the initial dose of study drug. May have received prior radiotherapy for their malignancy.
Subjects must not have received BLZ-100 within 30 days prior to re-treatment
Have received anti-CD38 antibody therapy and do not fulfill a 120-day washout period before receiving TAK-079.
Subjects must have received adequate prior therapy including at a minimum: