Phase I/II: Patients must have received ? 2 units of RBCs for hemoglobin ? 9.0 g/dL within 8 weeks prior to start of treatment.
Phase II only: Patients with a deletion 5q cytogenetic abnormality.
ELIGIBILITY CRITERIA - PHASE II (ARM D): ECOG performance status 0-2
RANDOMIZED PHASE II CLINICAL TRIAL: Disease stage IV, metastatic unresectable disease
RANDOMIZED PHASE II CLINICAL TRIAL: Patients received up to 2 prior regimens for their metastatic disease
RANDOMIZED PHASE II CLINICAL TRIAL: Patients are candidates for chemotherapy with carboplatin and gemcitabine
RANDOMIZED PHASE II CLINICAL TRIAL: ECOG performance status 0-2
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: Platelets >= 100,000 / mcL
RANDOMIZED PHASE II CLINICAL TRIAL: Patients with tumors that cannot be measured or clinically followed (i.e. evaluable disease)
RANDOMIZED PHASE II CLINICAL TRIAL: Patients with baseline grade 2 neuropathy
RANDOMIZED PHASE II CLINICAL TRIAL: Life expectancy of less than 3 months
RANDOMIZED PHASE II CLINICAL TRIAL: Patients known to be carriers of hepatitis virus B and C
RANDOMIZED PHASE II CLINICAL TRIAL: Active infection requiring systemic therapy
PHASE II: Patients must have received at least one prior chemotherapy or radiation regimen prior to radiographic progression
PHASE II: Tumor must be measurable in at least two dimensions on imaging
PHASE II EXCLUSION CRITERIA: Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study
PHASE II EXCLUSION CRITERIA: Untreated and uncontrolled second tumor in the past 2 years
PHASE II EXCLUSION CRITERIA: Logistical or psychological hindrance to participation in clinical research
Phase II only: Measurable disease according to RECIST v1.1 (Section 8) obtained by imaging within 28 days prior to study registration. Phase Ib: subjects may enroll with or without measurable disease.
Phase I Extension and Phase II: Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
Phase I extension and Phase II only: Prior treatment with a hypomethylating agent, such as prior treatment for MDS.
PHASE II: Patients must have received at least one prior chemotherapy or radiation regimen prior to progression
PHASE II: At least 3 months must have elapsed since the last dose of irradiation to the target tumor(s) at the time of enrollment
PHASE II
PHASE I AND II
FOR PHASE II PORTION OF THE STUDY:
FOR PHASE II ONLY:
PHASE II: ECOG performance status =< 2
Metastatic renal cell carcinoma\r\n* During Phase I - All prior treatments or none are allowed\r\n* During Phase II/Cohort A - No prior treatments are allowed\r\n* During Phase II/Cohort B - Must have at least one prior treatment with a PD1 inhibitor
Phase II only: blood EGF level >= pg/mL at baseline (to be determined based on Phase I results)
No more than two prior disease relapses to be eligible for the phase I portion of the study and no more than one prior relapse to be eligible for phase II
Evaluable disease in the phase I, and measurable disease for the phase II study
Central nervous system metastases, including lymphomatous meningitis will be allowed in the phase II study, but will not be allowed in the phase I
PHASE II: Patients must have an ECOG performance status of 0-1
PHASE II: Hemoglobin >= 9.0 g/dl
Prior chemotherapies more than 2 lines (Phase II part only) .
PHASE II SCLC: ECOG performance status =< 2
Randomized phase II: tumor proportional score of PD-L1 >= 1%.
PHASE II: Platelets > 100,000/mcl
PHASE II: Hemoglobin > 10 g/dL
PHASE II: Creatinine < 1.5 x the institutional ULN
PHASE II: Bilirubin < 1.5 x ULN
PHASE II: ALP < 2.5 x ULN
PHASE II: Patients must meet pre-entry requirements as specified
PHASE II: Patients who have previously received anti-CTLA-4 antibody therapy
Phase II only: patients volunteering for the Phase II part of the protocol must be willing to undergo a research endoscopy for tissue collection on day 8 (+/- 2 days) from the beginning of therapy
PHASE II: Patients may only have measurable disease
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
BOTH PHASE I AND PHASE II:
PHASE II:
Phase II: 0, 1 or 2
RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2
RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
For Phase II only: Patients must have evidence of FLT3 ITD in their most recent assessment.
For Phase I and II: ECOG Performance Status </= 2
Disease status: phase I: patients with refractory solid tumors must have evaluable disease, patients with NF1 PN must have measurable disease, patients with refractory leukemia must have M2 or M3 bone marrow; phase II: patients must have measurable disease; phase II temporarily suspended as requested by the FDA due to IND Safety Report of 07 October 2016
Individuals with malignant peripheral nerve sheath tumors will not be eligible to participate in the phase II portion of the trial
An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:\r\n* Measurable disease is defined as the presence of at least one solid lesion on MRI or CT scan that can be accurately measured with the longest diameter of at least 10 mm in at least one dimension\r\n* Patients with NB who do not have measurable soft tissue disease but have MIBG-positive evaluable skeletal disease are eligible for phase II study\r\n* Patients with NB who have evidence of tumor cells in bone marrow are eligible for phase II study
PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer
For phase II part of the trial: =< 3 prior lines of treatment in the metastatic setting for the current breast cancer; however, there is no limit on number of prior line of therapy in phase I part of the trial
RANDOMIZED PHASE II STUDY -- ARMS C AND D
PHASE II: Patients must NOT have locally advanced disease
PHASE II: Patients must NOT have received prior Wee1 inhibitors or AZD1775
PHASE II: Patients must have ECOG performance status of 0 or 1
PHASE II: Patients with biliary stents are allowed
PHASE II: Hemoglobin >= 9 g/dL
PHASE II: Platelets >= 100,000/mcL
PHASE II: The patient has consented in writing to participate in one of the imaging research studies
PHASE II:
PHASE I AND II:
PHASE II: ECOG performance status 0 or 1
PHASE II: Platelets >= 100,000/mm^3
PHASE II: Hemoglobin >= 9 g/dL
Subjects enrolled in phase II part of the protocol should not have metastatic disease; however, patients with oligometastatic disease that can be treated with localized treatment with definitive intent are eligible
Phase II only: at least one line of prior therapy for incurable disease
At least a single measurable lesion. Phase II patients only
Phase I (Cohorts A through S) and Phase II: Evaluable or measurable disease per RECIST version 1.1
For expansion phase (Phase II) distant metastatic disease only.
For expansion phase (Phase II) no prior therapy for pancreatic cancer is allowed except for adjuvant therapy as long as it was completed ? 6 months prior to study treatment start
Patients with RAEB-t/non-proliferative AML (as defined by 20-30% BMBL, WBC ? 25,000 x 10^9/L and stable for at least 4 weeks without intervention) are not eligible to participate in the Phase II Part 1 RPTD component of the study and patients with CMML will not be eligible for Phase II Part 2 of the study.
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies for the treatment of prostate cancer
Only for patients entering phase Ib dose escalation and phase II cohorts:
For Phase II part:
PHASE II: GCSF is allowed during screening and therapy for all phase II patients
PHASE II: ECOG performance status =< 1
PHASE II: Platelets >= 100,000/mcL
PHASE II: Patients with evidence of metastatic disease involvement in viscera or bone
PHASE II: Clinically significant malabsorption syndrome
PHASE II: Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as antineoplastic therapy
Evaluable disease in the Phase I, and measurable disease for the Phase II
Participants who previously received eribulin mesylate are not eligible for enrollment on the phase II portion
PHASE II PORTION ELIGIBILITY CRITERIA
PHASE II:
PHASE I and II:
PHASE II
PHASE I and II
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
For Phase Ib: patients with HER2 overexpressing disease must have been previously treated with trastuzumab (patients with HER2 overexpressing disease are not eligible for the Phase II trial)
In phase II study (PMLBL) patients with CNS involvement are not eligible
Non-secretory or oligo-secretory Multiple Myeloma (Phase II only; such disease is permissible in Phase I).
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
Concurrent tumor-specific hormonal therapy or antiestrogens. (Individuals manufactured under CL-PTL 105 (Phase II Ovarian) are not subject to this exclusion).
For participation in the Phase II portion, patients must have completed at least one line of prior therapy
A core tumor biopsy obtained after progression on the last treatment must be available at study entry for the phase II portion of the study; any available archival tissue (for both phase I and II) will also be collected
Patients with ECOG performance status of 2, secondary to the underlying disease, may be enrolled in the Phase II portion of the study
For Phase II, patients may have received a maximum of 1 prior line of therapy for recurrent or metastatic disease
Patients with swallowing dysfunction who are unable to swallow BYL719 whole tablets and are not using feeding tubes for study drug administration can participate in the Phase Ib Arm B. For the Phase II, these patients with swallowing dysfunction may participate if able to drink the suspension and results of Arm B confirm the use of this method. Patients with swallowing dysfunction requiring G tube (G/PEG tube) for study drug administration may participate in Phase II if Arm C confirms dispersible tablet via G tube administration is permitted if the administration of drinkable suspension of BYL719 is allowed to be used in Phase II.
For patients in the Phase II portion of the study, must have measurable disease defined by at least 1 of the following 3 measurements:
PHASE II SPECIFIC:
Measurable disease (only for the phase II portion)
No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only).
Prior hypersensitivity to triptan derivatives (Phase I and II)
PHASE II: All patients will be required to have measurable disease
During Phase II enrollment: prior therapy with cisplatin with the exception of when given concurrently with radiation therapy (cisplatin will be allowed as prior therapy during Phase I enrollment)
No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
Male or female for phase I and female for phase II and any race
Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
PHASE II: Completed primary surgery, chemotherapy, and radiation
PHASE II: Within 12 months of beginning AET
PHASE II: At least 18 months of AET recommended
PHASE II: Any diagnosis of cancer prior to age 21
PHASE II: Off treatment for at least 6 months
PHASE II: Significant developmental delay per patient, parent, or physician report
COHORT A OVERVIEW: patients age less than 60 with untreated stage III or IV classical Hodgkin lymphoma will be eligible for cohort A; in phase I, patients may enroll onto cohort A if they have a baseline IPS ? 3 OR if their PET scan after 2 cycles of ABVD is positive (Deauville 4 or 5); enrollment onto phase I has now ceased and enrollment will begin for phase II; in phase II, patients less than 60 years of age with stage III or IV HL are eligible; patients may enroll anytime within the first 2 cycles of ABVD or after PET-2
Phase II: Not completing participation in phase I of the study
Phase II: Myeloma diagnosis
Phase II: From 3–24 months post-surgical treatment
Cancer survivors will be partnered, cohabiting women with a diagnosis of non-metastatic breast cancer (stages I-III), and a body mass index (BMI) >= 30 who are healthy enough to participate in a home-based walking program (per medical provider clearance; Phase I, part B and Phase II only)
Survivors will have completed adjuvant chemotherapy and/or radiation treatment, with those participating in phase I within 5 years of completing treatment and those participating in phase II within three years (36 months) of completing treatment
Partners will be cohabiting with the cancer survivor and have a BMI >= 25, be healthy enough to participate in a home-based walking program (per medical provider clearance; Phase I, part B and Phase II only)
EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II)
PHASE II: Did not participate in phase 1
Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
Phase II: Self-identify as Hispanic/Latino
Phase II: Prefer to receive health information in Spanish
Phase II: Only patients who are not up-to-date with screening and are attending regularly scheduled clinic visits will participate
PHASE II: Use of IT at least 25 times in the past year
Completed the 1-year phase II low-fat fish oil study
Phase II:
PHASE II:
PHASE II: Women who do not have capacity to participate
PHASE II: women who state that there are still deciding on breast cancer treatment
PHASE II: Pregnant women will be eligible to participate
For phase II only: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).
Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1
PHASE I: Patients must have biopsiable disease and be amenable to having two research biopsies
Platelets >= 100 x 10^9/L (for treatment phase)
Clinically significant cardiovascular disease, including:\r\n* Corrected QT (QTc) interval by Bazett’s formula > 480 ms (for treatment phase)\r\n* Symptomatic bradycardia < 45 beats per minute (for treatment phase)\r\n* Other clinically significant electrocardiogram (ECG) abnormalities (e.g. bundle branch block) may be eligible after discussion with the principal investigator (for treatment phase)\r\n* Clinically uncontrolled hypertension in the investigator’s opinion (for treatment phase)\r\n* The following within 6 months prior to cycle 1 day 1:\r\n** Congestive heart failure (New York Heart class III or IV) (for treatment phase)\r\n** Cardiomyopathy (for treatment phase)\r\n** Arrhythmia or conduction abnormality requiring medication; note: patients with atrial fibrillation/flutter adequately controlled by medication in the opinion of the treating physician and arrhythmias controlled by pacemakers are eligible (for treatment phase)\r\n** Severe / unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction (for treatment phase)\r\n** Cerebrovascular accident or transient ischemia (for treatment phase)
Any serious, active infection at the time of treatment such as bacteremia (for treatment phase)
For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled.
Phase 1: Subjects who have received prior alectinib therapy
Phase 2:
Allowable prior therapy\r\n* Phase 1: Progressed on standard of care therapy, if one is available\r\n* Phase 2: MPNST with 0-3 prior cytotoxic systemic therapies (no prior radiotherapy is necessary)
For phase 2 specifically, agree to pre- and on-treatment tumor biopsies
For the phase I cohort, subjects with one prior systemic treatment are eligible
PHASE I SUBJECTS ONLY: Patients must not have received prior navitoclax, 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; in the phase II portion of the study
PHASE I
Phase 1b:
Participant with bone-only disease (Phase 1 only). Note: Phase 2 participants may have predominantly lytic bone-only disease.
PHASE I ONLY:
The participant has adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).
PHASE I
No more than 1 prior chemotherapy regimen in the metastatic setting for the phase 2 portion; patients in the phase 1 portion could have received any number of prior lines of therapy
Prior fulvestrant for metastatic breast cancer will be allowed for phase 1 portion but not for the phase 2 portion
The inability to participate/complete phase 1 care due to:
Phase 1b:
FOR PHASE Ib PORTION OF THE STUDY:
Hemoglobin >= 8 g/dL (phase Ib) or >= 10 g/dL (for phase II portion)\r\n* For phase Ib portion only: patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day of the erythrocyte transfusion
FOR PHASE Ib ONLY:
Any other previous antitumor therapies for the current cancer event; this exclusion does not apply to phase Ib part of cohort 1
For the treatment phase: Patients with any histological subtype are eligible
Phase I: active dermatologic disease >= grade 3
Phase Ib (dose expansion
PHASE I:
No leukemic phase >5,000/µL circulating tumor cells.
PHASE I: Patients do not need to have measurable disease to enroll on phase I
For the phase 1b study, patients may have had the diagnosis of BOS for any period of time; for the phase 2 study, patients must be within 2 years from the time of diagnosis; patients may be at any time interval after SCT as long as the criteria for chronic GVHD and BOS are met
PHASE I: Any number of prior relapses
PHASE I: Has known gliomatous meningitis, subependymal spread, or extracranial disease
Life expectancy of ? 3 months (Phase Ia, Arm A) or ? 6 months (Phase Ia, Arm B and Phase Ib)
Prior RT to the same region within 12 months (Phase Ia, Arm A; subjects with tumors localized in the head and neck region or thorax) or at any time previously (Phase Ia, Arm B; treatment-naïve subjects with SCCHN and Phase Ib; treatment-naïve subjects with Stage III A/B NSCLC or SCCHN)
PHASE I:
For phase 1b: HER2 negative, as defined for phase II; any ER/PR (negative or positive) can be enrolled in the phase 1b portion
There is a high likelihood that the patient, in the opinion of the principal investigator (PI) or lead associate investigator (LAI), will meet the research phase eligibility criteria and proceed to transplant after induction phase therapy is completed
Phase Ib: 0 or 1
PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
For Phase I/Ib enrollment, patients with a CLIA confirmed EGFR mutation may be treatment naive; all other patients must have received at least one previous line of therapy; there will be no limits to prior lines of treatment for the Phase 1 portion
For the phase I portion of the study, patients may be included without a CCyR provided they remain in chronic or accelerated phase CML and have at least a CHR. For the Phase II portion of the study patients must be in complete cytogenetic remission (CCyR), regardless of the stage of disease they had at the time they started therapy with TKI.
For the phase I portion of the study, patients in blast phase. For the phase II portion of the study, patients in accelerated or blast phase.
Phase Ib: no restriction on prior therapy
History of symptomatic Clostridium difficile infection within 1 month prior to dosing Additional phase specific exclusion criteria: Phase Ib Dose Escalation Arm A (Venetoclax and Cobimetinib)
For Part C (Phase 2): recurrent ALL patients with CNS 3 status are not eligible
PHASE I:
Phase 2 expansion: NSCLC
Phase 2 expansion: Melanoma
Phase 2 expansion: Transitional cell carcinoma of the GU tract
Phase 2 expansion: SCCHN
Phase 2 expansion: TNBC
Phase 2 expansion: Gastric Cancer
Patients will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase
Phase 1 and 2 (except Phase 2 subjects with known lymphoma) >=1500 cells/mm3
Phase 1 and 2 (except Phase 2 subject with known lymphoma) >=100,000 cells/mm3
Prior treatment with a VEGFR TKI (including pazopanib) (Phase 2 only)
adult Phase 1 Part A and Phase 2: ?16 years old at the time of screening
Be eligible for commercial receipt of therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab in the Phase 1b portion and nivolumab only in the Phase 2 portion);
Have received prior treatment with therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab) if enrolling in the Phase 2 portion of the study. This criterion does not apply to patients enrolling in the Phase 1b portion of the study.
Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation\r\n* NOTE: Phase I is closed to accrual effective 4/1/15
KEY INCLUSION CRITERIA\n\n          -  Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or\n             refractory disease who, for the lead-in phase, either have had a prior autologous or\n             allogeneic HSCT or are not eligible for HSCT, and , for the expansion phase, have had\n             a prior allogeneic HSCT. In the expansion phase there must be a documented CD3+ donor\n             chimerism of ?20%.\n\n          -  Patients must be off previous cHL therapy for at least 28 days prior to randomization\n             in the lead-in phase/first dose of study treatment in the expansion phase.\n\n          -  At least 1 fluorodeoxyglucose (FDG) PET avid (Deauville 4/5) measurable lesion >1.5 cm\n             on PET-CT scan as defined by the Response Criteria for Malignant Lymphoma (for the\n             lead-in phase) and the Lugano Classification (for the expansion phase) that has not\n             previously been irradiated.\n\n          -  Expansion phase: Required \de novo\ or \archival\ tumor biopsy, as well as required on\n             treatment biopsy\n\n          -  Estern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n\n        KEY EXCLUSION CRITERIA\n\n          -  Patients with prior allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) who\n             have had:\n\n               1. Lead-in phase: allo HSCT performed <12 months prior to randomization. Expansion\n                  phase: allo-HSCT performed ?4 months prior to the first dose of study treatment.\n                  NOTE: Patients who have had allo-HSCT performed >4 months prior to the first dose\n                  of study treatment must have discontinued all immunosuppressive therapy, and must\n                  have no clinical evidence of GVHD; or\n\n               2. Immunosuppressive treatment for acute or chronic GVHD within 3 months prior to\n                  randomization for the lead-in phase or prior to the first dose of study treatment\n                  for the expansion phase (with the exception of those patients who required 15\n                  mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral\n                  prednisone or equivalent must have discontinued it within 7 days prior to first\n                  dose of study treatment; or\n\n               3. Acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified\n                  Seattle Glucksberg criteria (Consensus Conference on Acute GVHD Grading\n                  Criteria); or\n\n               4. Prior chronic GVHD (as defined by the NIH Consensus Development Project) that\n                  persisted for >6 months and required systemic immunosuppression (with the\n                  exception of those patients who required 15 mg/day oral prednisone or\n                  equivalent). Patients who required 15 mg/day oral prednisone or equivalent must\n                  have discontinued it within 7 days prior to the first dose of study treatment; or\n\n               5. A donor lymphocyte infusion (DLI) within 3 months prior to randomization for the\n                  lead-in phase or first dose of study treatment for the expansion phase.\n\n          -  Prior therapy with an anti PD 1 or anti PD L1 mAb.\n\n               1. Lead-in Phase: May be enrolled if patient stopped prior anti PD1 or anti-PD-L1\n                  therapy more than one year prior to randomization and had a documented prior\n                  response.\n\n               2. Expansion Phase: Prior therapy with an anti-PD-1 or anti-PD-L1 agent following\n                  allo-HSCT is prohibited unless the therapy was stopped more than one year prior\n                  to the first dose of study treatment, and the patient had a documented prior\n                  response. NOTE: Prior therapy with an anti-PD-1 or anti-PD-L1 agent prior to\n                  allo-HSCT is permitted with no time limits and irrespective of a documented\n                  response.\n\n               3. Patients with a history of ?Grade 3 anti-PD-1 or anti-PD-L1-related immune\n                  toxicity are not eligible.
For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection.
Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator or Medical Monitor. BEV-Specific Concerns (Note: These exclusion criteria apply to the Phase 2 portion of the study even though BEV is not administered so that the patient populations between Phase 1 and Phase 2 are similar):
Any number of prior treatment regimens (in the phase I portion only); prior erlotinib is allowed in the dose finding phase and expansion cohort A; (only EGFR mutated patients are eligible)
Patients who currently are participating in other phase III therapeutic clinical trials and/or who have participated in other phase III therapeutic clinical trials in the previous 30 days
SECOND COURSE PHASE (RETREATMENT PERIOD FOR POST-COMPLETE RESPONSE RELAPSE ONLY)
For Phase 1A: no specific restriction
Phase Ib:
For patients who will be entering the “expansion phase” of the trial, the patient must be able to safely delay radiation by at least 6 weeks
Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM
Phase 2:
FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have measurable disease accessible for biopsy
FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have archival specimens from the time of primary or recurrence diagnosis
PHASE I: Filgrastim (GCSF) is not allowed during screening or during the first cycle for phase I patients
Patients agreeing to the optional biomarker study in the expansion phase only need to have an accessible primary tumor; (optional biomarker studies will be done in up to 18 patients in the expansion phase only)
PHASE I: Patients may not have received > 2 prior chemotherapies for advanced disease
Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.
PHASE I
Intermediate-2 and higher by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) post polycythemia vera (PV)/essential thrombocythemia (ET) MF and primary myelofibrosis (PMF) patients either in\r\n* Chronic phase (MF-chronic phase [CP])\r\n* Accelerated phase (MF-accelerated phase [AP])
For Phase 2 individuals either:
Phase 1b Subjects only:
For Phase 2 of the study, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
For Phase 2 of the study:
For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
Patients who have failed nilotinib, including those who are refractory to nilotinib at any dose or have relapsed on nilotinib at any dose will be eligible for the study; patients currently on nilotinib will continue on their prescribed dose of nilotinib and MEK-162 will be added based on the current cohort level in phase I or at the established MTD in phase II; in the instance the nilotinib dose is greater than the current cohort (in phase 1) or the MTD (in phase 2) patients will be dose reduced to the dosage as prescribed by protocol and then dose escalated as allowed in protocol at the principal investigator's (PIs) discretion
Subjects in the Phase 1b portion and in Group 1 and Group 3 of the Phase 2a portion may have received any number of prior therapies for breast cancer. Subjects in Group 2 of the Phase 2a portion may have received up to 3 lines of therapy in the metastatic setting (not including adjuvant or neoadjuvant therapy)
Patients must be considered good candidates for a phase 1 trial and the treating physician must intend to enroll the patient on a phase 1 clinical protocol, if possible; patients are not required to have progressed on their last line of therapy prior to enrollment\r\n* Other clinical trials are also acceptable; for example, an applicable phase 2 or phase 3 trial may exist for which the patient would be eligible and for which available information (inclusive of next generation sequencing [NGS]) would be relevant to such enrollment; regardless, the pertinent point is that it is the intent of the physician to use NGS data, to the degree possible, to select appropriate therapy, when selecting patients for this trial
Relapsed or relapse/refractory MM with at least 1 prior line of therapy for phase 1 and 1 to 5 prior lines of therapy for phase 2.
Bortezomib refractory patients are not permitted on the Phase 2 part of the study.
Patient willingness to undergo tumor biopsy at baseline and on treatment (optional for Phase 1; mandatory for Phase 2)
Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
For Phase 2 only: MET+ status
Whole brain or focal radiation therapy within 14 days prior to Cycle 1 Day 1 (C1D1) for Phase 1b or prior to randomization for Phase 2
Eligibility for phase 1 and phase 2 components:\r\n* Phase 1 – clinical T3 or T4 or N1 or M1 cancer which is untreated or previously treated with platinum based therapy with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated\r\n* Phase 2 – clinical T2-4 N0 or N1 untreated with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated
Prior enrollment in the OncoGenex Phase 2 Study OGX-427-02.
Prior temozolomide is not required for the phase 1 component; prior radiation is required for the phase 1 arm.
Patients on the phase 2 portion of the study may not have more than 2 prior regimens for recurrent disease for glioblastoma/gliosarcoma. Patients on the phase 1 portion of the study may not have had more than 3 prior regimens.
PHASE I PATIENTS:
Patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the coordinating center PI’s discretion, and should have recovered to eligibility levels from any toxicities
Prior treatment with immune checkpoint inhibitors, immunomodulatory monoclonal antibody (mAbs), and/or mAb-derived therapies is allowed provided that at least 6 weeks (Phase 1a) or 3 weeks (Phase 1b) have elapsed between the last dose and the proposed Cycle 1, Day 1, with the exceptions as specified in protocol Dose-Exploration/Expansion Cohorts in Phase 1b:
Life expectancy of > 3 months for the run in phase and > 6 months for the randomized phase
Corticosteroids initiated at the time of tumor diagnosis or recurrence for treatment of nerve compression or other symptoms is permitted during this phase of the trial, but will not be permitted during the immunotherapy phase, with the exception of a self-limited course of steroids
Participation in a Phase I lapatinib trial that has met its study objectives.
Enrollment in a Phase I trial
PHASE I: Any diagnosis of cancer prior to age 21
PHASE I: Off treatment
PHASE I: Pregnant (per patient report)
Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
PHASE 0: Ability to stand and walk unassisted
PHASE 1 & 2: Ability to stand and walk unassisted
PHASE 0: Not yet had surgery
PHASE 1 & 2: Identified within two weeks of surgery
Phase I: From 3–36 months post-surgical treatment
PHASE 1: PARENT ELIGIBILITY: Patient is at least 1.5 years from treatment
PHASE 2: PEER MENTOR ELIGIBILITY: Age 21-29
PHASE 2: PEER MENTOR ELIGIBILITY: At least 1.5 years from treatment
PHASE 2: PATIENT ELIGIBILITY: Age 18-25
PHASE 2: PATIENT ELIGIBILITY: At least 1.5 years from treatment
PHASE 3A: AYA SURVIVOR ELIGIBILITY: Age 18-29
PHASE 3B: PEER MENTOR ELIGIBILITY: Age 21-29
PHASE 3B: PEER MENTOR ELIGIBILITY: At least 2 years from treatment
PHASE 3B: PATIENT ELIGIBILITY: Age 18-25
PATIENTS AND PARTNERS: Prior enrollment in a couple-based mind-body intervention research study (protocols 2011-1179, 2013-0496, 2014-0036) conducted by the principal investigator including phase 1 or phase 2 of the current study
Treatment cannot begin prior to re-registering to the crossover phase and will ideally begin =< 7 days after registration for the crossover phase
PHASE 1 (DEVELOPMENT OF NARRATIVE MESSAGES)
PHASE 2 (RANDOMIZED CONTROLLED TRIAL [RCT] GROUP)
Phase 2: In Phase 2, clinician participants will be the oncology clinician of record (i.e., oncologist, nurse practitioner) of the first five patients enrolled in the intervention group of the randomized trial
Phase 2: The same four groups of stakeholders from Phase 1 will become involved as research collaborators/consultants for Phase 2 of the study and will not be considered study participants (i.e., will not be registered with Quality Assurance Office for Clinical Trials [QACT])
MONITORING PHASE:
Monitoring phase:
RANDOMIZATION PHASE:
Randomization phase:
At least 3 months into the maintenance phase, with at least 6 months left of\n             maintenance therapy
EVALUATION PHASE
Participants must not be eligible only for phase I trial
Phase I: Self-identify as Hispanic/Latino
PHASE I: MGUH patients presenting for well visits, and patients' parents
Women who are premenopausal, are on a stable contraceptive regimen, and are planning to continue the same regimen through surgery are eligible to participate; for women who are on hormonal contraception regimens that have a placebo phase, the following should be recorded regarding the day of baseline core biopsy and the day of surgery: the agent, whether they are in active or placebo phase, the day of the phase (e.g. day 13 of 21-day active phase or day 4 of 7-day placebo phase); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
RPFNA performed within 6 months of the study entry visit and in the follicular portion (day 1-10) of the menstrual cycle; note that day 1 is defined as the first day of bleeding; for non-menstruating women, RPFNA during the follicular phase must be confirmed by hormone levels drawn on the day of RPFNA; either clinical laboratory results are sent to protocol chair for assessment of menstrual cycle phase; or an additional frozen serum aliquot is sent to University of Kansas Medical Center (KUMC) for assay of hormone levels and phase confirmation; confirmation of follicular phase will be included in the eligibility report for the potential subject
Attend classes at either Houston Community College (HCC) Central Campus or Coleman Campus (Phase 1 and Phase 2) or Spring Branch Campus (Phase 2)
Own a smartphone capable of receiving texts from the study's text messaging resource (Phase 1 and Phase 2)
Use phone text-messaging features on a regular basis (Phase 1 and Phase 2)
Provide cell phone number (Phase 1 and Phase 2)
Phase I:
Phase Ib dose expansions Arms 1, 2 and 3
Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. triple phase or quadruple phase liver CT)
Eligible for the trial UPCC #01615, “A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma\
Ineligible for the trial UPCC #01615, “A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma\
PHASE I:
PHASE I: Women who do not have capacity to participate
Be a phase 1 trial in expansion, phase 2, or 3
PHASE I: Pregnant women will be eligible to participate
USABILITY PHASE: Pregnant women will be eligible to participate
Are eligible to participate in one of the phase III or IV BCCT open at the CTRC at the time of diagnosis