--- a
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+Biological parent(s) of participant (child) enrolling on SJMB12; these parents will be assigned to cohort P; the exclusion criteria below do not apply to this cohort
+Any factor included as exclusion criteria in the participating center’s treatment policy statement
+Further exclusion criteria apply
+Current or prior use of immunosuppressive medication within 14 days prior to the first dose Additional Exclusion Criteria for Arm A
+Subject requires continuous supplemental oxygen for any reason. Additional Exclusion Criteria for Arm B
+For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm. Exclusion Criteria: Exclusion criteria for the 2L Cohort:
+Has received trebananib or another angiopoietin-2 directed therapy (prior treatment with bevacizumab is not an exclusion criteria)
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Women who are pregnant or breastfeeding
+EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Anticipated patient survival under 2 months
+Patients who have been infected with HBV or HCV including those with inactive disease. Additional exclusion criteria for Combination arm PDR001+CJM112
+Olaparib\r\n* No additional exclusion criteria
+EXCLUSION CRITERIA FOR ENROLLMENT
+EXCLUSION CRITERIA FOR BONE MARROW TRANSPLANT
+EXCLUSION CRITERIA FOR BLOOD PROCUREMENT:
+EXCLUSION CRITERIA FOR T CELL TREATMENT:
+PHASE I EXCLUSION CRITERIA
+PHASE II EXCLUSION CRITERIA: Untreated and uncontrolled second tumor in the past 2 years
+Patients meeting any one of these exclusion criteria will be prohibited from participating in this study.
+Pregnancy or breastfeeding, or intending to become pregnant during the study Exclusion Criteria based on Organ Function or Medical History Cardiovascular Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
+PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
+TREATMENT EXCLUSION CRITERIA
+Anti-donor HLA antibodies. Additional exclusion criteria:
+EXCLUSION CRITERIA FOR PRE-REGISTRATION:
+EXCLUSION CRITERIA FOR REGISTRATION: Pregnant and/or breastfeeding
+EXCLUSION CRITERIA FOR REGISTRATION: Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
+EXCLUSION CRITERIA FOR REGISTRATION: Experiencing grade 2 or greater diarrhea
+EXCLUSION CRITERIA FOR REGISTRATION: Prior treatment with neratinib
+Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy Ipatasertib-Specific Exclusion Criteria:
+Other Exclusion Criteria May Apply.
+The following are considered criteria for exclusion from the exploratory genetic research:
+Medication-related exclusion criteria
+TREATMENT EXCLUSION: Active hemorrhagic cystitis
+Prior treatment with Cluster of differentiation 33 (CD33) antibody Further exclusion criteria apply.
+Pregnant or nursing (lactating) women Additional exclusion criteria for LXH254 in combination with PDR001
+Further exclusion criteria apply
+REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA:
+Preoperative Exclusion Criteria
+Intraoperative Exclusion Criteria
+EXCLUSION CRITERIA FOR STRATA A, B, D AND E
+EXCLUSION CRITERIA FOR STRATUM C: Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible
+Subjects with CNS disease are eligible, with exceptions as noted in the exclusion criteria
+PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
+PROCUREMENT EXCLUSION CRITERIA: Patients in remission who are enrolled on another study where time to progression or disease free survival is a primary endpoint
+TREATMENT EXCLUSION CRITERIA
+Major surgery within 14 days before enrollment; biopsies and line placement procedures are not exclusion criteria
+ARM A OR C EXCLUSION:
+ARM B OR D EXCLUSION:
+TREATMENT EXCLUSION
+RETREATMENT WITH MODIFIED T-CELLS EXCLUSION CRITERIA: Patient requiring supplemental oxygen or mechanical ventilation
+Cohort specific exclusion criteria (cohorts and groups without applicable specific exclusion criteria are not listed separately and should follow the general exclusion criteria)
+DONOR: The NMDP guidelines for exclusion criteria will be used.
+SCREENING PHASE EXCLUSION CRITERIA
+Other exclusion criteria may apply
+ARM I EXCLUSION CRITERIA: Any evidence of progressive systemic disease (by RECIST 1.1); those with stable systemic lesion(s) may be considered for enrollment
+EXCLUSION CRITERIA FOR DOSE ESCALATION COHORT
+ADDITIONAL EXCLUSION CRITERIA FOR DOSE EXPANSION COHORT
+Other protocol defined exclusion criteria could apply.
+Ejection fraction < 45% will be an exclusion criteria for intensive chemotherapy; such patients may receive low intensity therapy
+SCREENING EXCLUSION CRITERIA
+Normal MRI exclusion criteria will apply; a standard MRI safety form will be used to identify potential conditions warranting exclusion
+MEDICATION-RELATED EXCLUSION CRITERIA
+ATEZOLIZUMAB-SPECIFIC EXCLUSION CRITERIA
+BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA
+Use of corticosteroids or other immunosuppressive medications per exclusion criteria
+RECIPIENT EXCLUSION CRITERIA
+IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA
+MEDICATION-RELATED EXCLUSION CRITERIA:
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION- EXCLUSION
+ADDITION EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY
+STEP 1 SCREENING EXCLUSION CRITERIA
+COHORT 1 EXCLUSION CRITERIA
+COHORT 2 EXCLUSION CRITERIA
+COHORTS 1 AND 2 EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+EXCLUSION CRITERIA FOR ALL STUDY ARMS
+EXCLUSION CRITERIA SPECIFIC TO PATIENTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B1 SINGLE AGENT LEAD-IN)
+PART 1 EXCLUSION CRITERIA: Subjects < 0.5 M^2
+PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
+PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
+PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
+DRUG-SPECIFIC EXCLUSION CRITERIA
+EXCLUSION FOR TREATMENT WITH TCRC4-TRANSDUCED CD8+ CELLS
+EXCLUSION CRITERIA (ENROLLMENT)
+EXCLUSION CRITERIA (TRANSPLANT)
+PANOBINOSTAT MAINTENANCE EXCLUSION
+EXCLUSION CRITERIA FOR SCREENING:
+Known exclusion criteria for leukapheresis, JCAR014, or durvalumab therapy
+EXCLUSION CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION:
+EXCLUSION CRITERIA FOR LYMPHODEPLETION CHEMOTHERAPY, JCAR014 AND DURVALUMAB:
+EXCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL, OR ALL (COHORT A)
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Platelet count < 75,000/mm^3
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Active autoimmune disease requiring immunosuppressive therapy
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Serum creatinine > 2.5 mg/dL
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): SGOT > 5 x upper limit of normal
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Bilirubin > 3.0 mg/dL
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who are HIV seropositive
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Women who are breastfeeding
+EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who have contraindication to cyclophosphamide chemotherapy
+EXCLUSION CRITERIA FOR TNBC: ANC < 1000/mm^3
+EXCLUSION CRITERIA FOR TNBC: Hgb < 9 mg/dl (transfusion permitted to achieve this)
+EXCLUSION CRITERIA FOR TNBC: Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
+EXCLUSION CRITERIA FOR TNBC: SGOT > 5 x upper limit of normal
+EXCLUSION CRITERIA FOR TNBC: Bilirubin > 3.0 mg/dL
+EXCLUSION CRITERIA FOR TNBC: Patients who are HIV seropositive
+EXCLUSION CRITERIA FOR TNBC: Breast-feeding women
+EXCLUSION CRITERIA FOR TNBC: Patients who have contraindication to cyclophosphamide chemotherapy
+CAPMATINIB EXCLUSION CRITERIA: Uveal melanoma
+CAPMATINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
+CAPMATINIB EXCLUSION CRITERIA: Presence or history of carcinomatous meningitis
+CERITINIB EXCLUSION CRITERIA: Uveal melanoma
+CERITINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
+CERITINIB EXCLUSION CRITERIA: History of carcinomatous meningitis
+REGORAFENIB EXCLUSION CRITERIA: Uveal melanoma
+REGORAFENIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
+REGORAFENIB EXCLUSION CRITERIA: Previous assignment to treatment during this study; patients permanently withdrawn from study participation will not be allowed to reenter
+REGORAFENIB EXCLUSION CRITERIA: Any hemorrhage or bleeding event >= grade 3 within 4 weeks prior to start of regorafenib
+REGORAFENIB EXCLUSION CRITERIA: Renal failure requiring hemodialysis or peritoneal dialysis
+REGORAFENIB EXCLUSION CRITERIA: Patients with pheochromocytoma
+ENTRECTINIB EXCLUSION CRITERIA: Uveal melanoma
+ENTRECTINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
+ENTRECTINIB EXCLUSION CRITERIA: Incomplete recovery from any surgery prior to treatment
+ENTRECTINIB EXCLUSION CRITERIA: Pulmonary embolism in the 3 months prior to study drug administration
+Subjects where more than 10% of the total esophagus volume receives more than 50% of the prescribed RT dose Main exclusion criteria for cPoP
+EXCLUSION CRITERIA FOR ALL STRATA EXCEPT STRATUM P
+Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
+INCLUSION/EXCLUSION CRITERIA - PART B
+Any other ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the exclusion criteria and which is expected to significantly increase the risk of transplantation
+FIRST REGISTRATION-EXCLUSION:
+SECONDARY REGISTRATION-EXCLUSION:
+DONOR EXCLUSION CRITERIA:
+Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the exclusion criteria, with the exception of Criterion Number 6.
+EXCLUSION CRITERIA - ARM A:
+EXCLUSION CRITERIA - ARM B:
+EXCLUSION CRITERIA FOR ENROLLMENT: Most recent alloHCT performed did not utilize PTCy GVHD prophylaxis
+EXCLUSION CRITERIA FOR ENROLLMENT: The presence of active GVHD requiring treatment
+EXCLUSION CRITERIA FOR ENROLLMENT: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILs
+EXCLUSION CRITERIA FOR ENROLLMENT: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist
+EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The presence of active GVHD requiring treatment
+EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Creatinine >= 2.5
+EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: HIV-1/2 or HTLV-1/2 positivity
+SCREENING EXCLUSION CRITERIA
+MAIN STUDY COHORT EXCLUSION CRITERIA: Evidence of nodal or distant metastases
+SCREENING EXCLUSION CRITERIA:
+INTRA-OPERATION EXCLUSION CRITERIA (RANDOMIZATION ARMS ONLY)
+Any patient ?18 and ?89 who presents for a colonoscopy and who does not have criteria for exclusion
+BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA:
+TREATMENT EXCLUSION CRITERIA:
+CHEMOTHERAPY/CELL INFUSION EXCLUSION CRITERIA:
+EXCLUSION CRITERIA FOR CONSENT B
+Other exclusion criteria:
+Exclusion criteria (PET specific):\r\n* Pregnant or nursing women; extreme claustrophobia; weight near or greater than 350 pounds
+EXCLUSION CRITERIA AT TIME OF PROCUREMENT:
+EXCLUSION CRITERIA AT TIME OF INFUSION:
+INTRAOPERATIVE EXCLUSION CRITERIA:
+Tumor type specific exclusion criteria
+Additional exclusion criteria exist
+EXCLUSION CRITERIA FOR PRE-REGISTRATION
+EXCLUSION CRITERIA FOR REGISTRATION: mucinous adenocarcinoma, borderline tumors
+EXCLUSION CRITERIA FOR REGISTRATION: subjects who will undergo intraperitoneal chemotherapy
+EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving neoadjuvant chemotherapy for whom interval debulking surgery (assuming adequate response to therapy) is not planned
+EXCLUSION CRITERIA FOR REGISTRATION: subjects with comorbidities which would lead to a clinical expectation that they will not survive two years for reasons other than ovarian cancer
+PROCUREMENT EXCLUSION CRITERIA:
+TREATMENT EXCLUSION CRITERIA:
+EXCLUSION CRITERIA FOR CD34+ TOPOFF WITHOUT CONDITIONING (COHORT 2):
+EXCLUSION CRITERIA (ALL COHORTS)
+EXCLUSION CRITERIA (SUBJECTS STRATIFIED INTO THE THORAX HIGH VOLUME TREATMENT SITE)
+Is not receiving B-RAF treatment (Cohort C) (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
+Women who are pregnant or nursing will be excluded (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
+Laboratory criteria for exclusion within 14 days prior to randomization.
+Has received autologous HSCT within 6 weeks prior to start of treatment. Other Exclusion Criteria May Apply.
+Other exclusion criteria may apply
+Platelet count < 125x10^9 / L Exclusion criteria for Group 2
+Arm 1 and 2 Exclusion:
+Pregnant or lactation. Exclusion criteria for HSV-Tk infusion:
+PATIENT EXCLUSION CRITERIA:
+DONOR EXCLUSION CRITERIA:
+REGISTRATION – EXCLUSION CRITERIA
+EXCLUSION CRITERIA FOR TREATMENT: WBC less than or equal to 2000/uL
+EXCLUSION CRITERIA FOR TREATMENT: Hct less than or equal to 24%
+EXCLUSION CRITERIA FOR TREATMENT: Hgb less than or equal to 8 g/dL
+EXCLUSION CRITERIA FOR TREATMENT: ANC less than or equal to 1000
+EXCLUSION CRITERIA FOR TREATMENT: Platelets less than or equal to 75,000
+PHASE 2 SPECIFIC EXCLUSION CRITERIA
+PHASE 1 AND GENERAL EXCLUSION CRITERIA
+Patients should not enter the study if any of the following exclusion criteria are fulfilled
+ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS IN COMBINATION FULVESTRANT/CABOZANTINIB COHORT
+Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
+SCREENING EXCLUSION CRITERIA:
+EXCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
+EXCLUSION CRITERIA FOR MAINTENANCE THERAPY
+Other Exclusion Criteria
+Other protocol defined exclusion criteria could apply
+EXCLUSION CRITERIA:
+Must not meet any exclusion criteria defined in main study except for exclusion criteria \Subject must not have primary refractory disease\ which is related to prior carfilzomib
+Other exclusion criteria may apply
+Further Exclusion criteria apply
+Further exclusion criteria apply.
+EXCLUSION CRITERIA SEARCH PHASE
+EXCLUSION CRITERIA FOR TRANSPLANT PHASE: Life expectancy severely limited by concomitant illness or uncontrolled infection
+Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
+EXCLUSION FOR COLLECTION OF T CELLS/PBMCS: Females who are pregnant
+EXCLUSION FOR TREATMENT: Females who are pregnant
+Further exclusion criteria apply
+Further exclusion criteria apply
+Step I Exclusion Criteria:
+Step II Exclusion Criteria:
+PROCUREMENT EXCLUSION CRITERIA:
+TREATMENT EXCLUSION CRITERIA:
+MEDICATION-RELATED EXCLUSION CRITERIA
+METASTATIC SAFETY COHORT EXCLUSION CRITERIA
+NEOADJUVANT EXCLUSION CRITERIA
+Patients requiring treatment with strong CYP2C8 inhibitors Additional exclusion criteria for PDR001/Everolimus
+Patients requiring treatment with a strong CYP3A4 inhibitor or inducer Additional exclusion criteria for PDR001/Panobinostat-
+EXCLUSION FOR ENROLLMENT/SCREENING (ARMS 1 AND 2)
+EXCLUSION FOR TREATMENT (ARMS 1 AND 2)
+Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Exclusion from the genetic research may be for any of the exclusion criteria specified in the main study or any of the following:
+Other protocol defined exclusion criteria could apply
+Exclusion Criteria – Arms B and C
+EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
+PRE-REGISTRATION EXCLUSION CRITERIA: Previous treatment with trastuzumab or any other Her2 targeted therapy
+REGISTRATION EXCLUSION CRITERIA: Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
+STAGE I EXCLUSION CRITERIA:
+STAGE 2 EXCLUSION CRITERIA:
+Exclusion of patients with creatinine > 2.0
+Exclusion of patients with bilirubin > 2.0
+There will be no exclusion criteria based on organ function
+A positive hepatitis C serology is an exclusion criterion
+There will be no exclusion criteria based on organ function.
+EXCLUSION CRITERIA - MAIN PROTOCOL
+EXCLUSION CRITERIA FOR CONTINUING THERAPY ON THE EXTENSION PHASE:
+Exclusion criteria will include all criteria listed for the main protocol
+Additional Exclusion Criteria for dabrafenib and trametinib combination therapy (Cohort B and C as well as subjects that crossover from monotherapy to combination therapy):
+EXCLUSION CRITERIA PRIOR TO CELL COLLECTIONS FOR DENDRITIC CELL GENERATION:
+EXCLUSION CRITERIA – RECIPIENT ON STANDARD CARE THERAPY
+EXCLUSION CRITERIA - RECIPIENT
+IBRUTINIB-SPECIFIC EXCLUSION CRITERIA
+IDELALISIB-SPECIFIC EXCLUSION CRITERIA
+Previously-treated with any conditioning regimen and any GVHD immune suppression prophylaxis and formulation of steroids, except as noted in Exclusion Criteria #2.
+CARDIAC EXCLUSION CRITERIA:
+Other protocol defined exclusion criteria could apply
+Other protocol defined exclusion criteria could apply
+There is no exclusion for the presence of cytopenias
+REGISTRATION #1 EXCLUSION CRITERIA
+Other Exclusion Criteria
+IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA:
+RE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+Direct bilirubin =< 1.5 mg/dl; Note: as many eligible patients will be pancytopenic secondary to their disease or prior treatments, hematologic abnormalities will not be used as a criteria for entry or exclusion
+Cardiac Exclusion Criteria: Patients will be excluded if these meet any of the following:
+General Exclusion Criteria
+Prisoner -Impending Fracture-Specific Exclusion Criteria
+Any articular component to impending fracture site. -Actual Fracture-Specific Exclusion Criteria
+EXCLUSION CRITERIA FOR SCREENING:
+EXCLUSION CRITERIA FOR TREATMENT:
+EXCLUSION CRITERIA - INITIAL ENROLLMENT
+EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENT
+Other protocol defined exclusion criteria could apply
+EXCLUSION CRITERIA RELATED TO ZIV-AFLIBERCEPT
+No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
+Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are allowed and are not considered exclusion criteria)
+Other protocol defined exclusion criteria could apply
+Prior treatment with NaPi2b- targeted therapy. Bevacizumab-Specific Exclusion Criteria (for Participants in Second Ovarian Expansion Cohort Only):
+Other protocol defined exclusion criteria may apply.
+DOSE ESCALATION COHORT EXCLUSION:
+DOSE EXPANSION COHORT EXCLUSION:
+They are ineligible by virtue of meeting any exclusion criteria listed above
+Known history of MDS or AML Cohort 3 Exclusion Criteria:
+Other exclusion criteria may apply
+PHASE II REGISTRATION: EXCLUSION CRITERIA:
+Other Exclusion Criteria
+If female and of child-bearing age, donor must not be pregnant or breastfeeding. Recipient Exclusion Criteria
+COHORT 1 EXCLUSION CRITERIA FOR APHERESIS/TUMOR BIOPSY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
+COHORT 1 EXCLUSION CRITERIA FOR IMMUNOTHERAPY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
+COHORT 2 EXCLUSION CRITERIA:
+Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
+EXCLUSION CRITERIA FOR PATIENTS
+PATIENT EXCLUSION: Palliative performance scale rating < 40
+EXCLUSION CRITERIA FOR CROSSOVER THERAPY: History or evidence of active, noninfectious pneumonitis that required treatment with steroids
+Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
+PATIENT EXCLUSION CRITERIA
+EXCLUSION CRITERIA-PATIENTS
+EXCLUSION CRITERIA-FCGs
+EXCLUSION CRITERIA FOR PARENTS: Patient declines assent/consent (if >= 7 years)
+EXCLUSION CRITERIA FOR PARENTS: Parent or child participated on prior PRISM intervention study
+EXCLUSION CRITERIA FOR PATIENTS: Patient declines assent/consent (if >= 7 years)
+EXCLUSION CRITERIA FOR PATIENTS: Patient participated on a prior PRISM intervention study
+EXCLUSION - STUDY 1: Parkinson's disease
+EXCLUSION - STUDY 1: Stroke
+EXCLUSION - STUDY 1: Active foot ulcer
+EXCLUSION - STUDY 2: The inclusion/exclusion criteria follows similar criteria for study #1 except only patients with confirmed peripheral neuropathy (VPT big toe greater than 25 volt) will be included; patients who have completed clinical study 1 would be eligible for study 2 if they develop CIPN as defined by VPT assessment
+EXCLUSION CRITERIA FOR PATIENT PARTICIPANTS
+EXCLUSION CRITERIA FOR CAREGIVER PARTICIPANTS
+PHASE 1: No provider exclusion criteria
+PHASE 3A/3B: PATIENT EXCLUSION CRITERIA: Non-English speaker
+EXCLUSION CRITERIA SPECIFIC TO SURVIVORS:
+EXCLUSION CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:
+EXERCISE EXCLUSION CRITERIA:
+No allergic reactivity has been associated with olfactory training and thus there is no need for any exclusion criteria related to this
+No other agents have any possible potentiation or decreased activity related to olfactory training and thus there is no need for any exclusion criteria related to this
+There are no other agent-specific exclusion criteria
+EXCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)
+EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II)
+CAREGIVER EXCLUSION:
+PATIENT EXCLUSION CRITERIA:
+CAREGIVER EXCLUSION CRITERIA:
+There are no exclusion criteria to caregiver participation in this study
+PREPROCEDURAL EXCLUSION CRITERIA:
+PATIENTS EXCLUSION CRITERIA:
+Hepatic encephalopathy Exclusion Criteria Specific to Arm B (Gastric Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm B:)
+Ongoing treatment for epilepsy Exclusion Criteria Specific to Arm C (Metastatic Pancreatic Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm C:)
+PATIENT PARTICIPANT EXCLUSION CRITERIA (PHASE 1 & 2)
+EXCLUSION CRITERIA FOR GROUP 2A AND 2B
+No exclusion criteria relating to concomitant medications
+EXCLUSION CRITERIA-PATIENTS
+EXCLUSION CRITERIA-CAREGIVERS
+Patients who will be enrolled on the observational arm should not meet the 3rd and 4th exclusion criteria only
+Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
+Pre-procedure Exclusion Criteria
+GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
+GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
+READER STUDY EXCLUSION
+PRE-REGISTRATION EXCLUSION
+REGISTRATION EXCLUSION
+PRE-REGISTRATION EXCLUSION:
+REGISTRATION EXCLUSION:
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Pregnant or breastfeeding
+EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Non-hematologic malignancy with a life expectancy of < 5 years
+EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Active and uncontrolled acute GVHD grades III or IV
+EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Any uncontrolled active systemic infection
+EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Lactating or pregnant
+EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Uncontrolled cardiac arrhythmias
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA
+Exclusion criteria for RPFNA
+Exclusion criteria for study intervention
+DRIVERS EXCLUSION CRITERIA
+IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENT ONLY NEEDS TO MEET EXCLUSION CRITERIA 1 THROUGH 3
+Exclusion Criteria for 13C-MBT studies:
+Exclusion Criteria for 31P-MRS studies
+Eligible for donation according to the transplantation center Exclusion Criteria Donor:
+A history of miscarriage in the last 6 months, in and of itself, will not be considered an exclusion
+Daily treatment with thiazides or ?-blockers (exclusion only if < 3 months)
+Good performance status (as defined in Exclusion Criteria)
+PRE-REGISTRATION EXCLUSION CRITERIA
+REGISTRATION EXCLUSION CRITERIA
+Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3
+There will be no exclusion criteria relating to concomitant medications
+EXCLUSION CRITERIA FOR CALYPSO TRANSPONDERS:
+EXCLUSION CRITERIA (ALL PATIENTS)
+Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria); for patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion
+EXCLUSION CRITERIA FOR OPEN-ACCESS: More than 6 MET PET scans within the previous 12 months
+EXCLUSION CRITERIA FOR ORAL LESION AND NORMAL TISSUE
+EXCLUSION CRITERIA FOR DRY MOUTH STUDY
+EXCLUSION CRITERIA FOR GUM STUDY
+No other appropriate agent-specific exclusion criteria
+Other protocol defined exclusion criteria could apply
+CANCER-SPECIFIC EXCLUSION CRITERIA
+GENERAL MEDICAL EXCLUSION CRITERIA
+Having received an investigational drug in an investigational drug trial within the last 30 days before randomization for this clinical trial. Participation in a clinical trial without receiving other investigational drugs (e.g. follow-up phase of a trial, observational study) is permitted. Part B, Exclusion criteria: All exclusion criteria as for Part A, except for inclusion criteria 1 and 12 which are replaced by:
+STEP 1: EXCLUSION CRITERIA FOR TUMOR COLLECTION
+Other Exclusion Criteria May Apply
+Subject Exclusion Criteria for Cohort 1 and Cohort 2:
+Subject Exclusion Criteria for Optional Contrast MRIs –Cohort 1 Only:
+Prior therapy is not a consideration for protocol entry and prior therapy is not an exclusion criteria
+Common exclusion criterion
+EXCLUSION CRITERIA - FOR MALE COHORT
+EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Chronic therapy with any drugs, except oral contraceptives
+EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Hospitalization for any reason up to 8 weeks before enrollment
+EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial
+EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Pregnancy, labor or miscarriage within 12 weeks before admission predicted date
+HEALTHY VOLUNTEER EXCLUSION CRITERIA:
+PANCREATIC CANCER PATIENT EXCLUSION CRITERIA:
+SITE EXCLUSION CRITERIA:
+PATIENT EXCLUSION CRITERIA:
+PATIENT PARTICIPANTS EXCLUSION CRITERIA:
+GARAGE/SITE EXCLUSION:
+DRIVER EXCLUSION:
+TRIAL EXCLUSION:
+PATIENT EXCLUSION:
+PROSPECTIVE STUDY POPULATION EXCLUSION
+CHART AUDIT EXCLUSION CRITERIA:
+There are no specific exclusion criteria for this study.
+Criteria 7, Other Exclusion Criteria May Apply
+No exclusion criteria for this study
+Other Exclusion Criteria
+Other Exclusion Criteria May Apply
+Additional Exclusion Requirements for arm 1 only (nivolumab Plus TAK-580)
+Subjects must be otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below.