All subjects must have adequate archival tissue available prior to registration (i.e., at least 20 unstained slides or paraffin block); if acceptable archival tissue is not available, the subject must be willing to consent to providing a core or excisional biopsy for research prior to registration for protocol therapy; if archival tissue is not available and there are no sites amenable to biopsy, enrollment must be discussed with the sponsor-investigator on a case by case basis
Willingness to release archival tissue sample for research purposes, if available
For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
Willing and able to undergo a biopsy of at least one metastatic site or primary prostate; adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC; fresh or archival tissue must be obtained within 6 months of treatment start\r\n* RB positive as determined by local lab immunohistochemistry (IHC) testing (performed per lab manual) and if available, ship 10 slide (5 micron thickness) or alternatively the tissue block to Thomas Jefferson University (TJU) and 1 hematoxylin and eosin (H&E) slide
For patients with solid tumors, either archival tumor tissue must be available or patient must consent to undergo on-study tumor biopsy before administration of first dose
Archival tissue must be procured if available
Have PD-L1 expression level determined from the subject's archival tissue or fresh tumor specimen
All subjects must have archival tissue confirmed as available for enrollment; subjects who are TKI naive who do not have archival tissue may undergo a fresh tumor biopsy in lieu of the archival tissue requirement; the archival tissue requirement may be waived for subjects after discussion with the principal investigator
Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Agreement to allow the use of archival tissue from pre-ASCT tumor biopsies\r\n* If unavailable, exceptions may be granted with study principal investigator (PI) approval
For participants enrolling the phase Ib part of the study, willingness to provide archival tumor samples when available
Willing to provide a tumor sample via biopsy from a metastatic site of disease to be collected at screening if safe and feasible per treating investigator discretion; adequate archival metastatic tissue can be used if available in lieu of baseline biopsy if done when patient had CRPC
All patients should submit an archival tumor biopsy specimen (collected at diagnosis or relapse); patients who have no tumor tissue available may be permitted to participate after discussion with the principal investigator
Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment
A biopsy of the tumor tissue obtained at anytime from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. For Part 1B and Part 2B, any archival tumor specimen must have been obtained within 3 months of starting study drug.
Willing to provide a tumor sample via biopsy from a metastatic site of disease to be collected at screening if safe and feasible per discretion of treating investigator; adequate archival metastatic tissue can be used, if available, in lieu of baseline biopsy if done when patient had CRPC; patients without a site amenable to biopsy and lack of archival tissue may still join the study
Willing to provide archival or fresh tumor biopsy at Screening and Week 10
Participants must have archival tumor tissue available. Participants without archival tissue may be enrolled at the discretion of the principal investigator
Agreement to allow the use of archival tissue from diagnostic tumor biopsies will be retrieved and submitted post-enrollment \r\n* If unavailable, exceptions may be granted with study principal investigator (PI) approval.
Participants must have archival tumor tissue available; participants without archival tissue may be enrolled at the discretion of the principal investigator
For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
Be willing to provide tissue from an archival tissue specimen in selected patients, where available
Agree to provide archival tumor material for research
Patients must consent to analysis on archival tissue
Patients must have adequate archival material from a previous biopsy to determine EGFR mutation status and Cripto-1 expression, or undergo a biopsy of fresh tissue of the primary cancer or a metastatic site in order to make these determinations, if archival material is not available
Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
Availability of an archival tumor tissue sample. If archival tumour tissue is not available, then tissue from a fresh biopsy can be used.
Tumor tissue available if biopsy consent not provided, if no archival tumor tissue available and pt provides consent, pre-dose biopsy will be done
Subject’s archival prostate biopsy specimen is available, and subject consents to provide tissue for study endpoint analysis; the prostate biopsy slides or blocks must be available prior to starting any study treatment
Patient must consent to the access, review and analysis of previous medical and cancer history, including tumor archival tissue (if available) and imaging data by the sponsor or a third party nominated by the sponsor.
Patients enrolled in the escalation and expansion phases will be required to have archival tissue available for analysis.
Locally or centrally confirmed CEA expression in archival tumor tissue
Willingness to undergo tumor biopsy if the patient does not have a known familial cancer syndrome (MEN1, VHL and NF1) or archival tissue available
Tissue for correlative studies must be available (paraffinized or frozen), but confirmation at screening is not needed; archival tissue may be used instead of a fresh biopsy at baseline if it already exists
Parts B2, B3 & B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy
Archival tissue block or unstained tumor tissue available for correlative studies
Patients must have confirmation of folate receptor-a (FR-alpha) positivity by immunohistochemistry (IHC) (? 25% of tumor staining at ? 2 + intensity) on archival tissue or recent biopsy.
Patients must be willing and able to undergo tissue biopsy for research\r\n* If tumor tissue obtained from the biopsy is deemed inadequate, and the patient is unwilling or unable to have another biopsy, the patient may be considered for enrollment if archival tumor tissue is provided and deemed of adequate quality; this must occur prior to any treatment with rucaparib or mirvetuximab soravtansine\r\n* If biopsy is deemed unsafe to attempt or to perform, and if archival tumor tissue is available and deemed of adequate quality, the patient may enroll on trial\r\n* Biopsy must be of solid tumor tissue; ascites is not acceptable
Archival tumor samples must be available and sufficient for diagnostic and genetic testing; if archival sample insufficient for testing, subject must have lesions amenable to biopsy and be willing to undergo biopsy
Agreement to access archival tissue or agreement for tumor biopsy prior to treatment
Archival tissue for PD-L1 staining (alternatively a new biopsy [core] at baseline can be used); a minimum of 10 slides is required (unless approval from the principal investigator [PI] is obtained)
All subjects must have adequate archival tissue available prior to registration (i.e., at least 15 unstained slides or paraffin block). Archival tissue should represent invasive or metastatic urothelial cancer with a preference for metastatic tissue if available. Subjects without adequate tissue may be considered on a case by case basis after discussion with the sponsor-investigator.
Untreated/pretreatment archival tumor tissue must be available for correlative analyses
Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies; in cases where a fresh biopsy is not feasible (i.e., if an accessible site cannot be biopsied with acceptable clinical risk), archival tissue may be submitted instead, after discussion with and approval by the principal investigator
Arm A: Patients with glioma who are positive for the H3 K27M mutation (positive testing in CLIA laboratory) and have completed at least one line of prior therapy. Evidence of progression is not required so that ONC201 may be administered to patients in the maintenance setting or to patients with recurrent disease. No more than two prior episodes of recurrence from radiotherapy and/or chemotherapy are allowed. Use of bevacizumab solely for treatment of radiation necrosis, pseudoprogression, or treatment effect will not be considered a recurrence. Post-mortem biopsy is required if H3 K27M status of tumor is unknown and archival tumor tissue not available. Arm B: Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons, are eligible with or without histologic confirmation. Post-mortem biopsy is required if H3 K27M status of tumor is unknown and archival tumor tissue not available.
Agreement to provide mandatory archival tissue or fresh biopsy.
Have archival tissue where available
Tumor sample must be available for PD-L1 testing; archival tissue within 3 months of study enrollment will be used; if archival tissue is unavailable, a fresh biopsy will be taken
Agreement to provide archival primary or metastatic tumor tissue if available
Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
Archival tissue from a previous biopsy will be required
A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies; NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available
Adequate tumor tissue (archival or fresh) must be available for correlative studies\r\n* NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator; if prior tissue is not available, patient must be willing to undergo baseline tumor biopsy
Adequate archival tissue (metastatic tissue sample is preferable but primary tumor tissue will be acceptable) or willing to undergo pre-treatment biopsy (for central confirmation of molecular alteration and PTEN immunohistochemical assessment) if adequate archival tissue is unavailable
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the Memorial Sloan-Kettering [MSK] principal investigator)
Histologically confirmed, metastatic or unresectable neuroendocrine carcinoma of non-pulmonary origin, high grade as indicated by Ki-67 > 20% and/or > 20 mitoses/10 hpf; patients must have existing Ki67 results from archival tissue or available tissue for Ki-67 testing; if no archival tissue is available the subject must agree to a fresh biopsy for testing to qualify for the study
Inability to obtain Foundation One testing on archival tissue, or, lack of previous next generation sequencing
Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
PRE-SCREENING: Availability of archival or fresh tissue for testing of mesothelin expression level\r\n* Note: archival tissue is preferred and fresh biopsy should only be obtained if no archival tissue is available and if in the investigator’s judgement, there is no additional risk for the patient’s safety; patients with a sarcomatoid histology are not expected to have mesothelin overexpression and should not enter prescreening
Agreement to provide mandatory archival tissue or fresh biopsy.
Archival tumor tissue from diagnosis or, preferably, at relapse
Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by a designated central laboratory confirming MAGE-A10 expression.
Archival tumor tissue retinoblastoma-associated protein (pRb) positive by immunohistochemistry (IHC)
Archival tissue (paraffin block[s] or unstained slides from paraffin block[s]) from the primary tumor and/or a metastatic site judged reasonably available prior to initiating treatment, or willingness to undergo fresh pre-treatment tumor biopsy; (prior to initiating treatment, the screening team must have documentation that an archival or fresh tumor specimen has been requested from a local or outside facility; however, physical possession of requested tissue or waiting for histological analysis or confirmation that an acquired specimen contains tumor tissue sufficient for analysis is not a requirement prior to initiating treatment); if no archival tissue is available and patient consents to a fresh biopsy, but the patient’s lesion is deemed inaccessible to safe biopsy, the patient will be allowed to enroll if otherwise eligible
Be willing to provide archival tissue from a tumor lesion or obtain a new biopsy if tissue unavailable
Be willing to provide tissue from a newly obtained or archival tissue, if available
Must have archival tissue available for PD-L1 assessment
Having archival paraffin tissue is ideal for the correlative study but it is not mandatory
Archival tissue from diagnostic/core biopsy must be available; patients who had a biopsy at an outside institution are eligible as long as it is confirmed that an archival tumor specimen, with an associated pathology report, is available
Archival tumor tissue slides must be sent or available
Fresh or archived colorectal cancer tissue, preferably from a hepatic metastatic site; archival tissue is acceptable for enrollment into this study; subjects who have no archival tissue available do not need to undergo a new biopsy solely for the purpose of this study
For participants entering the Phase 1a dose escalation: have submitted, if available, the most recent archival tumor tissue sample.
Archival tumor tissue must be available for enrollment
UROTHELIAL CARCINOMA EXPANSION COHORT: Willingness to release archival tissue sample for research purposes, if available
Archival tissue samples and/or fresh tumor biopsy samples:
Subjects should agree to provide archival and/or fresh tumor biopsy samples
Archival tumor samples should be collected for all enrolled subjects; if archival tissue samples are not available, a recent core needle biopsy should be collected
PD-L1 expression in tumor tissue from any site is required for patients with NSCLC; tumor tissue can be archival, however if no archival tissue is available then a biopsy must be obtained for PD-L1 testing; PD-L1 expression will be analyzed by a Merck assay; PD-L1 expression is not required for patients with melanoma, but melanoma patients are required to submit an extra-cerebral specimen for analysis, unless it is not feasible to obtain one
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Be willing to provide tissue from an archival tissue sample
Have archival tissue where available; those patients enrolled on the phase 1 escalation trial where archival tissue is not available will undergo a fresh biopsy where clinically feasible after discussion with the sponsor
All patients must be willing to provide research tumor tissue for biomarker studies at baseline (from archival tumor tissue or through endoscopy if sufficient archival tissue is not available); all patients must also allow biomarker studies on the tissue obtained through surgery to remove the primary cancer
Availability of archival tumor material, either as a block or slides (Phase Ia and Ib). If no archival material is available then a fresh biopsy should be taken
Have archival tissue available or undergo a fresh biopsy where clinically feasible after discussion with the sponsor
Patient must have an available archival/pre-treatment block or fresh tumor biopsy for molecular profiling to be performed
Patients must have archival tissue, 10-20 slides, available for review and testing
No archival or newly biopsied tissue available for analysis
Subjects must agree to provide archival and/or fresh tissue biopsy samples, if available. Tumor biopsy will be done only if the subject has a lesion for which, in the opinion of the Investigator, a non- or minimally invasive tumor biopsy may be performed.
Consented for genome sequencing and database of Genotypes and Phenotypes (dbGAP)-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing; fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed
Prior to registration, all subjects must have adequate archival tissue available prior (unstained slides are to be submitted as outlined in the study procedures manual); if no acceptable archival tissue is available, the subjects must be willing to consent to providing a mandatory pre-treatment core biopsy for research; phase II subjects must be willing to consent to providing a mandatory post-treatment core biopsy for research; fine needle aspiration and cytology samples will not be acceptable
Consented for genome sequencing and database of Genotypes and Phenotypes (dbGAP)-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing; fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed
Patient must consent to the use of their archival tumor tissue for protocol use if available
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the MSK principal investigator)
Archival tumor tissue sample must be requested and available prior to study entry; a copy of the local pathology report must be submitted along with the specimens; patients without available archival tissue are excluded
Patients must have archival tissue sample (if available) or be willing to undergo a repeat biopsy (if feasible)
Willing to provide mandatory archival tumor tissue (block or minimum of 30 unstained slides from a primary or recurrent/metastatic thyroid cancer) for correlative research purposes; NOTE: patients with less archival tumor tissue available may still be eligible for the study after discussion with Academic and Community Cancer Research United (ACCRU); receipt of archival tumor tissue is not required for study registration and initiation of therapy
Agreement to provide mandatory archival tissue or fresh biopsy
Willing to provide tumor tissue for biomarker analysis and/or archival tissue available from original diagnostic block
Archival tumor tissue obtained at any time from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. Subjects enrolled in a PK/Pharmacodynamic Cohort must provide a fresh biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy.
High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
Available tissue for PD-L1 staining (archival or new core needle biopsy at baseline if no archival tissue available); a minimum of 10 slides are required (unless approval from the PI is obtained)
Consent to provide archival tumor tissue and pre/on-treatment biopsies
Appropriate archival OR current tissue blocks or biopsy specimens to determine ER/PR and APR status.
Fresh or archival biopsy tissue available to determine tumor mutation status
For patients recruited in the expansion cohort only, provision of archival (block) or fresh tumor tissue samples at baseline is mandatory. If archival tumor tissue is not available, patients should be willing to undergo a biopsy for provision of fresh tumor samples
High FGFR mRNA expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh tumor biopsy specimen.
Must have archival tissue available, be willing to undergo metastatic biopsy or have a sufficient plasma circulating tumor DNA (ctDNA) concentration in order to perform next-generation DNA sequencing
Ability to provide adequate tissue from archival tumor specimen; confirmation of adequate tissue is required prior to enrollment
Patients must have access to archival tumor tissue for proposed correlative studies; these may be derived from transurethral resection of bladder tumors (TURBT), cystectomy, or biopsy; if archival tissue is not available for proposed correlatives, patients may be enrolled at the discretion of the study principal investigator (PI) (SKP)
Patients must consent to analysis on archival tissue; if archival sample is not available, a sufficient tumor biopsy can be performed a minimum of 28 days prior to start of treatment if felt to be clinically reasonable
Whenever available, archival tissue (block or minimum 10 slides) is requested for molecular characterization, e.g. detection of somatic mutations and/or candidate biomarkers of response; this is not mandatory and lack of available tissue would not be an exclusion criteria
Participants must have archival tumor tissue available for analysis (minimum 20 5 um slide) or be able to undergo a baseline fresh tumor tissue biopsy
If archival tumor tissue from a metastatic melanoma lesion is unavailable OR designated pathologist from participating site cannot sign-off to ensure that “sufficient” tumor is available from existing archival tumor block for support of tumor imaging studies, patients must be willing to consent to undergo a biopsy to collect metastatic tumor tissue; collection of fresh biopsy tissue does not guarantee enrollment, unless the pathologist from the participating site signs-off that “sufficient” tumor has been collected
Must have confirmed viable archival prostate biopsy tissue available (only required for patients going on study after the MTD has been reached)
Available archival tumor tissue should be submitted to MSKCC for integrated mutation profiling of actionable cancer targets (IMPACT) analysis, but will not be required prior to registration; note: if tissue is depleted, patient will still be eligible after discussion with the principal investigator (PI)
Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
Archival tumor tissue specimen meeting protocol specifications or the participant will be offered the option of a pre-treatment biopsy to obtain adequate tissue sample.
Available pretreatment biopsy, either fresh (optimal) or archival (acceptable)
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent for a fresh tumor biopsy; (mandatory for Cohorts A, B, C; optional for dose escalation and Cohort D)
Available archival tumor tissue for the proposed correlative studies
Available archival tumor specimen of the soft tissue sarcoma that meets inclusion criterion #1, #2 or #3.
Willingness to provide archival tumor samples
Archival tumor tissue
Fresh Biopsy or Archival Tumor Tissue
Agreement to mandatory archival tissue or fresh biopsy
All patients must provide archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies (NOT required for patients enrolled on the dose escalation for intermittent ABT-888 portion of the study)
Available evaluable archival tumor tissue for correlative studies including assessment of immune infiltration and Btk expression is required; if archival tissue is unavailable, patients must be willing to undergo repeat prostate biopsy; tissue is considered sufficient for correlative endpoint analyses if they are obtained from at least 2 prostate cores and consist of at least 15 unstained slides from the largest tumor volume and/or highest Gleason score; the availability of archival tissue or consent for repeat prostate biopsy is required for study eligibility; determination of tissue sufficiency is not required for study eligibility
Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by a designated central laboratory confirming NY-ESO-1 and/or LAGE-1a expression.
Archival tissue of carcinoid biopsy must be available
Subjects with archival tumor tissue suitable for proteasome activity and genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
If the patient is enrolled at Memorial Sloan-Kettering (MSK) he/she must consent to a pre and post treatment biopsy (or have archived tissue available for the pretreatment analysis); pretreatment archival tissue for patients enrolled outside of MSK should be submitted to MSK; if there is no archival tissue available, a repeat biopsy is not required for non-MSK patients
Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a PD-L1 stratification test, as assessed by central pathologist
Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study
Has agreed to the collection of archival tumour tissue or recent tumour biopsy tissue, it taken for routine clinical purposes at baseline if archival tissue is not available, for molecular biomarker analyses. Inclusion Criteria Specific for Part B:
Neuroendocrine archival tissue from a previous biopsy will be required
Have sufficient archival tumor tissue for analysis.
Have confirmation of available tissue from an archived specimen of ovarian cancer; if there is no archival tissue available, the participant will be required to undergo a biopsy to obtain a fresh tumor sample
Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment; fresh biopsy (pre and post dose) of tumor tissue will be optional; NOTE: Patients without adequate tissue for bio correlates will not be excluded or required to have a repeat biopsy
Tissue for correlative studies must be available (paraffinized or frozen), but confirmation at screening is not needed; archival tissue may be used instead of a fresh biopsy at baseline if it already exists
Subjects in Phase 2 must have disease amenable to biopsy and must be willing to undergo pre- and post-treatment tumor biopsies. Optional for Phase 1. Note: archival tissue will be requested for all subjects preferably from primary tumor site prior to cancer treatment; however, archival tissue is not a requirement for study entry.
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Have permission to access tissue from an archival tissue sample; (absence of archival tissue will not preclude trial participation)
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the Memorial Sloan-Kettering [MSK] Principal Investigator)
Must be willing to provide and have available archival tissue for PD-L1 testing.
Willingness to provide blood and urine samples, and biopsy samples if on the expansion phase of the study, for research purposes; for the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or archival tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of archival tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements
Adequate archival tissue to perform molecular analysis through Memorial Sloan Kettering (MSK)-Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) if MSK-IMPACT has not been performed previously on the participant's tumor; if MSK-IMACT has not been previously performed and adequate archival tissue is not available, a participant should be agreeable to a pre-treatment biopsy
Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
Available archival tumor tissue or patient is willing to undergo new biopsy
Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
Archival and/or fresh biopsy tissue samples must be available prior to the first dose of the study drug
Patient has consented for tissue banking and a research biopsy after the lead-in treatment of trametinib (required to enroll on this study); patient also consents to another pre-treatment biopsy if insufficient archival tissue is available (minimum of 5 unstained slides) for cohorts 2a, 3, and expansion exists
Agree to undergo a biopsy of at least 1 metastatic site for gene-fusion status analysis; adequate archival metastatic tissue can be used if available in lieu of a biopsy; patients will only be eligible for protocol therapy if the biopsy has tumor and the tissue is evaluable for ETS fusion status
Have sufficient archival FFPE tumor tissue available for planned analyses. Archival tissue from the most recently collected biopsy or debulking surgery should be provided, if available.
Available tumor tissue (archival or recent acquisition)
Archival and screening tumor biopsy
Tumor tissue material available (archival or recent tumor biopsy)
Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Satisfactory archival tumor biopsy tissue is retrieved, or new tumor biopsy is performed, prior to starting Cycle 1
Subjects must have archival tumor tissue available for mutational analysis. A study specific biopsy can be performed if archival tissue is not available.
Extended RAS and BRAF wild type status documented on archival tumor tissue or on fresh biopsy if no archival tissue present
Known KRAS and NRAS mutation status (if unknown status for either of these genes, and no archival tissues is available, a fresh tumor biopsy will be made)
Must have archival tumor tissue available for biomarker analysis. A study-specific tumor core biopsy, pleural effusion or ascites sample must be obtained prior to treatment if archival tissue is not available.
Must have available recent (before treatment start) or archival tumor specimen.
Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination.
For all subjects: Availability of archival tissue, or willingness to undergo fresh biopsy if archival tissue is not available.
2. Histologically proven diagnosis of MPM. All subjects must have biopsy material (archival tissue is acceptable) available for immunohistochemistry determination of Merlin status prior to enrollment.
LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Mesothelin expression in at least 5% of cells as assessed in archival tumor tissue samples, determined by the immunohistochemistry (IHC) assay performed at Laboratory of Pathology/CCR/NCI; archival samples must be available for eligibility
Patients must have archival tissue sample available, collected either at the time of diagnosis or any time since; if archival tissue is unavailable, patient must be eligible and willing to undergo a fresh tissue biopsy
Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
Documented MUC16 expression from archival or fresh tissue by IHC central review
Patient must have access to archival tumor tissue sample or agree to undergo biopsy after study eligibility has been confirmed to obtain fresh sample for evaluation of WT1 expression. In place of archival tumor tissue samples, patients with AML should have available a bone marrow aspirate and/or bone marrow biopsy with PCR for WT1 transcript performed before the first dose of study drug.
Available archival tumor tissue or willingness to undergo repeat biopsy is required at trial initiation
Must have adequate fresh or archival tumour tissue at the late disease progression immediately prior to the study entry
If available, patient must agree to provide archival tissue for research purposes (either archival paraffin tissue block or 10 unstained slides of a primary or metastatic melanoma lesion) prior to enrollment; samples should be shipped within 1 month after enrollment
Consent to provide archival tumor tissue for biomarker testing
Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
Patient has tumor tissues available (archival or fresh).
Consent to provide archival tumor tissue for biomarker testing
MET Diagnostic-High tissue reported by the central authorized laboratory using archival or recent biopsy tumor samples
Availability of archival tumor tissue (core biopsy or surgical tumor blocks) for analysis. Sites will be asked to submit archival tissue (subjects may start the study if tissue is available at an outside hospital, but not yet requested or received).
PTEN deficient tumor as documented from archival or fresh (from biopsy) tumor tissue analyzed by GlaxoSmithKline selected laboratory
Provision of (archival or fresh) FFPE tumor tissue. (For Cohort 3 only: if diagnosis was made by cytology and archival tissue is not available, patient will not need to provide tumor tissue)
Consent to provide archival tumor tissue for biomarker testing
Willingness to provide archival tissue from the primary diagnosis (original lymphoma lymph node tissue biopsy)
Archival tissue available for Foundation One analysis
Participants must have an archival tumor sample available (1 block or 20 unstained slides); if no archival tissue is available, participants must be willing to undergo a research biopsy of their disease if it is safely accessible
Archival tumor tissue obtained at any time from the initial diagnosis to study entry; a fresh tumor biopsy using a procedure that is safe for the subject on a lesion not previously irradiated unless lesion progressed will be required if archival tissue is unavailable.
Willing to undergo fresh liver biopsy if provided archival tissue was taken greater than (>) 6 months from Cycle 1 Day 1
Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1, Day 1
Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1 Day 1
Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent to a fresh tumor biopsy (mandatory for dose expansion cohort only; optional for dose escalation)
Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Agree to undergo a biopsy of at least one metastatic site or primary prostate for determination of the RB status; adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC (within 6 months of treatment start)
Patients enrolled in Part 2 must have at least 20 (preferably 40) slides of archival tumor tissue from a prior surgery demonstrating GBM; patients enrolled in Part 1 will not be required to have archival tissue
All patients must agree to provide an archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies; however, patients are not considered ineligible if archival tumor is not available
Archival tumor tissue from biopsy or resection will be required for all patients; archival tissue should be of good quality based on total and viable tumor contents; fine needle aspiration, brushing, and cytologic cell pellets are not acceptable
Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).
Archival tumor specimen according to protocol-defined criteria.
Patients without either fresh or archival tumor tissue accessible.
Consent to provide archival tissue
Patients with archival tumor tissue suitable for measurement of proteasome activity and biomarker status must give permission to access and test the tissue. Patients without archival tumor tissue are eligible for the Dose-Escalation stage, but not the Dose-Expansion stage of the study
Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment; patients without adequate tissue for bio-correlates will not be excluded or required to have a repeat biopsy