Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Tissue blocks or slides must be sent if available; if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment
Patient must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two  mm cores of tumor from the block and - unstained slides of whole sections of representative tumor tissue are preferred. Where two  mm cores of tumor from the block are unavailable, - unstained slides of whole sections of representative tumor tissue alone are acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study.
Part C: Archived paraffin-embedded tissue ( unstained slides or a tumor block) from a prior resection must be available as a control for correlative studies; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Tissue blocks or slides must be sent if available, with exclusions; if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment
Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to determine PD-L expression) the tumor tissue must be adequate for PD-L testing, which typically requires a minimum of  cancer cells per slide\r\n* NOTE: Initial order for specimen kits should be placed at least two weeks prior to registering the first patient at each site
Archival tumor tissue or a newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis. In the case archival tissue cannot be provided, participants with inaccessible tumors for biopsy specimens can be enrolled without a biopsy upon consultation and agreement by the sponsor Note: In case of submitting unstained cut slides, freshly cut slides should be submitted to the testing laboratory within  days from when the slides are cut
Participants must have fifteen blank (unstained) slides or a diagnostic tissue block must be available for external quality assurance by the AMC Core Pathology Laboratory
The patient must have at least  block of tissue or  unstained slides at a minimum available for central pathology review and molecular profiling of the tissue sample
Availability of tumor specimen block or  unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than  slides available may be enrolled after discussion with the principal investigator.
Patients must have a tissue block (or  unstained slides) available with adequate tumor to perform multiplex immunohistochemistry and nucleic acids analyses (i.e. whole exome sequencing); patients with only a previous fine-needle aspirate are ineligible for enrollment
Archival tissue block or unstained slides (from primary or metastatic site) must be available, otherwise fresh tissue biopsy sample will be collected for patients with accessible tumors
Tissue blocks or slides must be sent if available, for patients who consent for the optional correlative pathology studies, with the exception of intrinsic brain stem tumors, optic pathway gliomas, or subjects with pineal tumors; for consenting patients, if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment
Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least  unstained slides and/or tumor block)
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: The availability of archival tissue to evaluate retrospectively the participants retinoblastoma (Rb) status; the requirement is a minimum of  unstained slides with each tissue cut measuring  microns in width; ideally  slides will be requested; patients without available archival tissue may be enrolled at the discretion of the principal investigator
Participants must have archival tissue from the primary tumor or metastases available for correlative studies; either a paraffin block or twenty unstained slides are acceptable; if twenty slides are not available, a lesser amount may be acceptable after discussion with the principal investigator
Archival tissue of tumors (slides or blocks [blocks preferred]) must be available for analysis; If tissue is not available, patients willing to undergo a pre-treatment biopsy may enroll
Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence; if a tissue block is not available, - unstained slides may be provided as an alternative; if unstained slides will be provided, they should not be sent until specifically requested by the Dana-Farber Cancer Institute (DFCI) study coordinator; if archival tumor tissue is not available, a fresh biopsy may be performed
Tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Only patients with available archival tumor tissue must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays (Correlative Studies) of this protocol may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two  mm cores of tumor from the block and - unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two  mm cores of tumor from the block, - unstained slides of representative tumor tissue are also acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study.
Patients must consent to the submission of FFPE blocks and/or unstained slides
Patients must have verbal or documented acknowledgement of availability of unstained slides or paraffin block tissue from archived tumor specimen; if not available the patient will undergo a fresh biopsy
INCLUSION CRITERIA FOR STRATUM C: Patients must have adequate pre-trial FFPE tumor material available and be willing to provide a blood sample for use in the genome wide sequencing studies; while tissue is required for genome-wide sequencing of tumor and germline samples, patients will be deemed eligible for the study with a minimum of approximately  unstained slides for the planned analysis
Archival tissue block or unstained tumor tissue available for correlative studies
All subjects must have adequate archival tissue available prior to registration (i.e., at least  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.
Archival tumor specimen: All subjects in Arm A must submit at least  unstained slides from a tumor specimen that harbors H KM mutation. For subjects in Arm B, at least  unstained slides must be submitted if archival tissue is available from the DIPG. For subjects in any arm, if no archival tumor tissue is available, or if H KM status of tumor is unknown, then subjects must agree to submit a post-mortem biopsy specimen.
Archival tumor (up to  unstained slides) will be obtained, whenever available for additional biomarker analyses
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of  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)
The tumor tissue (e.g. block or  unstained slides) must be available to be sent for immunophenotyping
Archival tumor sample available; a minimum of  unstained slides; no fine needle aspiration (FNAs) allowed or tumor tissue from bone
For breast cancer patients, at least  sections of unstained slides should be obtained; if sufficient slides or tissue is unavailable, the patient will be excluded from the trial; for colon cancer patients, confirmation of tissue availability is not required, but documentation that the block is available must be provided to confirm eligibility
Evaluable untreated tumor tissue for biomarker analysis ( unstained slides or FFPE tissue block); subjects with <  slides may be enrolled after discussion with the sponsor-investigator or co-investigator; untreated tumor tissue is defined as no intervening intravesical or systemic therapy since acquisition; subjects without tissue available must be willing and safe to undergo biopsy repeat biopsy (core needle or excisional) prior to enrollment
Availability of >=  unstained  micron slides (to be provided to HTRC at the University of Chicago); patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study
Tissue available for analysis at time of enrollment for biomarker analysis (may be obtained via biopsy prior to initiation of treatment, or submission of available archival tissue: - slides, or  slides with  sections per slide
Tissue available from the diagnostic biopsy in the form of blocks, tissue cores, or slides available for submission to central pathology is required for all participants enrolled to this study; formalin-fixed paraffin-embedded tissue from diagnostic tissue is acceptable and recommended; submission of the institutional diagnostic slides is also preferred for all participants enrolled in the study
Tumor block or unstained slides must be available for molecular profiling
Adequate archival tissue (- slides, or  slides with  sections per slide) for biomarker analysis
Archival tumor tissue slides must be sent or available
Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase  tumor block or a minimum of  unstained slides
Availability of archival tumor tissue for biomarkers analysis (minimum of  unstained slides are optional); specimen from primary site will be allowed
Patients must have archival tissue, - slides, available for review and testing
Archival tumor sample available; a minimum of  unstained slides; no fine needle aspiration (FNAs) allowed or tumor tissue from bone
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of  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)
Paired pre-treatment and post-treatment biopsies are required for all patients on Part  and first  patients in Part ; participants must have available archival tumor tissue (at least  unstained slides); if archival tissue is not available or is found not to contain tumor tissue, a fresh biopsy is required; if a patient is having a tumor biopsy, less than  unstained slides are acceptable with approval of the principal investigator (PI); biopsies will only be performed in a given patient if they are not deemed to involve unacceptable risk based on the sites of disease and other concurrent medical conditions
Paraffin block or slides must be available
Patients must have available archived tissues of - unstained slides; if frozen tissues are available, at least  mg would be preferred, but not mandatory for study eligibility
Archival tumor tissue sample (i.e., representative tumor tissue specimen in paraffin block [preferred] or at least  unstained slides) must be requested and available prior to study entry
Mandatory submission of H&E and p stained slides for central review of p staining is required for oropharyngeal patients and H&E stained slide block (or punch biopsy of paraffin block) for PD-L expression analysis for all patients
Whenever available, archival tissue (block or minimum  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
MANDATORY archival tumor tissue (prior to treatment with a PD- or PD-L inhibitor) must be identified during screening and confirmation of acquisition should occur prior to registration. Archival tissue should not be shipped until registration of patient to study. Unavailability of tissue will render the subject ineligible for study. Sample requirement is FFPE block +  haemotoxylin and eosin (H&E) stained slides or  unstained slides +  H&E stained slide.
For patients enrolling on Part B: tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the Study Chair must be notified prior to enrollment
Patients must have tissue available and must agree to submission of tissue and blood; one to two paraffin-embedded tissue blocks or - unstained slides are requested (a minimum of  slides is required); cytology (i.e. fine-needle aspirations, pleural effusion specimens) is acceptable if a cell block or sufficient unstained slides are available; tumor material must be reviewed by a local pathologist who must confirm that at least  viable tumor cells are present in the sample and sign the S Pathology Review Form prior to registration; patients must also be willing to submit blood samples for correlative research at baseline, during treatment and at progression
Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.
Patients must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of  ( micron) slides of formal-fixed paraffin embedded (FFPE) tissue, with  ( micron) slides at the start and end of the  slides, for a total of  unstained slides; the diagnostic TURBT sample must have been obtained within  days prior to registration; all sections should be placed on \plus\ slides, as is the standard procedure in most pathology units
Patients must consent, if residual tumor is present at the time of cystectomy, to the submission of  ( micron) unstained slides with  ( micron) slides at the start and stop of the series (total of  unstained slides)
Patients must have available and be willing to submit a minimum of five unstained slides from primary, lymph node, or metastatic site to determine PD-L expression; the tumor tissue must be adequate for PD-L testing (defined as >=  tumor cells as confirmed by the treating institutions local pathologist); this must be documented by having a pathologist sign the S Local Pathology Review form prior to step  registration; the specimens may come from an archived block but must be submitted within  days from cutting the slides
Baseline tumor tissue, either fresh (preferred) or from paraffin block/unstained slides if contemporary biopsy is unsafe or not otherwise obtainable from the primary tumor site or metastatic site to be available for use on correlative studies
Archival tumor tissue block or  freshly cut, unstained, serial slides available for submission, or willingness to undergo a core or excisional biopsy prior to enrollment (fine-needle aspiration, brush biopsy, and lavage samples are not acceptable). Participants with fewer than  slides available may be eligible for study entry following discussion with Medical Monitor
Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples
Has sufficient archival tumor tissue (a minimum of  slides or tumor block) available for central retrospective testing of BAP status
Patients must have tumor (slides or block) available for submission for VE BRAF testing
Patient must be able to provide either archival tumor samples (hematoxylin and eosin [H&E] slides and one paraffin block or  unstained slides) or undergo tumor biopsy
Tumor tissue (a minimum of  and up to  unstained slides, or paraffin block, ideally from the patient's most recent biopsy, must be available at the patient's local institution prior to the first dose of study therapy.
Patients must have available an archival paraffin tumor block (from surgery on any meningioma or schwannoma) sufficient to generate at least  unstained slides; or, if a paraffin tumor block is unavailable, at least  unstained slides; Note: tumor block from the target meningioma is not required
Patients must have archival tissue from the primary tumor or metastases available for correlative studies; either a paraffin block or twenty unstained slides are acceptable; (if less than twenty unstained slides are available, the patient may be able to participate at the discretion of the investigator)
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion; while  unstained slides or a tumor block are preferred, at least  unstained slides are requested for analysis; principal investigator (PI) approval for a lower number of slides is acceptable
All patients must submit unstained slides of primary or recurrent tumor for translational analysis
Availability of archived tumor tissue for correlative studies ( unstained slides)
Participates must be able to submit  unstained slides from the initial tissue diagnosis for confirmation of diagnosis and correlative studies
Must have tissue available from the pre-treatment diagnostic biopsy (tissue blocks if possible; if not possible,  unstained slides from each positive core sample for a total of  slides whenever possible)
Availability of >=  unstained  micron slides
At least  unstained slides or at least  tissue blocks must be collected from at least one prior surgery; frozen tissue is also requested if available
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of  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)
Patients must have archival tissue from the primary tumor or metastases available for correlative studies; either a paraffin block or twenty unstained slides are acceptable; if twenty slides are not available, a lesser amount may be acceptable after discussion with the principal investigator
The availability of archival tissue to evaluate retrospectively the participants retinoblastoma protein (Rb) status as well as to perform next generation (NextGen) sequencing for tumor protein p (TP) and liver kinase B (LKB) status; the requirement is a minimum of  unstained slides with each tissue cut measuring  microns in width; ideally  slides will be requested; patients without available archival tissue may be enrolled at the discretion of the principal investigator
Patients must have measurable disease according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for pleural mesothelioma, or standard RECIST for peritoneal mesothelioma; patients must have adequate tissue sample available for molecular profiling with Memorial Sloan-Kettering (MSK)-IMPACT (archived tissue block or - unstained slides); patients will sign a separate informed document (Institutional Review Board [IRB] #-) to allow this to be performed
Patients must have a block of banked tumor tissue and/or fresh tumor tissue or at least  unstained slides available to be sent to the central laboratory
Patients should have tumor tissue available, and a tissue block of sufficient size to make  slides, which must be sent to Dana-Farber Cancer Institute (DFCI) for correlative research; if a tissue block is unavailable, sites may send one H&E stained slide and  unstained sections of paraffin-embedded tissue on uncharged slides; slide sections should be - microns in thickness; it is also acceptable to submit  cores from a block of invasive tissue using a . mm diameter coring tool; if tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue
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.
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  unstained slides) for cohorts a, , and expansion exists
Patients should have archival tumor tissue (either unstained slides or tumor blocks) available for retrieval
Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence; if a tissue block is not available, - unstained slides may be provided as an alternative; if unstained slides will be provided, they should not be sent until specifically requested by the Dana-Farber Cancer Institute (DFCI) study coordinator
Availability of archival diagnostic tissue (paraffin tissue block of resected tumor, core biopsy, fine needle aspirate cell block, or if block cannot be submitted - [ micron] unstained slides cut from a block representative of tumor, is required)
For patients enrolled in Part  (surgical substudy), patients must be willing to undergo surgical resection and have pre-treatment archival tumor tissue ( unstained paraffin slides) available for molecular analysis
EXPANSION COHORT ONLY: Patients must have pre-treatment archival tumor tissue; one paraffin block, frozen curls, or at least  freshly-prepared unstained slides from the most representative single paraffin-embedded tumor tissue block should be submitted; slides from the primary tumor are preferred; if both the primary and metastatic tumor blocks are available, at least  slides from each of the sites should be submitted, if possible; if tissue from the primary tumor is not available, a paraffin block or unstained slides from a metastatic site are acceptable; fine needle aspirates (FNAs) have insufficient tumor tissue and are not permitted
Patients must have tissue from the primary tumor or metastases available for correlative studies; either a paraffin block or at least  unstained slides are acceptable ( unstained slides would be ideal); (if less than twenty unstained slides are available and a paraffin block is not available, the patient may be able to participate at the discretion of the investigator)
Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of >=  unstained slides)
Additional available archival tumor tissue in the form of - unstained slides should be submitted to MSKCC for future correlative analysis, but will not be required prior registration; Note: if tissue is depleted, patient will still be eligible after discussion with the MSK principal investigator (PI)
(For expansion cohort only): Tissue must be available to confirm positive expression of AG antigen, defined as proportional score ?, via slides or tumor block from either original diagnostic biopsy material or biopsy of relapsed disease
At least  unstained slides or  tissue block (frozen or paraffin embedded) available from the most recent biopsy or surgery (archival tumor material); Exception: Arm C patients may be allowed to enroll without minimum number of requested unstained slides available, however consultation and approval by overall principal investigator (PI) is required
Must submit unstained slides from archival tumor tissue for PD-L and exploratory analysis; sites must verify that a tumor block is available to obtain unstained slides from prior to registration to the trial
Appropriate slides of the primary lesion will be available for future review; if available, HER/neu positivity will be recorded
Have tissues from a biopsy, or have up to  unstained slides available from archived metastatic tissue block for biomarker evaluation
Cohort Expansion: Available archival tumor tissue block or - unstained, consecutive core biopsy slides from one archival tumor block that meet specific tissue requirements.
Archival tumor block (or  unstained slides) for biomarker testing. Patients without archived tumor block material will be allowed to participate in the study.
Patient has archival or fresh tumor tissue for the analysis of PIK-related biomarkers. One tumor block (preferred) or a minimum of  unstained slides to be provided. Enrollment in the study is contingent on confirmation of an adequate amount of tumor tissue.
Sufficient tissue (block or slides) from diagnostic biopsy to undergo testing for FRa
If available, patient must agree to provide archival tissue for research purposes (either archival paraffin tissue block or  unstained slides of a primary or metastatic melanoma lesion) prior to enrollment; samples should be shipped within  month after enrollment
A tumor tissue sample is provided for immunohistochemical analysis of relevant antigens, immune markers and potential prognostic factors. Preferably a paraffin block or - unstained slides will be submitted prior to study entry. Patients for whom tumor samples are unavailable or inadequate are permitted to participate in the study; however, the absence of available/adequate tumor specimen must be documented.
Subject has available and has provided consent to release to the sponsor (or designee) a tumor block with confirmed tumor content (or approximately  unstained charged slides [a minimum of  slides is mandatory]) and the corresponding pathology report
Availability of fixed tumor specimen (block or slides) for exploratory biomarker analysis. If no slides or block are available, fresh tumor biopsies should be obtained and used for these assessments
The patient must have at least  block of tissue available or  unstained slides at a minimum, for central pathology review and molecular profiling of the tissue sample
Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit to the Canadian Cancer Trials Group (CCTG) Central Tumour Bank, a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays described in the protocol may be conducted; where tissue exists but local center regulations prohibit submission of blocks of tumor tissue, the approval of the CCTG must be sought prior to randomization of the first patient to allow cores (two  mm cores of tumor from the block) and slides ( x  micro thick unstained slides) of representative tumor tissue to be substituted; where tumor tissue is available, failure to submit any tissue samples will result in the patient being considered ineligible
Willing to provide tumor samples and / or slides
Participants must have an archival tumor sample available ( block or  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
Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
Pre-intervention biopsy tissue (most proximal to enrollment) with sufficient tumor tissue to cut - unstained slides confirmed to be available upon request
The pathology report and either () tissue (blocks or an unstained slides) or () a photomicrograph of the ER IHC slides from at least one site of metastatic disease and/or from primary breast cancer must be available for central review and analysis\r\n* NOTE: if photomicrographs are submitted, the submission of hematoxylin and eosin (H&E), PR and Ki IHCs, if performed, are also to be submitted
Patients must have available an archival paraffin tumor block sufficient to generate at least  unstained slides of  micron thickness; or, if a paraffin tumor block is unavailable, at least  unstained slides of  micron thickness
Tumor tissue blocks or at least  unstained slides from a prior diagnosis will be requested; hematoxylin and eosin (H&E) to confirm diagnosis must be available; the  unstained slides is preferred, but not required