A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\r\n* NOTE: Complete the EA3132-specific FoundationOne requisition form
Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary tumor, mandatory\r\n* NOTE: for adjuvant patients this refers to the surgical specimen; for neoadjuvant patients, both the pre-treatment core biopsy and the surgical specimen with residual disease are requested but only one is mandatory; if the surgery tumor blocks are available, but cannot be submitted, sites may submit a portion of invasive tumor from the original block, either by taking at least one core of at least 3 mm in diameter, or by splitting the original block in two parts, and re-embedding one in a new block for central submission; if blocks containing pre-neoadjuvant treatment core biopsies are available but cannot be submitted, sections mounted on glass slides prepared from the block can be provided; if tumor sample can't be provided as requested above or if it's not available, approval by study team for patient's entry into the trial is required
Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence\r\n* NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient’s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment
Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis.
Oestrogen receptor, progesterone receptor and HER2 negative advanced adenocarcinoma of breast. Parts A, B or D1 (solid malignancies) - Consented provision of formalin fixed paraffin embedded blocks/ slides from most recent tissue sample. Part C (all patients):
Subjects must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1; acquisition of existing formalin fixed paraffin embedded (FFPE) tumor tissue by study investigators is not mandatory for enrolment on the trial; patients without previous histologic/cytologic confirmation must have freshly obtained biopsy for routine pathologic evaluation before enrolment on the study
Willingness to undergo biopsy; if biopsy is not felt to be possible or safe, permission must be received from Dr. Tung to forgo a biopsy; in that event, formalin fixed, paraffin embedded (FFPE) tumor sample from a prior metastatic biopsy (preferable) or from the primary tumor tissue will be collected, unless none is available and Dr. Tung provides approval; if paraffin blocks are unable to be sent to for analysis due to institutional policy, 15 unstained paraffin slides may be sent instead; a formal eligibility exception is not needed as long as approval is granted and documented by Dr. Tung
Be willing to allow the use of archival formalin-fixed paraffin-embedded tumor tissue for correlative analyses\r\n* Note: The archived tumor tissue specimens may be from prior surgery or from prior diagnostic biopsy of primary or metastatic tumor specimen; unavailability of archived tissue will not render subject ineligible for study
Tissue from a prior craniotomy or biopsy for clinical genetic sequencing (at least one formalin-fixed, paraffin-embedded [FFPE] block or 15 unstained slides); patients previously assessed for genetic sequencing who meet requirements do not need to have additional tissue available for prospective genetic screening
Participants must have sufficient tissue from prior surgery revealing glioblastoma or variants for confirmation of diagnosis and correlative studies; the following amount of tissue is required:\r\n* 15 (5 um thick) unstained formalin fixed paraffin embedded (FFPE) sections\r\n* 1-2 hematoxylin and eosin (H&E) stained slides, or additional unstained 5 um slide(s) for staining\r\n* NOTE: the overall principal investigator (PI) will allow for up to 2 participants to enroll with insufficient tissue; if a site is hoping to enroll a patient with less than the tissue required, prospective approval by the overall PI is required
Is willing to provide and there is confirmed availability of pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing fresh tumor biopsy is optional for subjects in Dose Escalation cohorts.
Participants must have a tumor tissue sample available (formalin-fixed paraffin embedded [FFPE] tissue block or unstained slides); may be newly obtained or obtained within 6 months prior to enrollment (without systemic therapy given after the sample was obtained); participants without sufficient archival tissue may be enrolled following successful completion of the pre-treatment tumor tissue biopsy; tissue must be a core needle biopsy, excisional, or incisional biopsy; fine needle aspirates (FNA) or malignant effusions are not adequate; bone biopsies without a soft tissue component are not adequate
Willingness and availability to submit formalin-fixed paraffin-embedded (FFPE) tissue for central confirmation of HER2 positivity and central assessment of PD-L1 status. This can be from archival tissue from unresectable loco-regional or metastatic disease obtained =< 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. Tissue obtained for the biopsy must not have been previously irradiated. If a patient does not have any available archival tissue =< 1 year old and the treating investigator does not feel that it would be safe to perform a fresh biopsy, the requirement for a fresh biopsy may be waived after discussion with the Principal Investigator.
Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue section’s (slides) of tumor biopsy sample must be available for biomarker evaluation from baseline and repeat esophagogastroduodenoscopy (EGD)
Able to provide a fresh formalin-fixed, paraffin-embedded (FFPE) tumor sample for central evaluation of HER2 status prior to enrolment; if a fresh biopsy is not feasible, sponsor approval is required and archived tumor biopsy must be provided for centralized testing by sponsor
Patients must have tumor block or slides available for testing, and tumor must be glucocorticoid receptor positive (defined as GR >= 10% moderate to strong staining by central lab); a formalin-fixed, paraffin-embedded surgical or core needle biopsy obtained from the primary tumor or from a metastasis and containing viable tumor tissue is required for this evaluation; fine needle aspirates or other alternative cytology samples are not acceptable
Patients must provide written consent to allow a core needle biopsy samples of tumor tissue (primary or metastatic) to be obtained during baseline for analysis of mutations associated with his/her malignancy, and for correlation studies; if available, patients may elect to provide a formalin fixed paraffin embedded (FFPE) tissue block (from his/her primary or metastatic tumor) obtained within 45 days prior to written consent for the clinical trial granting release of the paraffin block; planned to undergo standard surgical resection for potential cure or for palliation when applicable
PHASE I: Must be willing to provide tumor tissue biopsy samples (may be fresh or archival paraffin embedded) at baseline
PHASE IB: Must be willing to provide tumor tissue biopsy samples (may be fresh or archival paraffin embedded) at baseline
Patients must have adequate pre-trial formalin-fixed paraffin-embedded (FFPE) tumor material available for use in the biology studies mutational analysis and genome wide sequencing for each stratum\r\n* Patients with DIPG who have tissue available are requested to submit similar tissue as patients in other strata; however, this is not required for eligibility
Formalin fixed paraffin embedded tumor tissue (preferably from current recurrence) must be available to assess Rb1 protein status prior to enrollment; only patients with recurrent diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for Rb1 protein status confirmation
Willingness to provide paraffin-embedded tissue blocks of ovarian cancer
CD30 staining is to be performed on fresh biopsy or archival formalin-fixed paraffin-embedded (FFPE) tissue however CD30 positivity is not required for eligibility
Patients must have available and be willing to provide formalin fixed paraffin embedded tissue sample from archival tissue (patients who can’t provide archival tissue will be offered an optional biopsy; lack of tissue will not be exclusionary)
Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
Available archival formalin-fixed paraffin-embedded (FFPE) from a prior biopsy or, participant must be willing to have a tissue biopsy taken at a clinic visit prior to start of study treatment
Available tumor samples:\r\n* A formalin-fixed paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a Response Evaluation Criteria in Solid Tumors [RECIST] target lesion); alternatively, a recently obtained archival FFPE tumor tissue block (cut slides not\r\nacceptable) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of enrollment AND 2) the patient has not received any intervening systemic anticancer treatment from the time the tissue was obtained and randomization onto the\r\ncurrent study\r\n* Availability of an archival FFPE tumor tissue block from primary tumor resection specimen (if not provided per above); if an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable
A formalin fixed tissue block or equivalent of 24 slides of the tumor sample for analyses by Adaptive Sequenta and NeoGenomics must be available for analysis
Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
Prostate biopsy. If previous biopsy has been performed within 3 months of screening, second biopsy procedure will not be required, if archival biopsies and at least one formalin fixed paraffin embedded biopsy tissue block containing tumor is available.
Patients must agree to have a biopsy of non-bone metastatic tissue at baseline, and there must be a lesion that can be biopsied with acceptable clinical risk as judged by the investigator\r\n* Patients with unsuccessful baseline biopsies or inconclusive DNA damage repair status testing (either MSI or FA/BRCA signature) may undergo an additional biopsy attempt (at the same or a different site, determined by the investigator)\r\n* Patients with previously identified homozygous deletion or deleterious germline or somatic mutation(s) in DNA damage repair gene(s) (such as BRCA1, BRCA2, and ATM) identified in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory are allowed in Group 2\r\n** Somatic mutation(s) in DNA damage repair gene(s) needs to be identified on the biopsy of a castration-resistant metastatic site\r\n** Archival formalin-fixed paraffin-embedded (FFPE) tissue will be requested for determination of MSI and FA/BRCA signature status\r\n*** A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report before study enrollment\r\n*** If archival FFPE tissue is unable to be obtained or is insufficient, patients will be required to undergo biopsy of a metastatic site if feasible for determination of MSI and FA/BRCA signature status\r\n* Patients with germline mutation(s) in mismatch repair (MMR) gene(s) (i.e. Lynch syndrome), or have previously identified MSI-high tumor by polymerase chain reaction (PCR) or MMR deficient tumor by immunohistochemistry (IHC) are also allowed in Group 2\r\n** Archival FFPE tissue will be requested for determination of FA/BRCA signature status\r\n*** A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report before study enrollment\r\n** If archival FFPE tissue is unable to be obtained or is insufficient, patients will be required to undergo biopsy of a metastatic site if feasible for determination of FA/BRCA signature status.
Patients must have available tissue (archived formalin-fixed paraffin embedded [FFPE] blocks or fresh frozen biopsy from primary tumor or metastatic tumor biopsy) for correlative studies; tissue source needs to be located and available at the time of registration (tissue needs to be submitted within 3 weeks of study initiation); patients will not be able to start study drugs without tissue availability
Patient's tissue must be positive for p16 by immunohistochemical staining (> 70% staining); fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin fixed paraffin-embedded cell block material is available for p16 immunohistochemistry
Participant must consent to repeated biopsy to allow the acquisition of fresh and/or formalin-fixed paraffin-embedded (FFPE) material. Available archived tumor material may be submitted as the pretreatment biopsy provided that minimum requirements are met by local pathology review as defined in the laboratory manual. If archived tumor material is not available or does not meet minimum requirements, then a fresh tumor biopsy must be obtained in accordance with local institutional practice.
Available representative tissue (10-15 slides from fresh or formalin fixed paraffin embedded tissue) from the most recent biopsy or archival tumor tissue for clonotype evaluation for minimal residual disease (MRD) testing
Archival formalin-fixed paraffin-embedded (FFPE) tumor tissue must be available for correlative studies (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission)
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
Availability at the study site of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available, and willingness of the subject to undergo mandatory fresh tumor biopsy prior to treatment initiation unless determined medically unsafe or not feasible; a prior biopsy cannot take the place of the baseline mandatory biopsy\r\n* The archival specimen must contain adequate viable tumor tissue\r\n* The specimen may consist of a tissue block (preferred and should contain the highest grade of tumor) or at least 20 unstained serial sections; fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable\r\n* Fresh tumor biopsy at progression will be optional as detailed in study schema
Must give valid written consent to provide archival formalin-fixed paraffin-embedded (FFPE) and/or newly acquired tumor tissue for the purpose of establishing baseline PD-L1 status as well as consent to provide on- and/or post-treatment tumor biopsy sample
Available archival tumor tissue for correlative studies; submission of archival transrectal ultrasound (TRUS) prostate biopsy tissue is required if available, in the form of representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 slides, with an associated pathology report; if archival prostate tissue are unavailable or cannot be obtained, a repeat TRUS prostate biopsy is not required for eligibility
The subject must be medically capable of providing the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor\r\n* This requirement may be satisfied by providing an archival tissue sample in the form of a formalin-fixed paraffin-embedded or frozen tissue block from an earlier resection
Patients must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB] or fresh frozen tissue from original diagnosis or metastatic setting) for correlative studies; patients will not be able to start study drugs without tumor tissue availability; patients without available tumor tissue can still participate if willing to have a fresh biopsy of a metastatic lesion that is deemed to be medically safe (except for bone metastases)
Availability of tissue for correlative studies; patients must have at least 6-8 unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available; if not enough archived tissue is available, a fresh tumor biopsy prior to study initiation is mandatory; for patients who have undergone a fresh baseline biopsy at baseline, the archived tissue is not mandatory
Phase 1b only: Formalin-fixed paraffin embedded blocks (FFPB) or fresh frozen tissue from the original diagnosis or the metastatic setting should be located; tissue must be submitted with 3 weeks of study initiation
Patients must:\r\n* Be scheduled to undergo a standard-of-care resection of tumor tissue as part of treatment plan prior to beginning study therapy OR pre-treatment biopsy; patients may not have intervening systemic anti-cancer therapy between the time of resection/biopsy and treatment with nivolumab\r\n* Have collection of adequate pre-treatment tissue for correlative analysis defined as sufficient material for 1) frozen tissue for deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) extraction, 2) formalin-fixed, paraffin-embedded (FFPE) material for immunohistochemistry (IHC); adequacy of collected material will be determined within 5 business days of each collected case\r\n* Have measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 (those undergoing pre-treatment resection must have imaging assessment after resection to determine measurability)\r\n** Previously irradiated sites of tumor may be considered measurable if there is radiographic progression at that site subsequent to the time of completing radiation\r\n* Have a safely biopsiable tumor lesion
Provision of tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion\r\n* Tumor tissue may be from a diagnostic biopsy or a portion of a surgical specimen, if surgery is a component of definitive intent therapy\r\n* Formalin fixed paraffin embedded (FFPE) tissue samples are acceptable; a fine needle aspirate, frozen sample, plastic embedded sample, cell block, clot, bone, bone marrow or cytologic specimen will not be acceptable for immunohistochemistry (IHC) analysis\r\n* It is recommended that FFPE blocks be sectioned fresh (within 7 days of sectioning and sending for PD-L1 analysis) onto positively charged slides; slides should be stored and shipped (and stored upon receipt at Qualtek) at 2-8 Celsius (C) in the dark\r\n* Recommended fixation time for samples is 24 hours to 48 hours in 10% neutral buffered formalin
Tumor specimen (paraffin-embedded block or frozen tissue) from prior resection or biopsy available that is sufficient to perform pharmacodynamic assays (>= 3 slides for immunohistochemistry [IHC]) – mandatory for patients in the dose expansion cohort only; if the specific diagnosis occurs radiologically as standard of care and a diagnostic procedure is too dangerous for any reason, subjects may be enrolled on study without tissue that being available for correlative studies
Available archived tumor (formalin-fixed, paraffin-embedded tissue block) for genomic and proteomic analysis
Sufficient archival tissue available for correlative studies; submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue from a previous biopsy or resection is required, and the most recent specimen is preferred; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted; if insufficient archival tissue is available, a repeat biopsy will be necessary
Available core biopsies from the time of diagnosis; these may include sections paraffin-embedded material
Archival tumor biospecimen (when available) must be procured for correlative evaluation; if tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study\r\n* Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least 12 unbaked, unstained slides are required; tissue samples taken from a metastatic lesion prior to the start of screening are acceptable
Cohort 2 (MTD) only: patient willing to have paraffin-embedded slides of the primary pancreas tumor or metastatic site, if available, sent to Mayo investigators for this study
Subjects must provide sample of archival tumor tissue (tissue block preferred, at least 5 formalin-fixated, paraffin-embedded [FFPE] slides acceptable) collected any time before the general screening; a fresh biopsy will be collected if archival sample is unavailable or insufficient
Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review; fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry; FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review; if the p16 preparation is not adequate, additional specimens will be required to establish p16 status; centers are encouraged to contact the pathology chairs for clarification
Participant has one of the following available for PD analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.
Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
Subject has measurable disease according to RECIST 1.1. 4. Archival formalin-fixed, paraffin-embedded tumor sample collected within 90 days prior to subject consent available or subject has biopsiable metastatic lesion and is willing to undergo biopsy .
Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from surgery after neoadjuvant chemotherapy and from core-biopsy before start of neoadjuvant chemotherapy, which will be used for centralized retrospective confirmation of hormone- and HER2-status and to evaluate correlation between genes, proteins, and mRNAs relevant to the endocrine and cell cycle pathways and sensitivity/resistance to the investigational agents. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue or new biopsy, if archived tissue is unavailable for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible.
A paraffin-embedded tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the Mayo Clinic Lymphoma Laboratory following pre-registration; Note: excisional tumor biopsy is preferred; core needle biopsies will be considered adequate if there is enough tissue for the mandatory central pathology review immunohistochemistry and Genomics Education Partnership (GEP); submission of a tumor block is preferred, but if unavailable submit alternative materials
Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
Fresh core biopsy, frozen, must be performed before start of therapy and submitted for storage. This is optional only for the subjects who have a biopsy-accessible site and consent to the procedure. In case no prior fixed formalin paraffin embedded (FFPE) biopsy is available, this specimen can also be used for diagnostic confirmation.
Patients for whom a formalin-fixed, paraffin-embedded tumor block (or 16 unstained sections [charged, 4 um]) of the biopsy or curettage are unavailable and patient is unwilling to undergo repeat biopsy or curettage
Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) for assessment of tumor-based biomarkers and immune score is required for eligibility
Provided newly obtained formalin fixed tumor tissue from a biopsy of a tumor at the time of or AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiated
Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis
Participant has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made and from a site not previously irradiated to assess for a protein known as Programmed death-ligand 1( PD-L1) status. Fine needle aspirates, endobronchial ultrasound (EBUS) or cell blocks are not acceptable. Needle or excisional biopsies, or resected tissue is required. Archival tissue may be acceptable. Submission of formalin-fixed paraffin embedded tumor tissue sample blocks are preferred; if submitting unstained slides, the slides should be freshly cut and submitted to the testing laboratory within 14 days from site slide sectioning date otherwise a new specimen will be requested.
Subject has available formalin-fixed, paraffin-embedded tumor specimen with adequate viable tumor cells in a tissue block or unstained serial slides accompanied by an associated pathology report prior to enrollment. Archival or fresh biopsy tissue is required.
Availability of tumor tissue is required for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin embedded (FFPE) tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
Patients must be willing to provide and have available formalin fixed paraffin embedded tissue sample from archival tissue or newly obtained core or excisional biopsy of a tumor lesion for central analysis; Note: fine needle aspiration’s (FNA), frozen samples, plastic embedded samples, cell blocks, clots, bone, bone marrow, or cytologic specimens are exclusionary
Patients must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB] or fresh frozen tissue from original diagnosis or metastatic setting) for correlative studies; tissue needs to be located and available at the time of registration (tissue needs to be submitted within 3 weeks of study initiation); patients will not be able to start study drugs without tissue availability
Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening
Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening
Baseline paraffin embedded tissue from the patient’s primary diagnosis is requested before study enrollment and should be forwarded to the designated central laboratory where central assessment of Rb and p16 expression will be performed by using immunohistochemistry; in patients with measurable disease a tissue biopsy may be obtained by core biopsy and submitted to the designated central laboratory
Paraffin-embedded and/or snap-frozen tumor tissue samples (from primary tumor or metastasis) taken as part of routine clinical care must be available for study related correlative studies; if paraffin-embedded and/or snap-frozen tumor tissue samples are not available, at least 15 unstained tumor slides will be requested
Either a formalin fixed tissue block or a minimum of 10 slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling)
Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required
Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies required
Archival paraffin-embedded invasive tumor tissue or newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis; patients must be offered sequential biopsies at baseline and 6 weeks unless in the opinion of the trial principal investigator (PI) this would be hazardous
Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma with size >= 5 cm are eligible to enroll if the intention to treat is curative; they must have sufficient tissue to submit to central laboratory for review as well as for NGS sequencing (see submission requirement); availability of tumor tissue is mandatory for study eligibility; the patient must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue for future central pathology review, NGS sequencing and/or translational research
Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible
Archival tumor tissue available for immunohistochemistry (IHC) (1 paraffin-embedded block)
Representative archival tumor sample from glioblastoma (formalin-fixed paraffine embedded tissue) must be available.
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or minimum of 3 unstained slides of tumor sample obtained via excisional, incisional, or core needle biopsy from a metastatic or loco-regionally recurrent lesion; a new baseline biopsy does not need to be obtained for study purposes; if 3 unstained are unavailable from a metastatic or loco-regionally recurrent lesion, with permission of the principal investigator (PI), FFPE tumor tissue from the primary disease site at the time of original diagnosis is acceptable
Patients must have a site of disease that is amenable to pretreatment and on-treatment core biopsies; at least 3 formalin fixed, paraffin embedded (FFPE) slides at five microns each may be collected at each biopsy; determination of tissue accessibility and quantity will be made by the consenting clinician; patients must consent to the two study-required biopsy procedures
Patient must consent to provision of a representative formalin fixed paraffin block of tumor tissue, if available, in order that the specific correlative marker assays may be conducted.
All subjects must provide a tumor tissue sample from [Formalin Fixed Paraffin Embedded (FFPE) slides] archival tissue or fresh biopsy collected before Cycle 1, Day 1
Histologically confirmed all-rat sarcoma viral oncogene homolog (RAS) wild type; paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.
Paraffin-embedded sections of tissue acquired from surgery at the time of suspected recurrence must be available for analysis
Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic disease
Availability of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available, and willingness of the subject to undergo mandatory fresh tumor biopsy prior to treatment initiation unless determined medically unsafe or not feasible; given that fresh tumor tissue is required for correlative assessments, a prior biopsy cannot take the place of the pre-treatment mandatory biopsy\r\n* The archival specimen, when available, must contain adequate viable tumor tissue\r\n* The specimen may consist of a tissue block (preferred and should contain the highest grade of tumor) or at least 20 unstained serial sections; fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable\r\n* A mandatory biopsy at the time of radiographic progression will be requested from patients who have an initial response to treatment and then subsequently progress as determined by RECIST version 1.1
Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)
Subjects must have adequate fresh or paraffin embedded tissue
Paraffin-embedded and/or snap-frozen tumor tissue samples from the diagnostic procedure must be available for study-related correlative studies; if paraffin-embedded and/or snap-frozen tumor tissue samples are not available, at least 15 unstained tumor slides will be requested
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 2 mm cores of tumor from the block and 10-30 unstained slides of whole sections of representative tumor tissue are preferred. Where two 2 mm cores of tumor from the block are unavailable, 10-30 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.
Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume\r\n* The local interpreting pathologist must review the specimen\r\n* The pathologist must sign the S1400 Local Pathology Review Form confirming tissue adequacy prior to screening/pre-screening registration\r\n* Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker profiling and c-MET IHC; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment; patients must agree to have any tissue that remains after NGS testing retained for the use of the translational medicine (TM) studies (if such TM studies are defined) within any sub-study the patient is enrolled in
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-L1 expression) the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 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 14 days from when the slides are cut
A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
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 1 block of tissue or 15 unstained slides at a minimum available for central pathology review and molecular profiling of the tissue sample
Availability of tumor specimen block or 30 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 30 slides available may be enrolled after discussion with the principal investigator.
Patients must have a tissue block (or 26 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
Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and/or tumor block)
Availability of at least 12 unstained slides from archival FFPE tumor tissue.
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: The availability of archival tissue to evaluate retrospectively the participant’s retinoblastoma (Rb) status; the requirement is a minimum of 5 unstained slides with each tissue cut measuring 4 microns in width; ideally 15 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
Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence; if a tissue block is not available, 10-20 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
Confirmation of availability of FFPE tumor specimen with adequate tumor tissue (either one paraffin embedded tissue block OR 10 5-micron unstained slides from the block on regular (non-plus) slides and 1 hematoxylin and eosin [H&E] slide)
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 2 mm cores of tumor from the block and 5-20 unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block, 5-20 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.
Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable
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 10 unstained slides for the planned analysis
Archival tumor specimen: All subjects in Arm A must submit at least 5 unstained slides from a tumor specimen that harbors H3 K27M mutation. For subjects in Arm B, at least 5 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 H3 K27M status of tumor is unknown, then subjects must agree to submit a post-mortem biopsy specimen.
Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 1 cm^2 of tumor surface area, or 20 unstained slides from the glioblastoma tissue specimen if a tumor block cannot be submitted
Archival tumor (up to 10 unstained slides) will be obtained, whenever available for additional biomarker analyses
Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 1 cm^2 of tumor surface area, or 20 unstained slides from the tumor tissue specimen if a tumor block cannot be submitted
Archived or freshly biopsied primary and/or bone metastatic tumor tissue available in paraffin-embedded blocks or slides that is expected to yield 9 slides
The tumor tissue (e.g. block or 15 unstained slides) must be available to be sent for immunophenotyping
Archival tumor sample available; a minimum of 10 unstained slides; no fine needle aspiration (FNAs) allowed or tumor tissue from bone
For breast cancer patients, at least 6 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 (25 unstained slides or FFPE tissue block); subjects with < 25 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 >= 10 unstained 5 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
A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor or lymph node; a minimum of 8 slides must be available
Tumor block or unstained slides must be available for molecular profiling
Adequate archival tissue (10-15 slides, or 5 slides with 3 sections per slide) for biomarker analysis
Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase – tumor block or a minimum of 5 unstained slides
Availability of archival tumor tissue for biomarkers analysis (minimum of 10 unstained slides are optional); specimen from primary site will be allowed
Tumor tissue available from original diagnosis and/or recurrence; a minimum of 1 FFPE archival tumor tissue block (preferred) or a minimum of 20 FFPE unstained slides from initial and/or most recent pre-registration biopsy or resection. It is recommended that at least 1 cm^2 of tissue composed primarily (defined as greater than 85%) of tumor is present.
Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable
Archival tumor sample available; a minimum of 10 unstained slides; no fine needle aspiration (FNAs) allowed or tumor tissue from bone
Paired pre-treatment and post-treatment biopsies are required for all patients on Part 1 and first 15 patients in Part 2; participants must have available archival tumor tissue (at least 20 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 20 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 20-30 unstained slides; if frozen tissues are available, at least 200 mg would be preferred, but not mandatory for study eligibility
Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
Archival tumor tissue sample (i.e., representative tumor tissue specimen in paraffin block [preferred] or at least 20 unstained slides) must be requested and available prior to study entry
Mandatory submission of H&E and p16 stained slides for central review of p16 staining is required for oropharyngeal patients and H&E stained slide block (or punch biopsy of paraffin block) for PD-L1 expression analysis for all patients
MANDATORY archival tumor tissue (prior to treatment with a PD-1 or PD-L1 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 + 2 haemotoxylin and eosin (H&E) stained slides or 17 unstained slides + 1 H&E stained slide.
For stage 2 GBM participants, a block of paraffin embedded tissue or 30 unstained slides at standard 4-5 um thickness from any prior surgery demonstrating GBM pathology must be available for submission
Patients must have tissue available and must agree to submission of tissue and blood; one to two paraffin-embedded tissue blocks or 15-20 unstained slides are requested (a minimum of 12 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 100 viable tumor cells are present in the sample and sign the S1403 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 20 (10 micron) slides of formal-fixed paraffin embedded (FFPE) tissue, with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides; the diagnostic TURBT sample must have been obtained within 56 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 20 (10 micron) unstained slides with 2 (5 micron) slides at the start and stop of the series (total of 22 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-L1 expression; the tumor tissue must be adequate for PD-L1 testing (defined as >= 100 tumor cells as confirmed by the treating institution’s local pathologist); this must be documented by having a pathologist sign the S1404 Local Pathology Review form prior to step 1 registration; the specimens may come from an archived block but must be submitted within 20 days from cutting the slides
Confirmed availability of representative tumor specimens in paraffin blocks/unstained 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 15 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 15 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
Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report
Has sufficient archival tumor tissue (a minimum of 10 slides or tumor block) available for central retrospective testing of BAP1 status
Patients must have tumor (slides or block) available for submission for V600E BRAF testing
Paraffin-embedded tumor block(s) or 15 to 20 unstained slides available for centralized assessment of ER, PR, and HER2.
Patient must be able to provide either archival tumor samples (hematoxylin and eosin [H&E] slides and one paraffin block or 10 unstained slides) or undergo tumor biopsy
Pathology: representative urothelial carcinoma FFPE tumor specimens (tumor blocks or 30 unstained slides); patients with < 30 slides may be enrolled after discussion with the principal investigator
Tumor tissue (a minimum of 10 and up to 15 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.
Archived tumor tissue (block or 15-20 unstained slides) available, or be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in less accessible lymph nodes, 4 to 8 core biopsies).
Patients must have available an archival paraffin tumor block (from surgery on any meningioma or schwannoma) sufficient to generate at least 5 unstained slides; or, if a paraffin tumor block is unavailable, at least 5 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)
Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion; while 20 unstained slides or a tumor block are preferred, at least 14 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 (5 unstained slides)
Participates must be able to submit 20 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, 10 unstained slides from each positive core sample for a total of 30 slides whenever possible)
Availability of >= 10 unstained 5 micron slides
At least 15 unstained slides or at least 1 tissue blocks must be collected from at least one prior surgery; frozen tissue is also requested if available
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 participant’s retinoblastoma protein (Rb) status as well as to perform next generation (NextGen) sequencing for tumor protein p53 (TP53) and liver kinase B1 (LKB1) status; the requirement is a minimum of 5 unstained slides with each tissue cut measuring 4 microns in width; ideally 15 slides will be requested; patients without available archival tissue may be enrolled at the discretion of the principal investigator
Patients must have a block of banked tumor tissue and/or fresh tumor tissue or at least 10 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 15 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 15 unstained sections of paraffin-embedded tissue on uncharged slides; slide sections should be 4-5 microns in thickness; it is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 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 definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
Patients should have archival tumor tissue (either unstained slides or tumor blocks) available for retrieval
The mutational analysis (SNaPSHOT panel) requires a paraffin-embedded block or ten unstained slides from the untreated biopsy specimen obtained at the time of upper endoscopy or initial diagnostic biopsy; patients without sufficient material for SNaPSHOT will NOT be excluded from the study
Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence; if a tissue block is not available, 10-20 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 10 unstained slides or paraffin-embedded tissue block from archived tumor specimen
Availability of archival diagnostic tissue (paraffin tissue block of resected tumor, core biopsy, fine needle aspirate cell block, or if block cannot be submitted 20-25 [5 micron] unstained slides cut from a block representative of tumor, is required)
For patients enrolled in Part 2 (surgical substudy), patients must be willing to undergo surgical resection and have pre-treatment archival tumor tissue (15 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 10 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 10 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 20 unstained slides are acceptable (30 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 >= 10 unstained slides)
Additional available archival tumor tissue in the form of 15-20 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)
At least 15 unstained slides or 1 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-L1 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, HER2/neu positivity will be recorded
Have tissues from a biopsy, or have up to 20 unstained slides available from archived metastatic tissue block for biomarker evaluation
Cohort Expansion: Available archival tumor tissue block or 5-10 unstained, consecutive core biopsy slides from one archival tumor block that meet specific tissue requirements.
Archival tumor block (or 20 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 PI3K-related biomarkers. One tumor block (preferred) or a minimum of 12 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
A tumor tissue sample is provided for immunohistochemical analysis of relevant antigens, immune markers and potential prognostic factors. Preferably a paraffin block or 10-12 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 20 unstained charged slides [a minimum of 7 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
AR expression >= 5% by immunohistochemistry (IHC); in cases where multiple blocks are available staining will be performed on unstained slides from 3 separate blocks; if >= 5% AR tumor staining is seen on >= 1 slide the tumor will be considered to be AR+
The patient must have at least 1 block of tissue available or 15 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 2 mm cores of tumor from the block) and slides (20 x 5 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
A tumor block or 10 unstained slides must be available for determining EGFR mutational status; only those patients who have a mutation of the EGFR tyrosine kinase domain will be able to enroll in this study
Willing to provide tumor samples and / or slides
Availability at the site of tumor specimens in paraffin blocks (preferred) or 16 unstained slides, with an associated pathology report, prior to study entry
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 5-10 unstained slides confirmed to be available upon request
The pathology report and either (1) tissue (blocks or an unstained slides) or (2) 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 Ki67 IHC’s, if performed, are also to be submitted
Patients must have available an archival paraffin tumor block sufficient to generate at least 10 unstained slides of 8 micron thickness; or, if a paraffin tumor block is unavailable, at least 10 unstained slides of 8 micron thickness
Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 1 cm^2 of tumor surface area from a tissue specimen that demonstrates pathological transformation to glioblastoma (WHO grade IV) or a progressive specimen that harbors one of the genetic alterations\r\n* If a tumor block cannot be submitted, then 20 unstained slides (preferably 10 slides from two different tumor blocks from the same surgery) from the tumor specimen must be submitted
Tumor tissue blocks or at least 20 unstained slides from a prior diagnosis will be requested; hematoxylin and eosin (H&E) to confirm diagnosis must be available; the 20 unstained slides is preferred, but not required
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)
Unless the pre-screening was performed at Yale Clinical Molecular Pathology Lab (YCMPL), patients must have TCC tumor tissue available for submission in a form of at least 10 unstained slides or formalin-fixed paraffin-embedded (FFPE) block (FFPE block highly recommended and preferred) along with a buccal swab; if the number of slides is less than 10, a biopsy should be considered; if a biopsy is deemed unsafe, the case may be discussed with the study principal investigator (PI) and approval must be given for eligibility
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast resected at the time of definitive surgery completed
Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
An adequate amount of archived tumor tissue, either from primary colorectal cancer site or metastatic lesions, for central confirmation of dMMR status:\r\n* Either whole or part of the formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue; or\r\n* At least 8 unstained slides containing tumor sections
Must consent to allow the acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies
Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 25 unstained slides, collected ?3 months prior to randomization, with an associated pathology report, if available
Subject has consented to provide archival formalin-fixed, paraffin-embedded (FFPE) tumor block; if archival tissue is not available, Subject must consent to tumor biopsy.
Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Have available archival formalin-fixed paraffin-embedded block(s) containing tumor or at least 20 unstained slides containing tumor.
Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment
Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is requested, but not mandatory
Availability of archival tumor tissue for biomarkers analysis (formalin-fixed paraffin-embedded [FFPE] block or cell block will be required); specimen from primary site will be allowed; patients must have at least 10 slides available; repeat biopsy to obtain sufficient tissue for 10 slides is allowed
Availability of 20 archival formalin-fixed paraffin embedded (FFPE) tumor tissue slides (15 of 10 uM thick sections, and 5 of 5 uM thick sections)
Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block; a recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides [10 minimum] will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 3 years of trial screening; patients with tumor specimens older than 3 years may still be eligible if deemed so by study sponsor
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (metastatic specimens preferable but if not available primary tumor specimens that are at least muscle-invasive are acceptable) in paraffin blocks (blocks preferred) or at least 15 unstained slides. If archival tissue is not available, subjects may be considered for enrollment on a case by case basis after discussion with the sponsor-investigator
A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry. If 20 slides are not available or the tissue block is not of sufficient size, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor
Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 25 unstained slides with an associated pathology report, if available
Patients must agree to submission of tumor blocks or 15-20 formalin-fixed paraffin embedded (FFPE) slides of 5-10 microns in thickness from transurethral resection of bladder tumor (TURBT) and radical cystectomy tissues
The formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be available to be sent for retrospective central pathology review after registration)
At least one prior surgery with available archival formalin-fixed paraffin-embedded (FFPE) tumor blocks
Patients must be willing to provide archival tissue from prior biopsy or surgery for prostate cancer, if available\r\n* A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report before study enrollment
Formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival) - Biopsy should be excisional, incisional, or core. Needle aspiration is insufficient.
Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue
Pathology review demonstrates tumor cellularity no less than 30% in quantities sufficient to obtain 6-8 1 mm biopsies from the original formalin-fixed paraffin-embedded (FFPE) blocks
Participants must have sufficient tissue from most recent surgery revealing glioblastoma or variants for submission following registration. The following amount of tissue is required:\r\n* 1 formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) OR\r\n* 10 FFPE unstained slides (5 um thick)
The patient/legal representative must be willing to provide written consent for collection of formalin fixed paraffin-embedded blocks or slides from archival diagnostic histology samples, where available
Availability of tumor tissue (e.g. formalin-fixed, paraffin-embedded [FFPE]) for genomic profile (typically 12 unstained FFPE 5-10 micron slides, minimum of 10)
Patients must agree to submission of tumor tissue from transurethral resection of the bladder tumor (TURBT) including a paraffin block or 20 formalin-fixed paraffin embedded (FFPE) slides of 5-10 microns in thickness; patients must also agree to submission of tissue from cystectomy
Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
Subject has one archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
Provision of an archival tissue block, or 10 formalin-fixed paraffin-embedded (FFPE) slides, if available, and if not available having biopsiable disease and agreeing to pre-treatment biopsies
Availability of an archival (?5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated
Stratum 1: Recurrent or refractory primary malignant CNS tumor patients must have adequate pre-trial frozen or formalin-fixed paraffin-embedded (FFPE) tumor material (minimum of 10 unstained slides) available for use in the tumor mutation burden studies
Confirmation of availability of sufficient tissue from a prior surgery for correlative studies is required prior to enrollment; these samples must be sent to the DFCI Coordinating Center within 60 days of registration; Cohort 1 participants must have sufficient formalin fixed paraffin embedded (FFPE) tissue from any surgery; Cohort 2 participants must have tissue from biopsy or resection from the most recent recurrence surgery; the following amount of tissue is required:\r\n* 25 unstained formalin fixed paraffin embedded (FFPE) sections (standard 4-5 micrometer thickness)\r\n* AND 1 H&E stained slide (or 1 additional unstained 4-5 um slide for staining) \r\n* AND one of the following for genomics/nucleic acid extraction:\r\n** At least 10 (preferably 20) unstained FFPE sections of 10 micrometer thickness OR\r\n** At least 8 tissue cores from an FFPE block (200 micrometer total thickness of tissue from a block with a total surface area of 0.5 cm^2) OR\r\n** At least 200 mg of frozen tissue
There must be availability of a formalin-fixed, paraffin-embedded tumor specimen
Whenever possible, a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) for biomarker evaluation should be made available and submitted to the central lab for correlative studies
Fresh/archived tumor tissue available for molecular marker testing is required for entry; a tumor block or at least 5 unstained slides must be available; as an alternative formalin-fixed paraffin-embedded (FFPE) cell block that is sufficient for histologic analysis is acceptable
Patients must be willing to provide archival formalin-fixed paraffin-embedded (FFPE) or frozen specimens for central analysis, if available
Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
Availability of formalin-fixed paraffin-embedded tumor tissue diagnostic of glioblastoma.
Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for PIK3CA-mutation testing
The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ? 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report
Availability of adequate Formalin-fixed, paraffin embedded (FFPE) archival tumor material.
Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
Have an archived tissue sample to be submitted either as a formalin fixed paraffin-embedded (FFPE) tumor block, or 5 to 15 unstained slides
The formalin-fixed, paraffin-embedded (FFPE) tumor tissue block must be available to be sent for retrospective central pathology review after registration
Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained myxoid liposarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks or at least 4 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression.
Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of enrollment AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, 15 unstained slides (10 minimum) will be acceptable.
Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission)
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue from the original or most recent biopsy for mutational analysis; availability must be confirmed prior to enrollment
Availability of fresh and archive tumor in formalin fixed paraffin embedded tissue
PART A: Existing formalin fixed paraffin embedded biopsy of the lung cancer with potentially sufficient material for analysis
Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Adequate tissue sample from either archival formalin-fixed paraffin-embedded (FFPE) tumor tissue or new biopsy of tumor
Availability of a formalin-fixed paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment.
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides to demonstrate HER2 expression.
Availability of archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] tissue block or 10-15 unstained slides)
Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory
Availability of a representative formalin-fixed paraffin-embedded tumor specimen
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue, either fresh core-needle-biopsied or archived
Availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with MSC2156119J. From the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. An associated pathology report must also be sent with the sample
Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis:
Participants with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred), or sectioned tissue
Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
There must be availability of a formalin-fixed, paraffin-embedded tumor specimen with adequate viable tumor tissue
Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue from the original surgery or biopsy or from a biopsy of recurrent disease
All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
Participants should be able to submit 20 unstained formalin-fixed, paraffin-embedded (FFPE) slides from the initial tissue diagnosis prior to study registration for confirmation of diagnosis and correlative studies
The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis
Confirmation of availability of sufficient tissue from a prior surgery for correlative studies is required prior to enrollment; patients must have representative non-transitional cell carcinoma (non-TCC) or the urothelial tract formalin-fixed paraffin-embedded (FFPE) archival tumor specimens (tumor blocks or 30 unstained slides; preference for tumor blocks); these samples may be submitted between the time of consent and the start of treatment; patients with < 30 slides may be enrolled after discussion with the principal or co-principal investigators
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than [<] 10) may be eligible following discussion with the Medical Monitor
Patient must be able to provide a formalin-fixed and paraffin-embedded (FFPE) tumor tissue specimen prior to treatment. The specimen may have been taken at any time during the course of the disease and may be from the primary tumor or from a metastasis