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