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