Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
Patients must have undergone adequate (definitive) breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
Ability to provide adequate tissue sample
Provide tumor tissue sample.
Tumor tissue sample is required within 6 months prior to study enrollment; tissue sample may be fresh (core needle, excisional, or incisional biopsy), or archival if obtained within 6 months prior to enrollment; if a tissue sample is available but it has been > 6 months and there has been no intervening therapy, the principal investigator may approve the sample after discussion; PD-L1 IHC testing will be performed on the tumor tissue, but positivity on the PD-L1 IHC testing is not required to enroll in the study
Available and adequate baseline tumor tissue sample
Have available archival tumor or be willing to undergo diagnostic biopsy at screening. Sample must be of suitable quality and quantity to satisfy group assignment and biomarker endpoints.
Available tumor sample for testing
Patients who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy to assess for CD30 status (unless archival tumor tissue from orchiectomy or other previous sample is not obtainable despite efforts to do so and a fresh tumor biopsy is not feasible)
Subjects must provide either a fresh or archived tumor sample for correlative study analyses
Has an evaluable baseline tumor sample to submit for analysis.
Part A: subjects must have a FFPE tumor sample available (e.g., from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study
If a fresh tissue sample is provided, a blood sample is required.
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Must have provided tumor tissue sample, as follows:
Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within 4 weeks after enrollment Erlotinib
For patients where molecular testing was not performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is mandatory. For patients where molecular testing was performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is required, if available. The tissue sample must be submitted within 4 weeks after enrollment
Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib.
Have confirmed human papillomavirus-associated lesions based on in-situ hybridization testing and/or polymerase chain reaction which may be performed on a newly obtained biopsy or archived sample
Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
Willing and able to give blood sample
Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of proinflammatory and immunosuppressive factors;
Archival sample or fresh biopsy or tumor effusion must be available for confirmation of diagnosis
Subjects are to have tumor tissue sample available at central lab for PD -L1 immunohistochemical (IHC) testing during the screening period; subjects can initiate therapy before the result of IHC testing; the tumor tissue sample must be a core needle biopsy, excisional or incisional biopsy; it may be fresh or archival if obtained within 6 months prior to enrollment, and there can have been no systemic therapy (e.g., adjuvant or neoadjuvant chemotherapy) given after the sample was obtained
Consents to provide tumor tissue sample for the measurement of recent TROP2 levels by immunohistochemistry, which means archived sample following last treatment or pre-DS1062a treatment biopsy (there is no minimum TROP2 expression level required for inclusion)
Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
For disease-specific cohort participants: Must have an archival (banked) tumor sample or agree to have a new (fresh) tumor biopsy during the screening period. If a new tumor sample is needed, the disease should be accessible for a nonsignificant risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures not extending beyond the stomach or bowel). For participants in the Western safety cohort, this biopsy is optional.
Be willing to consider providing fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded block specimens are preferred to slides. Note: Information on 1 tumor biopsy sample is mandatory and is as follows: (1) To determine eligibility, historical (diagnostic) tumor biopsy official pathology report +/- an archival sample. Additional biopsy samples, preferably obtained from the same localized region, are highly desirable when feasible at the following time points: (2) Sample before the first dose of study treatment, (3) Sample after completion of Cycle 2 but before the start of Cycle 3 dosing, and (4) Sample either at the time of response or at the End of Study Visit (if no response).
The subject must have an archived tissue sample such as a prior surgical sample or biopsy sample that is adequate for testing
Able to provide an archival tumor tissue sample if no anticancer therapy was administered since the sample was collected; otherwise, a fresh tumor tissue sample is required prior to the first dose of study drug.
No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the time of the first intake of ODM-201.
Archival sample or fresh biopsy or tumor effusion must be available for confirmation of diagnosis
Have submitted a tumor tissue sample, as follows:
Relapsed, recurrent, or refractory malignancy; all solid tumor diagnoses will be eligible\r\n* Pathologic confirmation of the diagnosis either at original diagnosis or recurrence\r\n* Known non-synonymous mutation in the following genes: EGFR, ERBB2, or JAK2V617F (JAK2); genomic sample preferably from relapse, but may be from other stage of treatment if relapse sample is not reasonably obtainable; genetic analysis for determination of eligibility occurs as part of routine care and is not being performed specifically for the purposes of this study
An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Primary tumor sample collected before NACT started and
Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior to study
Submit an evaluable tumor sample for analysis.
A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
Representative baseline tumor tissue sample is available
It is preferable that patients have an adequate tissue sample available for correlative studies evaluating SAG expression, cullin neddylation, and KRAS^G12D mutation, but lack of availability of such a tissue sample is not a requirement for trial enrollment
Is able to submit a fresh tumor biopsy sample prior to starting study treatment if not already submitted for HER3 expression
PRE REGISTRATION – INCLUSION CRITERIA: Patient has disease amenable to biopsy if the archival tissue sample is unavailable; note: Archive sample must not be older than 12 months
Patient has a tumor sample from C. novyi-NT planned injected tumor lesion (newly obtained biopsy) for PD-L1 and immunologic response assessments; patients must submit the tumor sample during screening at a central pathology laboratory
Patients must have an archival sample of tumor or metastatic site core biopsy to be eligible
Tumor sample must be available for HPV p16 and PD-L1 testing
Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable
Patients who are willing to provide a specimen for genomic sequencing\r\n* Preferred method: tumor cell sample available and of sufficient quantity in the Tumor Tissue Shared Resource or patients who are willing to undergo additional tissue collection for tumor genomic sequencing through FoundationOne; available specimens must have been harvested within two years to be eligible\r\n* •\tAlternative method: patients who are unwilling or unable to provide a tumor tissue sample and who undergo liquid biopsy (Guardant360 or Foundation One) may be considered eligible by the treating physician
Subjects must have a tumor sample that is adequate for PD-L1 assessment prior to randomization.
Has an adequate tumor sample
Serum LDH > 2 x ULN; c. Minimal residual disease (MRD) positive (defined as more than 1 malignant cell in 105 cells) measured by ClonoSIGHT NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT NGS assay
If archival tumor is available for submission, patients must be willing to submit tumor sample
Willing to submit an evaluable tumor tissue sample, preferably from a liver metastasis, unless tumor is considered inaccessible or biopsy is otherwise considered not in the subject's best interest
Blood sample sent for free IGF-1 testing
Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening
Presence of an archived tumor sample (no size requirements)
Must consent to allow submission of archived tumor tissue sample from definitive surgery.
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
METex14 skipping alterations, as determined by the central laboratory (plasma and/or tumor biopsy sample)
An archival tumor sample from either a prior core needle biopsy or surgical specimen must be available to be submitted for correlative studies as an eligibility requirement prior to registration. The sample must be shipped within 6 weeks of enrollment. Participants without an available archival tumor sample are considered ineligible.
Participants must have biopsiable disease and be willing to undergo pre-treatment biopsy, or have an archival tumor sample obtained < 20 months prior to study entry
All patients must undergo a baseline tumor biopsy for programmed cell death ligand 1 (PD-L1) testing (PD-L1 positivity is determined by greater than or equal to 1% of cells staining in the membrane by immunohistochemistry); for patients with stage IV disease, site of tumor biopsy will preferably be from non-lymph node disease site; the 28-8 clone for PD-L1 testing is required for assessment of PD-L1 status; for PD-L1 testing, the biopsy should contain sufficient tumor content (>= 100 tumor cells/4-micron tissue section); if a sample contains insufficient tumor content, a re-biopsy will be required to obtain a sample with sufficient tumor content prior to treatment
Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by a central laboratory and other biomarker
Archived neuroendocrine tumor sample or biopsy sample (will also be used for genetic testing).
Must consent to allow submission of adequate archived tumor tissue sample from definitive surgery for genomic assessment of tumor.
Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy.
Available archived tumor tissue sample.
Willingness to provide consent for biopsy sample (dose-expansion only)
A tumor sample is required for enrollment (except for patients diagnosed > 7 years ago)
Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.
Be willing to consider providing fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded block specimens are preferred to slides. Note: Information on 1 tumor biopsy sample is mandatory and is as follows: (1) To determine eligibility, historical (diagnostic) tumor biopsy official pathology report +/- an archival sample. Additional biopsy samples, preferably obtained from the same localized region, are highly desirable when feasible at the following time points: (2) Sample before the first dose of study treatment, (3) Sample after completion of Cycle 2 but before the start of Cycle 3 dosing, and (4) Sample either at the time of response or at the End of Study Visit (if no response).
Optional: Willing to provide a fresh tumor sample if a sufficient quantity of archival tumor sample is not available (Arms B, C, and D). See Section 5.3.9 for tumor sample details.
All patients must provide a baseline tumor sample at registration. If an archival sample is not available, patients must have a metastatic biopsy collected at the screening visit.
Must consent to provide an archival tumor biopsy sample at any time point from screening to study exit
Has ability to submit archived or fresh tumor sample during the screening period
Tumor sample is available for retrospective CDH6 expression testing
The participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (Parts 2 and 3) and after (Part 2 only) receiving the study drug
Archival sample or fresh biopsy or tumor effusion must be available for retrospective mesothelin analysis Inclusion Criteria Part A: MAD and Extension Phase (Group 1 and Group 2)
Availability of a representative formalin fixed paraffin embedded tumor tissue sample. If archival tumor sample is not available, a newly obtained tumor sample needs to be submitted instead.
Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
Archived tissue sample or new biopsy sample.
Availability of a tumor sample taken after progression on the most recent line of systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.
Patient must have access to archival tumor tissue sample or agree to undergo biopsy after study eligibility has been confirmed to obtain fresh sample for evaluation of WT1 expression. In place of archival tumor tissue samples, subjects with AML should have available a bone marrow aspirate and/or, bone marrow biopsy, with PCR for WT1 transcript performed before the first dose of study drug. Note: The archived tumor tissue sample does not need to be delivered to the clinical site prior to enrollment of the patient, however its availability should be confirmed through provision of the accession number or other identification number. Patient Inclusion Criteria - Part 2:
Availability of archival tumour tissue sample. If archival sample is not available, a fresh tumour biopsy must be provided.
Patient agrees to having a blood sample (approximately 10 mL) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
Is willing to provide pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing a fresh tumor biopsy sample is optional.
Subjects with cutaneous melanoma must provide either a fresh or archived tumor sample for genetic analysis including determination of or confirmation of BRAF and NRAS genetic status based on local laboratory results. To ensure prompt delivery of tumor samples, tissue shipment tracking information must be provided before administration of study treatment can be initiated.
Must provide either a fresh or archived tumor sample for genetic analysis.
A representative FFPE tumor sample must be available for molecular testing along with a corresponding pathology report. An archival tumor sample may be submitted. However, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead.
Patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
Presence of tissue sample for IHC assay of MET receptor and HER2 status
Available archival tumor sample (excisional or core biopsy) that can be acquired and provide consent to biomarker testing of the tumor.
Availability of an existing tumor biopsy sample (or consent to allow pre-treatment tumor biopsy if sample not available)
Patient must agree to undergo tumor HRD testing at screening. The tumor sample must be submitted for HRD testing during the Screening Period. Patients do not have to wait for the HRD test result to be enrolled. If archival tumor tissue is not available for testing, the patient must agree to undergo a fresh biopsy.
A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
Patients who do not have an archival tumor sample (or sections of it) available or readily obtainable.
Consent to collection of a pre-treatment tumor sample, on-treatment biopsy, and, if applicable, a tumor tissue sample at the time of progressive disease (PD) Inclusion Criteria Specific to Obinutuzumab-Containing Cohorts
Subjects must consent to allow for the acquisition of tumor sample prior to starting treatment on study (in most cases patients will require a tumor biopsy); this biopsy site may be the only site of measurable disease if the site is > 2 cm; the biopsy site must, in the opinion of the investigator, be likely to yield acceptable tumor sample for core biopsies; it is also acceptable if tumor sample is obtained by excision biopsy or during surgery (i.e. if procedure was previously planned), provided the tumor sample can be processed; in the case that a patient had a tumor sample acquired prior to consenting to the study and this tumor sample is acceptable for processing (i.e. frozen sample stored) and the tumor sample was acquired within 60 days of starting treatment, this is acceptable and a new biopsy will not be required
Groups 1 and 2: A tumor sample (archival tissue or a new tumor biopsy) has been submitted for mutational testing.
Available tissue that was obtained at or after the time the usbject was found to have muscle invasive disease and is of suitable quality and quantity and to assess the FGFR3 status by genetic testing. For subjects participating in the Randomized Phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization even if a blood sample sample was used to determine FGFR3 genetic status
Willingness to provide consent for sample collection for blood, urine and saliva
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have a formalin fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto pediatric MATCH for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas)
Pre-intervention biopsy sample collected
Primary tumor sample was collected before NACT began and was evaluated for genomic testing (integral biomarker)
Willing to provide existing relapse-confirmatory DLBCL tumor sample
Subject consents to allow access to subject's diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test that is being developed in parallel with gilteritinib.
Patients eligible for this companion sample collection protocol sample collection protocol must meet all inclusion in CLEE011A2404.
Optional tumor biopsies: Patients will be asked permission (consent) to provide tissue from a recent (within 6 weeks of study entry) archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion; in addition, for on-study biopsies (after one week and after 7 weeks of initiating study therapy) and for baseline tumor biopsy if an archival tissue sample is not available: willingness to undergo biopsies will be asked; patients who consent to provide tumor biopsies for research should have tumors deemed relatively safely accessible for biopsies with low likelihood of complication
Must be able to provide tumor tissue obtained within 6 months of study enrollment. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
RANDOMIZED PHASE II CLINICAL TRIAL: Have provided tissue from a newly obtained biopsy (an archival tissue sample may be substituted if new biopsy cannot be obtained and by discretion of principal investigator only) obtained from a focus of metastatic disease (a tumor lesion in newly diagnosed metastatic TNBC de novo is acceptable) and agreed to providing a second newly obtained biopsy after completion of 2 cycles of the study drugs
Must agree to provide archival or newly obtained tumor tissue sample prior to the start of treatment in this study
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Previously obtained archival tumor tissue, or tissue obtained by endoscopically guided core biopsy at screening
For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b).
Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Be willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy of a tumor lesion is preferred; 20 unstained slides are preferred but a minimum of 15 slides will be acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
Have a histologically confirmed diagnosis of:\r\n* Arm 1: melanoma, with =< 5 measurable (as defined by Response Assessment in Neuro-Oncology-Bone Marrow [RANO-BM]) new brain metastases clinically eligible for stereotactic radiosurgery (SRS); tissue diagnosis of the brain metastasis is not required for enrollment if history and imaging is consistent with melanoma and a histopathology is available from the systemic disease; however, a biopsy or surgical excision of one or more of the brain lesions may be performed, if clinically indicated; patient must consent to providing tissue from archival biopsy tissue or newly obtained excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1\r\n* Arm 2: newly diagnosed glioblastoma (World Health Organization [WHO] grade IV)
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; if a freshly procured research specimen has already been made available to the Pollack Lab prior to consent as part of another sample collection research protocol, may be omitted with approval of the primary investigator so long as the patient has not received anti-cancer therapy or immunosuppressive therapy since the biopsy sample was collected
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion
Pathological diagnosis should be obtained by incisional or excisional tissue biopsy; core biopsy is only permissible if obtaining an incisional or excisional is not possible and if the grade can be assessed on the core biopsy
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion prior to starting study therapy or from archival tissue of a biopsy that was performed after the most recent systemic therapy
Have provided tissue from a newly obtained biopsy obtained from a focus of metastatic disease (an archival tissue sample may be substituted if new biopsy cannot be obtained and by discretion of sponsor investigator)
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion after 2 cycles of therapy
Have provided tissue for PD-L1 biomarker analysis from a newly obtained formalin fixed tumor tissue from a biopsy of a tumor lesion not previously irradiated; the tissue sample must be received and evaluated by the study site prior to start of treatment; fine needle aspirates are not acceptable; needle or excisional biopsies, or resected tissue is required
For participants participating ONLY in the Phase 1b expansion: have submitted tissue sample from either a newly obtained core or excisional biopsy of a tumor lesion (preferred) or a recent biopsy since last documented progression of disease.
For those participating ONLY in Phase 1b abemaciclib or merestinib expansions: Have submitted tumor tissue sample from a newly obtained core or excisional biopsy for a tumor lesion (preferred) or a recent biopsy taken with 3 months prior to study enrollment and following the participants most recent prior systemic treatment and be willing to undergo a biopsy procedure during the study treatment period for collection of additional tumor tissue sample.
Be willing to provide archival tissue; if archival tissue is not available, or a newly obtained core or excisional biopsy of a tumor lesion will be obtained; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; in cohort 9: paraganglioma-pheochromocytoma or cohort 10, where there is prominent bony disease, biopsies may not be possible due to the nature of the disease
Have provided tissue for PD-L1 biomarker analysis from either archived tissue or a newly obtained core or excisional biopsy
PHASE I AND PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Be willing to provide tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Available tissue from a newly obtained core biopsy of a tumor lesion not previously irradiated
Archival tissue is mandatory (a tumor biopsy-core or excisional) of a metastatic lesion obtained within 1 year prior to study registration (within 4 weeks preferred); tumor tissue from nephrectomy and site of metastasis will be requested; if archival tissue of a metastatic lesion obtained within the preceding year is not available, patients must have at least one site of disease (not including bone metastases) accessible for core needle or excisional biopsy; if archival tissue of a metastatic lesion is not available and biopsy of a new lesion is not feasible, the subject is not eligible for the study
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Be willing to consent for biopsy at baseline (if inadequate archival tissue per inclusion criteria above) and an on treatment biopsy; have a tumor in a location that in the opinion of the investigator that is amenable to biopsy or have provided tissue for PD-L1 and other biomarker analysis from a newly obtained (within 60 days) formalin fixed tumor tissue from a recent biopsy of a tumor lesion not previously irradiated; no systemic antineoplastic therapy may be administered between the PD- L1 biopsy and initiating study medication; fine needle aspirates are not acceptable; core needle or excisional biopsies, or resected tissue is required
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Have provided tumor tissue from a newly obtained core, punch, incisional or excisional tumor biopsy; patients must undergo biopsy (core, punch) or open incisional/excisional biopsy (if done as part of a clinically indicated baseline diagnostic procedure) within 4 weeks of registration on the study
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
For expansion cohort, patients must consent to provide tissue from newly obtained (during screening period) core or excisional biopsy of a tumor lesion.
Patients must provide tissue from an archival tumor sample (obtained within 2 years from screening visit) or newly obtained core, punch, or excisional biopsy of a tumor lesion if deemed relatively safe and technically feasible
Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since biopsy) core or excisional biopsy of a tumor lesion not previously irradiated.
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; in the opinion of the investigator, the patient must have tumor accessible by CT or ultrasound guided core biopsy; subjects for whom newly-obtained samples cannot be provided may submit an archived specimen provided it was obtained after last systemic treatment, within 6 months of signing consent and that tissue is available for either 2 cell blocks or 20 uncut slides (core or excisional biopsy required, fine needle aspirate is not acceptable)
Archival or newly obtained tissue sample of a tumor lesion.
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion obtained within 28 days prior to study enrollment
Archival tissue must be available or newly obtained core or excisional biopsy of a tumor lesion
Must have sufficient archival tissue block material (1.5 x 1.5 x 1.5 cm) and/or newly obtained core or excisional biopsy of tumor tissue; minimum of 2 cores
Is able to provide tumor tissue from a site not previously irradiated as follows: Cohort A must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC; Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible; and Cohort C with soft tissue disease must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available. Participants with bone metastasis only must provide an archival tumor tissue specimen
Has provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated from a muscle invasive urothelial carcinoma or a metastatic biopsy, originally from the original tumor.
Must provide adequate tissue for biomarker analysis for Cohorts A and B from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
Newly obtained core or excisional biopsy of a tumor lesion for part 2A and if they qualify, one pre-randomization biopsy for part 2B
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
Have available tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Provides an archival or newly obtained (?60 days prior to first dose of study treatment) tumor tissue sample (Cohort B).
Have tissue from an archival tissue sample that has been identified and confirmed as available for study, or newly obtained core or excisional biopsy of a tumor lesion
Have identified tissue from an archival tissue sample (preferably from a metastasis, but sample from primary tumor allowable) or newly obtained core or excisional biopsy of a tumor lesion.
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Can provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Have provided tissue from an archival tissue sample (< 6 months old) or newly obtained core biopsy of a tumor lesion before radiation therapy
Patients must provide tissue from an archival tumor sample or newly obtained core, punch or excisional biopsy of a tumor lesion if deemed relatively safe and technically feasible\r\n* Note: newly obtained biopsy is preferable
Able to provide tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ?3 years since last documented progression of disease
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of tumor lesion.
Have provided tumor tissue from a newly obtained core, punch, incisional or excisional tumor biopsy; patients must undergo biopsy (core, punch) or open incisional/excisional biopsy (if done as part of a clinically indicated baseline diagnostic procedure) within 4 weeks of registration on the study
Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion
Has provided a tumor tissue sample (archival or newly obtained core or excisional biopsy of a tumor lesion)
Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns.
Is able to provide an evaluable core or excisional lymph node biopsy for biomarker analysis from an archival (>60 days) or newly obtained (within 60 days) biopsy at Screening (Visit 1).
No other active malignancy that the investigator determines would interfere with the treatment and safety analysis
the analysis of results
Patients with inadequate tissue for analysis
Provide tissue for biomarker analysis from a newly or recently-obtained biopsy (within 90 days of Study Day 1) of a tumor lesion not previously irradiated
Patients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysis
Available tumor tissue for biomarker analysis
HLA A2+ by deoxyribonucleic acid (DNA) sequence analysis (by history with documentation or as part of this study)
Consent to provide an archival tumor tissue sample (if available) and to undergo baseline and on treatment tumor biopsies for pharmacodynamic biomarker analysis
Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
Tumor tissue from the resected site of disease must be provided for biomarker analyses; in order to be treated, a patient must have tissue available for PD-L1 expression analysis by immunohistochemistry (ICH) as determined by the New York University Langone Medical Center (NYULMC) Pathology lab; if insufficient tumor tissue content is provided for analysis, acquisition of additional archived tumor tissue (block and/or slides) for the biomarker analysis is required
Insufficient tissue on diagnostic core breast biopsy for analysis
Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis)
Patients must have analysis of PD-L1 expression in cancer cells quantitated by immunohistochemistry analysis
Provision of suitable tumor tissue for the analysis of Axl kinase expression and PD-L1 expression.
Evaluable tumor tissue (archived or new biopsy) must be available for pre-treatment biomarker analysis and baseline immune monitoring studies
Tissue available for analysis at time of enrollment for biomarker analysis (may be obtained via biopsy prior to initiation of treatment, or submission of available archival tissue: 10-15 slides, or 5 slides with 3 sections per slide
At the time of biopsy, prior to administration of virus, the presence of recurrent tumor must be confirmed by histopathological analysis
At the time of biopsy, prior to administration of virus, the presence of recurrent tumor must be confirmed by histopathological analysis
Available tissue to perform protein and genomic analysis
Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing of IHC and/or cytogenetics/FISH and/or DNA mutation analysis (required for study entry but enrollment based on local results)
If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis
The subject must be willing to undergo the two paired tumor tissue biopsy procedures to obtain samples for biomarker analysis; tissue obtained must not be previously irradiated
Following biopsy, prior to administration of D2C7-IT, the presence of recurrent tumor must be confirmed by histopathological analysis
>= 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis
Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis
Genotyping data available or in process (data must be available at time of initial registration if randomization probabilities differ across biomarker subgroups as determined by the Dana-Farber Cancer Institute [DFCI] Coordinating Center) to assign biomarker subgroups through whole exome sequencing, whole genome copy number analysis, or a combination
Sufficient pathologic material must be available for central analysis and review
Sufficient tumor tissue for planned analysis
Provides an archival or newly obtained tumor tissue sample and blood samples for biomarker analysis.
analysis of results
Tumor biopsy material must be provided for all patients for the purpose of biomarker analysis
MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
Tumor tissue must be provided for biomarker analysis
Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic KRAS G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy
Have provided tissue from an archival or newly obtained tissue sample of a tumor lesion, sufficient for analysis of programmed cell death 1 ligand 1 (PD-L1) and other biomarkers; patients who have had PD-L1 analysis previously performed at Merck can substitute earlier analysis results and are not required to submit additional tissue for PD-L1 testing; expression of PD-L1 is NOT required for study entry
Adequate tumor content as determined by institutional pathologist for nucleic acid extraction and DNA sequence analysis
Patients with confirmed p53 mutation by molecular analysis and/or evidence of p53 overexpression by immunohistochemistry (>= 10% of cells within tumor staining positive) will be eligible; this will be assessed semi-quantitatively by a Clinical Laboratory Improvement Act (CLIA) approved pathology core pathologist, using CLIA approved mutational analysis or immuno-histochemistry techniques on formalin-fixed paraffin-embedded tissue; in the case of equivocal immunohistochemistry (IHC) results, p53 involvement may be confirmed by detection of p53 molecular analysis on tumor deoxyribonucleic acid (DNA); patients on whom molecular analysis of p53 mutations is already available, will not require IHC analysis; molecular analysis may be performed as an additional research procedure at the end of the study (distinct from eligibility determination) if the principal investigator (PI) deems it of scientific value and research funding is available to cover the cost; patients must have PD-L1 positive ovarian cancer in order to be eligible for this clinical trial (defined as >= 1% PD-L1 expression within the tumor section, assessed by immunohistochemical staining)
Confirmed p53 involvement: patients with p53 over-expression by immunohistochemistry (>= 10% of cells within the tumor staining positive) or those with a p53 mutation as determined by mutational analysis of tumor tissue will be eligible; patients with prior exposure to p53-based vaccines will be eligible
A cell block or core biopsy must be submitted for central review and analysis of SMAD4 status as soon as possible following step 1 registration
Must have tumor tissue available for biomarker analysis. Biopsy should be excisional, incisional, punch, or core needle
Participant must consent to provide archived tissue or cytology sample of NSCLC lesion for analysis.
Patients must agree to have blood specimens submitted for pharmacokinetic analysis
Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.
Able to provide biopsy tissue for biomarker analysis
analysis of results
Available archived tumor tissue for central analysis
Can provide tissue for PD-L1 and mesothelin biomarker analysis
Primary tumor is available for shipment to central laboratory for analysis of FR? expression by IHC.
Have sufficient tumor tissue available for central analysis.
Subjects must have archival tumor tissues or agree to a tumor biopsy for analysis of predictive biomarkers such as PD-L1. (Fresh tumor biopsies are strongly recommended at baseline for biomarker analysis in subjects with readily accessible tumor lesions and who consent to the biopsies.)
Have tumor tissue available for biomarker analysis.
Must consent to collection of blood samples for PK analysis.
At least one site of disease must be accessible to provide repeat biopsies for tumor tissue for sequence and immunological analysis.
Availability of tumor tissue for biomarker analysis
PART A: Patient has agreed to two newly obtained tumor biopsies and as required re-biopsies (that can be biopsied on investigator’s assessment) and to providing the acquired tissue for biomarker analysis; analysis of one of the fresh biopsy samples for PD-1hiCD8+CTLA4hi in the CD8+CD45+ gate based on flow cytometry will be done; a second fresh biopsy sample is required for further biomarker analysis and confirmation at a later date of low PD-L1 expression using an immunohistochemistry (IHC) assay for PD-L1 expression; a valid flow cytometry result is not required for study participation, but repeated biopsy for reanalysis is strongly recommended for patient with insufficient TILs in the first tissue sample
Patients unwilling to consent to analysis of their tumor tissue.
Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
Willing to provide tumor tissue for PD-L1 biomarker analysis (new or archived specimens with agreement of Sponsor). As of 20 March 2016, participants must be PD-L1 positive to be enrolled.
Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
Available tissue for biomarker analysis
Tumor tissue available for PD-L1 biomarker analysis
Tumor not able to be reliably evaluated by volumetric analysis
No deletion of 17p13 on cytogenetic analysis by FISH
Must consent to collection of whole blood samples for genomic analysis
analysis of results
Archived tumor tissue must be available for all subjects for biomarker analysis and confirmation of the diagnosis before or during treatment; samples must be provided within 4 weeks of enrollment
Enrolled in Human Research Protection Office (HRPO) # 201011766 (“Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Malignancies”)
Subjects must be able to provide adequate bone marrow (BM) aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure
Patient must be enrolled in Human Research Protections Office (HRPO) # 201011766 (\Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases\)
Patient must have archival prostate tumor block available for analysis of correlatives
At the time of biopsy, prior to administration of virus, the presence of recurrent tumor must be confirmed by histopathological analysis
Blood and urine samples must be provided from all subjects for biomarker analysis before and during treatment with pazopanib
Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type status
The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
Ki67 index by central analysis of ?20% on untreated breast tissue
Tumor tissue available and adequate for analysis at screening
Has an archived, diagnostic tumor tissue available for analysis.
Patients must be willing to provide a screening and post-dose biopsy for biomarker analysis (extension phase only)
In the extension phase, patients must be willing to provide a screening and post-dose biopsy for biomarker analysis
Patients must provide a pretreatment saliva sample for genomic analysis
Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
Patients with confirmed p53 mutation by molecular analysis and/or evidence of p53 overexpression by immunohistochemistry (>= 10% of cells within the tumor staining positive) will be eligible; this will be assessed semi-quantitatively by a Clinical Laboratory Improvement Amendments (CLIA) approved pathology core pathologist, using CLIA approved mutational analysis or immunohistochemistry techniques on formalin-fixed paraffin-embedded tissue; in the case of equivocal immunohistochemistry (IHC) results, p53 involvement may be confirmed by detection of p53 molecular analysis on tumor deoxyribonucleic acid (DNA); patients on whom molecular analysis of p53 mutations is already available, will not require IHC analysis; molecular analysis may be performed as an additional research procedure at the end of the study (distinct from eligibility determination) if the principal investigator (PI) deems it of scientific value and research funding is available to cover the cost
Sufficient archival tumor specimen is available for HER3 immunohistochemistry (IHC) analysis, or subject is willing to undergo a fresh tumor biopsy for HER3 IHC analysis.
Primary prostate cancer tissue available for analysis is not required for inclusion onto this study but is strongly encouraged
Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue by next-generation sequencing (NGS)
For participants in Part B, C, D, E, and F, a tumor tissue sample is mandatory, when safe and feasible, for biomarker analysis
The participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
Specimens for cytogenetic analysis are required, and must be obtained prior to therapy initiation; for patient with refractory disease, the diagnostic specimen may be used
Consent to allowing his/her archival tumor tissues to be requested and analyzed; however, the non-availability or inadequate amount samples for analysis will not exclude the patient
Have normal urine analysis within 24 hours pre-surgery
Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis
Archived tissue from the CRC primary tumor in sufficient amounts to allow advanced quantitative real time-polymerase chain reaction (qRT-PCR) analysis; specimen from metastatic sites are not required but highly preferred
Signing consent for study imaging procedure and analysis of prostate biopsy
Patients must agree to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database, as evidenced by signing the informed consent form
The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results
Archived tumor blocks must be provided for all subjects for correlative analysis before or during treatment with pazopanib
Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
Tissue analysis demonstrating pathology other than glioblastoma
Patients must document their willingness to be followed for up to 24 months following enrollment in this imaging trial; by signing informed consent, the patients will document their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
Tissue specimen is inadequate for sampling and analysis
Cohort A: Screening visit peripheral blood must be available for retrospective analysis of spliceosome mutations of interest.
the analysis of results
All subjects must have adequate archival tissue available prior to registration (i.e., at least 20 unstained slides or paraffin block); if acceptable archival tissue is not available, the subject must be willing to consent to providing a core or excisional biopsy for research prior to registration for protocol therapy; if archival tissue is not available and there are no sites amenable to biopsy, enrollment must be discussed with the sponsor-investigator on a case by case basis
Willingness to release archival tissue sample for research purposes, if available
For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
Willing and able to undergo a biopsy of at least one metastatic site or primary prostate; adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC; fresh or archival tissue must be obtained within 6 months of treatment start\r\n* RB positive as determined by local lab immunohistochemistry (IHC) testing (performed per lab manual) and if available, ship 10 slide (5 micron thickness) or alternatively the tissue block to Thomas Jefferson University (TJU) and 1 hematoxylin and eosin (H&E) slide
For patients with solid tumors, either archival tumor tissue must be available or patient must consent to undergo on-study tumor biopsy before administration of first dose
Archival tissue must be procured if available
Have PD-L1 expression level determined from the subject's archival tissue or fresh tumor specimen
All subjects must have archival tissue confirmed as available for enrollment; subjects who are TKI naive who do not have archival tissue may undergo a fresh tumor biopsy in lieu of the archival tissue requirement; the archival tissue requirement may be waived for subjects after discussion with the principal investigator
Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Agreement to allow the use of archival tissue from pre-ASCT tumor biopsies\r\n* If unavailable, exceptions may be granted with study principal investigator (PI) approval
For participants enrolling the phase Ib part of the study, willingness to provide archival tumor samples when available
Willing to provide a tumor sample via biopsy from a metastatic site of disease to be collected at screening if safe and feasible per treating investigator discretion; adequate archival metastatic tissue can be used if available in lieu of baseline biopsy if done when patient had CRPC
All patients should submit an archival tumor biopsy specimen (collected at diagnosis or relapse); patients who have no tumor tissue available may be permitted to participate after discussion with the principal investigator
Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment
A biopsy of the tumor tissue obtained at anytime from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. For Part 1B and Part 2B, any archival tumor specimen must have been obtained within 3 months of starting study drug.
Willing to provide a tumor sample via biopsy from a metastatic site of disease to be collected at screening if safe and feasible per discretion of treating investigator; adequate archival metastatic tissue can be used, if available, in lieu of baseline biopsy if done when patient had CRPC; patients without a site amenable to biopsy and lack of archival tissue may still join the study
Willing to provide archival or fresh tumor biopsy at Screening and Week 10
Participants must have archival tumor tissue available. Participants without archival tissue may be enrolled at the discretion of the principal investigator
Agreement to allow the use of archival tissue from diagnostic tumor biopsies will be retrieved and submitted post-enrollment \r\n* If unavailable, exceptions may be granted with study principal investigator (PI) approval.
Participants must have archival tumor tissue available; participants without archival tissue may be enrolled at the discretion of the principal investigator
For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
Be willing to provide tissue from an archival tissue specimen in selected patients, where available
Agree to provide archival tumor material for research
Patients must consent to analysis on archival tissue
Patients must have adequate archival material from a previous biopsy to determine EGFR mutation status and Cripto-1 expression, or undergo a biopsy of fresh tissue of the primary cancer or a metastatic site in order to make these determinations, if archival material is not available
Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
Availability of an archival tumor tissue sample. If archival tumour tissue is not available, then tissue from a fresh biopsy can be used.
Tumor tissue available if biopsy consent not provided, if no archival tumor tissue available and pt provides consent, pre-dose biopsy will be done
Subject’s archival prostate biopsy specimen is available, and subject consents to provide tissue for study endpoint analysis; the prostate biopsy slides or blocks must be available prior to starting any study treatment
Patient must consent to the access, review and analysis of previous medical and cancer history, including tumor archival tissue (if available) and imaging data by the sponsor or a third party nominated by the sponsor.
Patients enrolled in the escalation and expansion phases will be required to have archival tissue available for analysis.
Locally or centrally confirmed CEA expression in archival tumor tissue
Willingness to undergo tumor biopsy if the patient does not have a known familial cancer syndrome (MEN1, VHL and NF1) or archival tissue available
Tissue for correlative studies must be available (paraffinized or frozen), but confirmation at screening is not needed; archival tissue may be used instead of a fresh biopsy at baseline if it already exists
Parts B2, B3 & B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy
Archival tissue block or unstained tumor tissue available for correlative studies
Patients must have confirmation of folate receptor-a (FR-alpha) positivity by immunohistochemistry (IHC) (? 25% of tumor staining at ? 2 + intensity) on archival tissue or recent biopsy.
Patients must be willing and able to undergo tissue biopsy for research\r\n* If tumor tissue obtained from the biopsy is deemed inadequate, and the patient is unwilling or unable to have another biopsy, the patient may be considered for enrollment if archival tumor tissue is provided and deemed of adequate quality; this must occur prior to any treatment with rucaparib or mirvetuximab soravtansine\r\n* If biopsy is deemed unsafe to attempt or to perform, and if archival tumor tissue is available and deemed of adequate quality, the patient may enroll on trial\r\n* Biopsy must be of solid tumor tissue; ascites is not acceptable
Archival tumor samples must be available and sufficient for diagnostic and genetic testing; if archival sample insufficient for testing, subject must have lesions amenable to biopsy and be willing to undergo biopsy
Agreement to access archival tissue or agreement for tumor biopsy prior to treatment
Archival tissue for PD-L1 staining (alternatively a new biopsy [core] at baseline can be used); a minimum of 10 slides is required (unless approval from the principal investigator [PI] is obtained)
All subjects must have adequate archival tissue available prior to registration (i.e., at least 15 unstained slides or paraffin block). Archival tissue should represent invasive or metastatic urothelial cancer with a preference for metastatic tissue if available. Subjects without adequate tissue may be considered on a case by case basis after discussion with the sponsor-investigator.
Untreated/pretreatment archival tumor tissue must be available for correlative analyses
Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies; in cases where a fresh biopsy is not feasible (i.e., if an accessible site cannot be biopsied with acceptable clinical risk), archival tissue may be submitted instead, after discussion with and approval by the principal investigator
Arm A: Patients with glioma who are positive for the H3 K27M mutation (positive testing in CLIA laboratory) and have completed at least one line of prior therapy. Evidence of progression is not required so that ONC201 may be administered to patients in the maintenance setting or to patients with recurrent disease. No more than two prior episodes of recurrence from radiotherapy and/or chemotherapy are allowed. Use of bevacizumab solely for treatment of radiation necrosis, pseudoprogression, or treatment effect will not be considered a recurrence. Post-mortem biopsy is required if H3 K27M status of tumor is unknown and archival tumor tissue not available. Arm B: Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons, are eligible with or without histologic confirmation. Post-mortem biopsy is required if H3 K27M status of tumor is unknown and archival tumor tissue not available.
Agreement to provide mandatory archival tissue or fresh biopsy.
Have archival tissue where available
Tumor sample must be available for PD-L1 testing; archival tissue within 3 months of study enrollment will be used; if archival tissue is unavailable, a fresh biopsy will be taken
Agreement to provide archival primary or metastatic tumor tissue if available
Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
Archival tissue from a previous biopsy will be required
A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies; NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available
Adequate tumor tissue (archival or fresh) must be available for correlative studies\r\n* NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator; if prior tissue is not available, patient must be willing to undergo baseline tumor biopsy
Adequate archival tissue (metastatic tissue sample is preferable but primary tumor tissue will be acceptable) or willing to undergo pre-treatment biopsy (for central confirmation of molecular alteration and PTEN immunohistochemical assessment) if adequate archival tissue is unavailable
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the Memorial Sloan-Kettering [MSK] principal investigator)
Histologically confirmed, metastatic or unresectable neuroendocrine carcinoma of non-pulmonary origin, high grade as indicated by Ki-67 > 20% and/or > 20 mitoses/10 hpf; patients must have existing Ki67 results from archival tissue or available tissue for Ki-67 testing; if no archival tissue is available the subject must agree to a fresh biopsy for testing to qualify for the study
Inability to obtain Foundation One testing on archival tissue, or, lack of previous next generation sequencing
Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
PRE-SCREENING: Availability of archival or fresh tissue for testing of mesothelin expression level\r\n* Note: archival tissue is preferred and fresh biopsy should only be obtained if no archival tissue is available and if in the investigator’s judgement, there is no additional risk for the patient’s safety; patients with a sarcomatoid histology are not expected to have mesothelin overexpression and should not enter prescreening
Agreement to provide mandatory archival tissue or fresh biopsy.
Archival tumor tissue from diagnosis or, preferably, at relapse
Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by a designated central laboratory confirming MAGE-A10 expression.
Archival tumor tissue retinoblastoma-associated protein (pRb) positive by immunohistochemistry (IHC)
Archival tissue (paraffin block[s] or unstained slides from paraffin block[s]) from the primary tumor and/or a metastatic site judged reasonably available prior to initiating treatment, or willingness to undergo fresh pre-treatment tumor biopsy; (prior to initiating treatment, the screening team must have documentation that an archival or fresh tumor specimen has been requested from a local or outside facility; however, physical possession of requested tissue or waiting for histological analysis or confirmation that an acquired specimen contains tumor tissue sufficient for analysis is not a requirement prior to initiating treatment); if no archival tissue is available and patient consents to a fresh biopsy, but the patient’s lesion is deemed inaccessible to safe biopsy, the patient will be allowed to enroll if otherwise eligible
Be willing to provide archival tissue from a tumor lesion or obtain a new biopsy if tissue unavailable
Be willing to provide tissue from a newly obtained or archival tissue, if available
Must have archival tissue available for PD-L1 assessment
Having archival paraffin tissue is ideal for the correlative study but it is not mandatory
Archival tissue from diagnostic/core biopsy must be available; patients who had a biopsy at an outside institution are eligible as long as it is confirmed that an archival tumor specimen, with an associated pathology report, is available
Archival tumor tissue slides must be sent or available
Fresh or archived colorectal cancer tissue, preferably from a hepatic metastatic site; archival tissue is acceptable for enrollment into this study; subjects who have no archival tissue available do not need to undergo a new biopsy solely for the purpose of this study
For participants entering the Phase 1a dose escalation: have submitted, if available, the most recent archival tumor tissue sample.
Archival tumor tissue must be available for enrollment
UROTHELIAL CARCINOMA EXPANSION COHORT: Willingness to release archival tissue sample for research purposes, if available
Archival tissue samples and/or fresh tumor biopsy samples:
Subjects should agree to provide archival and/or fresh tumor biopsy samples
Archival tumor samples should be collected for all enrolled subjects; if archival tissue samples are not available, a recent core needle biopsy should be collected
PD-L1 expression in tumor tissue from any site is required for patients with NSCLC; tumor tissue can be archival, however if no archival tissue is available then a biopsy must be obtained for PD-L1 testing; PD-L1 expression will be analyzed by a Merck assay; PD-L1 expression is not required for patients with melanoma, but melanoma patients are required to submit an extra-cerebral specimen for analysis, unless it is not feasible to obtain one
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Be willing to provide tissue from an archival tissue sample
Have archival tissue where available; those patients enrolled on the phase 1 escalation trial where archival tissue is not available will undergo a fresh biopsy where clinically feasible after discussion with the sponsor
All patients must be willing to provide research tumor tissue for biomarker studies at baseline (from archival tumor tissue or through endoscopy if sufficient archival tissue is not available); all patients must also allow biomarker studies on the tissue obtained through surgery to remove the primary cancer
Availability of archival tumor material, either as a block or slides (Phase Ia and Ib). If no archival material is available then a fresh biopsy should be taken
Have archival tissue available or undergo a fresh biopsy where clinically feasible after discussion with the sponsor
Patient must have an available archival/pre-treatment block or fresh tumor biopsy for molecular profiling to be performed
Patients must have archival tissue, 10-20 slides, available for review and testing
No archival or newly biopsied tissue available for analysis
Subjects must agree to provide archival and/or fresh tissue biopsy samples, if available. Tumor biopsy will be done only if the subject has a lesion for which, in the opinion of the Investigator, a non- or minimally invasive tumor biopsy may be performed.
Consented for genome sequencing and database of Genotypes and Phenotypes (dbGAP)-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing; fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed
Prior to registration, all subjects must have adequate archival tissue available prior (unstained slides are to be submitted as outlined in the study procedures manual); if no acceptable archival tissue is available, the subjects must be willing to consent to providing a mandatory pre-treatment core biopsy for research; phase II subjects must be willing to consent to providing a mandatory post-treatment core biopsy for research; fine needle aspiration and cytology samples will not be acceptable
Consented for genome sequencing and database of Genotypes and Phenotypes (dbGAP)-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing; fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed
Patient must consent to the use of their archival tumor tissue for protocol use if available
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the MSK principal investigator)
Archival tumor tissue sample must be requested and available prior to study entry; a copy of the local pathology report must be submitted along with the specimens; patients without available archival tissue are excluded
Patients must have archival tissue sample (if available) or be willing to undergo a repeat biopsy (if feasible)
Willing to provide mandatory archival tumor tissue (block or minimum of 30 unstained slides from a primary or recurrent/metastatic thyroid cancer) for correlative research purposes; NOTE: patients with less archival tumor tissue available may still be eligible for the study after discussion with Academic and Community Cancer Research United (ACCRU); receipt of archival tumor tissue is not required for study registration and initiation of therapy
Agreement to provide mandatory archival tissue or fresh biopsy
Willing to provide tumor tissue for biomarker analysis and/or archival tissue available from original diagnostic block
Archival tumor tissue obtained at any time from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. Subjects enrolled in a PK/Pharmacodynamic Cohort must provide a fresh biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy.
High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
Available tissue for PD-L1 staining (archival or new core needle biopsy at baseline if no archival tissue available); a minimum of 10 slides are required (unless approval from the PI is obtained)
Consent to provide archival tumor tissue and pre/on-treatment biopsies
Appropriate archival OR current tissue blocks or biopsy specimens to determine ER/PR and APR status.
Fresh or archival biopsy tissue available to determine tumor mutation status
For patients recruited in the expansion cohort only, provision of archival (block) or fresh tumor tissue samples at baseline is mandatory. If archival tumor tissue is not available, patients should be willing to undergo a biopsy for provision of fresh tumor samples
High FGFR mRNA expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh tumor biopsy specimen.
Must have archival tissue available, be willing to undergo metastatic biopsy or have a sufficient plasma circulating tumor DNA (ctDNA) concentration in order to perform next-generation DNA sequencing
Ability to provide adequate tissue from archival tumor specimen; confirmation of adequate tissue is required prior to enrollment
Patients must have access to archival tumor tissue for proposed correlative studies; these may be derived from transurethral resection of bladder tumors (TURBT), cystectomy, or biopsy; if archival tissue is not available for proposed correlatives, patients may be enrolled at the discretion of the study principal investigator (PI) (SKP)
Patients must consent to analysis on archival tissue; if archival sample is not available, a sufficient tumor biopsy can be performed a minimum of 28 days prior to start of treatment if felt to be clinically reasonable
Whenever available, archival tissue (block or minimum 10 slides) is requested for molecular characterization, e.g. detection of somatic mutations and/or candidate biomarkers of response; this is not mandatory and lack of available tissue would not be an exclusion criteria
Participants must have archival tumor tissue available for analysis (minimum 20 5 um slide) or be able to undergo a baseline fresh tumor tissue biopsy
If archival tumor tissue from a metastatic melanoma lesion is unavailable OR designated pathologist from participating site cannot sign-off to ensure that “sufficient” tumor is available from existing archival tumor block for support of tumor imaging studies, patients must be willing to consent to undergo a biopsy to collect metastatic tumor tissue; collection of fresh biopsy tissue does not guarantee enrollment, unless the pathologist from the participating site signs-off that “sufficient” tumor has been collected
Must have confirmed viable archival prostate biopsy tissue available (only required for patients going on study after the MTD has been reached)
Available archival tumor tissue should be submitted to MSKCC for integrated mutation profiling of actionable cancer targets (IMPACT) analysis, but will not be required prior to registration; note: if tissue is depleted, patient will still be eligible after discussion with the principal investigator (PI)
Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
Archival tumor tissue specimen meeting protocol specifications or the participant will be offered the option of a pre-treatment biopsy to obtain adequate tissue sample.
Available pretreatment biopsy, either fresh (optimal) or archival (acceptable)
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent for a fresh tumor biopsy; (mandatory for Cohorts A, B, C; optional for dose escalation and Cohort D)
Available archival tumor tissue for the proposed correlative studies
Available archival tumor specimen of the soft tissue sarcoma that meets inclusion criterion #1, #2 or #3.
Willingness to provide archival tumor samples
Archival tumor tissue
Fresh Biopsy or Archival Tumor Tissue
Agreement to mandatory archival tissue or fresh biopsy
All patients must provide archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies (NOT required for patients enrolled on the dose escalation for intermittent ABT-888 portion of the study)
Available evaluable archival tumor tissue for correlative studies including assessment of immune infiltration and Btk expression is required; if archival tissue is unavailable, patients must be willing to undergo repeat prostate biopsy; tissue is considered sufficient for correlative endpoint analyses if they are obtained from at least 2 prostate cores and consist of at least 15 unstained slides from the largest tumor volume and/or highest Gleason score; the availability of archival tissue or consent for repeat prostate biopsy is required for study eligibility; determination of tissue sufficiency is not required for study eligibility
Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by a designated central laboratory confirming NY-ESO-1 and/or LAGE-1a expression.
Archival tissue of carcinoid biopsy must be available
Subjects with archival tumor tissue suitable for proteasome activity and genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
If the patient is enrolled at Memorial Sloan-Kettering (MSK) he/she must consent to a pre and post treatment biopsy (or have archived tissue available for the pretreatment analysis); pretreatment archival tissue for patients enrolled outside of MSK should be submitted to MSK; if there is no archival tissue available, a repeat biopsy is not required for non-MSK patients
Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a PD-L1 stratification test, as assessed by central pathologist
Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study
Has agreed to the collection of archival tumour tissue or recent tumour biopsy tissue, it taken for routine clinical purposes at baseline if archival tissue is not available, for molecular biomarker analyses. Inclusion Criteria Specific for Part B:
Neuroendocrine archival tissue from a previous biopsy will be required
Have sufficient archival tumor tissue for analysis.
Have confirmation of available tissue from an archived specimen of ovarian cancer; if there is no archival tissue available, the participant will be required to undergo a biopsy to obtain a fresh tumor sample
Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment; fresh biopsy (pre and post dose) of tumor tissue will be optional; NOTE: Patients without adequate tissue for bio correlates will not be excluded or required to have a repeat biopsy
Tissue for correlative studies must be available (paraffinized or frozen), but confirmation at screening is not needed; archival tissue may be used instead of a fresh biopsy at baseline if it already exists
Subjects in Phase 2 must have disease amenable to biopsy and must be willing to undergo pre- and post-treatment tumor biopsies. Optional for Phase 1. Note: archival tissue will be requested for all subjects preferably from primary tumor site prior to cancer treatment; however, archival tissue is not a requirement for study entry.
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Have permission to access tissue from an archival tissue sample; (absence of archival tissue will not preclude trial participation)
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the Memorial Sloan-Kettering [MSK] Principal Investigator)
Must be willing to provide and have available archival tissue for PD-L1 testing.
Willingness to provide blood and urine samples, and biopsy samples if on the expansion phase of the study, for research purposes; for the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or archival tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of archival tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements
Adequate archival tissue to perform molecular analysis through Memorial Sloan Kettering (MSK)-Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) if MSK-IMPACT has not been performed previously on the participant's tumor; if MSK-IMACT has not been previously performed and adequate archival tissue is not available, a participant should be agreeable to a pre-treatment biopsy
Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
Available archival tumor tissue or patient is willing to undergo new biopsy
Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
Archival and/or fresh biopsy tissue samples must be available prior to the first dose of the study drug
Patient has consented for tissue banking and a research biopsy after the lead-in treatment of trametinib (required to enroll on this study); patient also consents to another pre-treatment biopsy if insufficient archival tissue is available (minimum of 5 unstained slides) for cohorts 2a, 3, and expansion exists
Agree to undergo a biopsy of at least 1 metastatic site for gene-fusion status analysis; adequate archival metastatic tissue can be used if available in lieu of a biopsy; patients will only be eligible for protocol therapy if the biopsy has tumor and the tissue is evaluable for ETS fusion status
Have sufficient archival FFPE tumor tissue available for planned analyses. Archival tissue from the most recently collected biopsy or debulking surgery should be provided, if available.
Available tumor tissue (archival or recent acquisition)
Archival and screening tumor biopsy
Tumor tissue material available (archival or recent tumor biopsy)
Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Satisfactory archival tumor biopsy tissue is retrieved, or new tumor biopsy is performed, prior to starting Cycle 1
Subjects must have archival tumor tissue available for mutational analysis. A study specific biopsy can be performed if archival tissue is not available.
Extended RAS and BRAF wild type status documented on archival tumor tissue or on fresh biopsy if no archival tissue present
Known KRAS and NRAS mutation status (if unknown status for either of these genes, and no archival tissues is available, a fresh tumor biopsy will be made)
Must have archival tumor tissue available for biomarker analysis. A study-specific tumor core biopsy, pleural effusion or ascites sample must be obtained prior to treatment if archival tissue is not available.
Must have available recent (before treatment start) or archival tumor specimen.
Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination.
For all subjects: Availability of archival tissue, or willingness to undergo fresh biopsy if archival tissue is not available.
2. Histologically proven diagnosis of MPM. All subjects must have biopsy material (archival tissue is acceptable) available for immunohistochemistry determination of Merlin status prior to enrollment.
LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Mesothelin expression in at least 5% of cells as assessed in archival tumor tissue samples, determined by the immunohistochemistry (IHC) assay performed at Laboratory of Pathology/CCR/NCI; archival samples must be available for eligibility
Patients must have archival tissue sample available, collected either at the time of diagnosis or any time since; if archival tissue is unavailable, patient must be eligible and willing to undergo a fresh tissue biopsy
Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
Documented MUC16 expression from archival or fresh tissue by IHC central review
Patient must have access to archival tumor tissue sample or agree to undergo biopsy after study eligibility has been confirmed to obtain fresh sample for evaluation of WT1 expression. In place of archival tumor tissue samples, patients with AML should have available a bone marrow aspirate and/or bone marrow biopsy with PCR for WT1 transcript performed before the first dose of study drug.
Available archival tumor tissue or willingness to undergo repeat biopsy is required at trial initiation
Must have adequate fresh or archival tumour tissue at the late disease progression immediately prior to the study entry
If available, patient must agree to provide archival tissue for research purposes (either archival paraffin tissue block or 10 unstained slides of a primary or metastatic melanoma lesion) prior to enrollment; samples should be shipped within 1 month after enrollment
Consent to provide archival tumor tissue for biomarker testing
Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
Patient has tumor tissues available (archival or fresh).
Consent to provide archival tumor tissue for biomarker testing
MET Diagnostic-High tissue reported by the central authorized laboratory using archival or recent biopsy tumor samples
Availability of archival tumor tissue (core biopsy or surgical tumor blocks) for analysis. Sites will be asked to submit archival tissue (subjects may start the study if tissue is available at an outside hospital, but not yet requested or received).
PTEN deficient tumor as documented from archival or fresh (from biopsy) tumor tissue analyzed by GlaxoSmithKline selected laboratory
Provision of (archival or fresh) FFPE tumor tissue. (For Cohort 3 only: if diagnosis was made by cytology and archival tissue is not available, patient will not need to provide tumor tissue)
Consent to provide archival tumor tissue for biomarker testing
Willingness to provide archival tissue from the primary diagnosis (original lymphoma lymph node tissue biopsy)
Archival tissue available for Foundation One analysis
Participants must have an archival tumor sample available (1 block or 20 unstained slides); if no archival tissue is available, participants must be willing to undergo a research biopsy of their disease if it is safely accessible
Archival tumor tissue obtained at any time from the initial diagnosis to study entry; a fresh tumor biopsy using a procedure that is safe for the subject on a lesion not previously irradiated unless lesion progressed will be required if archival tissue is unavailable.
Willing to undergo fresh liver biopsy if provided archival tissue was taken greater than (>) 6 months from Cycle 1 Day 1
Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1, Day 1
Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1 Day 1
Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent to a fresh tumor biopsy (mandatory for dose expansion cohort only; optional for dose escalation)
Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Agree to undergo a biopsy of at least one metastatic site or primary prostate for determination of the RB status; adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC (within 6 months of treatment start)
Patients enrolled in Part 2 must have at least 20 (preferably 40) slides of archival tumor tissue from a prior surgery demonstrating GBM; patients enrolled in Part 1 will not be required to have archival tissue
All patients must agree to provide an archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies; however, patients are not considered ineligible if archival tumor is not available
Archival tumor tissue from biopsy or resection will be required for all patients; archival tissue should be of good quality based on total and viable tumor contents; fine needle aspiration, brushing, and cytologic cell pellets are not acceptable
Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).
Archival tumor specimen according to protocol-defined criteria.
Patients without either fresh or archival tumor tissue accessible.
Consent to provide archival tissue
Patients with archival tumor tissue suitable for measurement of proteasome activity and biomarker status must give permission to access and test the tissue. Patients without archival tumor tissue are eligible for the Dose-Escalation stage, but not the Dose-Expansion stage of the study
Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment; patients without adequate tissue for bio-correlates will not be excluded or required to have a repeat biopsy
In the dose expansion cohort patients should be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion (pre-treatment) and a post-induction period biopsy; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; patients for whom newly-obtained samples cannot be provided (e.g., inaccessible, subject safety concern, or unwilling to undergo biopsy) may submit an archived specimen only upon agreement from the sponsor; post-induction\r\nbiopsy will be collected at the end of the Induction period, approximately 12 weeks from the start of study treatment (sometime between cycle 4 day 15 – cycle 4 day 21, prior to the re-staging scan)
Able to provide tissue from a newly obtained core or excisional biopsy of a chest wall tumor lesion; newly-obtained is defined as a specimen any time after the last systemic or local therapy utilized to treat the disease; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the study chair
Be willing to provide tissue from a newly obtained core needle or excisional biopsy; newly-obtained is defined as a specimen obtained up to and including 90 days prior to treatment day 1; subjects for whom newly obtained samples cannot be provided may be enrolled only with agreement by the overall principal investigator (PI)
If tumor is accessible and outside the field of radiation, the participant must be willing to undergo a research biopsy at baseline and around their second cycle of pembrolizumab; participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or safety concern) must be willing to submit an archival specimen
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator
Be required to provide tissue from a newly obtained biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to study registration; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from principal investigator (PI)
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the Sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion (phase II dose expansion cohort only); newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor
Have submitted an evaluable tissue sample for biomarker analysis from a newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated. The tumor tissue submitted for analysis must be from a single tumor tissue specimen and of sufficient quantity and quality to allow biomarker study. A newly obtained tumor specimen, defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1, for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation may be allowed for biomarker characterization upon agreement from Merck. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Merck.
In addition, patients enrolled on the clinical trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; patients for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from archival biopsy tissue or newly obtained excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1
Have biopsiable disease; be willing to provide tissue from a newly obtained biopsy of a tumor lesion; newly obtained is defined as a specimen obtained up to 28 days prior to initiation of treatment on day 1
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
Willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion in appropriate low risk cutaneous lesions\r\n* NOTE: if the tissue biopsy is deemed to be of increased risk for the patient, the biopsy should not be performed and is optional\r\n* NOTE: newly-obtained is defined as a specimen obtained up to 42 days prior to registration where no anti-cancer therapy after the specimen was obtained and registration
Patients should be willing to provide a newly obtained fresh core biopsy of a tumor lesion. Not required if there is a recently obtained fresh specimen on an Institutional Review Board (IRB) approved correlated trial up to 6 weeks (42 days) prior to initiation of treatment on day 1.
Adequate tissue specimens for correlative biomarker analysis; the patient should be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to120 days prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen or leukemic blood sample, only upon written agreement from the study principle investigator (PI)
Archived or newly obtained tumor material
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor-investigator
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Participants in cohorts B-D must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen within 4 weeks to initiation of treatment and AFTER the last dose of any prior therapy
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion from a metastatic site; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from Merck; the specimen must be from a biopsy site that would be accessible for at least one subsequent biopsy after initiation on the trial
Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 4 weeks (28 days) prior to initiation of treatment on day 1 and, after 3 cycles of study treatment; participants for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator
Be willing to provide archival or fresh tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on day 1; subjects from whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator
Be willing to provide tissue from a newly obtained bone marrow aspirate and/or biopsy; newly-obtained is defined as a specimen obtained up to 28 days prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator (PI)
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI or designee
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion or ascites or plural effusions via paracentesis or thoracentesis; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement of the investigator
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained for up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor; an optional core biopsy will be requested from an accessible metastatic site after 2 cycles of treatment
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived sample
In addition, patients enrolled on the phase 1 dose escalation, phase 1 expansion or phase II trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 3 months prior to initiation of treatment on day 1, and must be obtained after most recent treatment; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor)
Be willing to provide tissue from a recently obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day -7. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from Sanford Research.
Patient must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 months (168 days) prior to initiation of treatment on day 1; archived specimen can be used for subjects in whom newly-obtained samples cannot be provided
Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 12 weeks (84 days) prior to date of signing consent; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor; at least 4 mm of tumor tissue will be needed for programmed cell death-ligand (PD-L1) staining
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 10 weeks (70 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen (if available from prior biopsy) only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained oral biopsy
Be willing to provide tissue from a newly obtained transurethral resection of bladder tumor (TURBT) or biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 8 weeks (56 days) prior to initiation of treatment on say 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 10 weeks (70 days) before initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor or may undergo fine needle aspiration
Be willing to provide either archived tumor tissue or tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the study principle investigator (PI)
Willing to provide a sample from a recently obtained (within 42 days prior to initiation of day 1) biopsy of a tumor lesion;\r\n* If recently-obtained samples are unavailable an archived metastatic specimen not previously irradiated may be submitted upon agreement from the study principal investigator (PI)
Willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up-to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the study principal investigator (PI)
If an archived tumor tissue is available, be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1 of RT
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained biopsy of a tumor lesion, most commonly an esophagogastroduodenoscopy (EGD) biopsy from the esophagus; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor; please note, patients may not initiate therapy until the biopsy specimen is received at the Dana-Farber Cancer Institute
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor and primary investigator
Patients must have a tumor tissue form indicating availability of archived tissue from a previous surgery for glioblastoma, completed and signed by a pathologist
Confirmed availability of representative tumor specimens
Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation.
Confirmed availability of tumor tissue blocks or freshly cut tissue slides for NaPi2b testing.
Availability to provide a representative tumor specimen biopsy
Availability of an archival FFPE tissue specimen.
Confirmed availability of archived FFPE tumor tissue block, or a minimum of 15 slides. If archived FFPE tissue is not available, then fresh tumor sample may be obtained in accordance with local institutional practice for tumor biopsies.
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist; availability of tissue is not a requirement for study participation
Availability of archival or freshly collected tumor tissue before study enrolment
Availability of archival tissue for correlative analysis
Has archive tumor tissue from primary tumor or metastatic site (excluding bone), for which the source and availability have been confirmed.
Patients must have confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment
Availability of fresh tumor tissue and/or archival tumor tissue at Screening
Availability of fresh tumor tissue and/or archival tumor tissue (obtained within 5 years of the consent date) at Screening
Availability of tumor specimens is mandatory for patients in the confirmation phase;
Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.
Part 1 patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM, completed and signed by a pathologist
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist; availability of tissue is not a requirement for study participation
Availability of >= 4 clinical vials of HSPPC-96
Tumor specimen availability
Availability of recent tumor tissue with 3 months prior to enrollment, when feasible.
Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
Availability of archival or freshly collected tumor tissue before study enrollment
Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
Availability of archived or representative tumor material for assessment of DLL3 expression
Confirmation of the availability of a tumor sample from the primary or recurrent cancer must be provided
Willingness to release and confirmed availability of archival tissue sample for research purposes
Availability of tumor sample:
Availability of tumor tissue specimen
Availability of tumor tissue sample that can be used for assessment of PrR levels with the use of immunohistochemistry;
Availability of archival tumor tissue
Availability of adequate tumor tissue for exploratory analysis and plan to obtain the material
Availability of tumor tissue for HER2 status confirmation
Availability of an adequate archival tumor specimen or willingness to undergo a pretreatment tumor biopsy.
Availability of fresh tumor tissue at screening
Availability of tumor tissue for central laboratory analyses.
Availability of fresh or archived tumor tissue.
Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for Notch receptors genomic profiling
Tumor tissue biopsy within 60 days prior to study entry or availability of an archival specimen obtained within 60 days of study screening
-  Availability of tumor tissue from any time since diagnosis of prostate cancer disease. If no tumor samples are available the participant might still be eligible following discussion between the investigator and the medical monitor.
Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle aspiration is not acceptable.
Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived
Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy
Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
Availability of FFPE tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
Confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment
Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle aspiration is not acceptable.
Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.
Confirmed availability of archival or freshly collected tumor tissue
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist
availability of tissue sample for diagnostic testing is required
Availability and willingness to provide an adequate archival sample of tumor
Availability and willingness to provide sufficient tumor tissue sample for testing
All patients must consent to provide archival tumor samples; non-availability of evaluable tumor samples does not exclude patient from the study
Availability of archived tumor tissue sample that can be used for assessment of PrR status by the central laboratory;
Availability of archived tumor tissue for banking
Availability of tumor tissue (>= 10 slides) for PD-L1, gene expression profiling (GEP), and additional testing
Availability of tumor tissue at study enrollment
Availability of the patient’s medical information
Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested).
Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory
Patients must have pre-treatment blood and tissue specimens submitted for translational medicine as outlined; with patient consent, residuals will be banked for future research
Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification\r\n* Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery\r\n* The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution\r\n* NOTE: Tissue must and can be submitted any time during screening period, even if patient is getting radiation\r\n* NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately
Patients must be offered the opportunity to submit archival tissue for translational medicine; patients must also be willing to undergo biopsies and submit fresh tissue and blood for translational medicine
Sufficient tissue and blood must be available to submit for required biology studies
Provide adequate tissue (core or incisional/excisional biopsy) prior to starting study treatment; this tissue will be used for PD-L1 analysis; fresh tissue or archival tissue sample can be used; if adequate tissue cannot be safely obtained than the patient may still be enrolled on the trial after discussion with the study principal investigator as long as fine-needle aspiration (FNA) was done to confirm recurrent/second primary head and neck squamous cell carcinoma (HNSCC)
Patients with recurrent diffuse intrinsic brain stem glioma (DIPG) that has an atypical presentation must also submit the tumor tissue for Rb1 protein status confirmation or provide previous testing results from a CLIA certified laboratory; patients who have been biopsied for atypical DIPG but do not have sufficient tissue for Rb1 screening are not eligible
Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
1 cm^3 of available tissue for N=5 patients for correlative tissue studies; patients can enroll regardless of their tissue availability being checked beforehand but at least 5 patients will need to have sufficient tissue by study accrual completion; tissue availability will be checked after patients are successfully enrolled
Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses
Active skin or soft tissue infection including cellulitis, erysipelas, impetigo, furuncle,carbuncle, abscess, or fasciitis.
Phase II subjects must be willing to provide a tissue biopsy prior to registration if archived HCC tumor tissue is not available for correlative studies
Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released. TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.
For subjects with melanoma, archived or freshly biopsied tumor tissue (preferred) must be obtained prior to enrollment; tissue shipment tracking information should be provided before administration of study treatment is initiated; however, if shipping will be delayed and tissue shipment tracking information is unavailable, study drug may be administered prior to tissue receipt pending discussion with principal investigator
Have evidence of homozygous loss of CDKN2A or MTAP in the subject's tumor tissue.
Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
Participants must have biopsy tissue at time of diagnosis available for targeted next-generation sequencing; the testing does not have to be completed prior to study enrollment; biopsy can be performed at an outside institution as long as sufficient tissue is available
Willing to provide blood and tissue from diagnostic biopsy and at the time of surgery
Patients with tumor tissue uptake during NETSPOT PET that is equal to or higher than that in normal hepatic tissue (grade >= 2) will be eligible; at the discretion of the principal investigator, patients with SCLC whose tumors have lower levels of uptake than liver during NETSPOT PET may be eligible for the study
Participants must have biopsy tissue at time of diagnosis available for next-generation sequencing testing at the Dana-Farber Cancer Institute; biopsy can be performed at an outside institution as long as sufficient tissue is available
Willing to provide archived tissue, if available, from a previous diagnostic biopsy
Memorial Sloan Kettering (MSK) patient has tissue available from a previous biopsy for the evaluation of potential predictive biomarkers; if tissue is not available for MSK patient, a new tumor specimen will need to be obtained prior to the start of study treatment; if archived tissue is available, participating site patient will provide for the evaluation of potential predictive biomarkers; if tissue is not available for participating site patient, a new tumor specimen is optional prior to the start of study treatment
Tumor tissue from biopsy following progression on the most recent TKI available for mutation analysis; if tissue is inadequate for exploratory research testing, patient may enroll with permission of principal investigator
Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrolment) Vismodegib
Tissue from the initial diagnosis or recurrence must be made available for correlative testing
Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
Patients must have tumor tissues from transurethral resection of the bladder tumor (TURBT) that is within 120 days of registration and available for submission; tissue sample must be sufficient for IHC testing; that is, it must be sufficient tumor tissues for correlative science after pathologic diagnosis (i.e., enough tumor tissue to pass the staging criteria)
Has provided tumor tissue from locations not radiated prior to biopsy.
Pathological diagnosis for the resected tumor demonstrates transformation to higher grade (i.e. WHO grade III or IV) gliomas; if a patient who received neoadjuvant vaccines is diagnosed as high grade glioma (HGG), the patient will be withdrawn from the study and considered for therapeutic options for HGG (trials for HGG or standard of care); the tumor tissue of such a case would be brought to the lab before the pathological diagnosis is made; and thus would be processed before the lab is informed of the final HGG diagnosis; because HGG tissue may still reflect the vaccine effects, we will evaluate the tumor tissue to help us develop future approaches for HGG
Tumor tissue receptive to Wnt signalling in biopsy
Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative
Diagnostic primary tumor tissue must be available for ERCC1 staining
Patients with breast tumors that are AR+ (?10% staining by immunohisto-chemistry). Archived tumor tissue from a primary biopsy or metastatic lesion for centralized determination of AR expression is mandatory. If tissue is limited, the additional correlative testing is optional. If tissue is not available, a patient will not be eligible for enrollment into the study. Patients may enroll based on local laboratory AR assessment, but will need to submit tissue for confirmation at the central laboratory.
Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Expansion Arm A), for the 6-patient breast cancer gene (BRCA)-mutation expansion arm, patients must have measurable disease; however, tumor biopsies are optional; for Expansion Arm B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements
Have pre-resection tissue (Esophagogastroduodenoscopy [EGD] or EUS biopsy from the diagnosis) available
Other bone and soft tissue sarcomas cohort only: Subjects with other soft tissue sarcomas who have received at least one line of therapy.
Consent to provide mandatory paired tissue biopsies, obtained within 6 weeks prior to the first study dose of CORT125281 and/or enzalutamide and at Cycle 2 Day 1 (soft tissue biopsy is preferred, when possible)
Available primary tumor tissue for CMS4 biomarker assessment.
Tissue specimen available for B7-H3 and PD-L1 expression testing
DLL3-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ? 1% of tumor cells.
Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
Fresh or archived tumor tissue sample available for target expression analysis. [Phase 1b only: Subjects' tumor tissue must test positive for target expression.]
Mandatory tumor tissue must be submitted
Be willing to provide archival tissue (if available) for correlative studies\r\n* Note: The archived tumor tissue specimens may be from metastatic tumor specimen (first choice); in alternative, we can consider tissue from prior surgery or from prior diagnostic biopsy (second choice); unavailability of archived tissue will not render subject ineligible for study
Patients with breast tissue expanders must have those removed before enrollment
Available tumor tissue for pathologic review and correlative studies; tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and/or blocks) to be sent to Duke
Have archived tissue available or be willing to undergo a fresh biopsy during screening, if deemed feasible by the investigator/study principle investigator (PI); if neither available, the patients enrollment must be reviewed and approved by the PI
Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes; in addition, subjects must consent to allow use of their residual post-operative tissue for research purposes
STUDY TREATMENT: Tumor tissue from the most recently resected site of disease (preferable) or from the transurethral resection that yielded the initial muscle invasive diagnosis must be provided for biomarker correlative analyses; enrollment is permitted if adequate archived tissue is unavailable
Patients must have histologically or cytologically confirmed malignant pleural mesothelioma; for phase 2 of this study only, the malignant tissue must show moderate or stronger mesothelin expression in 30% of tumor cells by a companion assay for the patient to be eligible for and registered to the study; for patients in pre-registration for phase 2, submit slides or a tissue block from an archived tissue sample or a fresh tissue sample from biopsy if archived tissue is not available to the central lab for the mesothelin expression assay; central review of pathology will not be performed
Consent for use of available archived tissue and tumor obtained during a standard procedure, for research purposes
Retroperitoneal soft tissue sarcomas
(For Cohort A) - Archived tissue available at pre-screening to confirm FR alpha+ breast cancer
Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted (prior surgical score, PSS, of 0 or 1)
Subjects must agree to pre-treament and on-treatment biopsies\r\n* Patients that have available tissue that fulfills the pre-treatment biopsy requirement or other deviations in terms of the tissue requirement, may not need a fresh biopsy at baseline if discussed and approved by the medical monitor
Positivity on CD44 assay as defined by strong (+++) or moderate (++) staining in 20% or more of the tumor tissue/stroma as obtained by biopsy or paracentesis
Tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses
Agrees to provide available archived tumor tissue specimen; (patients who do not have available archived tumor must agree to have core or excisional biopsy of a tumor lesion obtained up to 42 days prior to the first dose of study drug, if safely accessible; if archived tissue is not available and the tumor is not amenable to safe biopsy, subject is still eligible to participate)
Must have a confirmed diagnosis of metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted
Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
Have tumor tissue for PD-L1 expression testing
If no archive tissue is available, the subject may elect to have a biopsy performed to obtain tissue.
Consented for tissue collection on Mays Cancer Center repository 07-32
Tumor must have dysregulation of the PI3K/AKT/mTOR pathway; for the purposes of this study, patients must have either PTEN protein or genomic loss, or PIK3CA/PTEN mutation; patients must be willing to provide sufficient archival tissue; if this is not available fresh tumor for biopsy is required; in the event that a patient has had tumor analyzed for PTEN/PIK3CA status through commercial means, their eligibility and need for additional tissue will be determined on a case by case basis by the principal investigator
Willing to donate tissue to research from the surgical specimen
Phase II archived tissue collection: will be requested when available, but is not mandatory for inclusion
Tumor tissue must be available for review to confirm histological diagnosis
For the neoadjuvant cohort, patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis; if evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study; for the CRPC lead in cohort, if histopathological documentation is unavailable, a rising PSA and a clinical course consistent with prostate cancer would be acceptable
Tissue available (archived or fresh tumor biopsy) for the PD-L1 assay
Willing to provide consent for an additional tissue biopsy for research purposes, to allow a part of their surgical tumor tissue to be utilized for research (in case tumor tissue has not already been saved in the tumor tissue bank), and to donate samples of blood and saliva collected weekly through the treatment
The patient must consent to a research biopsy at baseline, and during week 2 of cisplatin-IMRT; all patients will be evaluated for the feasibility of research biopsy at the time of enrollment, as a condition of eligibility; the performing physician must agree that a cup forceps biopsy or an 18 to 14 gauge core needle biopsy can be safely performed; every effort will be made to couple the baseline research biopsy to a standard of care diagnostic or staging procedure; NOTE: patients who have had research tissue procured under an omnibus tissue consent, who are determined to have sufficient fresh, fresh-frozen, and paraffin tissue for analysis of immune-inflammatory biomarkers per the translational science co-chair, may substitute the archived tissue and do not need to undergo baseline research biopsy; such tissue must have been obtained within the prior 24 weeks and no interval anti-cancer therapy administered
Patients at Washington University must be enrolled in HRPO# 201011766 (“Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases”); this is not a requirement for secondary sites; however, secondary sites must provide informed consent forms that document that permission for whole genome, whole exome, and/or genome wide sequencing, and data sharing among institutions, was obtained; because the study will also be sequencing non-diseased (normal) tissue, the informed consent forms must explicitly ask if patients wish to be informed, (or in the case of their death, their next-of-kin) if a deleterious mutation is identified in their non-diseased tissue, as this may be heritable
Pre-treatment tumor tissue available for research purposes; this tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy; this pre-treatment tumor must be amenable to repeat tissue sampling after induction therapy
History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification
Consent for use of archived tissue for research purposes
History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification
At screening, must have tissue available for NY-ESO-1 testing (if not previously performed) or be willing and able to undergo a fresh tissue biopsy
Patients must have adequate fresh or frozen tissue available; if tissue is needed, then subjects may have had it collected previously under protocol PA15-0176
No tissue is obtainable at thoracoscopy
Biopsy containing ? 10 tissue cores sampled
Tissue submitted for HRG-biomarker testing
Phase II only: Biopsy of a metastatic lesion in patients with reasonably accessible metastatic lesions (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases); if a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available; however, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy; any patients not undergoing biopsy must be approved for study enrollment by the Protocol Chair; biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guidelines; if a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes; patients without sites available for biopsy 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)
Subject has appropriate tissue available from the cytoreductive surgery for tumor lysate preparation
The subject must be expected to have an adequate amount of tumor burden to yield 2-4 pre-operative research core biopsy (14-gauge needle) specimens or the equivalent amount of tissue (4-6 mm punch biopsy), in addition, to the tissue required for diagnostic purposes
The subject must be expected to have an adequate amount of residual tumor after their pre-operative research tumor tissue collection, such that their operative research tumor collection will also yield at least 4-6 research core biopsy specimens or the equivalent amount of tissue
Tissue available (either initial diagnostic or recurrent tissue specimen) for p16 testing (if p16 status is already known, this criterion may be waived)
Patients who have tumor deposit(s) that are easily accessible by ultrasound or computed tomography (CT) guidance will be eligible for study; this is the case even in the event that a qualifying archived tumor sample is already available for a particular patient?qualifying archived tumor tissue is tissue extracted while the patient was in the same untreated state as when screened (usually tissue taken within 8 weeks prior to screening)
Tissue block of initial biopsy specimen is available
Patient does NOT have known intracranial metastatic neuroblastoma; skull based disease with soft tissue extension is allowed
Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites; if tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other Dana-Farber (DF)/Harvard Cancer Center (HCC) institution is required, but preliminary report only required prior to enrollment; if no tumor tissue was obtained, urinary catecholamine metabolites are required
Patients with the following histologies are excluded: melanoma, other soft tissue or bony sarcomas, giant cell tumor, aneurismal bone cyst or metastatic lesions from other histologies
Available tissue of primary lung tumor
Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
Subjects must provide samples of tumor tissue
Be willing to provide tissue
Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of ~10-30 grams tissue (\grape\ to \golf-ball\ size) or pleural fluid estimated volume ? 500mL (from a primary or secondary thoracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
Adequate archived primary or metastatic tumor tissue collected before the prior PARP therapy.
Willingness to provide pre- and post-treatment tissue for translational studies. Pre-treatment fresh frozen tissue must be available for research purposes. This tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy.
Must have diagnostic biopsy tissue (pre-neoadjuvant chemo) available for genetic testing.
Must have surgical tissue (post-neoadjuvant chemo) available for genetic testing.
Inadequate tissue acquisition to allow for neoantigen screening.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Confirmed MCL tissue diagnosis.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Patients must have relapsed/progressed after any therapy for MCL.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Patients must be willing to allow residual tissue to be collected for both in vitro, in vivo (PDX) testing and molecular profiling.
Tissue block of initial biopsy specimen is available
Patients must have adequate tissue (fresh or frozen) available or planned removal of adequate tissue for analysis; at least 250 mg of tumor are needed for peptide elution; there is no specific time limit on how long the tissue can remain frozen prior to use
Participants must have an image guided biopsy performed to yield fresh tissue for the in vitro organoid bio-assay and two biomarker testing (western blot and immunohistochemistry)
Stratum 2: Patients with DIPG who have pre-trial tumor tissue available are requested to submit tissue; however, this is not required for eligibility
The subject must have tumor tissue that is sufficient quantity and quality for sequencing
Patient is agreeable to allow tumor and normal tissue samples to be submitted for complete exome and transcriptome sequencing
At the point when tumor biopsies become mandatory (expansion phase only), disease amenable to biopsy and willingness to undergo biopsies or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements outlined
Central laboratory confirmation of the presence of the T790M mutation in tumor tissue\n             in Cohort A and the presence or absence of the T790M mutation in tumor tissue in\n             Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable.\n             Biopsy material obtained from either primary or metastatic tumor tissue and sent to\n             the central laboratory must be within 60 prior to dosing study drug but following\n             disease progression on the first EGFR TKI
Diagnostic primary tumor tissue must be available for biomarker correlatives, in both the dose-finding and expansion cohorts
Unresected disease that meets the following criteria:\r\n* Scheduled to undergo definitive surgery (lumpectomy or mastectomy)\r\n* Tumor size >= 1 cm (radiographically or clinically)\r\n* Grade 2 or 3 tumor or Ki-67 proliferation index of >= 10% (or both)\r\n* Any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) status; however, receptors must have been tested on a diagnostic specimen\r\n* NOTE: bilateral cancers are eligible as long as at least 1 tumor meets the eligibility criteria above; if possible, tissue should be collected from both cancers at the time of tissue collection\r\n* A patient planning to initiate preoperative therapy who would like to take part in the study may do so if she agrees to undergo a study biopsy at the completion of digoxin dosing and prior to start of treatment, or at any time prior to start of treatment in those patients randomized to receive no drug; in these patients, tissue from the definitive surgery may still be collected for study correlates at the discretion of the protocol chair and pathologist
Intent to submit tissue for central HER2 testing
Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
NSCLC and gastric adenocarcinoma subjects must have tissue available for HA-selection and PD-L1 testing.
Tumor tissue must be available for prospective determination of FGFR2b overexpression
Subject must consent to provide previously collected tumor tissue
adequate tumor tissue available prior to randomization
Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after treatment for biopsy and PD biomarker analyses.
Group 2 patients should have archived or fresh tumor tissue available from the non-craniotomy site and will have fresh tumor tissue available from the planned craniotomy
Can provide tumor tissue.
IHC greater than or equal to 20 percent of tumor on tissue sections must stain with NPC-1C.
Tumor tissue sections must be available for biomarker evaluation
For Parts B, C, D, E and F: Have available tumor tissue.
Subjects must be willing and able to have a fresh tumor biopsy prior to start of study treatment for research evaluations and cohort categorizing; Note: if insufficient fresh tissue is obtained to provide sub-classification for cohorts, then tissue material from a previous relapse biopsy and/or original diagnostic block may be requested to meet this criterion
Available TNBC diagnostic tumor tissue (archived tissue allowed)
Willing to provide tissue for translational research
Tumor tissue available from most recent biopsy to determine cell of origin
Must have available tumor tissue for TIM-1 expression testing
Lung cancer confirmed to express gpNMB, as assessed by immunohistochemistry at a central lab (using expression in ? 5% of tumor epithelial cells as a cut-off for positivity). This can be tested on archived tissue if available, although preferred tumor specimen is a biopsy after the most recent therapy.
FFPE tumor tissue either fresh core needle biopsied or archived (two FFPE cores preferred whenever possible) is required for participation in the study. If fresh tissue is obtained, the core biopsy must be done at least ?7 days prior to Day 0.
Screening for Rb applies to all patients with available tissue except for patients diagnosed with DIPG and bi-thalamic tumors.
Patients with diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for RB protein status confirmation.
Mandatory tumor tissue available
Inadequate tissue acquisition to allow for neoantigen screening
Patient must agree to provide tumor tissue
Archive tumour tissue is available prior to recruitment for pharmacogenomic tests
Patients must to have tumor tissue collected prior to enrolling on this trial; up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution\r\n* If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department
Patients must have additional tumor available and be willing to submit tissue and blood samples
Patient must agree to provide tumor tissue from metastatic tissue at baseline
Patients must have provided consent for tissue collection for the molecular testing through participation on study UPCC 22210 entitled; “PROTOCOL TO PERMIT THE ACQUISITION OF SAMPLES OF TUMOR AND NORMAL TISSUE FOR BIOLOGICAL ENDPOINTS IN PANCREATIC CANCER”
Patient must agree to provide tumor tissue
Tumor tissue is positive for EBV
Tissue available for PD-L1 testing and for correlative science testing
RAS (KRAS and NRAS) wild-type in primary or metastatic tumor tissue
Consent for use of available archived tissue for research purposes
Active connective tissue disease
The participant has evaluable tumor tissue available for biomarker analyses.
Non-soft tissue sarcomas, such as osteosarcoma and chondrosarcoma are excluded
If patient has a clinically indicated surgery or biopsy at any time during treatment with Reolysin, a tissue sample will be collected for correlative research purposes
Consent for use of available archived tissue for research purposes
Tumor tissue available for evaluation of PD-L1 expression
Histological confirmation of node positive (any T stage N1-3) proximal esophageal, distal esophagus or gastroesophageal (GE) junction adenocarcinoma (Siewert I, II, or III) after completing preoperative chemoradiation and surgery; supporting pathology report sufficient for registration; available tumor tissue from endoscopic biopsies prior to preoperative chemotherapy (chemo)/radiation therapy (RT), and tumor from surgical specimens will be submitted to Academic and Community Cancer Research United (ACCRU), but not be required prior registration; Note: if tissue is depleted, patient will still be eligible after discussion with the physician
Patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis; if evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study as an alternative to having available tissue available
Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from a biopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue.
HER2-overexpression in the patient's tumor tissue
Have hormone-sensitive metastatic disease (M1) as evidenced by soft tissue and/or bony metastases
ASS1 deficiency (defined as ?50% ASS expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (IHC). For subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. A new tissue specimen obtained after most recent chemotherapy is not required. Thus ASS1 deficiency is required for entrance into the study. If tissue is not available to determine ASS1 deficiency, then tissue must be obtained by biopsy to determine ASS1 status.
Tissue is required prior to enrollment. If patient was diagnosed outside and tumor tissue is not available, a pleural biopsy for frozen tissue collection is required.
Histological tumor tissue specimen
Participants must agree to undergo a research biopsy of a reasonably accessible metastatic lesion (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases); if a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available; however, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy; any patients not undergoing biopsy must be approved for study enrollment by the overall principal investigator at Dana-Farber Cancer Institute (DFCI); biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guideline; if a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes; patients without sites available for biopsy must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB], blocks from which slides can be created, 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
All patients must have adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue; cases with limited tissue available should be reviewed with the primary investigator prior to enrollment
Patients must have histologically confirmed metastatic breast cancer; if available, tissue (a minimum of 3 slides) from the most recent biopsy should be submitted for review and confirmation of eligibility; NOTE: Material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available; availability of tissue is not mandatory for confirmation of eligibility or enrollment to the study
A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
Consent to provide fresh tumor tissue during screening
Patients with evidence of soft tissue involvement by gross extranodal extension of tumor manifest by fixation to the fascia, or matting of nodal tissue that would compromise surgical resection as determined by the surgical oncologist
Tumor GANQ, GNA11, and BAP1 mutational status must be determined on all patients; if initial testing is performed locally or not available, MSKCC or Columbia University Medical Center (CUMC) patients must consent to provide a tumor block or unstained slides to MSKCC or CUMC for central review of mutational status; if tissue is not available, a pre-treatment biopsy will be necessary for eligibility \r\n* Patients enrolled at Vanderbilt University Medical Center may have GNAQ and GNA11 mutational status determined on a Clinical Laboratory Improvement Act (CLIA)-approved assay at Vanderbilt University Medical Center, CUMC, or MSKCC; tissue must be sent to MSKCC for BAP1 mutational status determination\r\n* The determination of mutational status may be performed retrospectively and will not delay patient treatment on study as long as tissue is available for molecular analysis
Invasive primary tumor or metastatic tissue confirmation of HER2-positive status, defined as presence of one or more of the following criteria
Presence of a BRAF V600E mutation in lung cancer tissue. Mutation must be locally confirmed in a CLIA-certified laboratory (or equivalent). An adequate amount of tumor tissue (archived tumor tissue, or fresh biopsy if archived tissue is not available) must be available at the time of enrolment for central validation of BRAF mutation;
inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging;
Group B: Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
Must have available tumor tissue and consent to biopsy while on study.
Must consent to allow the acquisition of new tissue biopsy samples during the study
Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
Tumor tissue available at time of screening for molecular profiling.
Must submit tumor tissue for correlative analyses
Must have available tumor tissue and consent to biopsy while on study.
Baseline tumor tissue to conduct molecular and / or genetic studies should be available from all study patients enrolled in this study. (optional in Phase 1b)
Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers.
Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
Available tissue for AR testing for research purposes
Tissue availability for programmed cell death ligand 1 (PD-L1) expression is mandatory for enrollment; however if archived tissue is unavailable the patient will be given the option to consent to pre and post treatment tissue biopsies; tissue biopsies will be collected pretreatment (prior to the first dose of therapy) and post treatment (after at least 1 dose, preferably 2 doses of nivolumab)
Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2
Tumor tissue from the resected site of disease must be provided for biomarker analyses
Available archived tissue to perform molecular analysis\r\n* Patients without available archived tissue can have repeat biopsies to determine EGFR status as per standard clinical care guidelines
Sufficient archived tumor samples (if taken within 6 months prior to treatment may be submitted) available for PD assessments, or willingness to undergo a pre-treatment core needle biopsy, preferably of the primary tumor, in order to obtain such tissue;
Patients must provide tissue from a punch biopsy of the skin at baseline, at the time of a clinical event (at the time of response, progression or appearance of a new lesion) and at the end of treatment; additional punch biopsies every 3 cycles are optional; an archival tissue sample is optional
HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
Must have submitted a diagnostic FFPE tumor tissue sample to confirm tumor GR positivity. Tumor tissue may be from primary or metastatic lesion. In the absence of sufficient tissue to complete IHC, a tumor biopsy will be required.
Availability of tissue from the initial diagnosis and the recurrent tumor that is estimated to be of sufficient quality and quantity for both genomic deoxyribonucleic acid (DNA) and total ribonucleic acid (RNA) isolation; preferably some of the tissue would be snap frozen for high quality RNA preparation
Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.
Subjects have available tumor tissue
Tumor tissue (archived or fresh) is required and must be available to be shipped to GSK or site specific laboratory.
EGFR-mutation negative tumor tissue as determined by sequencing; if an individual tissue test result is inconclusive (unable to be determined), it will be considered negative for study eligibility purposes
Tumor verified to be CD20+ (based on local evaluation), from a current or previous tissue biopsy. Tissue biopsy should be repeated if no report or specimen is available, CD20 staining was not previously performed, or there is clinical suspicion that the indolent lymphoma has transformed to aggressive lymphoma/higher malignancy grade.
Measurable soft tissue plasmacytoma
Consent to research use of their BCC tissue
Patients must have a signed tissue acquisition consent and have at minimum, adequate samples of primary fresh tissue or blood available for use in this study.
Documentation of disease: \r\n* Histologic documentation: histologically proven mucosal melanoma by local pathology\r\n* Tumor tissue: tumor tissue from the primary site of disease must be available for PD-L1 testing (stratification factor)
Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and whole exome sequencing
Have pre-resection tissue (esophagogastroduodenoscopy [EGD] or EUS biopsy from the diagnosis) available
Tumor tissue available and deemed adequate for genomic studies
History or current evidence of:\r\n* Tissue calcification including, but not limited to, the soft tissue, kidneys, intestines, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification\r\n* Endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
Unresectable thyroid cancer expressing TG as assessed by one of the following methods: real-time (RT)-polymerase chain reaction (PCR) on tumor tissue, or by immunohistochemistry of resected tissue
Subjects must have existing tissue available for correlative studies; if availability of tissue has been confirmed the study drug can be started prior to the tissue being obtained
Patients must be willing to submit blood and tissue specimens for translational medicine
Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)
Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
Patients receiving osseocutaneous free tissue transfer regardless of the indication for free tissue transfer; this includes osseocutaneous tissue from fibula and scapula
Preoperative surgical plan: immediate placement subpectoral tissue expander with ADM
No use will be made of fetal tissue
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nBiopsy prior to study enrollment that is obtainable AND has sufficient residual tumor tissue from such biopsy is obtainable and donated for the research
Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
Passage through non-aerated lung or tissue
Absence of HER2 expression documented as ISH-negative on previously collected and assessed tumor tissue upon initial diagnosis of disease
Tissue available for the evaluation of AR by IHC on pretreatment HCC samples; if tissue is not available, a pretreatment biopsy will not be necessary for eligibility
Pre-treatment fresh frozen tissue available for research purposes; this tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy
Non-surgical cohort only: positive phospho-EGFR assessment (>= 100 stained pixels) from tissue obtained from previous clinical liver biopsy
Willingness to provide blood and tissue samples for safety/toxicity monitoring and biomarker analyses
Consent to the tissue Cancer Therapy and Research Center (CTRC) biorepository
Patients with a known connective tissue disease
Breast patients with tissue expanders are not allowed with the exception of tissue expanders made of material that are MRI compatible; check with the MRI technician to confirm
Biopsy of tumor tissue for central evaluation, within 60 days prior to the first day of study treatment
HER2-overexpression in the patient's tumor tissue
Tumor tissue EBV positive
Patients must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 12 cycles of protocol therapy
Patients must have an ability to understand and the willingness to sign a written informed consent document; the patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research
Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database
Willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy
Patient’s that have complex DCIS as indicated on radiology, which would require excising a large tissue volume
Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database
Subject with normal oral tissue
Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
UNC patients must co-enroll into LCCC9819 for collection of tissue samples
Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist® injection) from a soft tissue or metastatic bone lesion (measuring >= 1.5 cm in diameter at computed tomography [CT] or MRI scan) available for OATP1B3 expression or
Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression
Have tissue block available from core biopsy for correlative biomarkers and genomic assay
Patients younger than 18 years of age with a histologically or cytologically confirmed diagnosis of cancer who are being treated for cancer at the NIH Clinical Center and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue collected
Tumor tissue:
Part 2, Expansion: tumor tissue
Patient must be willing to provide consent for use of archived tissue for research
DYNAMIC COHORT: Willing to consent to collection of pathology tissue for the purposes of research at the time of clinical biopsy or surgical procedure
Patients must be agreeable to provide tissue prior to enrollment
Soft tissue progression
Tissue confirmation.
Archive tumor tissue (obtained from a biopsy or surgical resection of a metastatic lesion done within 4 months from study enrollment) availability is required for patient participation. If the available tissue is insufficient for the required baseline analysis, the patients are given the option to repeat the biopsy for the purpose of study participation as long as they have not already started palbociclib or ribociclib.
Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).
Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping; biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R); determination of technical feasibility must be made independently of plasma genotyping results
has a substantial probability to cause an irreversible injury to any tissue and/or