Have documented IDH gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (RC/L/G/H/S mutation variants tested).
IDH mutation status of the primary tumor must be available or tumor samples must be available for pre randomization testing
Angiosarcoma tumor specimen, if available
Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\r\n* NOTE: Complete the EA-specific FoundationOne requisition form
Sufficient tissue and blood must be available to submit for required biology studies
Specimen Submission: Patients must have sufficient tissue available for the required biology study
Available and adequate baseline tumor tissue sample
Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses
Available tumor sample for testing
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
Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation.
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 <% ER+ and <% PgR+ cells, and HER immunohistochemistry score of or + and/or in situ hybridization (ISH) with HER gene copy number < or a ratio of less than between HER gene copy number and centromere of chromosome . Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER.
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 archived tissue for correlative studies. If no archived sample is available the patient will still be eligible
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
Patients must have archived tumor tissue from prior tumor biopsy or surgical resections available for submission that is sufficient to complete molecular profiling
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- expression
Available biopsy of primary tumor with adequate samples
Patients must have tumor tissues from transurethral resection of the bladder tumor (TURBT) that is within 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)
Tumor tissue available if biopsy consent not provided, if no archival tumor tissue available and pt provides consent, pre-dose biopsy will be done
Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
Diagnostic primary tumor tissue must be available for ERCC staining
Patients with breast tumors that are AR+ (?% 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.
Have pre-resection tissue (Esophagogastroduodenoscopy [EGD] or EUS biopsy from the diagnosis) available
Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if 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
Patients must have available tissue (archived formalin-fixed paraffin embedded [FFPE] blocks or fresh frozen biopsy from primary tumor or metastatic tumor biopsy) for correlative studies; tissue source needs to be located and available at the time of registration (tissue needs to be submitted within weeks of study initiation); patients will not be able to start study drugs without tissue availability
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
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
Patients must have histologically or cytologically confirmed malignant pleural mesothelioma; for phase of this study only, the malignant tissue must show moderate or stronger mesothelin expression in % 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 , 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
(For Cohort A) - Archived tissue available at pre-screening to confirm FR alpha+ breast cancer
Available archived tissue biopsies will be provided for correlative studies
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
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 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)
If no archive tissue is available, the subject may elect to have a biopsy performed to obtain tissue.
Phase II archived tissue collection: will be requested when available, but is not mandatory for inclusion
Tissue available (archived or fresh tumor biopsy) for the PD-L assay
Patients must have a pre-treatment tumor specimen available for correlative studies, either core needle biopsy or equivalent amount or via excisional specimen (cytology specimen not acceptable for this purpose); if an archival specimen is to be used then no interceding anticancer therapy (systemic therapy or radiation to the biopsied lesion) should have been administered since that specimen was obtained; patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy
Subjects must provide archived tumor specimens for correlative biomarker studies if sufficient tissue is available; a fresh biopsy is not required
Participant must have archived tumor tissue available from initial diagnosis or subsequent relapse(s) of Grade IV GBM for submission for central review at Investigational sites local laboratories.
Central pathology review to determine evaluability of archived esophagogastroduodenoscopy (EGD)/biopsy sample\r\n* NOTE: If archived sample was collected > weeks prior to pre-registration (reg), is not available in a timely manner, or was collected outside of Mayo Clinic and considered unevaluable, then baseline EGD with primary tumor biopsy at Mayo Clinic must be performed unless clinically contraindicated; patient is allowed to enroll regardless of whether this Mayo Clinic tissue sample is evaluable; (only EGD with primary tumor biopsy performed at Mayo Clinic =< weeks prior to pre-reg is required)\r\n* NOTE: For both archival or newly obtained tissue, only biopsies are adequate (fine needle aspiration [FNA] is not adequate)
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
Patients must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB] or fresh frozen tissue from original diagnosis or metastatic setting) for correlative studies; patients will not be able to start study drugs without tumor tissue availability; patients without available tumor tissue can still participate if willing to have a fresh biopsy of a metastatic lesion that is deemed to be medically safe (except for bone metastases)
At screening, must have tissue available for NY-ESO- 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 PA-
Availability of tissue for correlative studies; patients must have at least - unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available; if not enough archived tissue is available, a fresh tumor biopsy prior to study initiation is mandatory; for patients who have undergone a fresh baseline biopsy at baseline, the archived tissue is not mandatory
Phase 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 weeks of study initiation)
Subject has appropriate tissue available from the cytoreductive surgery for tumor lysate preparation
Fresh or archived tumor specimen should be available for correlative studies as required
Tissue available (either initial diagnostic or recurrent tissue specimen) for p testing (if p 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 weeks prior to screening)
Tissue block of initial biopsy specimen is available
Tumor specimen (paraffin-embedded block or frozen tissue) from prior resection or biopsy available that is sufficient to perform pharmacodynamic assays (>= slides for immunohistochemistry [IHC]) mandatory for patients in the dose expansion cohort only; if the specific diagnosis occurs radiologically as standard of care and a diagnostic procedure is too dangerous for any reason, subjects may be enrolled on study without tissue that being available for correlative studies
Patients must consent to participate in the correlative studies and should have available tumor tissue for tumor biopsies
An archived tumor specimen is available for collection
Available tissue of primary lung tumor
Representative baseline tumor tissue sample is available
Must have diagnostic biopsy tissue (pre-neoadjuvant chemo) available for genetic testing.
Must have surgical tissue (post-neoadjuvant chemo) available for genetic testing.
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 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
Stratum : Patients with DIPG who have pre-trial tumor tissue available are requested to submit tissue; however, this is not required for eligibility
Patient must have adequate tumor specimen available for submission
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 (Guardant or Foundation One) may be considered eligible by the treating physician
Patient has diagnostic tissue available for correlative studies
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-L testing.
Tumor tissue must be available for prospective determination of FGFRb overexpression
adequate tumor tissue available prior to randomization
Patients must have archived tumor specimens available unless pre-treatment biopsy is being performed; if pre-treatment biopsy is being performed, availability of archived specimen must still be assessed and collected if available
Group 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
Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or tumor protein (p) (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
For Parts B, C, D, E and F: Have available tumor tissue.
Available TNBC diagnostic tumor tissue (archived tissue allowed)
Tumor tissue available from most recent biopsy to determine cell of origin
Must have available tumor tissue for TIM- expression testing
Lung cancer confirmed to express gpNMB, as assessed by immunohistochemistry at a central lab (using expression in ? % 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.
A representative tumor specimen must be available for molecular testing.
Mandatory tumor tissue available
Archive tumour tissue is available prior to recruitment for pharmacogenomic tests
Patients must have additional tumor available and be willing to submit tissue and blood samples
Tissue available for PD-L testing and for correlative science testing
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
Patient must have adequate tumor specimen available for submission
Patient must have sufficient tumor tissue available for submission.
Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies
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.
ASS deficiency (defined as ?% 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 ASS deficiency is required for entrance into the study. If tissue is not available to determine ASS deficiency, then tissue must be obtained by biopsy to determine ASS 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.
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 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 weeks of study initiation); patients will not be able to start study drugs without tissue availability
Patients must have histologically confirmed metastatic breast cancer; if available, tissue (a minimum of 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
Available archived tumor tissue sample.
Tumor GANQ, GNA, and BAP 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 GNA 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 BAP 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
Presence of a BRAF VE 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;
Tumor tissue from surgery or biopsy must be available to determine MAGE-A expression for correlative studies.
Must have available tumor tissue and consent to biopsy while on study.
Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within days of the first day of study treatment, CD, 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 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 b)
Adequate tumour tissue (greater than .cm preferred, 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
For Part , willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
Tumor tissue (archived acceptable) available for biomarker studies. For Phase Part
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 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;
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.
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.
Available paraffin-embedded tissue should have been collected no longer than months prior to first administration of SAR. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.
Tumor verified to be CD+ (based on local evaluation), from a current or previous tissue biopsy. Tissue biopsy should be repeated if no report or specimen is available, CD staining was not previously performed, or there is clinical suspicion that the indolent lymphoma has transformed to aggressive lymphoma/higher malignancy grade.
The participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
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-L testing (stratification factor)
Sufficient tumor tissue must be available for histologic assessment of PD-L 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
Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
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
Sufficient archived tumor material available (equivalent to core biopsies or greater); if insufficient archived tumor material available new tumor biopsy is mandatory
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 OATPB expression
Have tissue block available from core biopsy for correlative biomarkers and genomic assay
Archive tumor tissue (obtained from a biopsy or surgical resection of a metastatic lesion done within 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.