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.