Clinical Trials Search
Phase II Study of Trametinib in Patients with Tumors with GNAQ or GNA11 mutations
EAY131-S2 (MATCH)
- Eligibility:Click Here to ViewSubprotocol S2 eligibility (in addition to master eligibility):
-Patients must have GNAQ or GNA11 mutations by the MATCH NGS assay.
-Patients who previously received prior treatment with other MEK inhibitors (including, but not limited to, trametinib, binimetinib, cobimetinib, selumetinib, RO4987655 (CH4987655), GDC-0623 and pimarsertib) will be excluded.
-Patients who previously received monoclonal antibody therapy (eg. ipilimumab, nivolumab, pembrolizumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib.
-Patients with glioblastoma must have histologically or radiographically confirmed recurrent or progressive WHO Grade 4 glioma (glioblastoma).
-Patients with uveal melanoma are excluded. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
GDC-0449 (vismodegib) in Patients with Tumors (except basal cell skin carcinoma) with Smoothened (SMO) or Patched 1 (PTCH1) Mutations
EAY131-T (MATCH)
- Eligibility:Click Here to ViewSubprotocol T eligibility (in addition to master eligibility):
-Patients must have activating mutations of Smoothened (SMO) or deleterious Patched 1 (PTCH1) as determined by the MATCH screening assessment.
-Patient must not have basal cell carcinoma.
-Patient must not have had any of the prior therapies: GDC-0449 (vismodegib) - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
VS-6063 (defactinib) in Patients with Tumors with NF2 Loss
EAY131-U (MATCH)
- Eligibility:Click Here to View
Subprotocol U Eligibility (in addition to master):
-Patients must have a tumor that harbors an inactivating mutation in NF2.
-Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block).
-Patients with known left ventricular dysfunction must have ECHO/MUGA within 4 weeks prior to treatment assignment and must not have left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible.
-Patients must not have known hypersensitivity to VS-6063 (defactinib) or compounds of similar chemical or biologic composition.
-Patients must not have a history of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
-Patients must not have prior treatment with a FAK inhibitor (eg. VS-6063 (defactinib) or GSK2256098) and must not be participating or have participated in the COMMAND trial of maintenance therapy of VS-6063 (defactinib) vs. placebo, for mesothelioma. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of Sunitinib in Patients with Tumors with cKIT Mutations (Excluding GIST, Renal Cell Carcinoma or Pancreatic Neuroendocrine Tumor)
EAY131-V (MATCH)
- Eligibility:Click Here to View
Subprotocol V Eligibility (in addition to master):
-Patients must have a somatic cKIT mutation in exon 9, 11, 13 or 14, excluding exon 17 or 18 mutations.
-Serum calcium must be less than or equal to 12.0 mg/dL
-Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
-Patients must have an ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN).
-Patients must not have known hypersensitivity or excess toxicity from sunitinib or compounds of similar chemical composition or biologic effect.
-Patients must not have had prior therapy with sunitinib.
-Patients must not have GIST, renal cell carcinoma, or pancreatic neuroendocrine tumor
-Patients must not have pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
-Patients may not have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting sunitinib.
-Patients with known brain metastases should be excluded
-Patients who require therapeutic doses of coumarin derivative anticoagulants such as warfarin are excluded, although doses up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided that the patient’s PT INR is < 1.5 - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway
EAY131-W (MATCH)
- Eligibility:Click Here to ViewSubprotocol W eligibility (in addition to master eligibility):
-Patients must have FGFR 1-3 amplification, mutation or translocation as determined by the MATCH screening assessment.
-Patients with squamous cell lung carcinoma, gastric cancer, gastroesophageal junction cancer that harbor FGFR amplifications will be excluded.
--Mutations or fusions of FGFR 1-3 in the above mentioned histologies will still be eligible for the trial.
-Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398, erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. Pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be allowed. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations
EAY131-X (MATCH)
- Eligibility:Click Here to ViewSubprotocol X eligibility (in addition to master eligibility):
-Patients must have one of the following missense mutation in DDR2: S768R, I638F, L239R.
-Patients with prior use of dasatinib will be excluded.
-Dasatinib should NOT be given in the presence of STRONG CYP 3A4 inhibitors/inducers.
-Dasatinib should NOT be given in the presence of H2-Antagonists or Proton Pump Inhibitors. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
AZD5363 in Patients with Tumors with AKT Mutations
EAY131-Y (MATCH)
- Eligibility:Click Here to ViewSubprotocol Y eligibility (in addition to master eligibility):
-Patients must have an AKT mutation as determined by the MATCH screening assessment.
-Patients with ER and/or PR positive AND HER2 negative unresectable breast cancerare allowed to continue fulvestrant or an aromatase inhibitor with AZD5363 if patient just progressed on this anti-estrogen therapy. GnRH agonists are allowed. However,
SERMs, such as tamoxifen or toremifene, are not allowed
-Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance.
-Patients may not have received treatment with another inhibitor of PI3K, AKT or mTOR in the neoadjuvant, adjuvant or metastatic setting with the exception of FDA approved rapalogs. Patients with metastatic cancer, who received PI3K/AKT/mTOR inhibitors on short preoperative window trials (treatment for 4 weeks or less) will be eligible if the treatment was over 6 months prior to registration. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations
EAY131-Z1A (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1A eligibility (in addition to master eligibility):
-Patients must have NRAS mutation in codon 12, 13, 61 as determined by the MATCH screening assessment.
-Patients with melanoma are excluded.
-Patients must not have any active central nervous system (CNS) lesionand/or leptomeningeal metastases.
--Patients treated with stereotactic radiotherapy or surgery are eligible if the patient remained without evidence of CNS disease progression for at least 3 months. Patients must be off corticosteroid therapy for at least 3 weeks.
-Patients who have received prior MEK inhibitors are excluded. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CDK4 or CDK6 Amplification and Rb Protein Expression by IHC
EAY131-Z1C (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1C eligibility (in addition to master):
-Patients must have CDK4 amplification or CDK6 amplification and tumor Rb protein expression by immunohistochemistry as determined by the MATCH screening assessment
-Patients must not have breast cancer, mantle cell lymphoma, myeloma, or liposarcoma
-Patients must not have received prior therapy with a CDK4 or CDK6 inhibitor - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Nivolumab in Patients with Tumors with Mismatch Repair Deficiency (Excluding Colorectal Cancer)
EAY131-Z1D (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1D eligibility (in addition to master eligibility):
-Patients must have mismatch repair deficiency as determined by the MATCH screening assessment.
-No prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti-CTLA-4 antibodies (or any other antibody targeting T cell co-regulatory pathways).
-Patients with colorectal cancer are excluded.
-Must not have received any of the following therapies within four weeks prior to the first dose of the study drug: IL-2, interferon, or other non-study immunotherapy regimens or immunosuppressive agents.The master protocol eligibility criterion regarding wash-out period from prior therapy is also applicable.
-Must not have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration. Use of such agents while on study is also prohibited.
-Must not have a history of any autoimmune disease
-Must not be on supplemental home oxygen.
-Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) within 14 days of study drug administration. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.