OncoMatch/Clinical Trials/NCT06440850
Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
Is NCT06440850 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Recombinant Thyrotropin Alfa and Cobimetinib for thyroid gland follicular carcinoma.
Treatment: Cobimetinib · Recombinant Thyrotropin Alfa · Vemurafenib — This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF. They are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: BRAF v600e
Allowed: TERT promoter mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radioiodine
Prior RAI treatment
Cannot have received: BRAF inhibitor (sorafenib, dabrafenib, vemurafenib, encorafenib)
Prior anti-BRAF...such as sorafenib, dabrafenib, vemurafenib, encorafenib
Cannot have received: MEK inhibitor (binimetinib, cobimetinib, trametinib, selumetinib)
Prior anti-MEK treatment such as...binimetinib, cobimetinib, trametinib, d selumitinib
Cannot have received: tyrosine kinase inhibitor (lenvatinib, sunitinib, axitinib, cabozantenib, vandatinib, pazopanib)
other TKIs like, lenvatinib, sunitinib, axitinib, cabozantenib, vandatinib, pazopanib use
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100 x 10^9/L
Kidney function
Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula
Liver function
Bilirubin ≤ 1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert's syndrome; ALP, ALT, and AST ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases); Normal blood coagulation function as evidenced by INR ≤ 1.5
Cardiac function
Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start; ECG with QTc interval < 480 msec; No history of congestive heart failure ≥ NYHA Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of treatment, or cardiac arrhythmia associated with significant cardiovascular impairment and uncontrolled hypertension
Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start; Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula; ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100 x 10^9/L; Normal blood coagulation function as evidenced by INR ≤ 1.5; Bilirubin ≤ 1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert's syndrome; ALP, ALT, and AST ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases); ECG with QTc interval < 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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