Clinical Trial

Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

Active, Not Recruiting Phase 2
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Summary
This phase II trial studies how well encorafenib and binimetinib given with or without nivolumab works in treating patients with BRAF V600 mutation positive thyroid cancer that has spread to other places in the body (metastatic) and does not respond to radioiodine treatment (refractory). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The trial aims to find out if the combination of encorafenib and binimetinib, with and without study nivolumab, is a safe and effective way to treat metastatic radioiodine refractory thyroid cancer.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-08-18; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2024-11-05
Status change: Not Yet Recruiting → Recruiting 2021-01-26
Status change: Withdrawn → Not Yet Recruiting 2020-02-03
Status change: Not Yet Recruiting → Withdrawn 2019-12-26
Trial Details
NCT Number NCT04061980
Lead Sponsor Providence Health & Services
Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute
Conditions BRAF NP_004324.2:p.V600M, BRAF V600E Mutation Present, Metastatic Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma, Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
Enrollment 24 participants
Start Date 2020-10-30
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-13