NCT04061980

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

Encorafenib/Binimetinib With or Without Nivolumab for Patients With Metastatic BRAF V600 Mutant Thyroid Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the overall rate of response among study participants treated with the combination of encorafenib and binimetinib, with or without nivolumab. SECONDARY OBJECTIVES: I. To assess the progression-free survival (PFS) among study participants treated with the combination of encorafenib and binimetinib with or without nivolumab. II. To assess the overall survival (OS) among study participants treated with the combination of encorafenib and binimetinib with or without nivolumab. III. To evaluate the duration of response (DOR). IV. To evaluate the safety and tolerability of study participants treated with the combination of encorafenib and binimetinib with or without nivolumab. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) once daily (QD) and binimetinib PO twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive encorafenib PO QD and binimetinib PO BID as in arm I. Patients also receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles with nivolumab repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Please note: Arm II is closed to accrual. Patients will only be enrolled into Arm I as of March 11th, 2022. After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 12 months.

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

Interventions

Type	Name	Description
DRUG	Binimetinib	Given PO
DRUG	Encorafenib	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2020-10-30
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2019-08-20
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study