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

NCT04061980 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-13

No results posted yet for this study

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.

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

DRUG

Binimetinib

Given PO

DRUG

Encorafenib

Given PO

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Matthew H Taylor · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2027-12-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061980 on ClinicalTrials.gov