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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT04061980
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Binimetinib — DRUG
    Given PO
  • Encorafenib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 30, 2020
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (encorafenib, binimetinib)
    Patients receive encorafenib PO QD and binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (encorafenib, binimetinib, nivolumab) - CLOSED
    Patients receive encorafenib PO QD and binimetinib PO BID as in arm I. Patients also receive nivolumab 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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From the start of randomization up to 6 months from first dose of study drugs ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97213-

Find similar trials in Portland, OR

By research site
Providence Portland Medical Center· Portland, OR

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