Encorafenib + Binimetinib +/- Nivolumab for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Matthew H Taylor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well encorafenib and binimetinib, with or without nivolumab, work in treating a specific type of thyroid cancer that has spread and doesn't respond to usual treatments. The drugs aim to stop cancer growth and help the immune system fight the cancer. Encorafenib and binimetinib are used in combination to treat BRAF V600 mutation-positive melanoma, showing improved response rates and survival.

Research Team

Matthew H Taylor

Principal Investigator

Providence Health & Services

Eligibility Criteria

This trial is for adults with metastatic, radioiodine-refractory thyroid cancer that has a BRAF V600 mutation. Participants must have measurable disease, be in good physical condition (ECOG status <=1), and not be pregnant or nursing. They should not have had certain prior treatments or conditions that could affect the study's safety.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Your heart's QT interval is not longer than 480 milliseconds after being adjusted for your baseline heart rate.

Your heart's pumping ability is good, with a left ventricular ejection fraction (LVEF) of 50% or higher.

Exclusion Criteria

I haven't taken any prohibited medications in the last week.

I had major surgery less than 3 weeks ago or am still dealing with its side effects.

I have heart problems or significant heart disease.

Treatment Details

Interventions

• Binimetinib (Kinase Inhibitor)
• Encorafenib (Kinase Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The effectiveness of encorafenib and binimetinib, with or without nivolumab, is being tested on patients with specific thyroid cancer. The goal is to see if these drugs can stop tumor growth by blocking enzymes needed for cell growth and boosting the immune system's ability to fight cancer.

Participant Groups

Group I: Arm II (encorafenib, binimetinib, nivolumab) - CLOSED Experimental Treatment 3 Interventions

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.

Group II: Arm I (encorafenib, binimetinib) Experimental Treatment 2 Interventions

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.

Binimetinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Dr. Laurel Soot

Providence Health & Services

Chief Medical Officer since 2024

MD, FACS

Erik Wexler

Providence Health & Services

Chief Executive Officer

Bachelor's degree in Business Administration from the University of Massachusetts Amherst

Providence Cancer Center, Earle A. Chiles Research Institute

Collaborator

Trials

21

Recruited

500+