Encorafenib + Binimetinib +/- Nivolumab for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for a specific type of thyroid cancer that has spread and does not respond to standard radioiodine therapy. It examines the combination of two drugs, encorafenib (Braftovi) and binimetinib (Mektovi), with or without nivolumab (Opdivo), an immunotherapy drug that may boost the immune system to fight cancer. The goal is to determine if these drug combinations are safe and effective for this type of cancer. Individuals with metastatic thyroid cancer with a BRAF V600 mutation who have not responded to radioiodine treatment might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot use certain prohibited medications, including some herbal supplements, within one week before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of encorafenib and binimetinib is generally safe for people with certain cancers, such as melanoma. In studies, patients with BRAF V600E-mutated thyroid cancer tolerated these drugs well, and they effectively reduced tumors. Most side effects were manageable and did not cause major issues for patients.
When researchers added nivolumab, the safety profile remained acceptable. This drug aids the immune system in fighting cancer and has been used safely in other conditions. While some side effects can occur, they are usually mild or moderate. Overall, based on available data, these combination treatments appear to be safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of encorafenib and binimetinib, with or without nivolumab, for thyroid cancer because these treatments target the disease in innovative ways. Unlike traditional treatments like surgery or radioactive iodine therapy, which are often the standard of care, this regimen uses targeted therapy and immunotherapy. Encorafenib and binimetinib target specific proteins in cancer cells to halt their growth, while nivolumab enhances the immune system's ability to attack cancer cells. This multi-faceted approach holds the promise of improved effectiveness, especially in cases where conventional treatments are less effective.
What evidence suggests that this trial's treatments could be effective for metastatic radioiodine refractory thyroid cancer?
Research has shown that using encorafenib and binimetinib together can benefit patients with the BRAFV600E mutation. Studies have found that this combination can extend patients' lives, with one study reporting a survival time of 33.6 months compared to 16.9 months with another treatment. In this trial, some participants will receive this combination of encorafenib and binimetinib.
Another group in this trial will receive encorafenib and binimetinib along with nivolumab. Adding nivolumab has been shown to delay cancer progression. This combination has produced promising results in patients with advanced cancers. Overall, these treatments target specific enzymes and boost the immune system to fight cancer cells, offering hope for better management of metastatic thyroid cancer.12678Who Is on the Research Team?
Matthew H Taylor
Principal Investigator
Providence Health & Services
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive encorafenib and binimetinib orally. In Arm II, participants also receive nivolumab intravenously. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Binimetinib
- Encorafenib
- Nivolumab
Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Providence Health & Services
Lead Sponsor
Providence Cancer Center, Earle A. Chiles Research Institute
Collaborator