BRAF-MEK Inhibitor Therapy for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may kill more tumor cells.
Do I need to stop my current medications to join the trial?
The trial allows patients to continue taking non-biologic disease modifying agents and low-dose corticosteroids (up to 10 mg of prednisone daily). However, hormonal contraceptives should not be used during the trial.
What safety information is available for BRAF-MEK inhibitor therapy in humans?
Encorafenib and binimetinib, used together for treating melanoma, can cause side effects like inflammatory colitis (inflammation of the colon) and skin issues. However, they have shown an acceptable safety profile in some studies, with fewer cases of fever and sensitivity to sunlight compared to other similar treatments.12345
How is the drug combination of Encorafenib, Binimetinib, and Nivolumab unique for treating melanoma?
This drug combination is unique because it targets specific mutations (BRAF V600E/K) in melanoma using a combination of BRAF and MEK inhibitors (Encorafenib and Binimetinib), which have shown to improve survival rates, and it includes Nivolumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells.24678
What data supports the effectiveness of the drug combination Encorafenib and Binimetinib for treating melanoma?
Research shows that the combination of Encorafenib and Binimetinib improves survival and quality of life in patients with BRAF-mutant melanoma, compared to other treatments like vemurafenib. This combination is effective in targeting specific mutations found in about 40% of metastatic melanoma cases.24689
Who Is on the Research Team?
Zeynep Eroglu
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
Adults with advanced BRAF mutant melanoma (stage IIIC-IV) who have measurable disease, good organ function, and an ECOG performance status of ≤2. They must not be pregnant or nursing, agree to use non-hormonal contraception for 6 months post-treatment, and haven't had certain prior treatments like BRAF/MEK inhibitors in the metastatic setting.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 450 mg Encorafenib daily, 45 mg Binimetinib twice daily, and 240 mg Nivolumab IV every 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for time to treatment failure and tumor response
What Are the Treatments Tested in This Trial?
Interventions
- Encorafenib; Binimetinib
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor