The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.
Age ≥ 18 years at the time of informed consent
Histologically confirmed diagnosis of melanoma. Any primary or unknown origin is permitted.
Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th edition).
ECOG performance status ≤ 2
Participants may have received prior therapy with BRAF and/or a MEK inhibitor if it was completed at least 6 months prior to study enrollment. Patients who had prior disease progression while on BRAF/MEK inhibitor therapy are not eligible. (Progression after stopping treatment is permitted.) Participants may have received prior therapy an anti-PD-1/PD-L1 or CTLA-4 inhibitor.
Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs due to toxicity.
Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure.
Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while they are taking encorafenib/binimetinib.
Parallel
Encorafenib Pill
DrugEncorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
Binimetinib Pill
DrugBinimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
Nivolumab
DrugNivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.
Rate of Disease Relapse
Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm.
Relapse Free Survival
Relapse free survival is defined as time from surgery until disease relapse
Rate of Pathologic Complete Response
Investigators will measure the rate of pathologic complete response after surgery.
Rate of Non-Pathologic Complete Response
Investigators will measure the rate of non-pathologic complete response after surgery.
Overall Response Rate
Overall response rate will be measured after neoadjuvant therapy (for participants who have measurable disease per RECIST 1.1 at start of neoadjuvant therapy).
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Pfizer
Collaborator
