H. Lee Moffitt Cancer Center and Research Institute
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.
Inclusion Criteria: * 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 * Adequate laboratory parameters as well: * a. Hemoglobin ≥ 8 g/dL. * b. Platelets ≥ 75 × 109/L; * c. AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN; * d. Total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL; OR total bilirubin \>1.5 × ULN with indirect biliru…
Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.
Arctuva estimate
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