Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

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 bilirubin \< 1.5 × ULN; * e. Serum creatinine ≤ 2.0 × ULN * Female participants of childbearing potential as described in protocol, must have a negative serum or urine β-HCG test result. Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, as described in Section 4.3.1. Participants must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy. Male participants must agree to use methods of contraception that are highly effective or acceptable per protocol. Exclusion Criteria: * 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 per…