A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma
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
• 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.