Study of Adjuvant Treatment After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma with BRAF V600 Mutation

What this Trial Is About

Researchers are studying the rate and timing of melanoma disease relapse after neoadjuvant therapy, focusing on whether participants achieve a complete pathologic response or not, and how postoperative adjuvant treatments affect outcomes. This early phase 1 trial targets patients with advanced melanoma that has a BRAF V600 mutation and evaluates different adjuvant therapies based on individual response to initial treatment. Participants will first receive 24 weeks of neoadjuvant oral encorafenib and binimetinib before planned surgery. After surgery, participants with a complete pathologic response may receive either 24 more weeks of encorafenib and binimetinib or another adjuvant treatment for 24 weeks. Those without a complete response will continue either encorafenib and binimetinib or receive nivolumab for 24 weeks. Imaging scans will be done every 12 weeks for at least one year post-surgery, then every 24 weeks for up to two additional years. During the study, participants will undergo regular imaging to monitor for disease relapse and response to treatment. Researchers will track relapse rates, survival, and response to therapy over several years. Safety and laboratory tests will also be conducted to ensure participant health. The total follow-up period includes evaluations after surgery for at least 24 weeks, with survival tracking up to five years.

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