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

NCT04741997 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	50
Start date	2021-05-24
Completion	2027-07

Conditions

• Melanoma Stage III
• Melanoma Stage IV
• BRAF V600 Mutation

Interventions

• Encorafenib Pill
• Binimetinib Pill
• Nivolumab

Primary outcomes

• Rate of Disease Relapse — After surgery up to 24 weeks
  Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm.

Countries

United States