NCT04741997

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Encorafenib Pill	Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
DRUG	Binimetinib Pill	Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
DRUG	Nivolumab	Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.

Timeline

• Start date: 2021-05-24
• Primary completion: 2026-07-22
• Completion: 2027-07-01
• First posted: 2021-02-05
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study