NCT03235245

Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Conditions

• Unresectable Stage III Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab + Ipilimumab	nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression.
DRUG	Encorafenib + Binimetinib	encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks

Timeline

• Start date: 2018-10-30
• Primary completion: 2023-10-24
• Completion: 2027-01-01
• First posted: 2017-08-01
• Last updated: 2025-08-01

Locations

38 sites across 9 countries: Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom