NCT05270044

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 815 (estimated)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

Detailed description

This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial. Participants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between: * stage IIB (i.e., pT3b or pT4a) * stage IIC (i.e., pT4b). The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Encorafenib and Binimetinib	Encorafenib 450 mg (6 × 75 mg capsules) once daily (QD) and binimetinib 45 mg (3 x 15 mg tablets) twice daily (BID) orally for a maximum of 12 months.
DRUG	Placebo to match Encorafenib ; Placebo to match Binimetinib	Encorafenib (6 × 75 mg placebo capsules) QD and binimetinib (3 × 15 mg placebo tablets) BID placebos orally for a maximum of 12 months.

Timeline

• Start date: 2022-05-02
• Primary completion: 2027-03-31
• Completion: 2035-05-02
• First posted: 2022-03-08
• Last updated: 2023-11-22

Locations

155 sites across 23 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom