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
Estimated Enrollment: 815 participantsAllocation: RandomizedActual Study Start Date: 02/05/2022Estimated Primary Completion Date: 31/03/2027Estimated Study Completion Date: 02/05/2035Sponsor: Pierre Fabre MedicamentClinical Trial Link: https://classic.clinicaltrials.gov/ct2/show/NCT05270044
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:
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.