Encorafenib + Binimetinib for Melanoma
(COLUMBUS-AD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy, you may continue as long as your blood tests are within the therapeutic range.
What data supports the effectiveness of the drug combination of Encorafenib and Binimetinib for melanoma?
The combination of Encorafenib and Binimetinib has shown to improve overall survival in patients with advanced BRAF mutation-positive melanoma, achieving a median overall survival of 33.6 months, which is longer than other similar drug combinations. Additionally, this combination may have fewer side effects like fever and sensitivity to sunlight, making it a potentially better option for patients.12345
Is the combination of Encorafenib and Binimetinib safe for humans?
How is the drug combination of encorafenib and binimetinib unique for treating melanoma?
The drug combination of encorafenib and binimetinib is unique for treating melanoma because it targets specific mutations in the BRAF gene, offering improved overall survival and progression-free survival compared to other treatments. It also has fewer side effects like fever and skin sensitivity, making it more tolerable for patients.12345
What is the purpose of this trial?
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).
Research Team
Alexander C.J. van AKKOOI, MD, PhD
Principal Investigator
European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria
Adults over 18 with high-risk Stage II melanoma that has a BRAF mutation, who've had surgery recently and are disease-free. They must have good organ function, agree to contraception if applicable, and not be pregnant or breastfeeding. Excluded are those with other cancers in the last 3 years, certain heart conditions, severe infections or lactose intolerance.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive encorafenib and binimetinib or placebo for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Binimetinib
- Encorafenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pierre Fabre Medicament
Lead Sponsor
Marie-Andrée Gamache
Pierre Fabre Medicament
Chief Executive Officer
MBA from HEC Montréal
Dr. Núria Perez-Cullell
Pierre Fabre Medicament
Chief Medical Officer since 2022
PhD in Pharmacy from the University of Barcelona
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator