W00090GE303 / EORTC-2139-MG, COLUMBUS-AD
Research type
Research Study
Full title
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
IRAS ID
1004469
Contact name
Mounia Foucart
Contact email
Sponsor organisation
Pierre Fabre Médicament
Eudract number
2021-004310-19
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat local melanoma (a type of skin cancer) after surgery. The purpose of the Columbus-AD trial is to assess whether the combination of encorafenib and binimetinib for 12 months in adjuvant setting (therapy applied after initial treatment) can decrease the risk for recurrence and improve distant metastasis-free (not spreading to another part of the body) survival and Overall Survival versus placebo in participants with stage II surgically resected BRAF V600E/K melanoma.
The BRAF V600 mutation is the most common type of genetic mutation in melanoma. This mutation has been linked to different mechanism of development of melanoma, including the impact on the BRAF and MEK proteins in the skin cells. These proteins that are responsible for cell growth become then out of control, which, when they are cancerous, means that the cancer cell will grow more rapidly.
The combination of encorafenib and binimetinib is a targeted therapy, a treatment that targets BRAF and MEK proteins to turn them off. This combination has already been proven to be safe and effective and is used nowadays to treat patients with advanced melanoma. This is the first time this combination is administered to patients with skin melanoma at an early stage after surgery.
Patients in the trial are put into 2 groups randomly (randomised); 1 to receive active treatment and 1 to receive placebo. This helps to make sure that there is a similar number of patients in each treatment group. Patients have a one out of two chance (50%) of receiving the active treatment.
Treatment will be administered for a maximum of 12 months or until disease recurrence or patient fulfils one of the criteria for treatment discontinuation according to the protocol. Participants will be followed-up monthly during treatment period, then every 3 months up to year 3, then every 6 months up to year 5 and once annually thereafter until year 10.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0002
Date of REC Opinion
1 Feb 2022
REC opinion
Further Information Favourable Opinion