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

Phase 3 Active not recruiting 815 enrolled Pierre Fabre Laboratories European Organisation for Research and Treatment of Cancer - EORTC · collab

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2022-05-02
Primary completion: 2027-03-31
Completion: 2035-05-02

Publications

van Akkooi AC, Hauschild A, Long GV, Mandala M, Kicinski M, Govaerts AS, Klauck I, Ouali M, Lorigan PC, Eggermont AM. COLUMBUS-AD: phase III study of adjuvant encorafenib + binimetinib in resected stage IIB/IIC BRAF V600-mutated melanoma. Future Oncol. 2023 Sep;19(30):2017-2027. doi: 10.2217/fon-2023-0414. Epub 2023 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Binimetinib	Small molecule	45 mg	Oral
Subject	Encorafenib	Small molecule	450 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications