Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

Phase 2 Completed 95 enrolled Pierre Fabre Laboratories Merck KGaA, Darmstadt, Germany · collab Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

Timeline

Start: 2019-01-17
Primary completion: 2020-06-29
Completion: 2023-04-27

Outcome

Met primary endpoint

paper Since the lower limit of the 95% CI exceeded 30%, the primary end point was met. PMID 36763936 ↗

Publications

Van Cutsem E, Taieb J, Yaeger R, Yoshino T, Grothey A, Maiello E, Elez E, Dekervel J, Ross P, Ruiz-Casado A, Graham J, Kato T, Ruffinelli JC, Andre T, Carriere Roussel E, Klauck I, Groc M, Vedovato JC, Tabernero J. ANCHOR CRC: Results From a Single-Arm, Phase II Study of Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer. J Clin Oncol. 2023 May 10;41(14):2628-2637. doi: 10.1200/JCO.22.01693. Epub 2023 Feb 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Binimetinib	Small molecule	45 mg	Oral
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Encorafenib	Small molecule	300 mg	Oral

Indications

No indication recorded.