The BEACON CRC Study
Research type
Research Study
Full title
A Multicentre, Randomised, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E-mutant Metastatic Colorectal Cancer
IRAS ID
208339
Contact name
Amrit Rai
Contact email
Sponsor organisation
Array BioPharma Inc.
Eudract number
2015-005805-35
Duration of Study in the UK
3 years, 8 months, 22 days
Research summary
Metastatic colorectal cancer (mCRC) continues to be a serious, life-threatening condition. It is the second most common type of cancer in Europe in both men and women. Standard therapy in patients with unresectable (unable to be removed with surgery) mCRC includes combination regimens with cytotoxic (drugs which include chemicals which are toxic to cells) and targeted agents. In the last decade, substantial advances in the treatment of mCRC have resulted in an improvement in overall survival from 10 to 12 months to more than 20 months. This improvement has occurred due to the addition of the following chemotherapy drugs; irinotecan, oxaliplatin, bevacizumab, cetumimab and panitumumab to the standard treatment with 5-fluorouracil/folinic acid.
BRAF is a human gene that makes a protein which is involved in sending signals inside cells which are involved in directing cell growth. BRAF mutation lead to cancer cells survival and can be considered an indication for poor prognosis in patients with mCRC.
This is a randomised (like the tossing of a coin), open-label (clinical and participant will know which treatment they have been assigned to), parallel group, 3 arm study in patients with previously treated BRAF mCRC comparing the efficacy and safety of the following chemotherapy arms;
Arm 1 – binimetinib + encorafenib + cetuximab
Arm 2 – encorafenib + cetuximab
Arm 3 – Control Arm (irinotecan/cetumimab or FOLFIRI/CETUMIMAB)
Approximately 640-645 participants will take part in this study in approximately 300 international study centres.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0386
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion