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)