A trial to evaluate whether encorafenib in combination with cetuximab is safe and effective in the Chinese mainland population with BRAFV600E mutant metastatic Colorectal Cancer.
A trial to evaluate whether encorafenib in combination with cetuximab is safe and effective in the Chinese mainland population with BRAFV600E mutant metastatic Colorectal Cancer.
A multicenter, randomized, open-label, 2-arm, Phase II trial with a safety lead-in phase evaluating the combination of encorafenib and cetuximab versus irinotecan/cetuximab or infusional 5-fluorouracil (5-FU)/folinic acid (FA)/irinotecan (FOLFIRI)/cetuximab in Chinese patients with BRAFV600E mutant metastatic colorectal cancer.
Brief summary
Previous clinical trials have shown that encorafenib in combination with cetuximab is effective to treat patients with metastatic colorectal cancer carrying a specific mutation in the BRAF gene (BRAFV600E).
Encorafenib is a marketed drug (Braftovi®). It is used in combination with cetuximab (Erbitux®) in several countries (European Union, USA, Australia, Japan, Switzerland...) for patients whose disease had worsened following prior systemic therapies.
The purpose of this trial is to prove that this combination would present the same benefits for the Chinese patients.
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