Study of Encorafenib and Cetuximab with FOLFIRI Chemotherapy for Adults with BRAF V600E Mutated Metastatic Colorectal Cancer Who Have Progressed After Prior Encorafenib and Cetuximab Treatment

What this Trial Is About

Researchers are evaluating the activity of encorafenib plus cetuximab combined with FOLFIRI chemotherapy in patients who have BRAF V600E mutated metastatic colorectal cancer that has progressed after treatment with encorafenib plus cetuximab in the second line. This phase II, single-arm trial aims to understand how this combination treatment works beyond progression in this specific patient group. Participants will receive encorafenib 300 mg orally once daily, cetuximab 500 mg per square meter intravenously every 14 days, and FOLFIRI chemotherapy intravenously every 14 days, which includes irinotecan, folinic acid, and 5-fluorouracil given both as a bolus and continuous infusion. Treatment continues until disease progression, unacceptable side effects, withdrawal of consent, or death. During the study, patients will be monitored for disease progression and response through imaging and clinical assessments. The primary measure is the rate of patients alive and progression-free at 6 months after starting the investigational treatment. Secondary measures include overall survival, duration of response, overall response rate, disease control rate, and adverse events. Participants will be evaluated regularly to track these outcomes and ensure safety throughout the trial period, which runs until June 2026.

Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.