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

This is a prospective, multicentre, phase II single-arm trial, evaluating encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemotherapy (FOLFIRI) in patients affected by BRAF V600E mutated metatstic colorectal cancer progressing on encorafenib plus cetuximab administered in second line. Eligible patients are: * affected by BRAF V600E mutated metastatic colorectal cancer; * progressing on encorafenib plus cetuximab administered in second line; * achieved complete response, or partial response, or stable disease lasting more than 3 moths, as best response to encorafenib plus cetuximab administered in second line. All patients eligible according to inclusion and exclusion criteria will receive encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemoterapy (FOLFIRI) as follows: * encorafenib 300 mg (75 mgx4 hard capsules) orally once daily; * cetuximab 500 mg/sqm iv every 14 days; * FOLFIRI iv every 14 days (Irinotecan 180 mg/sqm, Folinic Acid 400 mg/sqm, 5Fluorouracil 400 mg/sqm iv bolus and 2400 mg/sqm iv continuous infusion over 46-48 hours). Treatment will be administered until disease progression, unacceptable toxic effects, withdrawal of consent, or death. The primary end point of this trial is investigator-assessed 6-month progression free survival rate and is defined as the proportion of patients alive and progression-free by the 6-month time point from start of investigational treatment (encorafenib plus cetuximab beyond progression in combination with FOLFIRI).