Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.
Trial Parameters
Brief Summary
The aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line.
Eligibility Criteria
Inclusion Criteria: * written informed consent to study procedures; * age ≥ 18 years; * histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma; * radiological evidence of metastatic disease; * evidence of measurable disease according to RECIST 1.1 criteria; * presence of BRAF V600E mutation in tumor tissue (primary CRC and/or related metastasis) as previously determined by a local assay at any time prior to screening (only PCR and NGS-based local assays results will be acceptable); * disease progression while on treatment with EC received in 2nd line setting * EC administered after disease relapse during treatment or within 6 months following adjuvant therapy will be second line; * maintenance therapy given in the metastatic setting after a first line doublet or triplet chemotherapy will not be considered a separate regimen; * best response to previous treatment with EC: CR, PR or SD lasting for at least 3 months. * patient fit for a subsequent treatment line