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

ConditionsColorectal Carcinoma Colorectal Neoplasms Colorectal Tumor Colorectal Adenocarcinoma Colorectal Cancer (CRC)Colorectal Cancer Colon Cancer Colon Adenocarcinoma Colon Carcinoma Colon Neoplasm

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Qualifiers

written informed consent to study procedures;

age ≥ 18 years;

histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma;

radiological evidence of metastatic disease;

Disqualifiers

patients experiencing PD as best response to EC;

patients with specific BRAFi/AntiEGFR contraindications;

patients with specific irinotecan or fluoropyrimidines contraindications;

patients with DPYD deficiency;

Trial design

Treatments tested in this trial

encorafenib + cetuximab + FOLFIRI

Treatment groups

25 Participants

are divided into 1 treatment group

Sponsors and collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Pierre Fabre Pharma GmbH

Collaborator

Source ClinicalTrials.gov