NCT06640166

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	encorafenib + cetuximab + FOLFIRI	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).

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-10-15
• Last updated: 2025-02-12

Locations

3 sites across 1 country: Italy