RecruitingPhase 2NCT06640166

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

25 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether continuing encorafenib and cetuximab (a targeted therapy combination for colorectal cancer with a BRAF V600E mutation) plus adding FOLFIRI chemotherapy can still help patients whose colorectal cancer progressed while on encorafenib and cetuximab alone — a strategy known as "treatment beyond progression." **You may be eligible if...** - You are 18 or older with metastatic colorectal cancer confirmed to have the BRAF V600E mutation - You previously received encorafenib + cetuximab as second-line therapy and had at least some benefit (complete response, partial response, or stable disease for at least 3 months) - Your cancer has now progressed while on that treatment - You are healthy enough to receive additional chemotherapy (ECOG ≤ 1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have a microsatellite instability-high (MSI-H) or mismatch repair-deficient tumor - You are pregnant or breastfeeding - You have a life expectancy of less than 3 months - You have uncontrolled infections or serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGencorafenib + 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).


Locations(3)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, Italy

Ospedale Cardinale G. Panico

Tricase, Italy

View Full Details on ClinicalTrials.gov

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NCT06640166


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