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OncoMatch/Clinical Trials/NCT06640166

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

Is NCT06640166 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies encorafenib + cetuximab + FOLFIRI for colorectal carcinoma.

Phase 2RecruitingFondazione Policlinico Universitario Agostino Gemelli IRCCSNCT06640166Data as of May 2026

Treatment: encorafenib + cetuximab + FOLFIRIThe 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: BRAF v600e

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: BRAF inhibitor + anti-EGFR therapy (encorafenib, cetuximab) — second line

disease progression while on treatment with EC received in 2nd line setting

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0 g/dL; transfusions allowed to achieve this (≤2 units RBC in prior 4 weeks)

Kidney function

serum creatinine ≤ 1.5 × ULN, or calculated by Cockroft-Gault formula, or directly measured creatinine clearance ≥ 50 mL/min at screening

Liver function

serum total bilirubin ≤ 1.5 × ULN; ALT and/or AST ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases

Cardiac function

QTcF ≤480 msec

Adequate bone marrow function at screening: ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0 g/dL; transfusions allowed to achieve this. Adequate renal function at screening: serum creatinine ≤ 1.5 × ULN, or calculated by Cockroft-Gault formula, or directly measured creatinine clearance ≥ 50 mL/min at screening. Adequate hepatic function at screening: serum total bilirubin ≤ 1.5 × ULN; ALT and/or AST ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases. Adequate cardiac function: QTcF ≤480 msec.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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