OncoMatch/Clinical Trials/NCT06411600
Combination Therapy for BRAF-V600E Metastatic CRCm
Is NCT06411600 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Encorafenib and Cetuximab for metastatic colorectal cancer.
Treatment: Encorafenib · Cetuximab · Bevacizumab — The BRAVE is a phase II clinical trial aimed at evaluating the efficacy of the combination therapy of encorafenib, cetuximab, and bevacizumab in patients with metastatic colorectal cancer (CRC) harboring the BRAF-V600E mutation. This mutation is present in about 8-10% of CRC cases and is associated with poor prognosis and limited treatment options. The rationale behind this trial stems from preclinical studies suggesting that the overexpression and activation of vascular endothelial growth factor A (VEGFA) may contribute to resistance to BRAF inhibitors (BRAFi) in CRC. Thus, the trial hypothesizes that adding bevacizumab, an anti-angiogenic agent targeting VEGFA, to the combination of encorafenib and cetuximab may delay acquired resistance, leading to improved progression-free survival. The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC. This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF V600E
Presence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center, any time point before the enrollment in the study.
Required: MMR microsatellite stability
Microsatellite stability must be confirmed according to the guidelines of each center, any time point before the enrollment in the study.
Required: RAS eligible for cetuximab per locally approved label with regard to tumor RAS status
Eligible to receive cetuximab per locally approved label with regard to tumor RAS status, any time point before the enrollment in the study.
Disease stage
Metastatic disease required
measurable or evaluable non-measurable disease per RECIST, v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L; platelets ≥100 x 10^9/L; hemoglobin ≥9.0 g/dL (with or without transfusions).
Kidney function
Estimated creatinine clearance ≥50 mL/min (Cockcroft Gault or 24-hour urine collection or local standard). Protein <2+ on dipstick or ≤1.0 g in 24-hour urine collection.
Liver function
Serum total bilirubin ≤1.5 x ULN and <2 mg/dL (exceptions for direct/indirect bilirubin and non-hepatic causes allowed); ALT and/or AST ≤2.5 x ULN, or ≤5 x ULN in the presence of liver metastases.
Cardiac function
Mean triplicate QTcF ≤480 msec.
Adequate bone marrow function... Adequate hepatic and renal function... Adequate cardiac function characterized by the following at screening: Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤480 msec.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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