Combination Therapy for BRAF-V600E Metastatic CRCm - Trial NCT06411600
Access comprehensive clinical trial information for NCT06411600 through Pure Global AI's free database. This Phase 2 trial is sponsored by Vall d'Hebron Institute of Oncology and is currently Not yet recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 94 participants.
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Study Focus
Sponsor & Location
Vall d'Hebron Institute of Oncology
Timeline & Enrollment
Phase 2
May 01, 2024
May 01, 2029
Primary Outcome
Progression-Free Survival (PFS)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06411600
Non-Device Trial