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Combination Therapy for BRAF-V600E Metastatic CRCm

NCT06411600 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Encorafenib

Encorafenib is administered orally at a daily dose of 300 mg, typically in the form of four 75 mg capsules taken together.

DRUG

Cetuximab

Cetuximab is administered intravenously every two weeks at a dose of 500 mg/m².

DRUG

Bevacizumab

Bevacizumab is administered intravenously every two weeks at a dose of 5 mg/kg.

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Principal Investigators

  • Elena Elez, MD PhD · Vall d'Hebron Institute of Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2027-05-01
Completion
2029-05-01

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411600 on ClinicalTrials.gov