Actively Recruiting
Combination Therapy for BRAF-V600E Metastatic CRCm
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-11-08
94
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Combination Therapy for BRAF-V600E Metastatic CRCm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older at consent.
- Confirmed diagnosis of metastatic colorectal cancer.
- Presence of BRAF V600E mutation in tumor tissue.
- Confirmed microsatellite stability.
- Eligible to receive cetuximab based on tumor RAS status.
- Disease progression after 1 or 2 prior chemotherapy regimens in metastatic setting.
- Measurable or evaluable non-measurable disease per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Adequate bone marrow function with ANC 61.5 x 10^9/L, platelets 6100 x 10^9/L, hemoglobin 69.0 g/dL.
- Adequate liver and kidney function within specified laboratory limits.
- Adequate electrolytes within normal institutional limits.
- QTcF interval 6480 msec.
- Able to take oral medications.
- Use of highly effective contraception if risk of conception exists during and up to 6 months after treatment.
You will not qualify if you...
- Participation in another investigational drug study at enrollment or within 30 days prior.
- Inability to comply with study protocol due to psychological, social, or geographic reasons.
- Pregnant, breastfeeding, or expecting to conceive or father children during study.
- History of hypertensive crisis or hypertensive encephalopathy.
- Significant vascular disease within 6 months prior to treatment start.
- Bleeding disorders or clinically significant coagulation problems without anticoagulation.
- History of pulmonary hemorrhage or hemoptysis within 6 months.
- Known acute or chronic pancreatitis.
- Tumors with microsatellite instability or mismatch repair deficiency.
- Chronic inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
- Impaired cardiovascular function or significant cardiovascular diseases within 6 months.
- Uncontrolled hypertension despite therapy.
- Impaired hepatic function (Child-Pugh class B or C).
- Active HIV, hepatitis B, or hepatitis C infections.
- Spinal cord compression or active central nervous system metastases requiring corticosteroids or anticonvulsants.
- Leptomeningeal carcinomatosis.
- Impaired gastrointestinal function affecting drug absorption.
- Other malignancy within 5 years except certain noninvasive cancers.
- Thromboembolic or cerebrovascular events within 6 months.
- Any disease or medication interfering with study treatment.
- Known severe hypersensitivity to monoclonal antibodies or BRAF inhibitors.
- Hypersensitivity to encorafenib, cetuximab, bevacizumab-bvzr, or their components.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vall d'Hebron Hospital
Barcelona, Spain, 08035
Actively Recruiting
Research Team
E
Elena Elez, MD PhD
CONTACT
S
Susana Muñoz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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