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Bevacizumab plus encorafenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial
EU CTIS ID: 2023-509204-15-00
What this study is testing
To evaluate the antitumor activity of the combination of encorafenib, cetuximab and bevacizumab in subjects who have progressed to one or two chemotherapeutic regimens for BRAF V600E-mutant mCRC. For the safety lead-in phase only: To assess the safety and tolerability of the combination of encorafenib, cetuximab and bevacizumab.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 3. Histologically- or cytologically-confirmed mCRC that is metastatic.
- 4. 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.
- 6. Eligible to receive cetuximab per locally approved label with regard to tumor RAS status, any time point before the enrollment in the study.
- 7. Progression of disease after 1 or 2 prior regimens in the metastatic setting
You likely can't join if
- 5. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.
- 6. Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation).
- 9. Tumors with microsatellite instability or mismatch repair deficiency.
- 17. Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of encorafenib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption).
- 18. Concurrent or previous other malignancy within 5 years of study entry without Sponsor approval, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy.
- 19. History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary embolism.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.