2023-509204-15-00RecruitingPhase 2
Bevacizumab plus encorafenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 17 May 2024
- Lead sponsor
- Vall D Hebron Institute Of Oncology
- Diseases
- Colorectal cancer
- EU CT number
- 2023-509204-15-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 94
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic colorectal cancer that has a BRAF V600E mutation and has grown after 1 or 2 earlier treatment regimens.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Metastatic colorectal cancer, confirmed by tissue or cell tests. The disease has progressed after 1 or 2 earlier regimens in the metastatic setting.
- Earlier treatment
- Must have had 1 or 2 earlier treatment regimens for metastatic disease, with the disease progressing afterwards.
- Biomarker or test result
- BRAF V600E mutation in tumor tissue. Must be able to receive cetuximab according to the local label, based on tumor RAS status.
Main reasons for not taking part
- Significant vascular disease in the 6 months before cycle 1, day 1
- Bleeding disorder or clinically significant coagulopathy
- Tumors with microsatellite instability or mismatch repair deficiency
- Stomach or bowel problems that may change how encorafenib is absorbed
- Blood clot or stroke-type event in the 6 months before starting treatment
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.
- 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.
Other illness
- Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation).
- 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).
- 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.
Other
- Tumors with microsatellite instability or mismatch repair deficiency.
Who the study is looking for
- Histologically- or cytologically-confirmed mCRC that is metastatic.
- 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.
- Eligible to receive cetuximab per locally approved label with regard to tumor RAS status, any time point before the enrollment in the study.
- Progression of disease after 1 or 2 prior regimens in the metastatic setting
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital del Mar | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital General Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital Unviersitario Miguel Servet | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.