Bevacizumab plus encorafenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial
Key facts
- Where
- A Coruña, Barcelona, Córdoba, L'Hospitalet de Llobregat, Madrid, Málaga, Oviedo, Santander, Valencia és Zaragoza, SpanyolországSee the 15 sites
- Phase
- 2. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital del MarBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Reina SofiaCórdoba, SpanyolországTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországTaking people
- Hospital Clínico San CarlosMadrid, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
- Hospital Universitario 12 de OctubreMadrid, SpanyolországTaking people
- Hospital Universitario Regional de MálagaMálaga, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpanyolországTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországTaking people
- Hospital General Universitario de ValenciaValencia, SpanyolországTaking people
- Hospital Unviersitario Miguel ServetZaragoza, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vall D Hebron Institute Of Oncology
- Trial code
- EU 2023-509204-15-00
- Record updated
- 2026. június 19.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; Tumors with microsatellite instability or mismatch repair deficiency.