Bevacizumab plus encorafenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial

Phase 1

Recruiting

• Conditions: Metastatic colorectal cancer; MedDRA version: 21.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-509204-15-00
• Lead Sponsor: Vall D Hebron Institute Of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified