Bevacizumab plus encorafenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial - VHIO23001

Vall D Hebron Institute Of Oncology0 个研究点目标入组 94 人开始时间: 2023年10月30日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Vall D Hebron Institute Of Oncology