Combination Therapy for BRAF-V600E Metastatic CRCm
ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVall d'Hebron Institute of Oncology
About this trial
The BRAVE is a phase II clinical trial aimed at evaluating the efficacy of the combination therapy of encorafenib, cetuximab, and bevacizumab in patients with metastatic colorectal cancer (CRC) harboring the BRAF-V600E mutation. This mutation is present in about 8-10% of CRC cases and is associated with poor prognosis and limited treatment options. The rationale behind this trial stems from preclinical studies suggesting that the overexpression and activation of vascular endothelial growth factor A (VEGFA) may contribute to resistance to BRAF inhibitors (BRAFi) in CRC. Thus, the trial hypothesizes that adding bevacizumab, an anti-angiogenic agent targeting VEGFA, to the combination of encorafenib and cetuximab may delay acquired resistance, leading to improved progression-free survival.
The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC. This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form.
Age ≥18 years at time of informed consent.
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.
Disqualifiers
Treatment with another investigational drug or participation in another investigational study at enrolment or within 30 days prior to enrolment.
Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
Prior history of hypertensive crisis or hypertensive encephalopathy.
Trial design
Treatments tested in this trial
- Encorafenib
- Cetuximab
- Bevacizumab
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov