Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma
Status:
Terminated
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1)
standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor
cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood
vessel formation and can stimulate the immune system. Previous clinical studies in melanoma
have shown that bevacizumab may improve clinical benefit (progression free survival) if
combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a
role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of
bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and
clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior
therapies, excluding BRAF and MEK inhibitors.
Phase:
Phase 2
Details
Lead Sponsor:
Melanoma Research Foundation Breakthrough Consortium