drugset / Trial / NCT01656642

A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma

NCT01656642

Phase 1 Completed 67 enrolled Genentech, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled participants may continue treatment until they are no longer experiencing clinical benefit as assessed by the investigator and in alignment with the protocol.

Timeline

Start
2012-08-13
Primary completion
2020-03-25
Completion
2020-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 800 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Cobimetinib Small molecule 60 mg Intravenous
Subject Vemurafenib Small molecule 720 mg Oral

Indications