NCT01656642

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

A Phase Ib, Open-Label Study of The Safety and Pharmacology of Atezolizumab (Anti PD-L1 Antibody) Administered in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Patients With BRAFV600-Mutation Positive Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered q3w or q2w.
DRUG	Cobimetinib	Oral repeating dose
DRUG	Vemurafenib	Oral repeating dose, depending on arm/cohort

Timeline

• Start date: 2012-08-13
• Primary completion: 2020-03-25
• Completion: 2020-03-25
• First posted: 2012-08-03
• Last updated: 2020-07-21

Locations

8 sites across 1 country: United States