A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Official Title

A Phase III, Open-Label, Multicentre, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

Summary:

This is a Phase III, multicentre, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC)

• PFS as Determined by the Investigator
• Objective Response determined by the IRC
• Objective Response Rate determined by the Investigator
• Disease Control Rate (DCR)
• Overall Survival (OS)
• Duration of objective response determined by the IRC
• Duration of Objective Response determined by the Investigator
• Two-year Landmark Survival
• Change From Baseline in Health-related Quality of Life (HRQoL) Scores
• Number of Participants with Adverse Events (AEs)
• Number of Participants With Abnormal Vital Signs
• Number of Participants With Laboratory Abnormalities
• Plasma Concentration of Cobimetinib
• Serum Concentration of Atezolizumab
• Percentage of Participants with Anti-drug Antibodies (ADAs)

View this trial on ClinicalTrials.gov