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

Phase 3 Terminated 446 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase III, multicenter, 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.

Timeline

Start: 2017-12-11
Primary completion: 2019-04-15
Completion: 2021-02-19

Outcome

Missed primary endpoint

Stopped: “This study was terminated due to benefit/risk analysis.”

registry analysis (superiority test); Pembrolizumab vs Cobimetinib and Atezolizumab; p = 0.2954; Hazard Ratio (HR) 1.15 (95% CI 0.88 to 1.50); Regression, Cox NCT03273153 ↗

Publications

de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Cobimetinib	Small molecule	60 mg	Oral
Comparator	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous