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

NCT03273153 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2022-09-21

Study results available
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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.

Conditions

  • Advanced BRAFV600 Wild-type Melanoma

Interventions

DRUG

Cobimetinib

Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.

DRUG

Atezolizumab

Atezolizumab 840 mg as IV infusion once in every 2 weeks.

DRUG

Pembrolizumab

Pembrolizumab 200 mg as IV infusion once in every 3 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2019-04-15
Completion
2021-02-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273153 on ClinicalTrials.gov