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A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

NCT02908672•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (\</=)1% per year is required during treatment and for 6 months post treatment. Males should not expose pregnant partners to sperm and refrain from donating sperm for 6 months post treatment. Women must refrain from donating eggs during this same period
•Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
•Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
•Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
•Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1
•Measurable disease according to RECIST v1.1 (must be outside central nervous system (CNS))
•Life expectancy \>/=18 weeks
•For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to (\</=) 1.5\*upper limit of normal (ULN) within 28 days prior to initiation of study treatment
•For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

Exclusion Criteria

•Major surgical procedure within 4 weeks prior study treatment initiation
•Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation
•Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the participant has been disease-free for at least 3 years
•History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
•History of clinically significant cardiac dysfunction
•Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%
•Untreated or actively progressing CNS lesions (carcinomatous meningitis)
•History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage
•Uncontrolled diabetes or symptomatic hyperglycemia
•Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
+11 more criteria

Locations (110)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

UC Irvine Medical Center

Orange, California, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States

St. Luke's University Health network

Bethlehem, Pennsylvania, United States

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

January 13, 2017

Primary Completion Date

October 11, 2019

Completion Date

July 1, 2024

Last Updated

July 20, 2025

Enrollment

514

ACTUAL participants

Conditions

Melanoma

Interventions

Atezolizumab

DRUG

Atezolizumab Placebo

DRUG

Cobimetinib

DRUG

Vemurafenib

DRUG

Vemurafenib Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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