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

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT02908672

Run by

Hoffmann-La Roche

People needed

514

Starts

2017-01-13

Expected to finish

2024-07-01

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Cancer-Related 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
• Ocular Exclusion Criteria:
• 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
• Cardiac Exclusion Criteria:
• History of clinically significant cardiac dysfunction
• Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%
• Central Nervous System (CNS) Exclusion Criteria:
• 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
• Additional Exclusion Criteria:
• 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
• History of malabsorption or other clinically significant metabolic dysfunction
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (example: bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Active or history of autoimmune disease or immune deficiency
• Known clinically significant liver disease, inherited liver disease and active viral disease
• Active tuberculosis
• Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live, attenuated vaccine; or systemic immunosuppressive medication
• Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations
• Any grade >/=3 hemorrhage or bleeding event within 4 weeks prior to initiation of study treatment

Where it is running

• 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
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Medical University of Graz, Department of Dermatology — Graz, Austria
• LKH Innsbruck — Innsbruck, Austria
• Medizinische Universität Wien — Vienna, Austria
• Cliniques Universitaires St-Luc — Brussels, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• CHU Sart-Tilman — Liège, Belgium
• Sint Augustinus Wilrijk — Wilrijk, Belgium
• Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
• Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN — Florianópolis, Santa Catarina, Brazil
• Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil
• Clinicas Oncologicas Integradas - COI — Rio de Janeiro, Brazil
• Beneficencia Portuguesa de Sao Paulo — São Paulo, Brazil
• Arthur J.E. Child Comprehensive Cancer Center-Calgary — Calgary, Alberta, Canada
• Cancer Care Manitoba — Winnipeg, Manitoba, Canada
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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