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

Description

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

Study Start Date

January, 13 2017

Estimated Completion Date

November 2019

Interventions

  • Drug: Atezolizumab Placebo
  • Drug: Cobimetinib
  • Drug: Vemurafenib
  • Drug: Vemurafenib Placebo
  • Drug: Atezolizumab

Study ID

Hoffmann-La Roche -- CO39262

Status

Unknown

Trial ID

NCT02908672

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

500

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • Age greater than or equal to (>/=) 18 years
  • 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 ( 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
  • 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 ( For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

Exclusion Criteria

    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, 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 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

  • 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
  • History of autoimmune disease
  • 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (87)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Hackensack U Med Ctr - Hackensack, New Jersey 183.7 miles None None None
Overlook Hospital - Summit, New Jersey 204.1 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
MD Anderson Cancer Center at Cooper - Camden, New Jersey 268.3 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Indiana University Cancer Center - Indianapolis, Indiana 805.0 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Oncology Specialists SC - Park Ridge, Illinois 857.7 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology Sarah Cannon Cancer Center - Nashville, Tennessee 942.8 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,051.7 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Florida Cancer Specialists SCRI - Fort Myers, Florida 1,249.0 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Sarah Cannon Research Institute Kansas City HCA Midwest Health - Kansas City, Missouri 1,249.4 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Highlands Oncology Group - Fayetteville, Arkansas 1,305.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyTyler - Tyler, Texas 1,494.8 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
Texas OncologyAustin Midtown - Austin, Texas 1,695.0 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,759.8 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Centers LLP - Aurora, Colorado 1,760.5 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
HonorHealth Research Institute Pima Center - Scottsdale, Arizona 2,286.1 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
Arizona Oncology Associates PC HAL - Tempe, Arizona 2,294.7 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
Stanford Comprehensive Cancer Center - Stanford, California 2,694.5 miles None None None
Sutter Pacific Medical Foundation - Santa Rosa, California 2,695.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Pacific Campus - San Francisco, California 2,698.0 miles None None None

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