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Brief Title: A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Official Title: A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma
Study ID: NCT02017717
Brief Summary: The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.
Detailed Description: Allocation: Randomized (Cohorts 1, 2 and Part B of 1c/1d), Non-Randomized (Cohorts 1b, and Part A of 1c/1d)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Local Institution - 0055, Los Angeles, California, United States
Local Institution - 0009, Los Angeles, California, United States
UCLA Neuro-Oncology Program, Los Angeles, California, United States
Local Institution - 0014, San Francisco, California, United States
The Regents of the University of California, San Francisco, San Francisco, California, United States
Anschutz Cancer Pavilion, Aurora, Colorado, United States
Local Institution - 0021, Aurora, Colorado, United States
Local Institution - 0001, New Haven, Connecticut, United States
Yale University School Of Medicine, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Local Institution - 0002, Atlanta, Georgia, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States
Local Institution - 0008, Baltimore, Maryland, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Local Institution - 0006, Boston, Massachusetts, United States
Local Institution - 0043, Boston, Massachusetts, United States
Local Institution - 0056, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Local Institution - 0003, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Local Institution - 0007, Durham, North Carolina, United States
Preston Robert Tisch Brain Tumor Center at Duke University, Durham, North Carolina, United States
Local Institution - 0049, Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Thomas Jefferson University - Clinical Research Institute, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Local Institution - 0023, Charleston, South Carolina, United States
Medical University Of South Carolina, Charleston, South Carolina, United States
Local Institution - 0005, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Local Institution - 0024, Houston, Texas, United States
University Of Texas Md Anderson Cancer Ctr, Houston, Texas, United States
University Of Virginia Health System, Charlottesville, Virginia, United States
University of Washington - Seattle Cancer Care Alliance, Seattle, Washington, United States
Local Institution - 0020, Seattle, Washington, United States
Swedish Neuroscience Institute, Seattle, Washington, United States
Local Institution - 0035, Liverpool, New South Wales, Australia
Local Institution, Liverpool, New South Wales, Australia
Local Institution - 0034, East Bentleigh, Victoria, Australia
Local Institution, East Bentleigh, Victoria, Australia
Local Institution - 0033, Heidelberg, Victoria, Australia
Local Institution, Heidelberg, Victoria, Australia
Local Institution - 0032, Nedlands, Western Australia, Australia
Local Institution, Nedlands, Western Australia, Australia
Local Institution - 0050, Brussels, , Belgium
Local Institution, Brussels, , Belgium
Local Institution - 0051, Bruxelles, , Belgium
Local Institution, Bruxelles, , Belgium
Aarhus University Hospital, Aarhus C, , Denmark
Local Institution - 0058, Aarhus C, , Denmark
Local Institution - 0057, Odense C, , Denmark
Odense University Hospital, Odense C, , Denmark
Local Institution - 0062, Bron cedex, , France
Local Institution, Bron cedex, , France
Local Institution - 0063, Marseille Cedex 5, , France
Local Institution, Marseille Cedex 5, , France
Local Institution - 0064, Paris cedex 13, , France
Local Institution, Paris cedex 13, , France
Local Institution - 0068, Paris, , France
Local Institution, Paris, , France
Local Institution - 0037, Bonn, , Germany
Universitaetsklinikum Bonn, Bonn, , Germany
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main, Frankfurt Am Main, , Germany
Local Institution - 0036, Frankfurt Am Main, , Germany
Local Institution - 0038, Heidelberg, , Germany
Local Institution, Heidelberg, , Germany
Local Institution - 0041, Muenster, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Local Institution - 0010, Bologna, , Italy
Local Institution, Bologna, , Italy
Local Institution - 0011, Milano, , Italy
Local Institution, Milano, , Italy
Local Institution - 0012, Siena, , Italy
Local Institution, Siena, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza, Torino, , Italy
Local Institution - 0013, Torino, , Italy
Local Institution - 0067, Amsterdam, , Netherlands
Local Institution, Amsterdam, , Netherlands
Local Institution - 0066, Groningen, , Netherlands
Local Institution, Groningen, , Netherlands
Local Institution - 0060, Gdansk, , Poland
Local Institution, Gdansk, , Poland
Local Institution - 0059, Warszawa, , Poland
Local Institution, Warszawa, , Poland
Local Institution - 0047, Barcelona, , Spain
Local Institution, Barcelona, , Spain
Local Institution - 0045, Madrid, , Spain
Local Institution, Madrid, , Spain
Local Institution - 0046, Madrid, , Spain
Local Institution, Madrid, , Spain
Local Institution - 0070, Pamplona, , Spain
Local Institution, Pamplona, , Spain
Centre hospitalier universitaire Vaudois (CHUV), Lausanne, , Switzerland
Local Institution - 0039, Lausanne, , Switzerland
Local Institution - 0040, Zuerich, , Switzerland
UniversitaetsSpital Zurich, Zuerich, , Switzerland
Local Institution - 0018, London, Greater London, United Kingdom
Local Institution, London, Greater London, United Kingdom
Local Institution - 0015, Manchester, Greater Manchester, United Kingdom
Local Institution, Manchester, Greater Manchester, United Kingdom
Local Institution - 0017, Liverpool, , United Kingdom
Local Institution, Liverpool, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR