Spots Global Cancer Trial Database for An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
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Trial Identification
Brief Title: An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Official Title: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
Study ID: NCT02617589
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Local Institution - 0083, Phoenix, Arizona, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Local Institution - 0019, Los Angeles, California, United States
Sutter Institute For Medical Research, Sacramento, California, United States
Sharp Memorial Hospital, San Diego, California, United States
The Regents of the University of California, San Francisco, San Francisco, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University Of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
The University Of Chicago, Chicago, Illinois, United States
University Of Kansas Medical Center, Westwood, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Local Institution - 0006, Detroit, Michigan, United States
Washington University School OF Medicine-Siteman Cancer Center, Saint Louis, Missouri, United States
JFK Medical Center, Edison, New Jersey, United States
Local Institution - 0064, Hackensack, New Jersey, United States
Columbia University Medical Center (Cumc), 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
Preston Robert Tisch Brain Tumor Center at Duke University, Durham, North Carolina, United States
Local Institution - 0010, Cleveland, Ohio, United States
Local Institution - 0095, Columbus, Ohio, United States
Local Institution - 0132, Allentown, Pennsylvania, United States
Local Institution - 0007, Philadelphia, Pennsylvania, United States
Medical University Of South Carolina, Charleston, South Carolina, United States
Local Institution - 0090, Chattanooga, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University Of Texas Southwestern Medical Center, Dallas, Texas, United States
University Of Texas Md Anderson Cancer Ctr, Houston, Texas, United States
Local Institution - 0068, Salt Lake City, Utah, United States
Swedish Neuroscience Institute, Seattle, Washington, United States
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Local Institution - 0003, Heidelberg, Victoria, Australia
Local Institution - 0004, Prahran, Victoria, Australia
Local Institution - 0001, Nedlands, Western Australia, Australia
Local Institution - 0002, New South Wales, , Australia
Local Institution - 0061, Linz, , Austria
Local Institution - 0060, Vienna, , Austria
Universitair Ziekenhuis Brussel, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Uz Leuven, Leuven, , Belgium
BC Cancer - Vancouver, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
Local Institution, Copenhagen, , Denmark
Local Institution, Odense, , Denmark
Local Institution - 0032, Bron Cedex, , France
Local Institution, Lille Cedex, , France
Local Institution - 0024, Marseille, , France
Local Institution - 0101, Nancy, , France
Local Institution - 0038, Paris cedex 13, , France
Local Institution - 0023, Paris, , France
Centre Eugene Marquis, Rennes, , France
Local Institution - 0106, Toulouse, , France
Local Institution - 0051, Bonn, , Germany
Local Institution - 0072, Erlangen, , Germany
Local Institution - 0049, Frankfurt am Main, , Germany
Local Institution - 0073, Freiburg, , Germany
Local Institution - 0054, Hamburg, , Germany
Local Institution - 0052, Heidelberg, , Germany
Local Institution - 0139, Koeln, , Germany
Local Institution - 0050, Muenster, , Germany
Local Institution - 0138, Munich, , Germany
Local Institution - 0055, Regensburg, , Germany
Local Institution - 0056, Tuebingen, , Germany
Local Institution - 0096, Petach Tikva, , Israel
Local Institution - 0097, Tel Aviv, , Israel
Local Institution - 0076, Bologna, , Italy
Local Institution - 0079, Milano, , Italy
Local Institution - 0126, Padova, , Italy
Local Institution - 0135, Rozzano (milano), , Italy
Local Institution - 0078, Siena, , Italy
Local Institution - 0077, Torino, , Italy
Local Institution - 0115, Nagoya-shi, Aichi, Japan
Local Institution - 0125, Chiba-shi, Chiba, Japan
Local Institution - 0123, Hiroshima-Shi, Hiroshima, Japan
Local Institution - 0122, Sapporo-shi, Hokkaido, Japan
Local Institution - 0129, Kobe, Hyogo, Japan
Local Institution - 0111, Tsukuba-shi, Ibaraki, Japan
Local Institution - 0121, Kanazawa-shi, Ishikawa, Japan
Local Institution - 0131, Kagoshima-shi, Kagoshima, Japan
Local Institution - 0133, Sagamihara-shi, Kanagawa, Japan
Local Institution - 0119, Kumamoto-shi, Kumamoto, Japan
Local Institution - 0117, Kyoto-shi, Kyoto, Japan
Local Institution - 0116, Kyoto-shi, Kyoto, Japan
Local Institution - 0134, Okayama-shi, Okayama, Japan
Local Institution, Hirakata-shi, Osaka, Japan
Local Institution - 0130, Suita-shi, Osaka, Japan
Local Institution - 0113, Hidaka, Saitama, Japan
Local Institution - 0128, Bunkyo-ku, Tokyo, Japan
Local Institution - 0114, Chuo-ku, Tokyo, Japan
Local Institution - 0118, Mitaka-shi, Tokyo, Japan
Local Institution - 0110, Yamagata-shi, Yamagata, Japan
Local Institution - 0112, Tokyo, , Japan
NKI AVL, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus Mc, Rotterdam, , Netherlands
Local Institution - 0063, Utrecht, , Netherlands
Local Institution, Oslo, , Norway
Local Institution - 0080, Gdansk, , Poland
Local Institution - 0081, Warszawa, , Poland
Local Institution - 0070, Moscow, , Russian Federation
Local Institution - 0105, Moscow, , Russian Federation
Local Institution, Badalona-Barcelona, , Spain
Local Institution, Barcelona, , Spain
Local Institution - 0028, Barcelona, , Spain
Local Institution - 0029, Madrid, , Spain
Local Institution, Madrid, , Spain
Local Institution, Santiago De Compostela, , Spain
Local Institution - 0025, Valencia, , Spain
Local Institution, Lund, , Sweden
Local Institution, Solna, , Sweden
Local Institution - 0059, Geneve, , Switzerland
Local Institution - 0057, Lausanne, , Switzerland
Local Institution - 0053, Zuerich, , Switzerland
University College Hospital, London, Greater London, United Kingdom
Christie Hospital Nhs Found. Trust, Manchester, Greater Manchester, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Beaston West of Scotland Cancer Centre, Glasgow, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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