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)
NCT ID: NCT02617589
Last Updated: 2023-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
560 participants
INTERVENTIONAL
2016-03-01
2022-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
Nivolumab
Radiotherapy
Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
Temozolomide
Radiotherapy
Interventions
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Nivolumab
Temozolomide
Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
* Tumor test result shows MGMT unmethylated type
* Karnofsky performance status of ≥ 70 (able to care for self)
Exclusion Criteria
* Any known tumor outside of the brain
* Recurrent or secondary GBM
* Active known or suspected autoimmune disease
* Biopsy with less than 20% of tumor removed
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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 D.C., 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
St 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
Brussels, , 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, , France
Local Institution
Lille, , France
Local Institution - 0024
Marseille, , France
Local Institution - 0101
Nancy, , France
Local Institution - 0023
Paris, , France
Local Institution - 0038
Paris, , France
Centre Eugene Marquis
Rennes, , France
Local Institution - 0106
Toulouse, , France
Local Institution - 0051
Bonn, , Germany
Local Institution - 0139
Cologne, , Germany
Local Institution - 0072
Erlangen, , Germany
Local Institution - 0049
Frankfurt am Main, , Germany
Local Institution - 0073
Freiburg im Breisgau, , Germany
Local Institution - 0054
Hamburg, , Germany
Local Institution - 0052
Heidelberg, , Germany
Local Institution - 0138
Munich, , Germany
Local Institution - 0050
Münster, , Germany
Local Institution - 0055
Regensburg, , Germany
Local Institution - 0056
Tübingen, , Germany
Local Institution - 0096
Petah Tikva, , Israel
Local Institution - 0097
Tel Aviv, , Israel
Local Institution - 0076
Bologna, , Italy
Local Institution - 0079
Milan, , Italy
Local Institution - 0126
Padua, , Italy
Local Institution - 0135
Rozzano (milano), , Italy
Local Institution - 0078
Siena, , Italy
Local Institution - 0077
Torino, , Italy
Local Institution - 0115
Nagoya, Aichi-ken, Japan
Local Institution - 0125
Chiba, Chiba, Japan
Local Institution - 0123
Hiroshima, Hiroshima, Japan
Local Institution - 0122
Sapporo, Hokkaido, Japan
Local Institution - 0129
Kobe, Hyōgo, Japan
Local Institution - 0111
Tsukuba, Ibaraki, Japan
Local Institution - 0121
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0131
Kagoshima, Kagoshima-ken, Japan
Local Institution - 0133
Sagamihara-shi, Kanagawa, Japan
Local Institution - 0119
Kumamoto, Kumamoto, Japan
Local Institution - 0117
Kyoto, Kyoto, Japan
Local Institution - 0116
Kyoto, Kyoto, Japan
Local Institution - 0134
Okayama, Okayama-ken, 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, 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
Warsaw, , Poland
Local Institution - 0070
Moscow, , Russia
Local Institution - 0105
Moscow, , Russia
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
Geneva, , Switzerland
Local Institution - 0057
Lausanne, , Switzerland
Local Institution - 0053
Zurich, , 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
Countries
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References
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Grkovski M, Daras M, Bale T, Lyashchenko S, Reiner AS, Mellinghoff IK, Schoder H, Dunphy MPS. 18F-BMS-986229 PET imaging of tumor PD-L1 expression in glioblastoma patients. EJNMMI Res. 2025 Sep 26;15(1):124. doi: 10.1186/s13550-025-01283-x.
Omuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, Sumrall A, Baehring J, van den Bent M, Bahr O, Lombardi G, Mulholland P, Tabatabai G, Lassen U, Sepulveda JM, Khasraw M, Vauleon E, Muragaki Y, Di Giacomo AM, Butowski N, Roth P, Qian X, Fu AZ, Liu Y, Potter V, Chalamandaris AG, Tatsuoka K, Lim M, Weller M. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro Oncol. 2023 Jan 5;25(1):123-134. doi: 10.1093/neuonc/noac099.
Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2015-003739-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-498
Identifier Type: -
Identifier Source: org_study_id
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