An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
NCT ID: NCT02667587
Last Updated: 2025-06-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
716 participants
INTERVENTIONAL
2016-05-09
2024-04-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT02617589
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
NCT05685004
Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma
NCT03535350
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
NCT00262730
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
NCT00267592
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab + Temozolomide + Radiotherapy
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
Nivolumab
Temozolomide
Radiotherapy
Nivolumab placebo + Temozolomide + Radiotherapy
Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks
Temozolomide
Radiotherapy
Nivolumab Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Temozolomide
Radiotherapy
Nivolumab Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Newly diagnosed brain cancer or tumor called glioblastoma or GBM
* Karnofsky performance status of ≥ 70 (able to take care of self)
* Substantial recovery from surgery resection
* Tumor test result shows MGMT methylated or indeterminate tumor subtype
Exclusion Criteria
* Prior treatment for GBM (other than surgical resection)
* Any known tumor outside of the brain
* Recurrent or secondary GBM
* Active known or suspected autoimmune disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0023
Birmingham, Alabama, United States
Local Institution - 0003
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Local Institution - 0010
Los Angeles, California, United States
Local Institution - 0128
Sacramento, California, United States
Local Institution - 0029
San Diego, California, United States
Local Institution - 0006
San Francisco, California, United States
Local Institution - 0004
New Haven, Connecticut, United States
Local Institution - 0031
Washington D.C., District of Columbia, United States
Local Institution - 0087
Miami, Florida, United States
Local Institution - 0030
Tampa, Florida, United States
Local Institution - 0022
Chicago, Illinois, United States
Local Institution - 0060
Westwood, Kansas, United States
Local Institution - 0018
Louisville, Kentucky, United States
Local Institution - 0020
Baltimore, Maryland, United States
Local Institution - 0011
Boston, Massachusetts, United States
Local Institution - 0028
Boston, Massachusetts, United States
Local Institution - 0035
Detroit, Michigan, United States
Local Institution - 0002
St Louis, Missouri, United States
Local Institution - 0017
Edison, New Jersey, United States
Local Institution - 0012
Hackensack, New Jersey, United States
Local Institution - 0015
New York, New York, United States
Local Institution - 0024
New York, New York, United States
Local Institution - 0032
Charlotte, North Carolina, United States
Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, United States
Local Institution - 0001
Cleveland, Ohio, United States
Local Institution - 0027
Columbus, Ohio, United States
Local Institution - 0098
Allentown, Pennsylvania, United States
Local Institution - 0016
Philadelphia, Pennsylvania, United States
Local Institution - 0021
Charleston, South Carolina, United States
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee, United States
Local Institution - 0008
Nashville, Tennessee, United States
Local Institution - 0025
Dallas, Texas, United States
Local Institution - 0009
Salt Lake City, Utah, United States
Local Institution - 0005
Seattle, Washington, United States
Local Institution - 0049
Liverpool, New South Wales, Australia
Local Institution - 0052
St Leonards, New South Wales, Australia
Local Institution - 0050
Heidelberg, Victoria, Australia
Local Institution - 0051
Prahran, Victoria, Australia
Local Institution - 0122
Nedlands, Western Australia, Australia
Local Institution - 0062
Linz, , Austria
Local Institution - 0061
Vienna, , Austria
Local Institution - 0070
Brussels, , Belgium
Local Institution - 0069
Brussels, , Belgium
Local Institution - 0071
Leuven, , Belgium
Local Institution - 0046
Vancouver, British Columbia, Canada
Local Institution - 0048
Toronto, Ontario, Canada
Local Institution - 0047
Montreal, Quebec, Canada
Local Institution - 0084
Copenhagen, , Denmark
Local Institution - 0085
Odense, , Denmark
Local Institution - 0043
Lille, , France
Local Institution - 0041
Lyon, , France
Local Institution - 0040
Marseille, , France
Local Institution - 0042
Nancy, , France
Local Institution - 0038
Paris, , France
Local Institution - 0039
Paris, , France
Local Institution - 0044
Rennes, , France
Local Institution - 0045
Toulouse, , France
Local Institution - 0055
Bonn, , Germany
Local Institution - 0131
Cologne, , Germany
Local Institution - 0123
Erlangen, , Germany
Local Institution - 0053
Frankfurt am Main, , Germany
Local Institution - 0124
Freiburg im Breisgau, , Germany
Local Institution - 0057
Hamburg, , Germany
Local Institution - 0056
Heidelberg, , Germany
Local Institution - 0130
Munich, , Germany
Local Institution - 0054
Münster, , Germany
Local Institution - 0058
Regensburg, , Germany
Local Institution - 0059
Tübingen, , Germany
Local Institution - 0094
Petah Tikva, , Israel
Local Institution - 0093
Tel Aviv, , Israel
Local Institution - 0088
Bologna, , Italy
Local Institution - 0089
Milan, , Italy
Local Institution - 0092
Padua, , Italy
Local Institution - 0127
Rozzano (milano), , Italy
Local Institution - 0090
Siena, , Italy
Local Institution - 0091
Torino, , Italy
Local Institution - 0110
Nagoya, Aichi-ken, Japan
Local Institution - 0099
Chiba, Chiba, Japan
Local Institution - 0100
Hiroshima, Hiroshima, Japan
Local Institution - 0101
Sapporo, Hokkaido, Japan
Local Institution - 0105
Kobe, Hyōgo, Japan
Local Institution - 0116
Tsukuba, Ibaraki, Japan
Local Institution - 0103
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0102
Kagoshima, Kagoshima-ken, Japan
Local Institution - 0118
Sagamihara-shi, Kanagawa, Japan
Local Institution - 0106
Kumamoto, Kumamoto, Japan
Local Institution - 0120
Okayama, Okayama-ken, Japan
Local Institution - 0104
Hirakata-shi, Osaka, Japan
Local Institution - 0112
Suita, Osaka, Japan
Local Institution - 0121
Hidaka-shi, Saitama, Japan
Local Institution - 0114
Bunkyo-ku, Tokyo, Japan
Local Institution - 0111
Chuo-ku, Tokyo, Japan
Local Institution - 0107
Mitaka-shi, Tokyo, Japan
Local Institution - 0115
Shinjuku-ku, Tokyo, Japan
Local Institution - 0117
Yamagata, Yamagata, Japan
Local Institution - 0109
Kyoto, , Japan
Local Institution - 0108
Kyoto, , Japan
Local Institution - 0073
Rotterdam, South Holland, Netherlands
Local Institution - 0075
Amsterdam, , Netherlands
Local Institution - 0074
Groningen, , Netherlands
Local Institution - 0072
Utrecht, , Netherlands
Local Institution - 0083
Oslo, , Norway
Local Institution - 0086
Gdansk, , Poland
Local Institution - 0132
Warsaw, , Poland
Local Institution - 0095
Moscow, , Russia
Local Institution - 0097
Moscow, , Russia
Local Institution - 0126
Badalona-barcelona, , Spain
Local Institution - 0078
Barcelona, , Spain
Local Institution - 0125
Barcelona, , Spain
Local Institution - 0077
Madrid, , Spain
Local Institution - 0076
Madrid, , Spain
Local Institution - 0080
Santiago Compostela, , Spain
Local Institution - 0079
Valencia, , Spain
Local Institution - 0081
Lund, , Sweden
Local Institution - 0082
Solna, , Sweden
Local Institution - 0065
Geneva, , Switzerland
Local Institution - 0064
Lausanne, , Switzerland
Local Institution - 0063
Zurich, , Switzerland
Local Institution - 0066
Manchester, Greater Manchester, United Kingdom
Local Institution - 0119
Sutton, Surrey, United Kingdom
Local Institution - 0068
Glasgow, , United Kingdom
Local Institution - 0067
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.
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
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-004722-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-548
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.