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)

Last updated: March 1, 2023
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Gliomas

Brain Cancer

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT02617589
CA209-498
2015-003739-37
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and Females, age ≥ 18 years old
  • 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

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
  • Biopsy with less than 20% of tumor removed Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 560
Study Start date:
March 01, 2016
Estimated Completion Date:
March 04, 2022

Connect with a study center

  • Local Institution

    Liverpool, New South Wales 2017
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Local Institution - 0003

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Local Institution - 0004

    Prahran, Victoria 3181
    Australia

    Site Not Available

  • Local Institution - 0001

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0002

    New South Wales, 2170
    Australia

    Site Not Available

  • Local Institution - 0061

    Linz, 4020
    Austria

    Site Not Available

  • Local Institution - 0060

    Vienna, 1090
    Austria

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Local Institution

    Bruxellles,
    Belgium

    Site Not Available

  • Uz Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • BC Cancer - Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Local Institution

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Local Institution

    Odense, 5000
    Denmark

    Site Not Available

  • Local Institution

    Odense C, 5000
    Denmark

    Site Not Available

  • Local Institution

    Bobigny Cedex, 93009
    France

    Site Not Available

  • Local Institution - 0032

    Bron Cedex, 69677
    France

    Site Not Available

  • Local Institution

    Lille Cedex, 59037
    France

    Site Not Available

  • Local Institution - 0024

    Marseille, 13005
    France

    Site Not Available

  • Local Institution - 0101

    Nancy, 54035
    France

    Site Not Available

  • Local Institution - 0023

    Paris, 75010
    France

    Site Not Available

  • Local Institution - 0038

    Paris cedex 13, 75651
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35000
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes Cedex, 35042
    France

    Site Not Available

  • Local Institution - 0106

    Toulouse, 31100
    France

    Site Not Available

  • Local Institution

    Vandoeuvre Les Nancy, 54500
    France

    Site Not Available

  • Local Institution - 0051

    Bonn, 53105
    Germany

    Site Not Available

  • Local Institution - 0072

    Erlangen, 91054
    Germany

    Site Not Available

  • Local Institution - 0049

    Frankfurt am Main, 60528
    Germany

    Site Not Available

  • Local Institution - 0073

    Freiburg, 79106
    Germany

    Site Not Available

  • Local Institution - 0054

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution - 0052

    Heidelberg, 69120
    Germany

    Site Not Available

  • Local Institution - 0139

    Koeln, 50937
    Germany

    Site Not Available

  • Local Institution - 0050

    Muenster, 48149
    Germany

    Site Not Available

  • Local Institution - 0138

    Munich, 81675
    Germany

    Site Not Available

  • Local Institution - 0055

    Regensburg, 93053
    Germany

    Site Not Available

  • Local Institution - 0056

    Tuebingen, 72076
    Germany

    Site Not Available

  • Local Institution - 0096

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Local Institution - 0097

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Local Institution - 0076

    Bologna, 40139
    Italy

    Site Not Available

  • Local Institution - 0079

    Milano, 20133
    Italy

    Site Not Available

  • Local Institution - 0126

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0135

    Rozzano (milano), 20089
    Italy

    Site Not Available

  • Local Institution - 0078

    Siena, 53100
    Italy

    Site Not Available

  • Local Institution - 0077

    Torino, 10126
    Italy

    Site Not Available

  • Local Institution - 0115

    Nagoya-shi, Aichi 4668560
    Japan

    Site Not Available

  • Local Institution - 0125

    Chiba-shi, Chiba 2608677
    Japan

    Site Not Available

  • Local Institution

    Onsen-gun, Ehime 791-0204
    Japan

    Site Not Available

  • Local Institution - 0123

    Hiroshima-Shi, Hiroshima 7348551
    Japan

    Site Not Available

  • Local Institution - 0122

    Sapporo-shi, Hokkaido 0608648
    Japan

    Site Not Available

  • Local Institution - 0129

    Kobe, Hyogo 6500017
    Japan

    Site Not Available

  • Local Institution

    Kobe-shi, Hyogo 650-0017
    Japan

    Site Not Available

  • Local Institution - 0111

    Tsukuba-shi, Ibaraki 3058576
    Japan

    Site Not Available

  • Local Institution - 0121

    Kanazawa-shi, Ishikawa 9200934
    Japan

    Site Not Available

  • Local Institution - 0131

    Kagoshima-shi, Kagoshima 8908520
    Japan

    Site Not Available

  • Local Institution - 0133

    Sagamihara-shi, Kanagawa 2520375
    Japan

    Site Not Available

  • Local Institution - 0119

    Kumamoto-shi, Kumamoto 8608556
    Japan

    Site Not Available

  • Local Institution - 0116

    Kyoto-shi, Kyoto 6128555
    Japan

    Site Not Available

  • Local Institution - 0117

    Kyoto-shi, Kyoto 606-8507
    Japan

    Site Not Available

  • Local Institution - 0134

    Okayama-shi, Okayama 7008558
    Japan

    Site Not Available

  • Local Institution

    Hirakata-shi, Osaka 5731191
    Japan

    Site Not Available

  • Local Institution - 0130

    Suita-shi, Osaka 565-0871
    Japan

    Site Not Available

  • Local Institution - 0113

    Hidaka, Saitama 350-1298
    Japan

    Site Not Available

  • Local Institution

    Hidaka-shi, Saitama 3501298
    Japan

    Site Not Available

  • Local Institution - 0128

    Bunkyo-ku, Tokyo 1138655
    Japan

    Site Not Available

  • Local Institution - 0114

    Chuo-ku, Tokyo 1040045
    Japan

    Site Not Available

  • Local Institution - 0118

    Mitaka-shi, Tokyo 181-8611
    Japan

    Site Not Available

  • Local Institution

    Shinjuku-ku, Tokyo 1628666
    Japan

    Site Not Available

  • Local Institution - 0110

    Yamagata-shi, Yamagata 9909585
    Japan

    Site Not Available

  • Local Institution

    Kumamoto, 869-3201
    Japan

    Site Not Available

  • Local Institution - 0112

    Tokyo, 1628666
    Japan

    Site Not Available

  • NKI AVL

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 AP
    Netherlands

    Site Not Available

  • Erasmus Mc

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • Local Institution - 0063

    Utrecht, 3584CX
    Netherlands

    Site Not Available

  • Local Institution

    Oslo, 0379
    Norway

    Site Not Available

  • Local Institution - 0080

    Gdansk, 80952
    Poland

    Site Not Available

  • Local Institution - 0081

    Warszawa, 02-781
    Poland

    Site Not Available

  • Local Institution - 0070

    Moscow, 105229
    Russian Federation

    Site Not Available

  • Local Institution - 0105

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Local Institution

    Badalona-Barcelona, 08916
    Spain

    Site Not Available

  • Local Institution

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution - 0028

    Barcelona, 08036
    Spain

    Site Not Available

  • Local Institution

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 0029

    Madrid, 28007
    Spain

    Site Not Available

  • Local Institution

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Local Institution - 0025

    Valencia, 46014
    Spain

    Site Not Available

  • Local Institution

    Lund, 221 85
    Sweden

    Site Not Available

  • Local Institution

    Solna, 171 64
    Sweden

    Site Not Available

  • Local Institution

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Local Institution - 0059

    Geneve, 1211
    Switzerland

    Site Not Available

  • Local Institution - 0057

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Local Institution - 0053

    Zuerich, 8091
    Switzerland

    Site Not Available

  • University College Hospital

    London, Greater London NW1 2PG
    United Kingdom

    Site Not Available

  • Christie Hospital Nhs Found. Trust

    Manchester, Greater Manchester M20 4BX
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Beaston West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3410
    United States

    Site Not Available

  • Local Institution - 0083

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Local Institution - 0019

    Los Angeles, California 90095-1769
    United States

    Site Not Available

  • Sutter Institute For Medical Research

    Sacramento, California 95816
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • The Regents of the University of California, San Francisco

    San Francisco, California 94143-0372
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • University Of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • The University Of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Local Institution

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Local Institution

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins University School Of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Henry Ford Health System

    Detriot, Michigan 48202
    United States

    Site Not Available

  • Local Institution - 0006

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University School OF Medicine-Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School Of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • JFK Medical Center

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Local Institution - 0064

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Columbia University Medical Center (Cumc)

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Preston Robert Tisch Brain Tumor Center at Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Local Institution - 0010

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0095

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Local Institution

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Local Institution

    Oklahoma City, OK, Oklahoma 73104
    United States

    Site Not Available

  • Local Institution - 0132

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Local Institution - 0007

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University Of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Local Institution - 0090

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University Of Texas Southwestern Medical Center

    Dallas, Texas 75390-8852
    United States

    Site Not Available

  • University Of Texas Md Anderson Cancer Ctr

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0068

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

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