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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02617589 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Completed |
Countries | Australia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain Cancer |
Study Website: | View Trial Website |
Experimental: Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
Active Comparator: Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
Drug: - Nivolumab
Drug: - Temozolomide
Radiation: - Radiotherapy
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3410
Status
Address
Local Institution - 0083
Phoenix, Arizona, 85013
Status
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Address
Local Institution - 0019
Los Angeles, California, 90095-1769
Status
Address
Sutter Institute For Medical Research
Sacramento, California, 95816
Status
Address
Sharp Memorial Hospital
San Diego, California, 92123
Status
Address
The Regents of the University of California, San Francisco
San Francisco, California, 94143-0372
Status
Address
Yale Cancer Center
New Haven, Connecticut, 06520
Status
Address
Georgetown University Medical Center
Washington, District of Columbia, 20007
Status
Address
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Status
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Address
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Address
The University Of Chicago
Chicago, Illinois, 60637
Status
Address
University Of Kansas Medical Center
Westwood, Kansas, 66205
Status
Address
Norton Cancer Institute
Louisville, Kentucky, 40202
Status
Address
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21287
Status
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
Massachusetts General Hospital
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0006
Detroit, Michigan, 48202
Status
Address
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis, Missouri, 63110
Status
Address
JFK Medical Center
Edison, New Jersey, 08820
Status
Address
Local Institution - 0064
Hackensack, New Jersey, 07601
Status
Address
Columbia University Medical Center (Cumc)
New York, New York, 10032
Status
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Address
Levine Cancer Institute
Charlotte, North Carolina, 28204
Status
Address
Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, 27710
Status
Address
Local Institution - 0010
Cleveland, Ohio, 44195
Status
Address
Local Institution - 0095
Columbus, Ohio, 43210
Status
Address
Local Institution - 0132
Allentown, Pennsylvania, 18103
Status
Address
Local Institution - 0007
Philadelphia, Pennsylvania, 19107
Status
Address
Medical University Of South Carolina
Charleston, South Carolina, 29425
Status
Address
Local Institution - 0090
Chattanooga, Tennessee, 37404
Status
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Address
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390-8852
Status
Address
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, 77030
Status
Address
Local Institution - 0068
Salt Lake City, Utah, 84112
Status
Address
Swedish Neuroscience Institute
Seattle, Washington, 98122
Status
Address
Royal North Shore Hospital
St. Leonards, New South Wales, 2065
Status
Address
Local Institution - 0003
Heidelberg, Victoria, 3084
Status
Address
Local Institution - 0004
Prahran, Victoria, 3181
Status
Address
Local Institution - 0001
Nedlands, Western Australia, 6009
Status
Address
Local Institution - 0002
New South Wales, , 2170
Status
Address
Local Institution - 0061
Linz, , 4020
Status
Address
Local Institution - 0060
Vienna, , 1090
Status
Address
Universitair Ziekenhuis Brussel
Brussels, , 1090
Status
Address
Cliniques Universitaires Saint-Luc
Bruxelles, , 1200
Status
Address
Uz Leuven
Leuven, , 3000
Status
Address
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Status
Address
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Status
Address
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Status
Address
Local Institution
Copenhagen, , 2100
Status
Address
Local Institution
Odense, , 5000
Status
Address
Local Institution - 0032
Bron Cedex, , 69677
Status
Address
Local Institution
Lille Cedex, , 59037
Status
Address
Local Institution - 0024
Marseille, , 13005
Status
Address
Local Institution - 0101
Nancy, , 54035
Status
Address
Local Institution - 0038
Paris cedex 13, , 75651
Status
Address
Local Institution - 0023
Paris, , 75010
Status
Address
Centre Eugene Marquis
Rennes, , 35000
Status
Address
Local Institution - 0106
Toulouse, , 31100
Status
Address
Local Institution - 0051
Bonn, , 53105
Status
Address
Local Institution - 0072
Erlangen, , 91054
Status
Address
Local Institution - 0049
Frankfurt am Main, , 60528
Status
Address
Local Institution - 0073
Freiburg, , 79106
Status
Address
Local Institution - 0054
Hamburg, , 20246
Status
Address
Local Institution - 0052
Heidelberg, , 69120
Status
Address
Local Institution - 0139
Koeln, , 50937
Status
Address
Local Institution - 0050
Muenster, , 48149
Status
Address
Local Institution - 0138
Munich, , 81675
Status
Address
Local Institution - 0055
Regensburg, , 93053
Status
Address
Local Institution - 0056
Tuebingen, , 72076
Status
Address
Local Institution - 0096
Petach Tikva, , 49100
Status
Address
Local Institution - 0097
Tel Aviv, , 64239
Status
Address
Local Institution - 0076
Bologna, , 40139
Status
Address
Local Institution - 0079
Milano, , 20133
Status
Address
Local Institution - 0126
Padova, , 35128
Status
Address
Local Institution - 0135
Rozzano (milano), , 20089
Status
Address
Local Institution - 0078
Siena, , 53100
Status
Address
Local Institution - 0077
Torino, , 10126
Status
Address
Local Institution - 0115
Nagoya-shi, Aichi, 4668560
Status
Address
Local Institution - 0125
Chiba-shi, Chiba, 2608677
Status
Address
Local Institution - 0123
Hiroshima-Shi, Hiroshima, 7348551
Status
Address
Local Institution - 0122
Sapporo-shi, Hokkaido, 0608648
Status
Address
Local Institution - 0129
Kobe, Hyogo, 6500017
Status
Address
Local Institution - 0111
Tsukuba-shi, Ibaraki, 3058576
Status
Address
Local Institution - 0121
Kanazawa-shi, Ishikawa, 9200934
Status
Address
Local Institution - 0131
Kagoshima-shi, Kagoshima, 8908520
Status
Address
Local Institution - 0133
Sagamihara-shi, Kanagawa, 2520375
Status
Address
Local Institution - 0119
Kumamoto-shi, Kumamoto, 8608556
Status
Address
Local Institution - 0117
Kyoto-shi, Kyoto, 606-8507
Status
Address
Local Institution - 0116
Kyoto-shi, Kyoto, 6128555
Status
Address
Local Institution - 0134
Okayama-shi, Okayama, 7008558
Status
Address
Local Institution
Hirakata-shi, Osaka, 5731191
Status
Address
Local Institution - 0130
Suita-shi, Osaka, 565-0871
Status
Address
Local Institution - 0113
Hidaka, Saitama, 350-1298
Status
Address
Local Institution - 0128
Bunkyo-ku, Tokyo, 1138655
Status
Address
Local Institution - 0114
Chuo-ku, Tokyo, 1040045
Status
Address
Local Institution - 0118
Mitaka-shi, Tokyo, 181-8611
Status
Address
Local Institution - 0110
Yamagata-shi, Yamagata, 9909585
Status
Address
Local Institution - 0112
Tokyo, , 1628666
Status
Address
NKI AVL
Amsterdam, , 1066 CX
Status
Address
Universitair Medisch Centrum Groningen
Groningen, , 9713 AP
Status
Address
Erasmus Mc
Rotterdam, , 3015 CE
Status
Address
Local Institution - 0063
Utrecht, , 3584CX
Status
Address
Local Institution
Oslo, , 0379
Status
Address
Local Institution - 0080
Gdansk, , 80952
Status
Address
Local Institution - 0081
Warszawa, , 02-781
Status
Address
Local Institution - 0070
Moscow, , 105229
Status
Address
Local Institution - 0105
Moscow, , 115478
Status
Address
Local Institution
Badalona-Barcelona, , 08916
Status
Address
Local Institution
Barcelona, , 08035
Status
Address
Local Institution - 0028
Barcelona, , 08036
Status
Address
Local Institution - 0029
Madrid, , 28007
Status
Address
Local Institution
Madrid, , 28041
Status
Address
Local Institution
Santiago De Compostela, , 15706
Status
Address
Local Institution - 0025
Valencia, , 46014
Status
Address
Local Institution
Lund, , 221 85
Status
Address
Local Institution
Solna, , 171 64
Status
Address
Local Institution - 0059
Geneve, , 1211
Status
Address
Local Institution - 0057
Lausanne, , 1011
Status
Address
Local Institution - 0053
Zuerich, , 8091
Status
Address
University College Hospital
London, Greater London, NW1 2PG
Status
Address
Christie Hospital Nhs Found. Trust
Manchester, Greater Manchester, M20 4BX
Status
Address
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Status
Address
Beaston West of Scotland Cancer Centre
Glasgow, , G12 0YN