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The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus 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 |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
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. |
NCT02667587 |
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 | Active, not recruiting |
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 Neoplasms |
Study Website: | View Trial Website |
Experimental: 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
Placebo Comparator: 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
Drug: - Nivolumab
Drug: - Temozolomide
Radiation: - Radiotherapy
Other: - Nivolumab Placebo
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
Local Institution - 0023
Birmingham, Alabama, 35294-3410
Status
Address
Local Institution - 0003
Phoenix, Arizona, 85013
Status
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Address
Local Institution - 0010
Los Angeles, California, 90095-1769
Status
Address
Local Institution - 0128
Sacramento, California, 95816
Status
Address
Local Institution - 0029
San Diego, California, 92123
Status
Address
Local Institution - 0006
San Francisco, California, 94143-0372
Status
Address
Local Institution - 0004
New Haven, Connecticut, 06520
Status
Address
Local Institution - 0031
Washington, District of Columbia, 20007
Status
Address
Local Institution - 0087
Miami, Florida, 33136
Status
Address
Local Institution - 0030
Tampa, Florida, 33612
Status
Address
Local Institution - 0022
Chicago, Illinois, 60637
Status
Address
Local Institution - 0060
Westwood, Kansas, 66205
Status
Address
Local Institution - 0018
Louisville, Kentucky, 40202
Status
Address
Local Institution - 0020
Baltimore, Maryland, 21287
Status
Address
Local Institution - 0011
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0028
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0035
Detroit, Michigan, 48202
Status
Address
Local Institution - 0002
Saint Louis, Missouri, 63110
Status
Address
Local Institution - 0017
Edison, New Jersey, 08820
Status
Address
Local Institution - 0012
Hackensack, New Jersey, 07601
Status
Address
Local Institution - 0015
New York, New York, 10032
Status
Address
Local Institution - 0024
New York, New York, 10065
Status
Address
Local Institution - 0032
Charlotte, North Carolina, 28204
Status
Address
Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, 27710
Status
Address
Local Institution - 0001
Cleveland, Ohio, 44195
Status
Address
Local Institution - 0027
Columbus, Ohio, 43210
Status
Address
Local Institution - 0098
Allentown, Pennsylvania, 18105
Status
Address
Local Institution - 0016
Philadelphia, Pennsylvania, 19107
Status
Address
Local Institution - 0021
Charleston, South Carolina, 29425
Status
Address
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee, 37403
Status
Address
Local Institution - 0008
Nashville, Tennessee, 37232
Status
Address
Local Institution - 0025
Dallas, Texas, 75390-8575
Status
Address
Local Institution - 0009
Salt Lake City, Utah, 84112
Status
Address
Local Institution - 0005
Seattle, Washington, 98122
Status
Address
Local Institution - 0049
Liverpool, New South Wales, 2170
Status
Address
Local Institution - 0052
St. Leonards, New South Wales, 2065
Status
Address
Local Institution - 0050
Heidelberg, Victoria, 3084
Status
Address
Local Institution - 0051
Prahran, Victoria, 3181
Status
Address
Local Institution - 0122
Nedlands, Western Australia, 6009
Status
Address
Local Institution - 0062
Linz, , 4020
Status
Address
Local Institution - 0061
Vienna, , 1090
Status
Address
Local Institution - 0070
Brussels, , 1090
Status
Address
Local Institution - 0069
Bruxelles, , 1200
Status
Address
Local Institution - 0071
Leuven, , 3000
Status
Address
Local Institution - 0046
Vancouver, British Columbia, V5Z 4E6
Status
Address
Local Institution - 0048
Toronto, Ontario, M5G 2M9
Status
Address
Local Institution - 0047
Montreal, Quebec, H3A 2B4
Status
Address
Local Institution - 0084
Copenhagen, , 2100
Status
Address
Local Institution - 0085
Odense, , 5000
Status
Address
Local Institution - 0043
Lille Cedex, , 59037
Status
Address
Local Institution - 0041
Lyon Cedex 03, , 69394
Status
Address
Local Institution - 0040
Marseille, , 13385
Status
Address
Local Institution - 0042
Nancy, , 54035
Status
Address
Local Institution - 0039
Paris cedex 13, , 75651
Status
Address
Local Institution - 0038
Paris, , 75010
Status
Address
Local Institution - 0044
Rennes Cedex, , 35042
Status
Address
Local Institution - 0045
Toulouse, , 31100
Status
Address
Local Institution - 0055
Bonn, , 53127
Status
Address
Local Institution - 0123
Erlangen, , 91054
Status
Address
Local Institution - 0053
Frankfurt Am Main, , 60528
Status
Address
Local Institution - 0124
Freiburg, , 79106
Status
Address
Local Institution - 0057
Hamburg, , 20246
Status
Address
Local Institution - 0056
Heidelberg, , 69120
Status
Address
Local Institution - 0131
Koeln, , 50937
Status
Address
Local Institution - 0054
Muenster, , 48149
Status
Address
Local Institution - 0130
Munich, , 81675
Status
Address
Local Institution - 0058
Regensburg, , 93053
Status
Address
Local Institution - 0059
Tuebingen, , 72076
Status
Address
Local Institution - 0094
Petach Tikva, , 49100
Status
Address
Local Institution - 0093
Tel Aviv, , 64239
Status
Address
Local Institution - 0088
Bologna, , 40139
Status
Address
Local Institution - 0089
Milano, , 20133
Status
Address
Local Institution - 0092
Padova, , 35128
Status
Address
Local Institution - 0127
Rozzano (milano), , 20089
Status
Address
Local Institution - 0090
Siena, , 53100
Status
Address
Local Institution - 0091
Torino, , 10126
Status
Address
Local Institution - 0110
Nagoya-shi, Aichi, 4668560
Status
Address
Local Institution - 0099
Chiba-shi, Chiba, 2608677
Status
Address
Local Institution - 0100
Hiroshima-Shi, Hiroshima, 7348551
Status
Address
Local Institution - 0101
Sapporo-shi, Hokkaido, 0608648
Status
Address
Local Institution - 0105
Kobe-shi, Hyogo, 650-0017
Status
Address
Local Institution - 0116
Tsukuba-shi, Ibaraki, 3058576
Status
Address
Local Institution - 0103
Kanazawa-shi, Ishikawa, 9200934
Status
Address
Local Institution - 0102
Kagoshima-shi, Kagoshima, 8908520
Status
Address
Local Institution - 0118
Sagamihara-shi, Kanagawa, 2520375
Status
Address
Local Institution - 0106
Kumamoto-shi, Kumamoto, 8608556
Status
Address
Local Institution - 0120
Okayama-shi, Okayama, 7008558
Status
Address
Local Institution - 0104
Hirakata-shi, Osaka, 5731191
Status
Address
Local Institution - 0112
Suita, Osaka, 5650871
Status
Address
Local Institution - 0121
Hidaka-shi, Saitama, 3501298
Status
Address
Local Institution - 0114
Bunkyo-ku, Tokyo, 1138655
Status
Address
Local Institution - 0111
Chuo-ku, Tokyo, 1040045
Status
Address
Local Institution - 0107
Mitaka-shi, Tokyo, 181-8611
Status
Address
Local Institution - 0115
Shinjuku-ku, Tokyo, 1628666
Status
Address
Local Institution - 0117
Yamagata-shi, Yamagata, 9909585
Status
Address
Local Institution - 0109
Kyoto, , 6068507
Status
Address
Local Institution - 0108
Kyoto, , 612-8555
Status
Address
Local Institution - 0073
Rotterdam, Zuid-Holland, 3015 GD
Status
Address
Local Institution - 0075
Amsterdam, , 1066 CX
Status
Address
Local Institution - 0074
Groningen, , 9713 AP
Status
Address
Local Institution - 0072
Utrecht, , 3584 CX
Status
Address
Local Institution - 0083
Oslo, , 0424
Status
Address
Local Institution - 0086
Gdansk, , 80-214
Status
Address
Local Institution - 0132
Warszawa, , 02-781
Status
Address
Local Institution - 0095
Moscow, , 105229
Status
Address
Local Institution - 0097
Moscow, , 115478
Status
Address
Local Institution - 0126
Badalona-barcelona, , 08916
Status
Address
Local Institution - 0078
Barcelona, , 08035
Status
Address
Local Institution - 0125
Barcelona, , 08036
Status
Address
Local Institution - 0077
Madrid, , 28009
Status
Address
Local Institution - 0076
Madrid, , 28041
Status
Address
Local Institution - 0080
Santiago Compostela, , 15706
Status
Address
Local Institution - 0079
Valencia, , 46014
Status
Address
Local Institution - 0081
Lund, , 221 85
Status
Address
Local Institution - 0082
Solna, , 171 64
Status
Address
Local Institution - 0065
Geneve, , 1211
Status
Address
Local Institution - 0064
Lausanne, , 1011
Status
Address
Local Institution - 0063
Zuerich, , 8091
Status
Address
Local Institution - 0066
Manchester, Greater Manchester, M20 4BX
Status
Address
Local Institution - 0119
Sutton, Surrey, SM2 5PT
Status
Address
Local Institution - 0068
Glasgow, , G12 0YN
Status
Address
Local Institution - 0067
London, , NW1 2BU