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)
- Conditions
- Brain Cancer
- Interventions
- Registration Number
- NCT02617589
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Temozolomide + Radiotherapy Arm Radiotherapy Temozolomide + Radiotherapy dose as specified Nivolumab + Radiotherapy Arm Radiotherapy Nivolumab IV infusion + Radiotherapy dose as specified Nivolumab + Radiotherapy Arm Nivolumab Nivolumab IV infusion + Radiotherapy dose as specified Temozolomide + Radiotherapy Arm Temozolomide Temozolomide + Radiotherapy dose as specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) up to 3 years OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
- Secondary Outcome Measures
Name Time Method Kaplan-Meier Plot of Progression Free Survival From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Progression Free Survival in Tumor Mutational Burden (TMB) High Population From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Overall Survival Rate at 24 Months At 24 Months The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Overall Survival in Tumor Mutational Burden (TMB) High Population From randomization to the date of death due to any cause (up to approximately 6 years) OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Trial Locations
- Locations (115)
Johns Hopkins University School Of Medicine
🇺🇸Baltimore, Maryland, United States
Local Institution - 0090
🇺🇸Chattanooga, Tennessee, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Local Institution - 0029
🇪🇸Madrid, Spain
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Local Institution - 0003
🇦🇺Heidelberg, Victoria, Australia
Columbia University Medical Center (Cumc)
🇺🇸New York, New York, United States
Local Institution - 0001
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0132
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0064
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0004
🇦🇺Prahran, Victoria, Australia
Local Institution - 0002
🇦🇺New South Wales, Australia
Washington University School OF Medicine-Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Uz Leuven
🇧🇪Leuven, Belgium
Local Institution - 0115
🇯🇵Nagoya-shi, Aichi, Japan
Local Institution - 0122
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution
🇸🇪Solna, Sweden
Local Institution - 0050
🇩🇪Muenster, Germany
Local Institution - 0096
🇮🇱Petach Tikva, Israel
Local Institution - 0023
🇫🇷Paris, France
Christie Hospital Nhs Found. Trust
🇬🇧Manchester, Greater Manchester, United Kingdom
Beaston West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Local Institution - 0061
🇦🇹Linz, Austria
NKI AVL
🇳🇱Amsterdam, Netherlands
Local Institution - 0126
🇮🇹Padova, Italy
Local Institution - 0101
🇫🇷Nancy, France
Local Institution - 0072
🇩🇪Erlangen, Germany
Local Institution - 0073
🇩🇪Freiburg, Germany
Local Institution - 0125
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0123
🇯🇵Hiroshima-Shi, Hiroshima, Japan
Local Institution - 0055
🇩🇪Regensburg, Germany
Local Institution - 0111
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0079
🇮🇹Milano, Italy
Local Institution - 0119
🇯🇵Kumamoto-shi, Kumamoto, Japan
Local Institution - 0032
🇫🇷Bron Cedex, France
Centre Eugene Marquis
🇫🇷Rennes, France
Local Institution - 0049
🇩🇪Frankfurt am Main, Germany
Local Institution - 0054
🇩🇪Hamburg, Germany
Local Institution - 0028
🇪🇸Barcelona, Spain
Montreal Neurological Institute and Hospital
🇨🇦Montreal, Quebec, Canada
Local Institution - 0097
🇮🇱Tel Aviv, Israel
Local Institution - 0133
🇯🇵Sagamihara-shi, Kanagawa, Japan
Local Institution - 0114
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0024
🇫🇷Marseille, France
Local Institution - 0038
🇫🇷Paris cedex 13, France
Local Institution - 0139
🇩🇪Koeln, Germany
Local Institution - 0052
🇩🇪Heidelberg, Germany
Local Institution - 0138
🇩🇪Munich, Germany
Local Institution - 0106
🇫🇷Toulouse, France
Local Institution - 0056
🇩🇪Tuebingen, Germany
Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Local Institution - 0025
🇪🇸Valencia, Spain
University Of Texas Md Anderson Cancer Ctr
🇺🇸Houston, Texas, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
Local Institution - 0006
🇺🇸Detroit, Michigan, United States
Local Institution - 0060
🇦🇹Vienna, Austria
Local Institution - 0105
🇷🇺Moscow, Russian Federation
Local Institution - 0057
🇨🇭Lausanne, Switzerland
Preston Robert Tisch Brain Tumor Center at Duke University
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Local Institution - 0068
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0083
🇺🇸Phoenix, Arizona, United States
The Regents of the University of California, San Francisco
🇺🇸San Francisco, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
University Of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Local Institution - 0019
🇺🇸Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
BC Cancer - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0051
🇩🇪Bonn, Germany
Local Institution - 0117
🇯🇵Kyoto-shi, Kyoto, Japan
Local Institution - 0116
🇯🇵Kyoto-shi, Kyoto, Japan
Local Institution - 0113
🇯🇵Hidaka, Saitama, Japan
Local Institution - 0118
🇯🇵Mitaka-shi, Tokyo, Japan
Local Institution - 0059
🇨🇭Geneve, Switzerland
University College Hospital
🇬🇧London, Greater London, United Kingdom
Local Institution - 0078
🇮🇹Siena, Italy
Local Institution - 0076
🇮🇹Bologna, Italy
Local Institution - 0135
🇮🇹Rozzano (milano), Italy
Local Institution - 0077
🇮🇹Torino, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University - Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
The University Of Chicago
🇺🇸Chicago, Illinois, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Local Institution - 0010
🇺🇸Cleveland, Ohio, United States
Local Institution - 0095
🇺🇸Columbus, Ohio, United States
Local Institution - 0007
🇺🇸Philadelphia, Pennsylvania, United States
University Of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
Local Institution - 0121
🇯🇵Kanazawa-shi, Ishikawa, Japan
Local Institution - 0134
🇯🇵Okayama-shi, Okayama, Japan
Local Institution - 0110
🇯🇵Yamagata-shi, Yamagata, Japan
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Local Institution - 0128
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0081
🇵🇱Warszawa, Poland
Local Institution - 0053
🇨🇭Zuerich, Switzerland
Local Institution - 0129
🇯🇵Kobe, Hyogo, Japan
Local Institution - 0131
🇯🇵Kagoshima-shi, Kagoshima, Japan
Local Institution - 0112
🇯🇵Tokyo, Japan
Local Institution - 0080
🇵🇱Gdansk, Poland
Local Institution - 0130
🇯🇵Suita-shi, Osaka, Japan
Erasmus Mc
🇳🇱Rotterdam, Netherlands
Local Institution - 0063
🇳🇱Utrecht, Netherlands
Local Institution - 0070
🇷🇺Moscow, Russian Federation
Sutter Institute For Medical Research
🇺🇸Sacramento, California, United States
University Of Kansas Medical Center
🇺🇸Westwood, Kansas, United States