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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Overall Survival (OS)
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.
Time frame: up to 3 years
Kaplan-Meier Plot of Progression Free Survival
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.
Time frame: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
Overall Survival Rate 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.
Time frame: At 24 Months
Overall Survival in Tumor Mutational Burden (TMB) High Population
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.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Local Institution - 0083
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Local Institution - 0019
Los Angeles, California, United States
Sutter Institute For Medical Research
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
The Regents of the University of California, San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
...and 115 more locations
Time frame: From randomization to the date of death due to any cause (up to approximately 6 years)
Progression Free Survival in Tumor Mutational Burden (TMB) High Population
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.
Time frame: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)