A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
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.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
San Francisco, California 94143-0372, United States
St Louis, Missouri 63110, United States
Durham, North Carolina 27710, United States
New South Wales, 2170, Australia
Sagamihara-shi, Kanagawa 2520375, Japan
Hirakata-shi, Osaka 5731191, Japan
Suita-shi, Osaka 565-0871, Japan
Bunkyo-ku, Tokyo 1138655, Japan
Chuo-ku, Tokyo 1040045, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Badalona-Barcelona, 08916, Spain