Study of Nivolumab Versus Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498)

The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving nivolumab every two weeks in addition to radiation therapy (RT), and then every four weeks, compared with patients receiving standard therapy with temozolomide in addition to RT.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)
Estimated Enrollment: 550
Study Start Date: January 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Nivolumab + Radiotherapy Arm
- Active Comparator: Temozolomide + Radiotherapy Arm