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.
18 Years and up
Accepting Healthy Volunteers?
- 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