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 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.
Phase 3
NCT02617589
Neuroscience - Brain Tumor, Neuroscience
Tara L. Benkers MD
Mary Lessig
Inclusion Criteria:
  • 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)
Exclusion Criteria:
  • 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
Mary Lessig
206-386-3878