A Randomized Phase 2 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma - CheckMate 548: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 548

The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab in addition to temozolomide plus radiation therapy.
Phase 2
NCT02667587
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
  • Karnofsky performance status of ≥ 70 (able to take care of self)
  • Substantial recovery from surgery resection
  • Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion Criteria:
  • Biopsy-only of GBM with less than 20% of tumor removed
  • 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

Other protocol defined inclusion/exclusion criteria could apply
Mary Lessig
206-386-3878
206-997-5365