SHS_543114 BENT CBRI 16031

A Randomized Phase 2 Single Blind Study of Temozolmide Plus Radiation Therapy Combined with Nivolumab or Placebo in Newly Diagnosed Adult Subject with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma

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.

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
Phase II
Tara Benkers, M.D.
BMS (Bristol-Myers Squibb)
Nathan Hansen
  • Swedish Medical Center