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

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.

Eligibility Criteria

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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

Principal Investigator

Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:,

Estimated Completion Date

Friday, March 1, 2019 #