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Phase 3
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18+Age Range
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Active, Not Recruiting
Active, Not Recruiting
An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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
Experimental: Nivolumab + Temozolomide + Radiotherapy
Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy