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This study compares adding either the immunotherapy Nivolumab or a placebo to Temozolomide plus radiation therapy in patients newly diagnosed with glioblastoma (a malignant brain cancer). Patients aged 18 and over with an MGMT-methylated or indeterminate tumor subtype could take part. It was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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