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This study compares the immunotherapy Nivolumab, given with radiation therapy, against Temozolomide, also given with radiation therapy, in newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer). Adults aged 18 and over with newly diagnosed, MGMT-unmethylated glioblastoma who have not had prior treatment for GBM (other than surgery) may take part. The study 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.
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 Other protocol-defined inclusion/exclusion criteria apply