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# BMS Says Opdivo Phase 3 Trial Misses Endpoint
- URL: https://www.fdaweb.com/bms-says-opdivo-phase-3-trial-misses-endpoint/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144079

Bristol-Myers Squibb says its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme did not meet its primary endpoint of overall survival at final analysis. The drug’s safety profile was consistent with previously reported studies in solid tumors, the company says. Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. It is FDA-approved for treating metastatic melanoma, non-small cell lung cancer with progression on or after platinum-based chemotherapy, advanced renal cell carcinoma, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck, among other indications.