Clinical trial · Interventional
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab + Radiotherapy Arm
- description
- Nivolumab IV infusion + Radiotherapy dose as specified
- interventionNames
- Drug: Nivolumab
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Temozolomide + Radiotherapy Arm
- description
- Temozolomide + Radiotherapy dose as specified
- interventionNames
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDGrkovski M, Daras M, Bale T, Lyashchenko S, Reiner AS, Mellinghoff IK, Schoder H, Dunphy MPS. 18F-BMS-986229 PET imaging of tumor PD-L1 expression in glioblastoma patients. EJNMMI Res. 2025 Sep 26;15(1):124. doi: 10.1186/s13550-025-01283-x. PMID 41003913
- DERIVEDOmuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, Sumrall A, Baehring J, van den Bent M, Bahr O, Lombardi G, Mulholland P, Tabatabai G, Lassen U, Sepulveda JM, Khasraw M, Vauleon E, Muragaki Y, Di Giacomo AM, Butowski N, Roth P, Qian X, Fu AZ, Liu Y, Potter V, Chalamandaris AG, Tatsuoka K, Lim M, Weller M. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro Oncol. 2023 Jan 5;25(1):123-134. doi: 10.1093/neuonc/noac099. PMID 35419607
- DERIVEDWoroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available. PMID 32691060