Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Summary
This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. BMS-986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and BMS-986205 may work better compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed glioblastoma.
Timeline
- Start
- 2019-08-13
- Primary completion
- 2027-02-15
- Completion
- 2027-06-01
Publications
- Lukas RV, Zhai L, Lauing KL, Kim M, Koch T, Penco-Campillo M, Bommi P, Dixit K, Kumthekar P, Sharp L, Lezon R, Garcia D, Sonabend AM, McCortney K, Castro BA, Chandler JP, Gondi V, Grimm SA, Miska JM, Heimberger AB, Dobinda K, Zhang H, Sachdev S, Juhasz C, James CD, Allen JM, Horbinski C, Lesniak MS, Stupp R, Wainwright DA. Phase 1 evaluation of patients with newly diagnosed glioblastoma treated with radiation, nivolumab, and IDO1 enzyme inhibitor BMS-986205. Clin Cancer Res. 2026 May 26. doi: 10.1158/1078-0432.CCR-26-1124. Online ahead of print.
- Wainwright D, Lukas R, Zhai L, Lauing K, Kim M, Koch T, Penco-Campillo M, Bommi P, Dixit K, Kumthekar P, Sharp L, Lezon R, Garcia D, Sonabend A, McCortney K, Castro B, Chandler J, Gondi V, Grimm S, Heimberger A, Dobinda K, Zhang H, Sachdev S, Juhasz C, James CD, Allen J, Horbinski C, Lesniak M, Stupp R, Miska J. Newly diagnosed glioblastoma IDHwt patients treated with radiation, nivolumab, and BMS-986205. Res Sq [Preprint]. 2025 Sep 25:rs.3.rs-7567487. doi: 10.21203/rs.3.rs-7567487/v1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LINRODOSTAT | Small molecule | 25 mg | Oral |
| Subject | LINRODOSTAT | Small molecule | 50 mg | Oral |
| Subject | LINRODOSTAT | Small molecule | 100 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Temozolomide | Small molecule | — | Oral |