drugset / Trial / NCT04056910
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
Phase 2
Completed
15 enrolled
Jason J. Luke, MD
Agios Pharmaceuticals, Inc. · collabBristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
In this study, response to treatment and (progression free and overall) survival will be described and safety events of ivosidenib in combination with nivolumab will be summarized in patients with advanced solid tumors (nonresectable or metastatic) or enhancing gliomas.
Timeline
- Start
- 2021-09-20
- Primary completion
- 2023-11-13
- Completion
- 2023-11-13
Publications
- Nguyen MK, Jelinek M, Singh A, Isett B, Myers ES, Mullett SJ, Eisele Y, Beumer JH, Parise RA, Urban J, Rose A, Sellitto L, Singh K, Doerfler R, Dadey RE, Kim C, Rhee JC, Davar D, Villaruz LC, Burgess M, Drappatz J, Mantica M, Goodman AE, Wang H, Singhi AD, Luke JJ, Zandberg DP, Bao R. Clinical and translational study of ivosidenib plus nivolumab in advanced solid tumors harboring IDH1 mutations. Oncologist. 2025 Nov 11;30(11):oyaf362. doi: 10.1093/oncolo/oyaf362.
- Nguyen MK, Jelinek M, Singh A, Isett B, Myers ES, Mullett SJ, Eisele Y, Beumer J, Parise R, Urban J, Rose A, Sellitto L, Singh K, Doerfler R, Dadey RE, Kim C, Rhee JC, Davar D, Villaruz LC, Burgess M, Drappatz J, Mantica M, Goodman AE, Wang H, Singhi AD, Luke JJ, Zandberg DP, Bao R. Clinical and translational study of ivosidenib plus nivolumab in advanced solid tumors harboring IDH1 mutations. medRxiv [Preprint]. 2025 Jul 21:2025.07.19.25331848. doi: 10.1101/2025.07.19.25331848.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivosidenib | Small molecule | 250 mg | Oral |
| Subject | Ivosidenib | Small molecule | 500 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |