7 recruiting, 5 active not recruiting, 5 completed, 2 not yet recruiting. 11 Phase 1, 4 Phase 3, 2 Phase 2, 1 Not applicable.
Follow vorasidenib: new trials by email Literature Review of vorasidenib trials Research Report on vorasidenib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL) IDH1R132H-vac, Vorasidenib 40 mg Oral Tablet, Aldara - Imiquimod 5% - Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 | Phase 1 | Not yet recruiting | Heidelberg University | 45 | 2027-01-01 | 2026-10-16 |
| VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations Vorasidenib, Lomustine - Recurrent Glioma, IDH-mutant Gliomas | Phase 1 | Not yet recruiting | Megan Mantica | 36 | 2026-11-30 | 2026-10-22 |
| Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation Vorasidenib - Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation | Phase 2 | Recruiting | Institut de Recherches Internationales Servier (I.R.I.S.) | 10 | 2026-07-23 | 2026-09-08 |
| Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer Intensity-Modulated Radiation Therapy, Volume Modulated Arc Therapy, Pencil Beam Scanning - Astrocytoma, IDH-Mutant, Grade 3 | Phase 3 | Recruiting | Alliance for Clinical Trials in Oncology | 408 | 2026-06-24 | 2026-10-02 |
| Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants Vorasidenib 20mg - Severe Hepatic Impairment, Normal Hepatic Function | Phase 1 | Recruiting | Institut de Recherches Internationales Servier (I.R.I.S.) | 20 | 2026-04-23 | 2026-06-05 |
| Vorasidenib Maintenance for IDH Mutant Astrocytoma Vorasidenib, Vorasidenib Placebo - IDH-mutant Grade 2 or 3 Astrocytoma | Phase 3 | Recruiting | European Organisation for Research and Treatment of Cancer - EORTC | 468 | 2026-01-16 | 2026-10-07 |
| Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma Vorasidenib - Glioma | Recruiting | iOMEDICO AG | 150 | 2025-12-08 | 2026-01-09 | |
| A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants Vorasidenib, DRSP/EE - Healthy Adult Female Participants | Phase 1 | Completed | Institut de Recherches Internationales Servier (I.R.I.S.) | 28 | 2025-11-05 | 2026-05-12 |
| Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants Vorasidenib, Bupropion, Flurbiprofen - Healthy Adult Participants | Phase 1 | Completed | Institut de Recherches Internationales Servier (I.R.I.S.) | 28 | 2025-10-07 | 2026-02-17 |
| A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study) Vorasidenib - Gliomas | Not applicable | Active not recruiting | Servier (Tianjin) Pharmaceutical Co. LTD. | 62 | 2025-09-02 | 2026-07-21 |
| ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas PEPIDH1M vaccine + vorasidenib - Low Grade Glioma of Brain | Phase 1 | Recruiting | Katy Peters, MD, PhD | 48 | 2025-07-15 | 2026-08-24 |
| Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared Vorasidenib, Radiotherapy, active surveillance - Glioma, Glioma of Brain | Recruiting | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | 90 | 2025-04-23 | 2026-04-23 | |
| Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma Vorasidenib, Temozolomide (TMZ) - IDH1-mutant Glioma, IDH2-mutant Glioma | Phase 1 / Phase 2 | Active not recruiting | Institut de Recherches Internationales Servier | 51 | 2025-01-22 | 2026-07-08 |
| Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation Vorasidenib, Placebo - Residual or Recurrent Grade 2 IDH Mutant Glioma | Phase 3 | Active not recruiting | Servier | 57 | 2024-10-18 | 2026-06-04 |
| A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects Vorasidenib 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet, Vorasidenib 10 mg Oral Tablet - Healthy Subjects | Phase 1 | Completed | Servier Bio-Innovation LLC | 64 | 2023-04-14 | 2025-02-14 |
| A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function Vorasidenib - Hepatic Impairment | Phase 1 | Completed | Institut de Recherches Internationales Servier | 16 | 2023-03-14 | 2024-02-08 |
| Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma Vorasidenib, Pembrolizumab - Astrocytoma, Oligodendroglioma | Phase 1 | Active not recruiting | Institut de Recherches Internationales Servier | 60 | 2023-01-20 | 2026-03-12 |
| Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) Vorasidenib, Matching Placebo - Grade 2 Glioma, Residual Glioma | Phase 3 | Active not recruiting | Institut de Recherches Internationales Servier | 331 | 2020-01-05 | 2025-04-03 |
| A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants AG881 - Healthy Volunteers | Phase 1 | Completed | Agios Pharmaceuticals, Inc. | 32 | 2019-10-02 | 2020-04-02 |
| Vorasidenib Expanded Access Program Vorasidenib - Glioma, Recurrence | Approved for marketing | Servier | 2026-07-24 |
Glioma (7) · Astrocytoma (5) · Oligodendroglioma (2) · Brain Neoplasms (1) · Disease Attributes (1) · Lymphoma, Follicular (1) · Neoplasms (1) · Neoplasms by Histologic Type (1) · Neoplasms, Germ Cell and Embryonal (1) · Neoplasms, Glandular and Epithelial (1) · Neoplasms, Nerve Tissue (1) · Neoplasms, Neuroepithelial (1) · Neuroectodermal Tumors (1) · Pathologic Processes (1) · Recurrence (1)
Institut de Recherches Internationales Servier (4) · Institut de Recherches Internationales Servier (I.R.I.S.) (4) · Servier (2) · Agios Pharmaceuticals, Inc. (1) · Alliance for Clinical Trials in Oncology (1) · European Organisation for Research and Treatment of Cancer - EORTC (1) · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (1) · Heidelberg University (1) · Katy Peters, MD, PhD (1) · Megan Mantica (1) · Servier (Tianjin) Pharmaceutical Co. LTD. (1) · Servier Bio-Innovation LLC (1) · iOMEDICO AG (1)
United States (11) · United Kingdom (5) · Germany (4) · Italy (4) · China (3) · France (3) · Netherlands (3) · Spain (3) · Australia (2) · Austria (2) · Canada (2) · Israel (2) · Japan (2) · Switzerland (2) · Belgium (1)
Jonathan Dewey, MD (1) · Katherine Peters, MD, PhD (1) · Marjolein Geurts (1) · Matthias Preusser (1) · Megan Mantica, MD (1) · Michael Platten, Prof. Dr. med. (1) · Patrick Y Wen, MD (1) · Rifaquat M. Rahman, MD (1) · Sara Morlino, MD (1) · Ugonma N Chukwueke, MD (1)
PMID 37272516, PMID 41175888, PMID 42053456
2019 (1)