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Vorasidenib

DRUG13 trials

Sponsors

Institut de Recherches Internationales Servier, Servier, European Organisation for Research and Treatment of Cancer - EORTC, Servier (Tianjin) Pharmaceutical Co. LTD., Alliance for Clinical Trials in Oncology

Conditions

AstrocytomaAstrocytoma, IDH-Mutant, Grade 3Disease AttributesGliomaGliomasGrade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationGrade 2 GliomaHealthy Adult Female Participants

Phase 1

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
Active, not recruitingNCT05484622
Institut de Recherches Internationales ServierAstrocytoma, Oligodendroglioma
Start: 2023-01-20End: 2027-08-30Updated: 2026-03-12
A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
CompletedNCT05674474
Institut de Recherches Internationales ServierHepatic Impairment
Start: 2023-03-14End: 2023-07-18Updated: 2024-02-08
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
Active, not recruitingNCT06478212
Institut de Recherches Internationales ServierIDH1-mutant Glioma, IDH2-mutant Glioma
Start: 2025-01-22End: 2028-06-01Updated: 2026-03-13
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
CompletedNCT07235748
Institut de Recherches Internationales Servier (I.R.I.S.)Healthy Adult Participants
Start: 2025-10-07End: 2025-12-23Updated: 2026-02-17
A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
RecruitingNCT07235774
Institut de Recherches Internationales Servier (I.R.I.S.)Healthy Adult Female Participants
Start: 2025-11-05End: 2026-03-13Target: 28Updated: 2026-03-16

Phase 2

Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Not yet recruitingNCT07286292
Institut de Recherches Internationales Servier (I.R.I.S.)Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Start: 2026-03-15End: 2033-05-02Target: 10Updated: 2025-12-16

Phase 3

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Active, not recruitingNCT04164901
Institut de Recherches Internationales ServierGrade 2 Glioma, Recurrent Glioma, Residual Glioma
Start: 2020-01-05End: 2028-05-31Updated: 2025-04-03
Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation
Active, not recruitingNCT06780930
ServierResidual or Recurrent Grade 2 IDH Mutant Glioma
Start: 2024-10-18End: 2030-10-31Updated: 2026-01-09
Vorasidenib Maintenance for IDH Mutant Astrocytoma
RecruitingNCT06809322
European Organisation for Research and Treatment of Cancer - EORTCIDH-mutant Grade 2 or 3 Astrocytoma
Start: 2026-01-16End: 2037-05-31Target: 468Updated: 2026-03-31
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
Not yet recruitingNCT07215910
Alliance for Clinical Trials in OncologyAstrocytoma, IDH-Mutant, Grade 3
Start: 2025-10-20End: 2040-01-31Target: 408Updated: 2025-10-14

Unknown Phase

Vorasidenib Expanded Access Program
NCT05592743
ServierDisease Attributes, Glioma, Neoplasms +8
Updated: 2024-11-05
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)
Not yet recruitingNCT06969352
Servier (Tianjin) Pharmaceutical Co. LTD.Gliomas
Start: 2025-06-30End: 2027-02-28Target: 60Updated: 2025-05-13
Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
RecruitingNCT07240662
iOMEDICO AGGlioma
Start: 2025-12-08End: 2032-01-31Target: 150Updated: 2026-01-09

Related Papers

10199-CS-20 IDH-mutant glioma patients treated with Vorasidenib: rationale, design and trial in progress of the Vorasidenib Expanded Trial in Japan
Neuro-Oncology Advances2025-12-01
10197-CS-19 A global, randomized, double-blinded, Phase 3 study of Vorasidenib versus placebo in patients with adult-type diffuse glioma with an IDH1/2 mutation (INDIGO): updated data from the Japan subgroup analysis
Neuro-Oncology Advances2025-12-01
CTNI-53. PATIENTS WITH ISOCITRATE DEHYDROGENASE-MUTANT GLIOMA TREATED WITH VORASIDENIB: UPDATED DATA FROM THE VORASIDENIB EXPANDED ACCESS PROGRAM
Neuro-Oncology2025-11-011 citations
IMG-99. Volumetric tumor growth rate (TGR) modeling predicts clinical outcomes in patients with Grade 2, isocitrate dehydrogenase 1/2 mutant (mIDH1/2) glioma receiving vorasidenib or placebo in the Phase 3 INDIGO trial
Neuro-Oncology2025-11-01
TIP-12. A multicenter, retrospective-prospective real-world study: to evaluate the effectiveness and safety of Vorasidenib in Chinese patients with IDH1/2 mutant grade 2 astrocytoma or oligodendroglioma (VICTORIA): a trial-in-progress
Neuro-Oncology2025-11-01
IMG-89. Volumetric (3D) compared with traditional bidirectional (2D) assessment in patients with Grade 2, isocitrate dehydrogenase 1/2 mutant (mIDH1/2) glioma receiving vorasidenib or placebo in the Phase 3 INDIGO trial
Neuro-Oncology2025-11-01
CTNI-34. PHASE 1B SAFETY RESULTS OF VORASIDENIB IN COMBINATION WITH TEMOZOLOMIDE IN PATIENTS WITH MUTANT IDH1 OR IDH2 GLIOMA
Neuro-Oncology2025-11-01
Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial.
2025-10-292 citations
OS09.4.A EARLY TUMOR VOLUME CHANGES PREDICT CLINICAL OUTCOMES IN MIDH1/2 GLIOMA: POST-HOC RESULTS FROM THE PHASE 3 INDIGO TRIAL
Neuro-Oncology2025-10-01
JS05.6.A EXPLORATORY ANALYSES FROM PHASE 3 INDIGO STUDY SUGGEST POTENTIAL MECHANISM OF SEIZURE CONTROL THROUGH TUMOR VOLUME REDUCTION UNDER TREATMENT WITH VORASIDENIB
Neuro-Oncology2025-10-01
10311- ACT-19 A GLOBAL, RANDOMIZED, DOUBLE-BLINDED, PHASE 3 STUDY OF VORASIDENIB VERSUS PLACEBO IN PATIENTS WITH ADULT-TYPE DIFFUSE GLIOMA WITH AN IDH1/2 MUTATION (INDIGO): UPDATED EFFICACY RESULTS
Neuro-Oncology Advances2024-11-292 citations
10312- ACT-20 A GLOBAL, RANDOMIZED, DOUBLE-BLINDED, PHASE 3 STUDY OF VORASIDENIB VERSUS PLACEBO IN PATIENTS WITH ADULT-TYPE DIFFUSE GLIOMA WITH AN IDH1/2 MUTATION (INDIGO): JAPAN SUBGROUP ANALYSIS
Neuro-Oncology Advances2024-11-29
CTNI-53. A GLOBAL, RANDOMIZED, DOUBLE-BLINDED, PHASE 3 STUDY OF VORASIDENIB VERSUS PLACEBO IN PATIENTS WITH ADULT-TYPE DIFFUSE GLIOMA WITH AN IDH1/2 MUTATION (INDIGO): UPDATED EFFICACY RESULTS
Neuro-Oncology2024-11-015 citations
CTNI-66. IDH-MUTANT GLIOMA PATIENTS TREATED WITH VORASIDENIB: ONGOING DATA FROM THE VORASIDENIB EXPANDED ACCESS PROGRAM
Neuro-Oncology2024-11-011 citations
CTIM-19. A PHASE 1, SAFETY LEAD-IN AND RANDOMIZED, OPEN-LABEL, PERIOPERATIVE STUDY OF VORASIDENIB COMBINED WITH PEMBROLIZUMAB IN RECURRENT OR PROGRESSIVE ENHANCING IDH-1 MUTANT GLIOMA: TRIAL IN PROGRESS
Neuro-Oncology2024-11-01
A.6 INDIGO: a global, randomized, double-blinded, Phase 3 study of vorasidenib versus placebo in patients with grade 2 glioma with an IDH1/2 mutation (mIDH1/2)
Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2024-05-23
LTBK-06. IMPACT OF VORASIDENIB TREATMENT ON MUTANT <i>IDH1</i> OR <i>IDH2</i> DIFFUSE GLIOMA TUMOR GROWTH RATE: RESULTS FROM THE RANDOMIZED, DOUBLE-BLIND, PHASE 3 INDIGO STUDY
Neuro-Oncology2023-11-0116 citations
QOL-26. A RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF VORASIDENIB VS PLACEBO IN PATIENTS WITH MUTANT <i>IDH1/2</i>DIFFUSE GLIOMA (INDIGO): ANALYSIS OF HEALTH-RELATED QUALITY OF LIFE, NEUROCOGNITION AND SEIZURES
Neuro-Oncology2023-11-0115 citations
CTIM-14. PHASE 1 SAFETY LEAD-IN AND RANDOMIZED OPEN-LABEL PERIOPERATIVE STUDY OF VORASIDENIB COMBINED WITH PEMBROLIZUMAB IN RECURRENT OR PROGRESSIVE ENHANCING IDH1-MUTANT ASTROCYTOMAS: SAFETY LEAD-IN RESULTS
Neuro-Oncology2023-11-014 citations
CTNI-51. A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF VORASIDENIB VS PLACEBO IN PATIENTS WITH MUTANT <i>IDH1</i>/<i>2</i> DIFFUSE GLIOMA (INDIGO): EXPLORATORY ANALYSIS OF VARIANT ALLELE FREQUENCY AND PROGRESSION-FREE SURVIVAL
Neuro-Oncology2023-11-013 citations

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