Vorasidenib

DRUG15 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 3Brain CancerDisease AttributesGliomaGlioma of BrainGliomasGrade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation

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: 2026-07-08

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

CompletedNCT07235774

Institut de Recherches Internationales Servier (I.R.I.S.)Healthy Adult Female Participants

Start: 2025-11-05End: 2026-03-13Updated: 2026-05-12

VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

Not yet recruitingNCT07629089

Megan ManticaBrain Cancer

Start: 2026-06-30End: 2035-06-30Target: 24Updated: 2026-06-05

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: 2026-06-04

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: 2026-05-22

Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer

RecruitingNCT07215910

Alliance for Clinical Trials in OncologyAstrocytoma, IDH-Mutant, Grade 3

Start: 2026-07-20End: 2040-01-01Target: 408Updated: 2026-07-02

Unknown Phase

Vorasidenib Expanded Access Program

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

Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared

RecruitingNCT07547163

Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaGlioma, Glioma of Brain, IDH Mutation +2

Start: 2025-04-23End: 2027-10-01Target: 90Updated: 2026-04-23

Related Papers

Alliance A072301: A phase III trial of radiotherapy followed by adjuvant temozolomide in combination with vorasidenib vs placebo in <i>IDH</i> -mutated newly diagnosed grade 3 astrocytoma (VORTEX).

Journal of Clinical Oncology2026-05-28

A global, randomized, double-blinded, phase 3 trial of vorasidenib vs placebo in patients with grade 2 glioma with an <i>IDH1/2</i> mutation (INDIGO): Updated efficacy and safety.

Journal of Clinical Oncology2026-05-27

Impact of vorasidenib vs placebo on seizure rates and quality of life: Exploratory analysis from the phase 3 INDIGO study.

Journal of Clinical Oncology2026-05-27

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

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