Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

NCT Number	NCT04164901
Lead Sponsor	Institut de Recherches Internationales Servier
Conditions	Grade 2 Glioma, Residual Glioma, Recurrent Glioma
Enrollment	331 participants
Start Date	2020-01-05
Primary Completion	2022-09-06 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2025-04-03