Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Grade 2 Glioma, Residual Glioma, Recurrent Glioma
In brief
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.
Key facts
- Study ID
- NCT04164901
- Run by
- Institut de Recherches Internationales Servier
- People needed
- 331
- Starts
- 2020-01-05
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2025-04-03
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- University of California San Diego — La Jolla, California, United States
- UCLA Oncology Center — Los Angeles, California, United States
- University of California Irvine - Hospital — Orange, California, United States
- University of California San Francisco — San Francisco, California, United States
- Stanford Cancer Center — Stanford, California, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
- Yale University, Yale Cancer Center — New Haven, Connecticut, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics — Miami, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Indiana University Medical Center — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Kentucky — Lexington, Kentucky, United States
- Maine Medical Partners Neurology — Scarborough, Maine, United States
- John Hopkins Cancer Center — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Metro Minnesota Community Oncology — Minneapolis, Minnesota, United States
- Mayo Comprehensive Cancer — Rochester, Minnesota, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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