Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) (NCT04164901)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (84 Sites)
Showing the first 25 of 84 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- City of Hope — Duarte, California
- University of California San Diego — La Jolla, California
- UCLA Oncology Center — Los Angeles, California
- University of California Irvine - Hospital — Orange, California
- University of California San Francisco — San Francisco, California
- Stanford Cancer Center — Stanford, California
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado
- Yale University, Yale Cancer Center — New Haven, Connecticut
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics — Miami, Florida
- Northwestern University — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- Indiana University Medical Center — Indianapolis, Indiana
- University of Kansas Medical Center — Kansas City, Kansas
- University of Kentucky — Lexington, Kentucky
- Maine Medical Partners Neurology — Scarborough, Maine
- John Hopkins Cancer Center — Baltimore, Maryland
- Tufts Medical Center — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan
- Henry Ford Hospital — Detroit, Michigan
- Metro Minnesota Community Oncology — Minneapolis, Minnesota
- Mayo Comprehensive Cancer — Rochester, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Grade 2 Glioma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.