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Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
NCT04164901 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Vorasidenib
Study Locations (20)
California
- City of Hope — Duarte
- University of California San Diego — La Jolla
- UCLA Oncology Center — Los Angeles
- University of California Irvine - Hospital — Orange
- University of California San Francisco — San Francisco
- Stanford Cancer Center — Stanford
Florida
- Mayo Clinic Jacksonville — Jacksonville
- Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics — Miami
Illinois
- Northwestern University — Chicago
- University of Chicago — Chicago
Massachusetts
- Tufts Medical Center — Boston
- Massachusetts General Hospital — Boston
Alabama
- University of Alabama at Birmingham — Birmingham
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora
Connecticut
- Yale University, Yale Cancer Center — New Haven
Indiana
- Indiana University Medical Center — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2020-01-05 |
| Est. Completion | 2028-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04164901
The ClinicalTrials.gov registry entry for NCT04164901 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Recurrent Glioma appearing as the primary indexed condition, and to 2 interventions — of which Matching Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04164901 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04164901 about?
NCT04164901 is a clinical study titled "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 wi...
What is the current status of trial NCT04164901?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2020-01-05. Estimated completion is 2028-05.
What conditions does trial NCT04164901 study?
This clinical trial studies the following conditions: Recurrent Glioma, Grade 2 Glioma, Residual Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04164901?
The interventions under investigation include: Matching Placebo (DRUG), Vorasidenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04164901?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04164901 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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