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Clinical Trials in Germany / NCT04164901
Active, not recruiting Phase 3

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

NCT04164901 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2020-01-05
Last updated
2025-04-03

Condition(s) studied

Grade 2 GliomaResidual GliomaRecurrent Glioma

Investigational drug(s) / intervention(s)

Vorasidenib →Matching Placebo

Vorasidenib: Vorasidenib oral film-coated tablets

Matching Placebo: Matching Placebo oral tablets

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Be at least 12 years of age and weigh at least 40 kg. * Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria. * Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. * Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization \[FISH\], comparative genomic hybridization \[CGH\] array, sequencing) using an accredited laboratory. * Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC. * Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%. Key Exclusion Criteria: * Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc. * Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).

Primary outcome measure(s)

Trial sites (84)

FacilityCityRegionStatus
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
Washington University School of Medicine St Louis Missouri
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Duke University Medical Center Durham North Carolina
Ohio State University Comprehensive Cancer Center Columbus Ohio
Oregon Health and Science University Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
University of Pittsburgh Hillman Cancer Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Tennessee Oncology Nashville Tennessee
Baylor University Medical Center Dallas Texas
University of Texas Southwestern Medical Center Dallas Texas
MD Anderson Cancer Center Houston Texas
The University of Utah, Huntsman Cancer Hospital Salt Lake City Utah
Seattle Cancer Care Alliance Seattle Washington

+ 44 more sites — see the full list on the official registry below.

More Institut de Recherches Internationales Servier trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04164901 on ClinicalTrials.gov ↗ ← All trials in Germany