Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Sponsor: Institut de Recherches Internationales Servier
ClinicalTrials ID:NCT04164901
This phase 3 trial evaluates vorasidenib versus placebo in patients with Grade 2 glioma with IDH1/IDH2 mutations post-surgery. Eligible participants are aged ≥12, with confirmed IDH mutations, and no prior anticancer therapy. They must have measurable, non-enhancing disease and a performance score of ≥80%. Interventions include vorasidenib or a matching placebo, both administered orally.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 Criteria
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).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| City of Hope | 91010 | Duarte | California |
| University of California San Diego | 92093 | La Jolla | California |
| UCLA Oncology Center | 90095 | Los Angeles | California |
| University of California Irvine - Hospital | 92868 | Orange | California |
| University of California San Francisco | 94143 | San Francisco | California |
| Stanford Cancer Center | 94305 | Stanford | California |
| University of Colorado Hospital - Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| Yale University, Yale Cancer Center | 06510 | New Haven | Connecticut |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
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