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

  • STATUS
    Recruiting
  • End date
    Aug 20, 2027
  • participants needed
    340
  • sponsor
    Institut de Recherches Internationales Servier
Updated on 20 November 2021

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.

Details
Condition Recurrent Glioma, Grade 2 Glioma, Residual Glioma
Treatment Matching Placebo, AG-881, Vorasidenib
Clinical Study IdentifierNCT04164901
SponsorInstitut de Recherches Internationales Servier
Last Modified on20 November 2021

Eligibility

Yes No Not Sure

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%

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)
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