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NCT Number: NCT06780930

Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

The objective of this study is to determine the efficacy, safety, and pharmacokinetics of vorasidenib in Asian participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation. The study will begin with a safety lead-in (SLI) phase and then will transition to a randomized double-blind placebo-controlled phase. During the study participants will have study visits on day 1 and 15 of the first two cycles, and then only on day 1 of treatment cycles in the frequency included in the study schedule of assessments. All participants will have an end of treatment visit within 7 days after their last dose of study treatment. Approximately 28 (+5) days after treatment has ended, a safety follow-up visit will occur. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination. Beginning at the end of treatment visit participants will be contacted by phone every 6 months for overall survival up to 5 years after the last participant is randomized or until death, withdrawal of consent from overall study participation, lost to follow-up, or sponsor ending the study, whichever occurs first.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Residual or Recurrent Grade 2 IDH Mutant Glioma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second People's Hospital of Shenzhen, Shenzhen, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.
  • 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%.
  • Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
  • Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy.
  • 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
  • Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC for double blind part.

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.
  • Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
  • Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results.
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.

Treatment and study plan

Vorasidenib

Drug

For oral administration once daily

Placebo

Drug

For oral administration once daily

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Approximately 1.5 years

    The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.

Secondary outcomes

  1. Dose limiting toxicities (DLTs) (for open-label Safety Lead In (SLI) phase)

    Time frame: Through Cycle 1 (28 days)

  2. Number of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death

    Time frame: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)

  3. Severity of AEs

    Time frame: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)

  4. Time-To-Next-Intervention (TTNI)

    Time frame: Through the PFS Follow-up (approximately 6.5 years)

    The time from randomization to the initiation of the first subsequent anticancer therapy (including vorasidenib, for participants randomized to placebo who subsequently cross over) or death due to any cause.

  5. Tumor Growth Rate (TGR) as assessed by volume

    Time frame: Through the PFS Follow-up (approximately 6.5 years)

    Defined as the percentage change in tumor volume every 6 months

  6. Objective response

    Time frame: Through the PFS Follow-up (approximately 6.5 years)

    Best overall response of Complete Response (CR), Partial Response (PR), or Minor Response (MR)

  7. Time to response

    Time frame: Through the PFS Follow-up (approximately 6.5 years)

    The time from the date of randomization to the date of first documented CR, PR, or MR for responders as assessed by the Investigator and by the BIRC

  8. Duration of response

    Time frame: Through the PFS Follow-up (approximately 6.5 years)

    The time from the date of first documented CR, PR, or MR to the earlier of the date of death due to any cause or first documented radiographic PD as assessed by the Investigator and by the BIRC

  9. Overall survival

    Time frame: Through the Overall Survival Follow-up (approximately 6.5 years)

    The time from the date of randomization to the date of death due to any cause

  10. Plasma concentrations of vorasidenib

    Time frame: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)

  11. Number of seizures by month

    Time frame: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)

Sponsors and collaborators

Lead sponsor

Servier

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Jan 17, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.