Treatment of recurrent Grade 2 glioma with Vorasidenib in Asian patients

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

This study is testing if a new drug called Vorasidenib can help Asian patients with recurring Grade 2 glioma that has certain genetic mutations feel better and live longer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Servier (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Shenzhen, Guangdong and 16 other locations)
• Trial ID: NCT06780930 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy, safety, and pharmacokinetics of Vorasidenib in Asian participants diagnosed with residual or recurrent Grade 2 glioma harboring IDH1 or IDH2 mutations. The trial will commence with a safety lead-in phase, followed by a randomized double-blind placebo-controlled phase. Participants will undergo regular study visits for assessments, including questionnaires, blood tests, and physical examinations, with follow-up for overall survival extending up to five years post-treatment. The study is designed to provide comprehensive data on the treatment's impact on this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are Asian individuals aged 12 years and older with a confirmed IDH1 or IDH2 mutation and residual or recurrent Grade 2 glioma.

Not a fit: Patients who have received prior anticancer therapies other than surgery or those requiring immediate chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent Grade 2 glioma, potentially improving their outcomes.

How similar studies have performed: Other studies targeting IDH-mutant gliomas have shown promising results, indicating that this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong and 16 other locations

• The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Recruiting)
• West China Hospital Sichuan University — Chendu, Sichuan, China (Recruiting)
• Tiantan Hospital — Beijing, China (Recruiting)
• Bejing Tsinghua Changgung Hospital — Beijing, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, China (Not_yet_recruiting)
• Sanbo Brain Hospital, Capital Medical University — Beijing, China (Recruiting)
• Xuanwu Hospital Capital Medial University — Beijing, China (Not_yet_recruiting)
• The First Affilated Hospital of Fujian Medical University — Fuzhou, China (Not_yet_recruiting)
• SUN Yat-Sen University Cancer Center — Guangzhou, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Not_yet_recruiting)
• Huashan Hospital Fudan University — Shanghai, China (Recruiting)
• The Second Affiliated Hospital of Air Force Military Medical University — Xi'an, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical Hospital — Xuzhou, China (Not_yet_recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Not_yet_recruiting)
• Chang Gung Memorial Hospital, — Taoyuan, Taiwan (Not_yet_recruiting)

Study contacts

• Study coordinator: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

Conditions Residual or Recurrent Grade 2 IDH Mutant Glioma