ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1
The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.
| Condition(s) | Low Grade Glioma of Brain |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years 2. IDH1R132H expression in primary tumor 3. Clinical and/or radiographic, progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane. 4. 1st recurrence only 5. Signed informed consent 6. For females of child-bearing potential, negative serum pregnancy test at screening 7. Women of childbearing potential and male participants must agree to practice contraception 8. Karnofsky Performance Status (KPS) of ≥ 70 9. Expected survival of ≥ 12 months 10. Recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management 11. Complete Blood Count (CBC)/differential with adequate bone marrow function as defined below within 2 weeks of enrollment: |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Katy Peters, MD, PhD |
| Locations | Durham, North Carolina, United States |
| Start date | 2025-07-15 |
| NCT ID | NCT05609994 |
| Official listing | https://clinicaltrials.gov/study/NCT05609994 |