OncoMatch/Clinical Trials/NCT05609994
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
Is NCT05609994 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies PEPIDH1M vaccine + vorasidenib for low grade glioma of brain.
Treatment: PEPIDH1M vaccine + vorasidenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 r132h
Disease stage
Required: Stage GRADE 2, GRADE 3 (WHO CNS)
progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane
Prior therapy
Cannot have received: mIDH1 targeted therapeutics
Prior therapy with mIDH1 targeted therapeutics
Lab requirements
Blood counts
ANC ≥ 1000 cells/mm3; Platelet count ≥ 100,000 cells/mm3; Hemoglobin ≥ 10 g/dl (transfusion/intervention allowed)
Kidney function
BUN ≤ 25 mg/dl; Creatinine ≤ 1.7 mg/dl
Liver function
Bilirubin ≤ 2.0 mg/dl; ALT ≤ 3 x normal range; AST ≤ 3 x normal range
CBC/differential with adequate bone marrow function as defined below within 2 weeks of enrollment: ANC ≥ 1000 cells/mm3; Platelet count ≥ 100,000 cells/mm3; Hemoglobin ≥ 10 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.) Adequate renal function as defined below within 2 weeks of enrollment: BUN ≤ 25 mg/dl; Creatinine ≤ 1.7 mg/dl Adequate hepatic function as defined below within 2 weeks of enrollment: Bilirubin ≤ 2.0 mg/dl; ALT ≤ 3 x normal range; AST ≤ 3 x normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Medical Center · Durham, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05609994 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mIDH1 targeted therapeutics disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 r132h is a required biomarker for enrollment.
What disease stage is eligible?
Stage GRADE 2 or GRADE 3 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages