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 (May 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
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
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