ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
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.
• Age ≥ 18 years
• IDH1R132H expression in primary tumor
• Clinical and/or radiographic, progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane.
• 1st recurrence only
• Signed informed consent
• For females of child-bearing potential, negative serum pregnancy test at screening
• Women of childbearing potential and male participants must agree to practice contraception
• Karnofsky Performance Status (KPS) of ≥ 70
• Expected survival of ≥ 12 months
⁃ Recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management
⁃ Complete Blood Count (CBC)/differential with adequate bone marrow function as defined below within 2 weeks of enrollment:
∙ Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
‣ Platelet count ≥ 100,000 cells/mm3
‣ Hemoglobin (Hgb) ≥ 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:
∙ Blood urea nitrogen (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
‣ Alanine transaminase (ALT) ≤ 3 x normal range
‣ Aspartate aminotransferase (AST) ≤ 3 x normal range