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
Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years (e.g., carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
Metastases detected below the tentorium or beyond the cranial vault
More than 1 cm X 1 cm of enhancing disease on gadolinium contrasted MRI imaging
Unstable angina and/or congestive heart failure requiring hospitalization