Background: Glioblastoma (GBM) is the most frequently diagnosed high-grade glioma with an incidence of 3-4/100,000 in the US. Although treatments have improved, median survival remains 15–18 months for newly diagnosed patients. DSP-7888 is an investigational peptide cancer vaccine comprised of peptides derived from the Wilms’ Tumor 1 (WT1) protein, with immunomodulating and antineoplastic activities. DSP-7888 may induce a WT1-specific cytotoxic T-lymphocytes against WT1-expressing tumor cells in HLA-A*02:01+, HLA-A*02:06+, and HLA-A*24:02+. DSP-7888 may induce a helper T-lymphocyte–mediated immune response against WT1-expressing tumor cells. Methods: This phase 2, active-controlled, multicenter, open-label randomized study (NCT03149003; WIZARD201G) is randomizing patients with recurrent or progressive GBM 1:1 to treatment with DSP-7888 + Bev or Bev alone. A screening phase of ≤28 d determines eligibility. DSP-7888 is administered intradermally at 10.5mg every 7 d (±1 d) for 5 doses (induction phase), then every 14 d (±3 d) for 6–15 doses (consolidation phase), then every 28 d (±7 d) for each additional dose (maintenance phase). Bev is administered every 14±3 d IV at 10mg/kg. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, response rate, and 12-month survival. Safety will be evaluated based on adverse events (AEs) recorded at each visit, physical examinations, and laboratory test results. The severity of AEs or abnormal laboratory results will be based on the CTCAE V4.03. About 200 patients will be enrolled. The study has 2 parts. In part 1, 3 patients are to receive DSP-7888 + Bev in a single-arm manner. If no patients experience a dose limiting toxicity (DLT), the study proceeds to part 2. If ≥1 patient experiences DLT, 3 more patients will be treated in the same manner. If ≥1 patient again experiences a DLT, the dose is reduced to 3.5mg. In part 2, new patients are randomized to one of the 2 treatment arms. Treatment continues in the absence of clear progression, clinical neurologic deterioration, or until 150 deaths have occurred. Study funding: Boston Biomedical, Inc. Clinical trial information: NCT03149003