CTIM-20. PROSPECTIVE RANDOMIZED PHASE II PLACEBO-CONTROLLED TRIAL OF SURVAXM PLUS ADJUVANT TEMOZOLOMIDE FOR NEWLY DIAGNOSED GLIOBLASTOMA (SURVIVE)

Abstract BACKGROUND Newly diagnosed glioblastoma (nGBM) has a dismal prognosis with survival of 15-18 months. Tumor associated “survivin” protein is expressed in >95% nGBM and targetable the use SurVaxM, shown to be effective at generating cytotoxic T lymphocytes. METHODS patients are being enrolled this randomized placebo-controlled trial phase II study. Eligibility Criteria includes age ≥ 18, KPS 70, IHC confirmed survivin-expression, residual contrast enhancement ≤1 cm3 by MRI, within 72 hours surgical resection. Patients 3:2 into two arms A:B treatment SurVaxM emulsion Montanide plus sargramostim (local injection) standard-of-care TMZ (Arm A), or placebo (saline Montanide) saline B). There three active phases study vaccine priming (VP) phase; adjuvant Vaccine Maintenance (VM) phase. A total four (4) doses (“SurVaxM/sargramostim”) Montanide/saline (“Placebo/Placebo”) will administered every weeks ( ± 3 days) during phase, subsequent dosing 8 1 week) maintenance After doses, SurVaxM/sargramostim Placebo/Placebo until tumor progression for maximum 24 The sample size 265 patients, 159 arm 106 control arm. primary objective determine overall (OS), secondary objectives include progression-free (PFS), OS pre-specified time points (OS-15, OS-18 OS-24), PFS (PFS-3, PFS-6 PFS-12) evaluation toxicities. Study duration expected 36 months, enrollment ongoing several centers planned 20 participating centers.