Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)

Brief description of study

You can participate in this study if you are newly diagnosed with brain cancer (glioblastoma). The purpose of this study is to evaluate a peptide vaccine (SurVaxM) in emulsion with Montanide given together with locally administered sargramostim plus adjuvant oral temozolomide (TMZ) (Arm A) versus saline-Montanide emulsion with locally administered saline (instead of sargramostim) plus adjuvant oral temozolomide (TMZ) (Arm B). Patients will be randomized 3:2 = A:B to treatment with SurVaxM in emulsion with Montanide plus sargramostim (local injection) and standard-of-care TMZ (Arm A), or placebo (saline in emulsion with Montanide) plus saline (local injection) and standard-of-care TMZ (Arm B). To be eligible to participate, patients must have undergone a contrast enhanced, post-operative MRI scan within 72 hours of surgical resection. All patients must undergo randomization within 16 weeks of surgical tumor resection in order to participate.

Clinical Study Identifier: s22-00457 Identifier: NCT05163080

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