Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Inclusion Criteria

• •Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type
• •Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated
• •Available paraffin embedded tumor tissue for the study
• •Have completed standard radiotherapy with or without temozolomide
• •18 years of age or older
• •Able to undergo contrast-enhanced MRI
• •Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2
• •Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field
• •Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications
• •Have the ability to understand and willingness to sign a written informed consent prior to registration on study.
• •Be willing and able to comply with the protocol.
• •Have adequate organ and bone marrow function
• •Agree to use adequate contraception if appropriate
• •Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa.
• •Uncontrolled epilepsy.
• •Received other investigational agents within 2 weeks of registration
• •Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
• •Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease)
• •Uncontrolled illness
• •History of active malignancy other than the brain tumor within 12 months prior to registration.
• •Are pregnant or breastfeeding.