Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Inclusion Criteria:

• Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2wild-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 performancestatus ≤ 2

• Size and location of the residual tumor and/or resection cavity must allow to beable to be covered by the sonication field

• Have not received any prior treatment with immunotherapeutic agents treatments forglioblastoma or other indications

• Have the ability to understand and willingness to sign a written informed consentprior 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

Exclusion Criteria: Patients will be ineligible if they have:

• Multifocal tumor (unless all localized in a 50-mm diameter area accessible toultrasound 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 tocompounds of similar chemical or biologic composition to agents used in this study.

• Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmunedisease)

• Uncontrolled illness

• History of active malignancy other than the brain tumor within 12 months prior toregistration.

• Are pregnant or breastfeeding.