【米国FDAの承認または認可を受けていない機器の治験】

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

Exclusion Criteria: Patients will be ineligible if they have:

• 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.