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Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

This study is testing a new way to treat newly diagnosed glioblastoma (a type of aggressive brain cancer). It uses a device called Sonocloud-9 (SC-9) that creates ultrasound waves to temporarily open the blood-brain barrier. This barrier normally prevents medicines from reaching the brain, so opening it might help drugs get to the tumor better. You would receive three drugs: Balstilimab, Botensilimab, and Liposomal Doxorubicin, which are given through an IV (into a vein). These drugs work by affecting your immune system or directly targeting cancer cells. To join, you must have newly diagnosed glioblastoma that has specific genetic features (IDH-wildtype and unmethylated MGMT gene promoter) and have finished standard radiation treatment. The study will look at how safe the treatment is and how long people live. The current status of this study is unclear, and it plans to enroll 25 participants.

Study design
This is an interventional study that plans to enroll 25 participants. It is not specified if it is randomized or blinded.
What's involved
You would have a Sonocloud-9 device implanted after radiation. About 1-3 weeks after surgery, you would receive ultrasound activation and IV medications every 3 weeks for about 6 months, with potential for more cycles. You would also have regular brain MRIs and blood samples taken.
Compensation
Not stated in the trial record.
Follow-up
The study will measure survival at 18 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05864534

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Northwestern University
~25 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:BalstilimabBotensilimabLiposomal DoxorubicinSonocloud-9 (SC-9)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Unacceptable toxicity rate
Measured over 42 days
+1 more outcome measured

Conditions

Newly Diagnosed Glioblastoma
Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype
Gliosarcoma
Glioblastoma Multiforme

Explore related trials

GlioblastomaMGMT Gene

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Adam Sonabend, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Roger Stupp, MD · STUDY_DIRECTOR · Northwestern University

Who to contact

Neurological Surgery
[email protected]
(312) 695-8143
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Unacceptable toxicity rate42 days

    Unacceptable toxicity rate in cycle 1 of \< 33%

  • Landmark survival analyses18 months

    Overall survival and progression-free survival at 12 and 18 months, as well as median progression-free and overall survival.