RecruitingPhase 2NCT05864534

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma


Sponsor

Northwestern University

Enrollment

25 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Brain tumor treatment is hampered by the blood-brain barrier (BBB). This barrier prevents drugs carried in the bloodstream from getting into the brain. If the BBB can be opened, making it temporarily more permeable, drugs may able to better reach the brain tumor. In this trial we will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the BBB to maximize brain penetration of drugs that modulate the immune system. The device will be implanted after radiation is completed. Immune modulating drugs will be given every 3 weeks in conjunction with activation of the device to open the BBB. The objectives of this trial are to establish whether it is safe and feasible to administer immune modulating drugs in this manner, and identify whether the treatment is effective in treating glioblastoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests whether therapeutic ultrasound (sound waves directed at the brain to stimulate the immune system) combined with standard treatment can improve outcomes for people with newly diagnosed glioblastoma, the most aggressive type of brain tumor. **You may be eligible if...** - You are 18 or older with a newly diagnosed confirmed glioblastoma (IDH wild-type) - Your tumor lacks a specific protective gene modification (MGMT unmethylated) - You have completed standard radiation therapy, with or without the chemotherapy drug temozolomide - You are in reasonably good physical condition (ECOG 0–2) - You have not previously received immunotherapy for any condition **You may NOT be eligible if...** - Your tumor is in multiple locations or in the back of the brain (posterior fossa) - You have uncontrolled seizures - You have had prior treatment with immune checkpoint drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBalstilimab

Balstilimab 450 mg IV over 30 minutes every 3 weeks

DRUGBotensilimab

Botensilimab1mg/kg mg IV over 30 minutes every 6 weeks

DRUGLiposomal Doxorubicin

Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks

DEVICESonocloud-9 (SC-9)

Device activation of 9 ultrasound emitters during IV injection of microbubbles every 3 weeks


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT05864534


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