NCT05864534 Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
| NCT ID | NCT05864534 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northwestern University |
| Condition | Newly Diagnosed Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2031-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-01-19 with a primary completion date of 2031-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Adam Sonabend, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05864534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Newly Diagnosed Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05864534 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05864534 currently recruiting?
Yes, NCT05864534 is actively recruiting participants. Contact the research team at braintumortrials@nm.org for enrollment information.
Where is the NCT05864534 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05864534 clinical trial?
NCT05864534 is sponsored by Northwestern University. The principal investigator is Adam Sonabend, MD at Northwestern University. The trial plans to enroll 25 participants.
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