NCT05864534
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Registry fields
- Overall status
- RECRUITING
- Conditions
- Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype, Gliosarcoma, Glioblastoma Multiforme
- Study type
- INTERVENTIONAL
- Phase
- PHASE2
- Primary purpose
- TREATMENT
- Intervention type
- DRUG, DEVICE
- Interventions
- Balstilimab, Botensilimab, Liposomal Doxorubicin, Sonocloud-9 (SC-9)
- Lead sponsor
- Northwestern University (OTHER)
Cached at: 2026-08-15 00:33:08
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.
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.
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