OncoMatch/Clinical Trials/NCT05864534
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Is NCT05864534 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Balstilimab and Botensilimab for newly diagnosed glioblastoma.
Treatment: Balstilimab · Botensilimab · Liposomal Doxorubicin · Sonocloud-9 (SC-9) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Required: IDH2 wild-type
Required: MGMT promoter unmethylated
Performance status
ECOG/WHO 0–2
Prior therapy
Must have received: radiation therapy — standard
Have completed standard radiotherapy with or without temozolomide
Cannot have received: immunotherapeutic agents
Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications
Cannot have received: investigational agent
Exception: within 2 weeks of registration
Received other investigational agents within 2 weeks of registration
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
Liver function
Have adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
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