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NCT05864534 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
A Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05864534: Recruiting Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Northwestern University.
NCT05864534 is a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 25 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864534, a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Unacceptable toxicity rate in cycle 1 of \< 33%
Conditions Studied
Interventions
- DRUG Balstilimab
- DRUG Liposomal Doxorubicin
- DRUG Botensilimab
- DEVICE Sonocloud-9 (SC-9)
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What NCT05864534 shows while recruiting
NCT05864534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 4 interventions - of which Balstilimab is the first listed.
NCT05864534 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05864534 about?
NCT05864534 is a clinical study titled "Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma". 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 nove...
What is the current status of trial NCT05864534?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2024-01-31. Estimated completion is 2026-08.
What conditions does trial NCT05864534 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype.
What interventions are being tested in trial NCT05864534?
The interventions under investigation include: Balstilimab (DRUG), Liposomal Doxorubicin (DRUG), Botensilimab (DRUG), Sonocloud-9 (SC-9) (DEVICE).
Who is sponsoring clinical trial NCT05864534?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05864534 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05864534's enrollment target sits among peer trials
25 65th of 88 higher than 24 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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