Pilot Study of Navigated Focused Ultrasound and Pembrolizumab for Recurrent Glioblastoma
This study is testing a new approach for recurrent glioblastoma (a type of aggressive brain tumor) in patients with mismatch repair (MMR) deficiency (a genetic change that can affect how cancer cells respond to treatment). It combines Pembrolizumab, an immunotherapy drug, with Navifus Focused Ultrasound Sonification, a device that uses sound waves. The study aims to see if this combination is safe and practical to use. You might be able to join if you are 18 or older, have recurrent glioblastoma (WHO grade 4 IDH-wildtype) with MMR deficiency, and have already had surgery and standard treatments. The study plans to enroll 8 participants, but its current status is unclear.
- Study design
- This is a pilot study, meaning it's an early-stage study to test safety and feasibility. It plans to enroll 8 participants.
- What's involved
- Participants will receive Pembrolizumab every three weeks for up to six months, or until the disease progresses. After each Pembrolizumab infusion, you will receive Navifus Focused Ultrasound Sonification.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be assessed at each study visit from baseline through 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Study of Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma With Mismatch Repair Deficiency
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Safety of using navigated focused ultrasound (NaviFUS) CTCAE v6.0Assessed at each study visit from baseline through 2 years.
To evaluate the safety of using navigated focused ultrasound (NaviFUS) combined with pembrolizumab (PEM) after repeat surgery for patients with recurrent glioblastoma (rGBM) and mismatch repair (MMR) deficiency. Given that NaviFUS and PEM have defined intracranial dosing, no dose-escalation scheme will be employed. A CTCAE v6.0 grade 4 or higher toxicity probably or definitely attributable (see Section 13.2.3) to the administration of NaviFUS or PEM will be used as the definition for unacceptable toxicity
- Feasibility of using navigated focused ultrasound (NaviFUS) -CTCAE v6.0 criteriaAssessed at each study visit from baseline through 2 years.
To evaluate feasibility of using navigated focused ultrasound (NaviFUS) combined with pembrolizumab (PEM) after repeat surgery for patients with recurrent glioblastoma (rGBM) and mismatch repair (MMR) deficiency. Given that NaviFUS and PEM have defined intracranial dosing, no dose-escalation scheme will be employed. A CTCAE v6.0 grade 4 or higher toxicity probably or definitely attributable (see Section 13.2.3) to the administration of NaviFUS or PEM will be used as the definition for unacceptable toxicity