Pembrolizumab + Focused Ultrasound for Glioblastoma

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jennifer Leddon

Must not be taking: Immune checkpoint inhibitors, Corticosteroids

Disqualifiers: Multifocal disease, Prior malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma with Mismatch Repair Deficiency.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent Grade 4 IDH-wildtype Glioblastoma, confirmed by genomic/histopathological analysis. They must have had prior surgery and standard treatments, a Karnofsky Performance Scale score above 70, adequate blood counts, and be able to consent. Pregnant women are excluded.

Inclusion Criteria

I have had more than one surgery for my brain tumor.

I have given or can give my consent to participate.

My cancer has MMR deficiencies confirmed by tests on my surgical sample.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab every three weeks along with focused ultrasound sonication following surgery for up to six months or until disease progression

Up to 6 months

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Navifus Focused Ultrasound Sonification
• Pembrolizumab

Trial Overview

The study tests Navigated Focused Ultrasound (Navifus) combined with Pembrolizumab in patients whose glioblastoma has returned. It targets those with Mismatch Repair Deficiency to see if this combo can improve outcomes compared to current therapies.

How Is the Trial Designed?

Group I: Pembrolizumab + focused ultrasound sonication Experimental Treatment 2 Interventions

Pembrolizumab along with focused ultrasound sonication following surgery for recurrent glioblastoma. Treatment dosing will be 200mg of pembrolizumab every three weeks for up to six months or until disease progression, whichever occurs first. The primary endpoint will be safety and tolerability, with secondary efficacy endpoints and exploratory biomarker and radiographic analyses.

Who Is Running the Clinical Trial?

Jennifer Leddon

Lead Sponsor

NaviFUS Corporation

Industry Sponsor

Trials

10

Recruited

120+