Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma with Mismatch Repair Deficiency.
Patient previously diagnosed with WHO grade 4 IDH-wildtype GBM, determined through genomic and/or histopathological analysis.
Prior treatment for GBM with surgical resection and standard of care TMZ and radiation therapy.
Patient who has undergone repeat surgery (including biopsy or resection) for rGBM.
MMR deficiencies confirmed per standard of care immunohistochemical analysis or Next Generation Sequencing (NGS) of the patient's surgical sample from the time of initial GBM diagnosis or recurrence.
Multifocal or leptomeningeal disease observed at the time of GBM recurrence.
Patient for whom the repeat surgical cavity is ≤30 mm from the skull surface or otherwise not reasonably accessible for sonification using the NaviFUS platform, assessed on screening MRI.
Patient with a prior or concurrent malignancy that is deemed to be clinically significant in the context of rGBM.
Patient receiving concurrent treatment with an immune checkpoint inhibitor, other investigational agent, or live vaccine administered within 14 days prior to the first dose of trial treatment.
Jennifer Leddon
Lead sponsor
University of Cincinnati
Sponsor institution
NaviFUS Corporation
Collaborator