Award
NIH Reporter #1UG3NS140118-01A1
Augmenting immunotherapy pharmacodynamics in glioma
Recipient
Mayo Clinic Rochester
Award Amount
$712,838.00
Ceiling
$712,838.00
Awarded
September 11, 2026
Identifier
1UG3NS140118-01A1
A clinical trial investigating the combination of DFMO and pembrolizumab to improve immunotherapy outcomes in glioma patients by enhancing immune response and assessing safety and biomarkers.
Description
This Phase I/IIa trial evaluates the safety and efficacy of combining difluoromethylornithine (DFMO) with pembrolizumab in patients with recurrent glioblastoma or grade 4 IDH-mutant astrocytomas. The study aims to assess intratumoral drug concentrations, immune profile changes, T cell infiltration, and myeloid cell abundance, as well as safety, optimal dosing, and potential biomarkers in cerebrospinal fluid (CSF). The trial includes surgical window-of-opportunity components and long-term safety and efficacy assessments.