Clinical Trial

Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)

Recruiting Early Phase 1
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Summary
High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-30
Trial Details
NCT Number NCT07210632
Lead Sponsor Eben Rosenthal
Collaborators: Vanderbilt-Ingram Cancer Center
Conditions Brain Cancer, HGG, Glioma, High Grade Glioma, High Grade Gliomas, High Grade Glioma (III or IV), High Grade Glioma (HGG) of the Brain With BRAF Aberration
Enrollment 38 participants
Start Date 2026-03-27
Primary Completion 2030-03-30 (estimated)
Study Completion 2031-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-01