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

Phase 0 Recruiting 38 enrolled Eben Rosenthal Vanderbilt-Ingram Cancer Center · collab

Non-randomizedSingle-groupOpen-labelSupportive care

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.

Timeline

Start: 2026-03-27
Primary completion: 2030-03-30
Completion: 2031-03-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	90 mg	Other
Subject	Nivolumab	Monoclonal antibody	140 mg	Other
Subject	Nivolumab	Monoclonal antibody	190 mg	Other
Subject	Nivolumab-IRDye800	Unknown	5 mg	Other
Subject	Nivolumab-IRDye800	Unknown	50 mg	Other
Subject	Nivolumab-IRDye800	Unknown	100 mg	Other
Subject	Nivolumab-IRDye800	Unknown	150 mg	Other

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

Summary

Timeline

Drugs

Indications