Early Phase 1 Study of Nivolumab-IRDye800 Nivo800 Imaging in Adults with High Grade Glioma Undergoing Surgery

What this Trial Is About

High-grade gliomas HGGs are aggressive brain tumors that often resist treatment. This trial evaluates a new form of immunotherapy using nivolumab labeled with a near-infrared fluorescent dye nivolumab-IRDye800 or nivo800 to visualize drug distribution in tumor tissue in real time. The study aims to understand the safety and imaging potential of this novel agent in patients with high-grade glioma undergoing surgery. Participants will receive a single infusion of nivo800 with varying doses across cohorts, combined with nivolumab to a total dose of no more than 240 mg, except for the initial safety cohort receiving only a test dose of nivo800. Surgery to remove the tumor is planned 1 to 4 days after the infusion as part of standard care. Different dose levels will be tested to determine the optimal nivo800 dose for imaging, with an expansion cohort at the selected dose. During the study, participants will be monitored for adverse events from infusion through 15 days post-infusion to assess safety. Imaging assessments using near-infrared fluorescence will be performed from the day of surgery to three months to evaluate drug distribution in tumor tissue. Participants will undergo regular evaluations including laboratory tests and imaging as part of their surgical care. The total study duration extends through surgery and follow-up to assess both safety and imaging outcomes.

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