Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
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.
Arms & interventions
- DrugNivolumab
Participants will receive a single infusion of nivolumab following an infusion of nivolumab-IRDye800 (nivo800), for a combined total dose of 240 mg. This dosing applies to all cohorts except Cohort 1, which is designated as the safety group. Each cohort, other than Cohort 1, will receive no more than 240 mg in total of nivolumab and nivo800 combined. Participants will then undergo planned Standard of Care (SOC) surgical resection 1 to 4 days after the infusion.
- DrugNivolumab-IRDye800
Participants will receive an infusion of nivolumab-IRDye800 (nivo800). Nivo800 has never been assessed in patients before and therefore Cohort 1 will receive only a test dose to determine the safety (3 participants). Cohorts 2-4 will receive escalating doses of nivo800, keeping the overall dose nivolumab + nivo800 no more than 240 mg. Participants will undergo planned Standard of Care surgical resection at 1-4 days after infusion.
Outcome measures
Primary
Determine the safety of fluorescently labeled nivolumab-IRDye800 (nivo800) as a molecular imaging agent via assessing adverse events.
As defined by the number of Grade ≥ 2 Adverse Events (AEs) determined that are clinically significant and considered definitely or probably related to nivo800. Safety data will be summarized by grade, severity, and type.
Time frame: From infusion to 15 days post-infusion.
Secondary
Determine the optimal dose of nivolumab-IRDye800 (nivo800) for near-infrared (NIR) fluorescence imaging in the tumor, via microscopic imaging.
Time frame: From Day of Surgery Resection to 3 months
Eligibility criteria
Study locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232