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NOT YET RECRUITING
NCT07210632
EARLY_PHASE1

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

Sponsor: Eben Rosenthal

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2026-03-30

Completion Date

2031-03-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

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.

DRUG

Nivolumab-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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States