Nivolumab-IRDye800 for High-Grade Glioma

This study is testing a new way to see how a drug called nivolumab-IRDye800 (nivo800) works in people with high-grade glioma (HGG), a type of brain cancer. Nivo800 is nivolumab, an immunotherapy drug, with a special fluorescent dye attached. This dye helps doctors see the drug in real-time during surgery. The main goal is to find out if nivo800 is safe. You might be able to join if you are 18 or older, have highly suspicious HGG, and are scheduled for brain surgery. The study is currently recruiting 38 participants, but the overall status is unclear.

Study design
This study involves giving participants nivolumab-IRDye800, with a small group first receiving a test dose to check for safety. It is an interventional study with 38 planned participants.
What's involved
Participants will receive an infusion of nivolumab-IRDye800, followed by a standard nivolumab infusion for most. The safety of nivolumab-IRDye800 will be monitored for 15 days after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed from the time of infusion up to 15 days post-infusion.

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NCT07210632

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalSupportive care
Eben Rosenthal
~38 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:NivolumabNivolumab-IRDye800

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety of fluorescently labeled nivolumab-IRDye800 (nivo800) as a molecular imaging agent via assessing adverse events.
Measured over From infusion to 15 days post-infusion.
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
1 sites across 1 states
Tennessee1
  • Patrick Kelly, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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  • Determine the safety of fluorescently labeled nivolumab-IRDye800 (nivo800) as a molecular imaging agent via assessing adverse events.From infusion to 15 days post-infusion.

    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.