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

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 1, 2026

Primary Completion Date

January 1, 2030

Study Completion Date

January 1, 2031

Conditions
Brain CancerHGGGliomaHigh Grade GliomaHigh Grade GliomasHigh Grade Glioma (III or IV)High Grade Glioma (HGG) of the Brain With BRAF Aberration
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.

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
collaborator

Vanderbilt-Ingram Cancer Center

OTHER

lead

Eben Rosenthal

OTHER

NCT07210632 - Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG) | Biotech Hunter | Biotech Hunter