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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Eben Rosenthal
Study ID
NCT07210632
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Brain Cancer
  • Glioma
  • HGG
  • High Grade Glioma
  • High Grade Glioma (HGG) of the Brain With BRAF Aberration
  • High Grade Glioma (III or IV)
  • High Grade Gliomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Nivolumab-IRDye800 — DRUG
    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.

Study Details

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 Dates

Start date
Mar 27, 2026
Status verified
May 2026
Primary completion
Mar 30, 2030
Completion
Mar 30, 2031

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nivo800 (5mg)
    5mg nivo800
  • Experimental: Nivo800 + Nivo (50mg +190)
    50 mg nivo800 +190 mg nivolumab
  • Experimental: Nivo800 + Nivo (100mg + 140mg)
    100 mg nivo800 +140 mg nivolumab
  • Experimental: Nivo800 + Nivo (150mg + 90mg)
    150 mg nivo800 +90 mg nivolumab
  • Experimental: Nivo800 + Nivo (expansion at optimal dose cohort)
    Expansion at optimal dose

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Nicole Jones
[email protected]
615-936-2807
Makenna Brown
[email protected]
615-421-4370
Patrick Kelly, MD (PRINCIPAL_INVESTIGATOR)
Eben Rosenthal, MD (SUB_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Vanderbilt University Medical Center· Nashville, TN

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