Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG) (NCT07210632) | Clinical Trial Compass
RecruitingEarly Phase 1
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
United States38 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Age ≥ 18 years
✓. Patient must have imaging of highly suspicious high grade glioma (HGG)
✓. Patients for whom surgical craniotomy is planned as standard of care (SOC)
✓. Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU/L) ALT 7-110 (IU/L) BUN 6-50 (mg/dL) Creatinine 0.5-3.0 (mg/dL) Negative hepatitis B surface antigen (HBsAg) test at screening
Exclusion criteria
✕. Patients not eligible for SOC surgical resection
✕. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
✕. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
✕
What they're measuring
1
Determine the safety of fluorescently labeled nivolumab-IRDye800 (nivo800) as a molecular imaging agent via assessing adverse events.
Timeframe: From infusion to 15 days post-infusion.
. Severe unresolved infection within 4 weeks prior to initiation of study treatment.
✕. Prior allogeneic stem cell or solid organ transplantation
✕. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
✕. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\>10 mg/day of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions: