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.
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)
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.
Severe unresolved infection within 4 weeks prior to initiation of study treatment.
Eben Rosenthal
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
Vanderbilt-Ingram Cancer Center
Collaborator