Actively Recruiting
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Led by Eben Rosenthal · Updated on 2026-05-11
38
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
E
Eben Rosenthal
Lead Sponsor
V
Vanderbilt-Ingram Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Imaging showing highly suspicious high grade glioma (HGG)
- Planned surgical craniotomy as standard of care
- Adequate blood counts and organ function suitable for surgery and anesthesia within 30 days prior to infusion
- Negative hepatitis B surface antigen test at screening
You will not qualify if you...
- Not eligible for standard of care surgical resection
- Active or history of autoimmune disease or immune deficiency, except controlled hypothyroidism on thyroid replacement, controlled Type 1 diabetes on insulin, or certain controlled skin conditions covering less than 10% of body area
- History of specific lung diseases or active pneumonitis on chest CT scan, except prior radiation pneumonitis with fibrosis
- Significant cardiovascular disease within 3 months before study treatment
- Severe unresolved infection within 4 weeks before study treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins
- Chronic systemic immunosuppressive medication above physiologic maintenance doses, with some exceptions for low-dose steroids and certain conditions
- Pregnant, breastfeeding, or intending pregnancy during or within 2 months after study treatment
- Baseline QTcF interval greater than 480 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
CONTACT
M
Makenna Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
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