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
52 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 aggressive and treatment-resistant brain tumors. Researchers are studying a new form of nivolumab called nivolumab-IRDye800 (nivo800), which includes a near-infrared fluorescent dye to allow real-time imaging of drug distribution in tumor tissue. This early phase 1 trial aims to better understand the safety and imaging capabilities of nivo800 in patients with HGG undergoing surgery. Participants receive an infusion of nivo800 at varying doses, with some groups also receiving additional nivolumab to keep the total dose at 240 mg or less. After the infusion, patients undergo planned standard of care surgical tumor removal within 1 to 4 days. The study includes a safety group receiving only a test dose and dose escalation groups to find the optimal nivo800 amount for imaging. During the study, researchers monitor adverse events from the infusion up to 15 days afterward to assess safety. They also evaluate the imaging quality of the fluorescent drug in tumor tissue from surgery day to 3 months later. Participants must have imaging suggesting high-grade glioma and be eligible for surgery. The trial includes ongoing assessments to determine the best dose for clear tumor visualization and to monitor participants' health closely throughout the process.
CONDITIONS
Brief Title
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older
- Have imaging showing a highly suspicious high-grade glioma
- Planned surgical craniotomy as part of standard care
- Have adequate blood counts and organ function suitable for surgery and anesthesia, including WBC 63 2,000, 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 test at screening
You will not qualify if you...
- Not eligible for standard of care surgical resection
- Active or history of autoimmune or immune deficiency diseases, with some exceptions for controlled conditions like thyroid disease, diabetes, and certain skin conditions
- History of lung diseases like idiopathic pulmonary fibrosis or pneumonitis, except radiation-related fibrosis
- Significant cardiovascular disease within 3 months prior to treatment
- Severe unresolved infection within 4 weeks before treatment
- Prior allogeneic stem cell or solid organ transplant
- History of severe allergic reactions to similar antibodies or proteins
- Chronic systemic immunosuppressive treatment above physiologic doses, with some exceptions
- Pregnant, breastfeeding, or planning pregnancy during or within 2 months after treatment
- Baseline QTcF heart interval greater than 480 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (infusion) plus 1 to 4 days until surgery
Participants receive an infusion of fluorescently labeled nivolumab-IRDye800 (nivo800), followed by a single infusion of nivolumab. This is followed by planned Standard of Care surgical resection 1 to 4 days after infusion.
1 infusion visit and 1 surgery visit
Duration - Up to 3 months after surgery
Participants are monitored for safety and optimal dosing of nivo800 for near-infrared fluorescence imaging in the tumor after surgery.
Visits as scheduled for safety assessments up to 15 days post-infusion and imaging assessments up to 3 months
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
M
Makenna Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here