Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Recruiting
Early Phase 1
Interventional Study
Brain Cancer
HGG
Glioma
High Grade Glioma
High Grade Gliomas
High Grade Glioma (III or IV)
High Grade Glioma (HGG) of the Brain With BRAF Aberration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 38 (estimated)
- Sponsor
- Eben Rosenthal · Other
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About This Trial
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) fluor…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent
2. Age ≥ 18 years
3. Patient must have imaging of highly suspicious high grade glioma (HGG)
4. Patients for whom surgical craniotomy is planned as standard of care (SOC)
5. Adequate hematologic, hepatic function and end-organ function appropriate for …
Contacts