Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Recruiting
Phase 1
Interventional Study
Hnscc
Head and Neck
Squamous Cell Cancer
Squamous Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Squamous Cell Carcinoma Mouth
Squamous Carcinoma Poorly Differentiated
Squamous Cell Cancer of the Head and Neck
Squamous Cell Carcinoma (SCC) of the Oral Cavity
Squamous Cell Carcinoma (SCC)
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
- Phase 1
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 40 (estimated)
- Sponsor
- Vanderbilt-Ingram Cancer Center · Other
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About This Trial
The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection.
The main questions it aims to answer are:
* Is nivolumab-IRDye800CW (nivo800) safe when administe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Written informed consent
* Age ≥ 18 years
* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.
* Adequate hematologic, hepatic function and end-organ function appropriate for surgical rese…
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