Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Public ClinicalTrials.gov record NCT07460765. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 administered before surgery, as measured by the occurrence of clinically significant Grade ≥2 adverse events that are possibly, probably, or definitely related to the study drug? * What is the extent of pathological response at each dose level, including residual viable tumor, fibrosis, necrosis, and tumor-infiltrating lymphocyte characteristics? Participants will: * Receive two intravenous infusions during the preoperative period, approximately 2-3 weeks before surgery and again 1-2 days before surgery. * Undergo standard-of-care surgical resection with collection of tumor and lymph node specimens for pathological and imaging studies.
Study identification
- NCT ID
- NCT07460765
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 40 participants
Conditions and interventions
Conditions
- 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)
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2026
- Primary completion
- Mar 31, 2030
- Completion
- Mar 31, 2031
- Last update posted
- Jul 6, 2026
2026 – 2031
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07460765, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 6, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07460765 live on ClinicalTrials.gov.