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NCT07460765 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07460765 is a Phase 1 study that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 40 participants.
The verdict
NCT07460765, a Phase 1 study, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Nivolumab
- DRUG Nivo800
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-07 |
| Est. Completion | 2031-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07460765
The ClinicalTrials.gov registry entry for NCT07460765 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT07460765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07460765 about?
NCT07460765 is a clinical study titled "Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)". 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....
What is the current status of trial NCT07460765?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-07. Estimated completion is 2031-04.
What interventions are being tested in trial NCT07460765?
The interventions under investigation include: Nivolumab (DRUG), Nivo800 (DRUG).
Who is sponsoring clinical trial NCT07460765?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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