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. 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.

NCT Number	NCT07460765
Lead Sponsor	Vanderbilt-Ingram Cancer Center
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 +3 more
Enrollment	40 participants
Start Date	2026-07
Primary Completion	2030-04 (estimated)
Study Completion	2031-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-07