NCT07460765

Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.

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)

Interventions

Type	Name	Description
DRUG	Nivo800	Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
DRUG	Nivolumab	Participants will receive nivolumab and nivo800 prior to their standard of care surgery.

Timeline

• Start date: 2026-04-30
• Primary completion: 2030-04-01
• Completion: 2031-04-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study