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

NCT07460765 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Eben Rosenthal, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2030-04-30
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07460765 on ClinicalTrials.gov