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

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

Last updated 2026-07-07

No results posted yet for this 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.

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 nivo800 prior to their standard of care surgery.

DRUG

Nivolumab

Participants in Cohort 4 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
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
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