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HnsccDiagnostics and screeningDental and oral healthCancerDrugPhase 1

What this study is

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.

What's being tested

  • Nivo800

    Intervention · DRUG

    Participants will receive nivo800 prior to their standard of care surgery.

  • Nivolumab

    Intervention · DRUG

    Participants in Cohort 4 will receive nivolumab and nivo800 prior to their standard of care surgery.

Study details

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 · Squamous Cell Cancer of the Head and Neck · Squamous Cell Carcinoma (SCC) of the Oral Cavity · Squamous Cell Carcinoma (SCC)
Enrolling
40 people
Starts
2026-07-03
Est. completion
2031-04
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗