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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 7 wordsv3 See this version in full on ClinicalTrials.gov ↗
  2. Recruitment opened Start date: Apr 30, 2026 to Jul 2026 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Apr 30, 2026 to Jul 2026
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov