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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07460765
Phase
PHASE1
Status
Recruiting
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Conditions

  • Head and Neck
  • Hnscc
  • Squamous Carcinoma
  • Squamous Carcinoma Poorly Differentiated
  • Squamous Cell Cancer
  • Squamous Cell Cancer of Head and Neck (SCCHN)
  • Squamous Cell Cancer of the Head and Neck
  • Squamous Cell Carcinoma (SCC)
  • Squamous Cell Carcinoma (SCC) of the Oral Cavity
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Squamous Cell Carcinoma Mouth

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivo800 — DRUG
    Participants will receive nivo800 prior to their standard of care surgery.
  • Nivolumab — DRUG
    Participants in Cohort 4 will receive nivolumab and nivo800 prior to their standard of care surgery.

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1 - Nivo800 (10 mg)
    All participants will receive 10mg of nivo800.
  • Experimental: Cohort 2 - Nivo800 (25 mg)
    Participants will receive 25 mg of nivo800 for each infusion visit.
  • Experimental: Cohort 3 - Nivo800 (50 mg)
    Participants will receive 50 mg of nivo800 every infusion visit.
  • Experimental: Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg)
    Participants will receive 190 mg nivolumab and 50 mg nivo800 for every infusion visit.

Primary Outcome Measure

Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. [ Time Frame: Within 15 days of drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Nicole Jones
[email protected]
615-936-2807

Find similar trials in Nashville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Vanderbilt University Medical Center· Nashville, TN

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