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
Not Yet 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 nivolumab and nivo800 prior to their standard of care surgery.
  • Nivolumab — DRUG
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Nivo - 10 mg / Nivo800 - 10 mg
    All participants will receive 10mg of unlabeled nivolumab and nivo800.
  • Experimental: Nivo - 20 mg / Nivo800 - 20 mg
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
  • Experimental: Nivo - 40 mg / Nivo800 - 40 mg
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
  • Experimental: Nivo - 240 mg / Nivo800 - 100 mg and Nivo - 140 mg
    Participants will receive nivolumab and nivo800 prior to their standard of care surgery.

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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