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

March 4, 2026 updated by: Eben Rosenthal, Vanderbilt-Ingram Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent
  • Age ≥ 18 years
  • Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.
  • Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2.
  • Negative hepatitis B surface antigen (HBsAg) test at screening

Exclusion Criteria:

  • Patients not planning for SOC surgical resection

  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:

    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:

      1. Rash must cover < 10% of body surface area
      2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids
      3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months
  • History of hepatitis C that has not been treated with curative intent.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • Severe unresolved infection within 4 weeks prior to initiation of study treatment.
  • Prior allogeneic stem cell or solid organ transplantation.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

  • Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (>10 mg/day of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:

    1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.
    2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
    3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if >30 days from first infusion.
    4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
    5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.
  • Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.
  • Participants presenting with a baseline QTcF interval > than 480 milliseconds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivo - 10 mg / Nivo800 - 10 mg
All participants will receive 10mg of unlabeled nivolumab and nivo800.
Drug: Nivo800
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Other Names:
  • nivolumab
Drug: Nivolumab
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Experimental: Nivo - 20 mg / Nivo800 - 20 mg
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Drug: Nivo800
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Other Names:
  • nivolumab
Drug: Nivolumab
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.
Drug: Nivo800
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Other Names:
  • nivolumab
Drug: Nivolumab
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.
Drug: Nivo800
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Other Names:
  • nivolumab
Drug: Nivolumab
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent.
Time Frame: Within 15 days of drug administration
As defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered possibly, probably, or definitely related to nivo800. Safety data will be summarized by grade, severity, and type.
Within 15 days of drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Investigators

  • Principal Investigator: Eben Rosenthal, MD, Vanderbilt University/Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICCHN25078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to post the results of this study and may share data upon request and proper agreements with other institutions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe