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

NCT07460765 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VICCHN25078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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)

Keywords

nivo800; neoadjuvant; surgery; head and neck cancer; head and neck; surgical resection; oral cancer; SCC; HNSCC

Outcome Measures

Primary Outcomes (1)

• Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent.

  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

Study Arms (4)

Cohort 1 - Nivo800 (10 mg)

EXPERIMENTAL

All participants will receive 10mg of nivo800.

Drug: Nivo800

Cohort 2 - Nivo800 (25 mg)

EXPERIMENTAL

Participants will receive 25 mg of nivo800 for each infusion visit.

Drug: Nivo800

Cohort 3 - Nivo800 (50 mg)

EXPERIMENTAL

Participants will receive 50 mg of nivo800 every infusion visit.

Drug: Nivo800

Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg)

EXPERIMENTAL

Participants will receive 190 mg nivolumab and 50 mg nivo800 for every infusion visit.

Drug: Nivo800; Drug: Nivolumab

Interventions

Nivo800 DRUG

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

Also known as: nivolumab

Cohort 1 - Nivo800 (10 mg); Cohort 2 - Nivo800 (25 mg); Cohort 3 - Nivo800 (50 mg); Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg)

Nivolumab DRUG

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

Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, hepatic function 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.

You may not qualify if:

• 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:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• 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:
• Rash must cover \< 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Mouth Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Eben Rosenthal, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makenna Brown

CONTACT

(615)421-4370; makenna.l.brown@vumc.org

Nicole Jones

CONTACT

615-936-2807; nicole.l.jones@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

US (1)