Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT07741565 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: VICCHN26044
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether intratumoral (injected directly into the tumor) fluorescently labeled nivolumab (nivo800) is safe for adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo surgery. Researchers also want to learn how well nivo800 travels to nearby lymph nodes and whether it can be used to study immune responses in and around the tumor. The main questions it aims to answer are:

• Is intratumoral nivo800 safe and well tolerated in patients with HNSCC?
• How much of the injected nivo800 reaches and remains in nearby lymph nodes, and how is drug delivery related to immune and tumor responses? Participants will:
• Receive a first injection of nivo800 directly into the tumor approximately 14-21 days before surgery.
• Receive a second injection of nivo800 directly into the tumor approximately 1-3 days before surgery.
• Have physical exams, vital signs assessments, blood tests, and safety monitoring during the study.
• Undergo their planned standard-of-care surgery, during which tumor and lymph node tissues will be collected for research analyses.
• Provide blood samples and complete follow-up assessments to evaluate side effects and study drug distribution.

Conditions

HNSCC; SCC - Squamous Cell Carcinoma; Oral Cancer

Keywords

Nivo800; Fluorescent Guided Surgery; Head and Neck Cancer; SCC

Outcome Measures

Primary Outcomes (1)

• Determine the safety nivo800 administered intratumorally.

  Number of Grade ≥ 2 adverse events (AE) determined to be clinically significant and considered definitely or probably related to nivo800.

  Up to 30 Days

Study Arms (2)

Cohort 1 - Nivo800 (2.5 mg/cm)

EXPERIMENTAL

Participants in Cohort 1 will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 2.5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be performed directly into the tumor using a multi-quadrant technique when feasible to maximize drug distribution within the tumor.

Drug: Nivolumab-IRDye800

Expansion Cohort - Nivo800 (5 mg/cm)

EXPERIMENTAL

Participants in the Expansion Cohort will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be delivered directly into the tumor using a multi-quadrant technique when anatomically feasible to maximize intratumoral distribution.

Drug: Nivolumab-IRDye800

Interventions

Nivolumab-IRDye800 DRUG

Nivolumab-IRDye800 (nivo800) is an investigational fluorescent imaging agent consisting of the anti-PD-1 monoclonal antibody nivolumab conjugated to IRDye800CW, a near-infrared fluorescent dye. Unlike standard therapeutic nivolumab, nivo800 is administered intratumorally rather than intravenously and is used to evaluate local drug distribution, lymphatic trafficking, and molecular imaging in patients with head and neck squamous cell carcinoma. Participants receive two preoperative intratumoral injections of nivo800 at a dose level determined by study cohort (2.5 mg/cm or 5 mg/cm of greatest tumor diameter).

Cohort 1 - Nivo800 (2.5 mg/cm); Expansion Cohort - Nivo800 (5 mg/cm)

Eligibility Criteria

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

You may qualify if:

• Participants must have biopsy proven HNSCC.
• Planned to undergo surgical excision.
• Age ≥ 18 years.
• Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).
• Written informed consent.

You may not qualify if:

• Patients not eligible for SOC surgical resection
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, 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 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.
• 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 6 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:

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenji Kobayashi, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makenna L Brown, MD

CONTACT

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

Nicole L Jones, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: Otolaryngology

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: August 3, 2026

Record last verified: 2026-07