Intratumoral fluorescent nivolumab before surgery in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial investigates the safety and distribution of intratumorally injected nivo800 (fluorescently labeled nivolumab) in adults with head and neck squamous cell carcinoma who are planned for tumor resection. Participants receive two injections into the tumor spaced about a week or two apart, with monitoring for safety and tolerability. The study also aims to understand how much of the drug travels to adjacent lymph nodes and how delivery relates to tumor and immune responses. Outcomes include basic safety data and exploratory information on immune activity in the tumor vicinity. The trial is conducted at Vanderbilt University Medical Center under an investigator-initiated framework with the lead sponsor as Vanderbilt-Ingram Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients not eligible for SOC surgical resection
2. 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.
3. 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.
4. 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
5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.
6. Prior allogeneic stem cell or solid organ transplantation
7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
8. 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:

   * Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.
   * 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.
   * Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
   * Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
   * Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard pre-medication are permitted.
9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final administration of study treatment.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Kenji Kobayashi, MD — Vanderbilt University Medical Center
• Study coordinator: Makenna L Brown, MD
• Email: makenna.l.brown@vumc.org
• Phone: 615-421-4370

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.