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:
Participants will:
Inclusion Criteria:
Exclusion Criteria:
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:
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.
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:
Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final administration of study treatment.
makenna.l.brown@vumc.org615-421-4370
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.
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.
nicole.l.jones@vumc.org615-936-2807
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