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.
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).
Patients not eligible for SOC surgical resection
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.
Rash must cover < 10% of body surface area
Sequential
Nivolumab-IRDye800
DrugNivolumab-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).
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.
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Vanderbilt-Ingram Cancer Center
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
