NCT07741565Not yet recruitingPhase 1
Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 18
- Primary Endpoint
- Determine the safety nivo800 administered intratumorally.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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:
- •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:
- •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.
- •Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final administration of study treatment.
Outcomes
Primary Outcomes
Determine the safety nivo800 administered intratumorally.
Time Frame: Up to 30 Days
Number of Grade ≥ 2 adverse events (AE) determined to be clinically significant and considered definitely or probably related to nivo800.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kenji Kobayashi
Assistant Professor: Otolaryngology
Vanderbilt University Medical Center
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