Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head … (NCT07741565) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)
18 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the safety nivo800 administered intratumorally.
. 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: