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Safety of Nivolumab-IRDye800CW for Head and Neck Cancer Surgery

This study is looking at the safety of a drug called nivolumab-IRDye800CW (nivo800) for adults with head and neck squamous cell carcinoma (HNSCC), which is a type of cancer that starts in the moist linings of the head and neck. Participants will receive nivo800 before their standard surgery. Some participants will also receive nivolumab. The main goal is to see if nivo800 is safe and how well it works as an imaging agent to help doctors see the cancer. We are also looking at how the tumor responds to the treatment. This study is currently recruiting about 40 participants who are at least 18 years old and have HNSCC confirmed by a biopsy or imaging, and are scheduled for surgery.

Study design
This is a Phase 1 interventional study aiming to enroll 40 participants. It is designed to evaluate the safety and feasibility of nivo800.
What's involved
Participants will receive nivo800 prior to their standard surgery. Some participants will also receive nivolumab prior to surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint is measured within 15 days of drug administration.

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NCT07460765

Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

Recruiting
Phase 1All Ages
Updated 2026-08-26T02:16:22.235886+00:00 on ClinicalTrials.gov

Conditions

Hnscc
Head and Neck
Squamous Cell Cancer
Squamous Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Squamous Cell Carcinoma Mouth
Squamous Carcinoma Poorly Differentiated
Squamous Cell Cancer of the Head and Neck
Squamous Cell Carcinoma (SCC) of the Oral Cavity
Squamous Cell Carcinoma (SCC)

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Head and Neck Squamous Cell Carcinoma

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Written informed consent
Age ≥ 18 years
Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.
Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).
Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2.

Exclusion

Patients not planning for SOC surgical resection
Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, 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 hepatitis C that has not been treated with curative intent.
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 on active systemic therapy.
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 3 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 2 months after the final dose of study drug administration.
Participants presenting with a baseline QTcF interval \> than 480 milliseconds.