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Can a glowing drug light up head and neck tumors?

NCT ID NCT07741565

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This early-phase trial is testing whether injecting a fluorescently labeled version of the immunotherapy drug nivolumab directly into head and neck tumors is safe and helps visualize the tumor and nearby lymph nodes during surgery. Adults with head and neck squamous cell carcinoma who are scheduled for surgery will receive two injections of the study drug before their operation. Researchers will also study how the drug travels to lymph nodes and how it relates to immune responses, which could improve surgical guidance and understanding of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nivolumab-IRDye800 (nivo800), a fluorescently labeled version of the immunotherapy drug nivolumab, injected directly into the tumor
What this could lead to
If successful, this approach could improve surgical precision by highlighting tumors and lymph nodes, and may help personalize immunotherapy for head and neck cancer.
What could go wrong
This is a very early, small trial focused on safety and imaging, not treatment effectiveness. The fluorescent dye or injection method could cause side effects, and results may not apply to larger populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must have biopsy proven HNSCC. 2. Planned to undergo surgical excision. 3. Age ≥ 18 years. 4. Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion). 5. Written informed consent. Exclusion Criteria: 1. Patients not eligible for SOC surgical resection 2. 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. 3. 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. 4. 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 5. Severe unresolved infection within 4 weeks prior to initiation of study treatment. 6. Prior allogeneic stem cell or solid organ transplantation 7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins 8. 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. 9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final administration of study treatment.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma lip and oral cavity carcinoma Mouth Neoplasms squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.