HnsccPhase 1NCT07460765
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study testing Nivo800 and Nivolumab in people with Hnscc and Head and Neck, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hnscc, Head and Neck, Squamous Cell Cancer
- What is being tested?
- Nivo800 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2026to Apr 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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
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- 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 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:
- 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 steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if >30 days from first infusion.
- 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 premedication is permitted.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Nicole Jones, 615-936-2807, nicole.l.jones@vumc.org
About this study
The goal of this Phase 1 clinical trial is to evaluate the safety and feasibility of nivolumab-IRDye800CW (nivo800) as a molecular imaging agent in adults with biopsy-confirmed or presumed head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo standard-of-care surgical resection.
The main questions it aims to answer are:
Read more
- Is nivolumab-IRDye800CW (nivo800) safe when administered before surgery, as measured by the occurrence of clinically significant Grade ≥2 adverse events that are possibly, probably, or definitely related to the study drug?
- What is the extent of pathological response at each dose level, including residual viable tumor, fibrosis, necrosis, and tumor-infiltrating lymphocyte characteristics?
Participants will:
- Receive two intravenous infusions during the preoperative period, approximately 2-3 weeks before surgery and again 1-2 days before surgery.
- Undergo standard-of-care surgical resection with collection of tumor and lymph node specimens for pathological and imaging studies.
- 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)
- Being tested
- Nivo800, Nivolumab
- Keywords
- nivo800, neoadjuvant, surgery, head and neck cancer, head and neck, surgical resection, oral cancer, SCC, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms, Squamous Cell, Carcinoma, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivo800Drug
Also called nivolumab
Participants will receive nivo800 prior to their standard of care surgery.
NivolumabDrug
Participants in Cohort 4 will receive nivolumab and nivo800 prior to their standard of care surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Nivo800 (10 mg) | Experimental | All participants will receive 10mg of nivo800. Receives: Drug: Nivo800 |
| Cohort 2 - Nivo800 (25 mg) | Experimental | Participants will receive 25 mg of nivo800 for each infusion visit. Receives: Drug: Nivo800 |
| Cohort 3 - Nivo800 (50 mg) | Experimental | Participants will receive 50 mg of nivo800 every infusion visit. Receives: Drug: Nivo800 |
| Cohort 4 - Nivo800 (50 mg) and Nivolumab (190 mg) | Experimental | Participants will receive 190 mg nivolumab and 50 mg nivo800 for every infusion visit. Receives: Drug: Nivo800; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent.
As defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered possibly, probably, or definitely related to nivo800. Safety data will be summarized by grade, severity, and type.
Measured: Within 15 days of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start3 Jul 2026
- Primary completionApr 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HnsccStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eben Rosenthal, Vanderbilt-Ingram Cancer Center
- Investigators
- Eben Rosenthal, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460765
- Sponsor's protocol ID
- VICCHN25078
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to post the results of this study and may share data upon request and proper agreements with other institutions.