HNSCCEarly Phase 1NCT07741565
Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)
A Early Phase 1 study testing Nivolumab-IRDye800 in people with HNSCC and SCC - Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC, SCC - Squamous Cell Carcinoma, Oral Cancer
- What is being tested?
- Nivolumab-IRDye800
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
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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 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.
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
Makenna Brown, 615-421-4370, makenna.l.brown@vumc.org
Nicole Jones, 615-936-2807, nicole.l.jones@vumc.org
About this study
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:
Read more
- 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.
- Conditions
- HNSCC, SCC - Squamous Cell Carcinoma, Oral Cancer
- Being tested
- Nivolumab-IRDye800
- Keywords
- Nivo800, Fluorescent Guided Surgery, Head and Neck Cancer, SCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab-IRDye800Drug
Nivolumab-IRDye800 (nivo800) is an investigational fluorescent imaging agent consisting of the anti-PD-1 monoclonal antibody nivolumab conjugated to IRDye800CW, a near-infrared fluorescent dye. Unlike standard therapeutic nivolumab, nivo800 is administered intratumorally rather than intravenously and is used to evaluate local drug distribution, lymphatic trafficking, and molecular imaging in patients with head and neck squamous cell carcinoma. Participants receive two preoperative intratumoral injections of nivo800 at a dose level determined by study cohort (2.5 mg/cm or 5 mg/cm of greatest tumor diameter).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Nivo800 (2.5 mg/cm) | Experimental | Participants in Cohort 1 will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 2.5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be performed directly into the tumor using a multi-quadrant technique when feasible to maximize drug distribution within the tumor. Receives: Drug: Nivolumab-IRDye800 |
| Expansion Cohort - Nivo800 (5 mg/cm) | Experimental | Participants in the Expansion Cohort will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be delivered directly into the tumor using a multi-quadrant technique when anatomically feasible to maximize intratumoral distribution. Receives: Drug: Nivolumab-IRDye800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety nivo800 administered intratumorally.
Number of Grade ≥ 2 adverse events (AE) determined to be clinically significant and considered definitely or probably related to nivo800.
Measured: Up to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenji Kobayashi, Vanderbilt University Medical Center
- Investigators
- Kenji Kobayashi, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741565
- Sponsor's protocol ID
- VICCHN26044
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT07741565
- Acronym / sponsor ID
- VICCHN26044
- Conditions
- HNSCC, SCC - Squamous Cell Carcinoma, Oral Cancer
- Keywords
- Nivo800, Fluorescent Guided Surgery, Head and Neck Cancer, SCC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Nivo800 (2.5 mg/cm) | Experimental | Drug: Nivolumab-IRDye800Participants in Cohort 1 will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 2.5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be performed directly into the tumor using a multi-quadrant technique when feasible to maximize drug distribution within the tumor. |
| Expansion Cohort - Nivo800 (5 mg/cm) | Experimental | Drug: Nivolumab-IRDye800Participants in the Expansion Cohort will receive two intratumoral injections of nivolumab-IRDye800 (nivo800) at a dose of 5 mg per centimeter of greatest tumor diameter. The first injection will be administered approximately 14-21 days before planned surgical resection, and the second injection will be administered approximately 1-3 days before surgery. Injections will be delivered directly into the tumor using a multi-quadrant technique when anatomically feasible to maximize intratumoral distribution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab-IRDye800Nivolumab-IRDye800 (nivo800) is an investigational fluorescent imaging agent consisting of the anti-PD-1 monoclonal antibody nivolumab conjugated to IRDye800CW, a near-infrared fluorescent dye. Unlike standard therapeutic nivolumab, nivo800 is administered intratumorally rather than intravenously and is used to evaluate local drug distribution, lymphatic trafficking, and molecular imaging in patients with head and neck squamous cell carcinoma. Participants receive two preoperative intratumoral injections of nivo800 at a dose level determined by study cohort (2.5 mg/cm or 5 mg/cm of greatest tumor diameter). | Drug | Cohort 1 - Nivo800 (2.5 mg/cm), Expansion Cohort - Nivo800 (5 mg/cm) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenji Kobayashi, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nivolumab-IRDye800 in people with HNSCC and SCC - Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Makenna L Brown, MD (615-421-4370, makenna.l.brown@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety nivo800 administered intratumorally. (time frame: Up to 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.