Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07741565
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • HNSCC
  • Oral Cancer
  • SCC - Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab-IRDye800 — DRUG
    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 Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1 - Nivo800 (2.5 mg/cm)
    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.
  • Experimental: Expansion Cohort - Nivo800 (5 mg/cm)
    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.

Primary Outcome Measure

Determine the safety nivo800 administered intratumorally. [ Time Frame: Up to 30 Days ]

Central Contacts

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