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

NCT07741565 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-03

No results posted yet for this study

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. 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.

Conditions

  • HNSCC
  • SCC - Squamous Cell Carcinoma
  • Oral Cancer

Interventions

DRUG

Nivolumab-IRDye800

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).

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Kenji Kobayashi, MD · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-09-30
Completion
2031-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741565 on ClinicalTrials.gov