Nivolumab for Head and Neck Squamous Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Kenji Kobayashi, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with biopsy-confirmed head and neck squamous cell carcinoma who are scheduled for surgery. Participants must be healthy enough for surgery and anesthesia, and able to give informed consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab-IRDye800
Trial Overview
Researchers are testing the safety of injecting a fluorescently labeled drug called nivo800 (a form of nivolumab) directly into tumors before surgery. The study also tracks how the drug moves to nearby lymph nodes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
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