Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) (NCT07460765)
🩺 Plain-English Summary (8th-Grade Level)
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: * 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.
Who can join: Review the eligibility criteria below.
Location: Vanderbilt University Medical Center — Nashville, Tennessee
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Vanderbilt University Medical Center — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (615) 421-4370
Email: makenna.l.brown@vumc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hnscc
- Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors — Portland, Oregon
- Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC — Cincinnati, Ohio
- Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC — Orange, California
- A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors — Denver, Colorado
- Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer — Nashville, Tennessee
Explore by condition: All Hnscc clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.