Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (NCT06790966)
A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
This is a global, multi-center, Phase 3 study that is randomized 1:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Phoenix, Arizona
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 (28 Sites)
Showing the first 25 of 28 sites.
- Mayo Clinic Arizona — Phoenix, Arizona
- Marin Cancer Care — Greenbrae, California
- University of California, Orange — Orange, California
- Yale University — New Haven, Connecticut
- Mayo Clinic Florida — Jacksonville, Florida
- Florida Cancer Affiliates - Ocala Oncology — Ocala, Florida
- SCRI - Florida Cancer Specialists — Orlando, Florida
- Emory University - Winship Cancer Institute (WCI) — Atlanta, Georgia
- University of Kansas — Westwood, Kansas
- University of Kentucky — Lexington, Kentucky
- Norton Cancer Institute — Louisville, Kentucky
- University of Louisville — Louisville, Kentucky
- University of Maryland — Baltimore, Maryland
- University of Michigan — Ann Arbor, Michigan
- Karmanos Cancer Institute — Detroit, Michigan
- Mayo Clinic Rochester — Rochester, Minnesota
- University of North Carolina — Chapel Hill, North Carolina
- The Ohio State University- James Cancer Hospital — Columbus, Ohio
- Penn State Health — Hershey, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- University of Tennessee Medical Center — Knoxville, Tennessee
- Texas Oncology — Austin, Texas
- UT Health San Antonio — San Antonio, Texas
- Texas Oncology-Northeast Texas — Tyler, Texas
📞 Contact the Study Coordinator
Phone: (800) 664-4580
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.
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💡 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.