Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT06790966. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06790966
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Combination Treatment of PDS0101 and Pembrolizumab Combination Product
- Pembrolizumab Monotherapy Drug
Combination Product · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2025 (Actual)
- Primary completion
- Aug 25, 2026 (Actual)
- Completion
- Aug 25, 2026 (Actual)
- Last update posted
- Sep 2, 2026
2025 – 2026
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| University of California, Orange | Orange | California | 92686 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Florida Cancer Affiliates - Ocala Oncology | Ocala | Florida | 34474 | — |
| SCRI - Florida Cancer Specialists | Orlando | Florida | 32827 | — |
| Emory University - Winship Cancer Institute (WCI) | Atlanta | Georgia | 30322 | — |
| University of Kansas | Westwood | Kansas | 66205 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7025 | — |
| The Ohio State University- James Cancer Hospital | Columbus | Ohio | 43210 | — |
| Penn State Health | Hershey | Pennsylvania | 17033 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19103 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29407 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Texas Oncology | Austin | Texas | 78705 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| Texas Oncology-Northeast Texas | Tyler | Texas | 75702 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| West Virginia University Cancer Center | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06790966, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06790966 live on ClinicalTrials.gov.