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NCT06790966 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by PDS Biotechnology.
- Active
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT06790966: Active Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by PDS Biotechnology.
NCT06790966 is a Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer that is active but no longer recruiting, run by PDS Biotechnology. The registered enrollment target is 351 participants, above the 70-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (401% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06790966, a Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, is active but no longer recruiting, sponsored by PDS Biotechnology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 351 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a global, multi-center, Phase 3 study that is randomized 2:1, 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.
Primary Outcome
OS is defined as the time from randomization until death from any cause.
Conditions Studied
Interventions
- DRUG Pembrolizumab Monotherapy
- COMBINATION_PRODUCT Combination Treatment of PDS0101 and Pembrolizumab
Study Locations (20)
Florida
- Mayo Clinic Florida - Jacksonville
- Florida Cancer Affiliates - Ocala Oncology - Ocala
- SCRI - Florida Cancer Specialists - Orlando
Kentucky
- University of Kentucky - Lexington
- Norton Cancer Institute - Louisville
- University of Louisville - Louisville
California
- Marin Cancer Care - Greenbrae
- University of California, Orange - Orange
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
Pennsylvania
- Penn State Health - Hershey
- Fox Chase Cancer Center - Philadelphia
Arizona
- Mayo Clinic Arizona - Phoenix
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Winship Cancer Institute (WCI) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2029-02 |
| Phase | Phase 3 |
What the registry record for NCT06790966 still lists
NCT06790966 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, above the 70-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (401% higher).
The record links to 5 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab Monotherapy is the first listed.
NCT06790966 names 20 study sites across 13 states, led by Florida, Kentucky, California.
Frequently Asked Questions
What is clinical trial NCT06790966 about?
NCT06790966 is a clinical study titled "Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma". This is a global, multi-center, Phase 3 study that is randomized 2:1, 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...
What is the current status of trial NCT06790966?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2025-05-30. Estimated completion is 2029-02.
What conditions does trial NCT06790966 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Neoplasms, Head and Neck, Recurrent Head and Neck Cancer, Unresectable Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06790966?
The interventions under investigation include: Pembrolizumab Monotherapy (DRUG), Combination Treatment of PDS0101 and Pembrolizumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06790966?
This trial is sponsored by PDS Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06790966 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06790966's enrollment target sits among peer trials
351 1st of 16 higher than 16 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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