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NCT04260126 · ClinicalTrials.gov registry record · Phase 2
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
A Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by PDS Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT04260126: Completed Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by PDS Biotechnology.
NCT04260126 is a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer that has completed, run by PDS Biotechnology. The registered enrollment target is 95 participants, above the 86-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260126, a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, has completed, sponsored by PDS Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Primary Outcome
RECIST 1.1
Conditions Studied
Interventions
- COMBINATION_PRODUCT Pembrolizumab (KEYTRUDA®) and PDS0101
Study Locations (20)
California
- Marin Cancer Center - Greenbrae
- University of California San Francisco - San Francisco
Florida
- Mayo Clinic - Jacksonville
- Cleveland Clinic Florida - Weston
Michigan
- University of Michigan - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
Kentucky
- University of Kentucky Chandler Medical Center - Markey Cancer Center - Lexington
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Minnesota
- Mayo Clinic - Rochester
New Jersey
- Atlantic Health - Morristown
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2025-05-14 |
| Phase | Phase 2 |
What the finished NCT04260126 record still lists
NCT04260126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 86-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (10% higher).
The record links to 4 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab (KEYTRUDA®) and PDS0101 is the first listed.
NCT04260126 names 20 study sites across 17 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04260126 about?
NCT04260126 is a clinical study titled "Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC". VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
What is the current status of trial NCT04260126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-03-29. Estimated completion is 2025-05-14.
What conditions does trial NCT04260126 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.
What interventions are being tested in trial NCT04260126?
The interventions under investigation include: Pembrolizumab (KEYTRUDA®) and PDS0101 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04260126?
This trial is sponsored by PDS Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04260126 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Maryland, Michigan. 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 NCT04260126's enrollment target sits among peer trials
95 7th of 16 higher than 10 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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