Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
← catalyst calendarNCT06790966 · readout ≤ 923 d
Sponsored by PDS Biotechnology Corp. (industry) · PDSB — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
252estimated
Sites
28
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-30 | actual | When the study began enrolling |
| Primary completion | Feb 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Recurrent Head and Neck Cancer
- Metastatic Head and Neck Cancer
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Neoplasms, Head and Neck
- Unresectable Head and Neck Squamous Cell Carcinoma
Interventions
- Combination product: Combination Treatment of PDS0101 and Pembrolizumab — also filed as Versamune HPV, KEYTRUDA
- Drug: Pembrolizumab Monotherapy — also filed as KEYTRUDA
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS)
measured Up to 54 months
Progression-Free Survival (PFS)
measured Up to 18 months
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