Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
← catalyst calendarSponsored by PDS Biotechnology Corp. (industry) · PDSB — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
95actual
Sites
23
Countries
Ireland, Puerto Rico, United Kingdom +1
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 | 2021-03-29 | actual | When the study began enrolling |
| Primary completion | 2025-05-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-14 | actual | The whole study's end, after follow-up |
| First posted | 2020-02-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Head and Neck Cancer
- Recurrent Head and Neck Cancer
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Neoplasms, Head and Neck
Intervention
- Combination product: Pembrolizumab (KEYTRUDA®) and PDS0101
Primary outcome
what the primary-completion date above is the date OFBest Overall Response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) of the combination of pembrolizumab and PDS0101.
measured 24 Months
Publications
- PMID 31053626 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · PDSB's whole pipeline · Catalyst calendar · Every registered study · What changed