deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT04260126

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (VERSATILE002)

A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects With Recurrent and/or Metastatic HNSCC and High-Risk HPV16 Infection

Sponsor: Merck Sharp & Dohme LLC

Updated 29 times since 2020 Last updated: Sep 25, 2025 Started: Mar 29, 2021 Primary completion: May 14, 2025 Completion: May 14, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer and is currently completed. Merck Sharp & Dohme LLC leads this study, which shows 29 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Dec 2020 · 6 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Jul 2023 · 5 months · monthly snapshot~Jul 2023 – ~Apr 2024 · 9 months · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Nov 2025 · 10 months · monthly snapshot~Nov 2025 – present · 9 months · monthly snapshot

Change History

29 versions recorded
  1. Nov 2025 — Present [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Jan 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

Show 24 earlier versions
  1. Apr 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Jul 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  3. Feb 2023 — Jul 2023 [monthly]

    Recruiting PHASE2

  4. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE2

  6. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  7. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  8. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  9. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  10. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  11. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  12. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  13. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  14. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  15. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  16. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  17. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  18. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  19. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  20. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  21. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  22. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  23. Jun 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE2

  24. Mar 2020 — Jun 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
  • PDS Biotechnology Corp.
Data source: PDS Biotechnology Corp.

For direct contact, visit the study record on ClinicalTrials.gov .