Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06790966 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT06790966 · ClinicalTrials.gov record · last posted 2026-04-06

Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Study acronym: VERSATILE-003
StatusActive, Not Recruiting
PhasePhase 3
Started2025-05-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This is a global, multi-center, Phase 3 study that is randomized 1:1, 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.

Amendment record 15 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 15 times since 2025-01-18; most recent amendment 2026-03-31. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-10-30
Status change Recruiting→Active, Not Recruitingv13
2025-03-10
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06790966
Lead Sponsor PDS Biotechnology Corp.
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
Enrollment 252 participants
Start Date 2025-05-30
Primary Completion 2029-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-04-06