NCT06790966

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

A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: PDS Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PDS0101 is a T cell activating immunotherapy designed to induce HPV-specific CD8 and CD4 T cells. A Phase 2 study has shown promising signs of safety and efficacy when PDS0101 is combined with pembrolizumab in patients with HPV16-positive R/M HNSCC with CPS ≥1, which is the population for this study. The dual primary objectives of this study are to compare the effect of the combination of PDS0101 plus pembrolizumab vs. pembrolizumab monotherapy on progression-free survival (PFS) and overall survival (OS). Secondary objectives for this study include comparison of effects on objective response rate (ORR), disease control rate (DCR), and duration of response (DOR).

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

Type	Name	Description
COMBINATION_PRODUCT	Combination Treatment of PDS0101 and Pembrolizumab	* Pembrolizumab (IV) every 3 weeks for up to 35 Cycles * PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12
DRUG	Pembrolizumab Monotherapy	Pembrolizumab (IV) every 3 weeks for up to 35 cycles.

Timeline

• Start date: 2025-05-30
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2025-01-24
• Last updated: 2026-04-06

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study