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

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.

Timeline

Start

2025-05-30

Primary completion

2026-08-25

Completion

2026-08-25

Outcome

Outcome not reported

Stopped (Business): “The study is being discontinued solely based on financial constraints and is not related to the safety of study participants, the investigational product, PDS0101, nor the conduct of the study.”

Drugs

Indications