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

Phase 2 Completed 95 enrolled PDS Biotechnology Corp. Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Timeline

Start: 2021-03-29
Primary completion: 2025-05-14
Completion: 2025-05-14

Publications

Background Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response. J Immunol. 2019 Jun 15;202(12):3524-3536. doi: 10.4049/jimmunol.1801634. Epub 2019 May 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PEXIPEPIMUT-S	Vaccine	0.5 ml	Subcutaneous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications