Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer

Summary

This randomized pilot trial studies vaccine therapy and pembrolizumab in treating patients with prostate cancer that does not respond to treatment with hormones (hormone-resistant) and has spread to other places in the body (metastatic). Vaccines made from deoxyribonucleic acid (DNA), such as pTVG-HP plasmid DNA vaccine, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may find tumor cells and help kill them. Giving pTVG-HP plasmid DNA vaccine and pembrolizumab may kill more tumor cells.

Timeline

Start

2015-07-01

Primary completion

2021-08-09

Completion

2023-07-27

Publications

• Results McNeel DG, Eickhoff JC, Wargowski E, Zahm C, Staab MJ, Straus J, Liu G. Concurrent, but not sequential, PD-1 blockade with a DNA vaccine elicits anti-tumor responses in patients with metastatic, castration-resistant prostate cancer. Oncotarget. 2018 May 22;9(39):25586-25596. doi: 10.18632/oncotarget.25387. eCollection 2018 May 22.
• Results McNeel DG, Eickhoff JC, Wargowski E, Johnson LE, Kyriakopoulos CE, Emamekhoo H, Lang JM, Brennan MJ, Liu G. Phase 2 trial of T-cell activation using MVI-816 and pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2022 Mar;10(3):e004198. doi: 10.1136/jitc-2021-004198.
• Rastogi I, McNeel DG. Prostate tumor immune microenvironment changes following immunotherapy shared by patients who developed anti-tumor response or immune-related adverse events. Oncoimmunology. 2025 Dec 31;14(1):2595788. doi: 10.1080/2162402X.2025.2595788. Epub 2025 Dec 11.
• Scarpelli M, Zahm C, Perlman S, McNeel DG, Jeraj R, Liu G. FLT PET/CT imaging of metastatic prostate cancer patients treated with pTVG-HP DNA vaccine and pembrolizumab. J Immunother Cancer. 2019 Jan 30;7(1):23. doi: 10.1186/s40425-019-0516-1.

Drugs

Indications