pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Phase 2 Active not recruiting 19 enrolled University of Wisconsin, Madison AIQ Solutions · collab Bristol-Myers Squibb · collab Madison Vaccines Inc. (MVI) · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).

Timeline

Start: 2018-09-10
Primary completion: 2022-11-07
Completion: 2027-12

Publications

McNeel DG, Emamekhoo H, Eickhoff JC, Kyriakopoulos CE, Wargowski E, Tonelli TP, Johnson LE, Liu G. Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in patients with castration-sensitive non-metastatic (M0) prostate cancer. J Immunother Cancer. 2023 Dec 14;11(12):e008067. doi: 10.1136/jitc-2023-008067.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	pTVG-HP	Vaccine	100 ug	Intravenous
Background	sargramostim	Protein / enzyme biologic	208 ug	Intravenous

pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications