NCT03600350

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

Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	pTVG-HP	Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
DRUG	Nivolumab	Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
DRUG	GM-CSF	Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.

Timeline

• Start date: 2018-09-10
• Primary completion: 2022-12-05
• Completion: 2027-12-01
• First posted: 2018-07-26
• Last updated: 2025-05-09
• Results posted: 2023-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study