CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 19 enrolled
Drug / intervention
pTVG-HP +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03600350
NCT03600350Phase 2Active
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Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer

University of Wisconsin, Madison·interventional·Posted Jul 26, 2018·Updated Jun 1, 2026

In Brief

A Phase 2 clinical trial evaluating pTVG-HP, Nivolumab, and 1 other intervention for Prostate Cancer. Active but no longer recruiting, targeting 19 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Madison Vaccines Inc. (MVI), AIQ Solutions

Timeline

Phase 2Active
2019202020212022202320242025202620272028
First PostedJul 26, 2018
Enrollment StartSep 10, 2018
Primary CompletionNov 7, 2022
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.9 years ago

Interventions

pTVG-HPbiological

Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)

Nivolumabdrug

Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.

GM-CSFdrug

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.