Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT03600350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2018-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: