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NCT04090528 · ClinicalTrials.gov registry record · Phase 2
pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer
A Phase 2 study of Prostate Cancer and Metastatic Cancer, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04090528: Active Phase 2 study of Prostate Cancer and Metastatic Cancer, sponsored by University of Wisconsin, Madison.
NCT04090528 is a Phase 2 study of Prostate Cancer and Metastatic Cancer that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04090528, a Phase 2 study of Prostate Cancer and Metastatic Cancer, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer. The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines and/or objective radiographic responses. Participants must be 18 years of age or older and can expect to be on treatment for 2 years (32 cycles) and on study for up to 7 years (including 5 years of follow up via phone).
Primary Outcome
The expected 6-months PFS rate in Arm 1 (pTVG-HP DNA vaccine and Pembrolizumab) in this participant population is 20-30%. It is hypothesized that adding pTVG-AR DNA vaccine (Arm 2) will increase the 6-months PFS rate to at least 55%. The 6-month PFS rate will be calculated for each study arm along with the corresponding two-sided 95% confidence interval which will be constructed using the Wilson score method. Participants who withdraw from the study without a progression or death event before t
Conditions Studied
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL pTVG-AR
- BIOLOGICAL pTVG-HP
Study Locations (2)
Missouri
- Washington University Siteman Cancer Center - St Louis
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT04090528 still lists
NCT04090528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04090528 reports a single indexed study location in Missouri, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04090528 about?
NCT04090528 is a clinical study titled "pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer". This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the...
What is the current status of trial NCT04090528?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-10-21. Estimated completion is 2026-10.
What conditions does trial NCT04090528 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Cancer, Castration-resistant Prostate Cancer.
What interventions are being tested in trial NCT04090528?
The interventions under investigation include: Pembrolizumab (DRUG), pTVG-AR (BIOLOGICAL), pTVG-HP (BIOLOGICAL).
Who is sponsoring clinical trial NCT04090528?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04090528 being conducted?
This trial has 2 study locations across Missouri, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04090528's enrollment target sits among peer trials
60 421st of 735 higher than 293 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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