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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 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.

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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).

Conditions Studied

Prostate Cancer Metastatic Cancer Castration-resistant Prostate Cancer

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

FieldValue
Enrollment Target 60 participants
Start Date 2019-10-21
Est. Completion 2026-10
Phase Phase 2

Sponsor

University of Wisconsin, Madison

1,039 total trials

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What the Registry Record Tells You About NCT04090528

The ClinicalTrials.gov registry entry for NCT04090528 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.