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NCT04471974 · ClinicalTrials.gov registry record · Phase 2

ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer

A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Rahul Aggarwal.

Active
Registry status
Phase 2
Development phase
61
Enrollment target
3
Study locations

NCT04471974 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is active but no longer recruiting, run by Rahul Aggarwal. The registered enrollment target is 61 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04471974, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is active but no longer recruiting, sponsored by Rahul Aggarwal.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
61 participants
Enrollment target
3
Study locations

Study Summary

This phase II trial investigates how well ZEN-3694, enzalutamide, and pembrolizumab work in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). ZEN-3694 blocks the expression of the MYC gene to prevent cellular growth in certain types of tumors, including castrate resistant prostate cancer. Enzalutamide has been shown to block testosterone from reaching prostate cancer cells by binding to a receptor on prostate cancer cells, called androgen receptors. This works similar to a lock and key. When enzalutamide (key) inserts into the androgen receptor (lock) testosterone cannot attach to the androgen receptor, which slows the growth of tumor cells and may cause them to shrink. Pembrolizumab is a monoclonal antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) designed to block a specific control switch which may be activated by tumor cells to overcome the body's natural immune system defenses. It also enhances the activity of the body's immune cells against tumor cells. The purpose of this study is to find out the effects ZEN-3694, enzalutamide, and pembrolizumab on patients with metastatic castration-resistant prostate cancer who have previously experienced disease progression.

Conditions Studied

Stage IVB Prostate Cancer AJCC v8 Castration-Resistant Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Metastatic Prostate Adenocarcinoma Metastatic Prostate Small Cell Carcinoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Enzalutamide
  • DRUG BET Bromodomain Inhibitor ZEN-3694

Study Locations (3)

California

  • University of California, San Francisco - San Francisco

Illinois

  • University of Chicago - Evergreen Park

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2021-01-26
Est. Completion 2028-05-31
Phase Phase 2

Sponsor

Rahul Aggarwal

13 total trials

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What the Registry Record Tells You About NCT04471974

The ClinicalTrials.gov registry entry for NCT04471974 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (65% lower). The listed sponsor is Rahul Aggarwal, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT04471974 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Illinois, Michigan.

Frequently Asked Questions

What is clinical trial NCT04471974 about?

NCT04471974 is a clinical study titled "ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer". This phase II trial investigates how well ZEN-3694, enzalutamide, and pembrolizumab work in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). ZEN-3694 blocks the expression of the MYC gene to prevent cellular growth in certain types...

What is the current status of trial NCT04471974?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2021-01-26. Estimated completion is 2028-05-31.

What conditions does trial NCT04471974 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma.

What interventions are being tested in trial NCT04471974?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Enzalutamide (DRUG), BET Bromodomain Inhibitor ZEN-3694 (DRUG).

Who is sponsoring clinical trial NCT04471974?

This trial is sponsored by Rahul Aggarwal, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04471974 being conducted?

This trial has 3 study locations across California, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.