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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 54 to confirmed 61
    • Site details revised at 3 of 3 sites
    v12
  3. Primary and study completion dates: Apr 30, 2027 to May 31, 2028v11
  4. Primary and study completion dates: Dec 31, 2025 to Apr 30, 2027
    • Study sites: 2 to 3
    v10
  5. Eligibility criteria expanded, about 44 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 1 to 2v8
  2. Start date: Dec 7, 2020 to Jan 26, 2021
    • Eligibility criteria revised
    v7
  3. Eligibility criteria shortened, about 22 wordsv6
  4. Site contact updatedv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2020 to Dec 7, 2020
    • Site details revised
    v4
  6. Start date: Oct 3, 2020 to Dec 30, 2020
    • Primary and study completion dates: Oct 31, 2025 to Dec 31, 2025
    v3
  7. Start date: Aug 3, 2020 to Oct 3, 2020
    • Primary and study completion dates: Aug 31, 2025 to Oct 31, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rahul Aggarwal
5 trials monitored
See 1 trial at risk
Prostate Cancer
2,546 trials monitored
See 172 trials at risk
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.
Trial Details
NCT Number NCT04471974
Lead Sponsor Rahul Aggarwal
Collaborators: Zenith Epigenetics, Merck Sharp & Dohme LLC, U.S. Army Medical Research and Development Command
Conditions
(from sponsor)		 Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Metastatic Prostate Small Cell Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov