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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: Active Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Rahul Aggarwal.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as either objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (complete response (CR), partial response (PR)) or confirmed \>= 50% decline from serum prostate-specific antigen (PSA) at baseline confirmed by repeat measurement performed ≥ 4 weeks later for each study cohort. To be considered evaluable for PSA50 response, patients must have a serum PSA \>=2 ng/mL at baseline. To be considered evaluable for objective response, patients must have measura
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What the registry record for NCT04471974 still lists
NCT04471974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Stage IVB Prostate Cancer AJCC v8
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 NCT04471974's enrollment target sits among peer trials
61 22nd of 45 higher than 23 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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