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Anti-androgen

ZEN-3694 + Enzalutamide + Pembrolizumab for Prostate Cancer

Phase 2
Recruiting
Led By Rahul R Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic castration resistant prostate cancer with evidence of disease progression by PCWG3 criteria at study entry
Castrate level of serum testosterone at study entry (< 50 ng/dL). Patients without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with prostate cancer that has spread and is resistant to hormone therapy. The drugs work in different ways to attack the cancer cells.

Who is the study for?
Men with metastatic castration-resistant prostate cancer that has spread and shows progression despite low testosterone levels. Participants must have measurable disease, no prior chemotherapy for metastatic cancer within 6 months, and a maximum of two previous chemo treatments in this setting. They should not have used certain medications or had major surgery recently, nor should they have active infections or severe health conditions that could affect the trial.Check my eligibility
What is being tested?
The effectiveness of ZEN-3694 combined with enzalutamide and pembrolizumab is being tested on men with advanced prostate cancer resistant to hormonal therapy. The study aims to see if these drugs can slow down tumor growth by blocking specific genes and receptors involved in cancer cell proliferation while also enhancing the body's immune response against tumor cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, fatigue, skin issues, changes in hormone levels affecting normal bodily functions, possible infusion-related reactions from pembrolizumab administration, and other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is spreading despite hormone therapy.
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My testosterone levels are very low, and I'm on hormone therapy if not surgically treated.
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I am mostly able to carry out my daily activities.
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I haven't had chemotherapy for advanced prostate cancer but may have had it earlier if it was more than 6 months ago.
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My prostate cancer is getting worse according to tests.
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I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, whichever is shorter, and my side effects from previous treatments are minimal.
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I am willing to have a biopsy of my cancer if needed, or I have recent biopsy samples.
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I have prostate cancer that has spread and is not responding to hormone therapy.
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My PSA level is over 2 ng/mL or my cancer can be measured using specific criteria.
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I have had no more than two chemotherapy treatments for my advanced prostate cancer.
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I am 18 years old or older.
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My prostate cancer has changed into a more aggressive form based on specific tests.
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I am currently taking enzalutamide and can continue without stopping before the study.
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My organ functions are within normal ranges according to recent tests.
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My cancer progressed despite treatment with medications like abiraterone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Response Rate
Secondary outcome measures
Incidence of treatment-related adverse events
Median Duration of Response
Objective Response Rate (ORR)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Safety CohortExperimental Treatment3 Interventions
Patients receive 96mg pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort B: mCRPC without evidence of transdifferentiationExperimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Cohort A: Transdifferentiated mCRPCExperimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,499 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Zenith EpigeneticsIndustry Sponsor
9 Previous Clinical Trials
558 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,105 Total Patients Enrolled

Media Library

Enzalutamide (Anti-androgen) Clinical Trial Eligibility Overview. Trial Name: NCT04471974 — Phase 2
Prostate Cancer Research Study Groups: Cohort B: mCRPC without evidence of transdifferentiation, Cohort A: Transdifferentiated mCRPC, Safety Cohort
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT04471974 — Phase 2
Enzalutamide (Anti-androgen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04471974 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the typical applications of Pembrolizumab?

"Pembrolizamab can target malignant neoplasms, microsatellite instability high and unresectable melanoma."

Answered by AI

How many participants will be admitted to this clinical trial?

"Affirmative. Clinicaltrials.gov conveys that this clinical study, which debuted on January 26th 2021, is actively recruiting individuals to join the trial. A total of 54 participants are needed from 2 separate sites."

Answered by AI

Is Pembrolizumab a dependable therapeutic option for patients?

"Power's internal assessment of Pembrolizumab gave it a rating of 2 due to limited data that suggests the drug is safe and no evidence indicating efficacy."

Answered by AI

Is enrolment for this experiment still ongoing?

"Indeed, clinicaltrials.gov reveals that this medical study is currently recruiting patients with the trial having been initially posted on January 26th 2021. The most recent update was done on August 8th 2022 and 54 participants are sought from two different research sites."

Answered by AI

Have there been any other investigations into the use of Pembrolizumab?

"Currently, 1050 different studies are using pembrolizumab as a drug intervention. Of those trials, 148 have progressed to Phase 3. Primarily based in Houston, Texas, there is an expansive network of 40727 sites running research with this medication."

Answered by AI
~18 spots leftby Dec 2025