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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

Must not have

Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1

Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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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 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 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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My organ functions are within normal ranges according to recent tests.

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My cancer progressed despite treatment with medications like abiraterone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed IV antibiotics for an infection in the last 7 days.

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I have or had lung inflammation that needed steroids.

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I have previously been treated with immune checkpoint inhibitors.

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I have been treated with a BET inhibitor before.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have been treated for an autoimmune disease in the last 2 years.

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My heart condition meets specific health criteria.

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I have not had major surgery in the last 4 weeks.

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My hepatitis B virus load is undetectable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Response Rate

Secondary study objectives

Incidence of treatment-related adverse events

Median Duration of Response

Objective Response Rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Pembrolizumab

2017

Completed Phase 3