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Anti-androgen

ZEN-3694 + Enzalutamide + Pembrolizumab for Prostate Cancer

Q: What are the typical applications of Pembrolizumab?

Pembrolizamab can target malignant neoplasms, microsatellite instability high and unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>.

Q: 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.

Q: 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.

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there is an expansive network of 40727 sites running research with this medication.

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

Select...

My prostate cancer is spreading despite hormone therapy.

Select...

My testosterone levels are very low, and I'm on hormone therapy if not surgically treated.

Select...

I am mostly able to carry out my daily activities.

Select...

My prostate cancer is getting worse according to tests.

Select...

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.

Select...

I have prostate cancer that has spread and is not responding to hormone therapy.

Select...

My PSA level is over 2 ng/mL or my cancer can be measured using specific criteria.

Select...

I am 18 years old or older.

Select...

My prostate cancer has changed into a more aggressive form based on specific tests.

Select...

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

Select...

My cancer progressed despite treatment with medications like abiraterone.

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

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

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,617 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

286 Previous Clinical Trials

245,705 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

Recent research and studies

clinicaltrials.govStudy

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

Rahul Aggarwal 2021. "ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04471974.

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