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Pembrolizumab + ADT for Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Willing to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 59 months
Awards & highlights

Study Summary

This trial will test whether a combination of drugs is better than placebo at extending radiographic progression-free survival and overall survival for men with metastatic hormone-sensitive prostate cancer.

Who is the study for?
Men with advanced prostate cancer that has spread, who haven't had certain treatments like anti-PD-1 or anti-PD-L1 therapy. They must be able to perform daily activities with little help (ECOG status of 0 or 1), have good organ function, and agree to use contraception. Excluded are those with seizure history, vaccine within the last month, organ transplants, active autoimmune diseases needing recent treatment, significant heart issues or uncontrolled blood pressure.Check my eligibility
What is being tested?
The trial is testing if adding pembrolizumab to enzalutamide and ADT improves survival without cancer growth compared to placebo plus enzalutamide and ADT in men with metastatic hormone-sensitive prostate cancer. The study was blinded but now all participants will receive standard care after stopping pembrolizumab/placebo.See study design
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects affecting various organs including lungs (pneumonitis), liver problems, skin reactions, hormonal gland changes leading to hormone deficiencies; also possible are infusion reactions and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent biopsy from a non-irradiated area or from a tumor in a previously radiated area.
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I am willing to continue hormone therapy or have had both testicles removed.
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My organs are functioning well.
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I am a male and agree to not donate sperm and either abstain from sex or use contraception for 120 days after the last dose.
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I have been on a stable dose of medication for bone health before joining the study.
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I am a male with a specific type of prostate cancer.
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My cancer has spread to my bones or organs, confirmed by scans.
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I agree to use a condom during any sexual activity.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 59 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Duration of Response (DOR) Per PCWG- Modified RECIST 1.1 as Assessed by BICR
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
+9 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + Enzalutamide + ADTExperimental Treatment3 Interventions
Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Group II: Placebo + Enzalutamide + ADTPlacebo Group3 Interventions
Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~530
Enzalutamide
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,660 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,458 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,060,949 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT04191096 — Phase 3
Prostate Cancer Research Study Groups: Placebo + Enzalutamide + ADT, Pembrolizumab + Enzalutamide + ADT
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT04191096 — Phase 3
Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191096 — Phase 3

Frequently Asked Questions

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

Has Pembrolizumab received regulatory approval from the FDA?

"Pembrolizumab has received a 3 for safety. This is due to this being a Phase 3 trial, where there is some efficacy data and multiple rounds of safety data."

Answered by AI

Which hospitals are conducting this research project at the moment?

"33 clinical trial sites are currently recruiting patients for this study. While Billings, Fairfax and Durham are some of the locations, there are 30 other sites where patients can be enrolled. To minimize the burden of travel, patients should select the location nearest to them."

Answered by AI

What medical conditions does Pembrolizumab typically treat?

"Pembrolizumab is a medication that can be used to treat various cancers, including those that are considered inoperable. It can also be helpful for patients with microsatellite instability high or those that have seen disease progression after chemotherapy."

Answered by AI

What is the total number of individuals taking part in this experiment?

"This particular clinical trial is no longer recruiting patients. Although, according to the latest data, there are 1507 trials actively recruiting participants with prostate cancer and 1092 trials for Pembrolizumab."

Answered by AI

What other Pembrolizumab research is currently being conducted?

"Pembrolizumab was first studied in 2005 at the Edinburgh Cancer Centre. As of now, there have been 18,559 completed clinical trials. Out of these, 1,092 are actively recruiting patients. These trials are being conducted in various locations, with a significant number taking place in Billings, Montana."

Answered by AI

Are there still open positions for trial volunteers?

"This particular trial is not currently looking for patients, according to the latest update on clinicaltrials.gov. The trial was first posted on February 12th, 2020 and was last edited on August 18th, 2020. If you are looking for other studies, there are presently 1507 trials actively searching for participants with prostate cancer and 1092 studies for Pembrolizumab actively recruiting patients."

Answered by AI

What are the chief goals of this scientific experiment?

"The sponsor of this study, Merck Sharp & Dohme Corp., has stated that the primary objective of this clinical trial will be to measure Overall Survival (OS) over the course of Up to approximately 77 months. Additionally, this trial will be assessing secondary outcomes including Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST), Prostate-specific antigen (PSA) Undetectable Rate, and Time to Prostate-specific Antigen (PSA) Progression."

Answered by AI
~246 spots leftby Mar 2025