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Hormone Therapy

Pembrolizumab + Enzalutamide 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 histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 months (through database cut-off date of 12-dec-2022)
Awards & highlights
Pivotal Trial

Study Summary

This trial will test whether a combination of two drugs is better than one of the drugs alone at treating prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?
Men with metastatic castration-resistant prostate cancer who haven't had chemotherapy for it, are either naive to or have not progressed on abiraterone acetate, and whose cancer has worsened despite hormone therapy. Participants must have a low testosterone level, be willing to avoid fathering children during the study, and cannot have had certain prior treatments including specific anti-cancer drugs.Check my eligibility
What is being tested?
The trial is testing if pembrolizumab combined with enzalutamide improves survival compared to placebo plus enzalutamide in men with advanced prostate cancer. It looks at overall survival and time without disease progression using scans reviewed by experts blinded to treatment assignment.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects affecting various organs, infusion reactions, fatigue, skin issues, digestive problems and can increase infection risk. Enzalutamide could lead to seizures, hypertension, fatigue among other symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is confirmed and not of the small cell type.
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My prostate cancer has worsened while on hormone therapy or after testicle removal in the last 6 months.
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My cancer has spread, as shown by bone scans or CT/MRI.
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I have either never taken abiraterone, took it without my cancer getting worse, or my cancer got worse after 8+ weeks on abiraterone.
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I am on hormone therapy for cancer, and my testosterone levels are low.
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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 agree not to donate sperm and to either not have sex or use a condom for 90 days after my last dose.
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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 fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 months (through database cut-off date of 12-dec-2022)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 months (through database cut-off date of 12-dec-2022) 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
Secondary outcome measures
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
+8 more

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + EnzalutamideExperimental Treatment2 Interventions
Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.
Group II: Placebo + EnzalutamidePlacebo Group2 Interventions
Participants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2700
Pembrolizumab
2017
Completed Phase 3
~2050

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,684 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,843 Previous Clinical Trials
5,044,732 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,947 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,754 Previous Clinical Trials
8,058,399 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03834493 — Phase 3
Prostate Cancer Research Study Groups: Pembrolizumab + Enzalutamide, Placebo + Enzalutamide
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT03834493 — Phase 3
Enzalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03834493 — Phase 3

Frequently Asked Questions

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

What are the conditions that Pembrolizumab is most commonly employed against?

"Pembrolizumab can be used as treatment for various conditions such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Are there any empty slots left in this research project for new participants?

"Unfortunately, this particular clinical trial is not actively recruiting patients at this time. According to the latest update on clinicaltrials.gov (from June 15th, 2022), the study is not looking for participants. There are, however, 2,370 other trials that are currently searching for patients."

Answered by AI

To what extent has Pembrolizumab been studied in the past?

"Out of the 1093 active trials for Pembrolizumab, 148 are in the third and final stage. Pembrolizumab trials are running in 40972 locations, with several in Houston, Texas."

Answered by AI

Are there any risks or side effects associated with Pembrolizumab?

"Pembrolizumab has been given a safety score of 3 by our team at Power. This is because Pembrolizumab is in Phase 3 clinical trials, which means that there is some data that supports its efficacy as well as multiple rounds of data that support its safety."

Answered by AI
~226 spots leftby Feb 2025