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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 met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Must not have
Has an active infection (including tuberculosis) requiring systemic therapy
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 months (through database cut-off date of 12-dec-2022)
Awards & highlights

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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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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My cancer has spread, as shown by bone scans or CT/MRI.
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My prostate cancer is confirmed and not of the small cell type.
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I am on hormone therapy for cancer, and my testosterone levels are low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an active infection.
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I have a condition that affects how my body absorbs food or I can't swallow pills.
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I have or had lung inflammation that needed steroids.
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My heart rate was below 50 beats per minute on my last ECG.
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My prostate cancer got worse despite ketoconazole treatment.
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I have an active HIV, HBV, or HCV infection.
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I have cancer that has spread to my brain or spinal cord.
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I have received an organ or tissue transplant from another person.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have received a monoclonal antibody treatment for cancer before.
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I have had treatment with radium or similar for prostate cancer.
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I have a history of seizures or conditions that could lead to seizures.
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I have been treated with docetaxel or another chemotherapy for advanced prostate cancer.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been treated with specific immune therapy for cancer.
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I have been treated with specific prostate cancer medications, but not abiraterone acetate.
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My blood pressure is either below 86 or above 170/105 mmHg.
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I have not had a live vaccine in the last 30 days.
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I have an immune system disorder or am on long-term steroids.

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 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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
~2760
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,768 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,019 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,398 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,086 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: Placebo + Enzalutamide, Pembrolizumab + 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
~210 spots leftby Jul 2025