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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 months (through database cut-off date of 12-dec-2022)
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 months (through database cut-off date of 12-dec-2022)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 months (through database cut-off date of 12-dec-2022)
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
4,580,584 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,309 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,242 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an active infection.I have a condition that affects how my body absorbs food or I can't swallow pills.I am fully active or restricted in physically strenuous activity but can do light work.I have a recent biopsy from a non-irradiated area or from a tumor in a previously radiated area.I have or had lung inflammation that needed steroids.I have been on a stable dose of medication for bone health before joining the study.I agree not to donate sperm and to either not have sex or use a condom for 90 days after my last dose.I have a history of seizures or conditions that could lead to seizures.My heart rate was below 50 beats per minute on my last ECG.I have used herbal products like saw palmetto before joining the study.My prostate cancer got worse despite ketoconazole treatment.You have recently been involved in a study testing a new medicine or using a new medical device.My prostate cancer has worsened while on hormone therapy or after testicle removal in the last 6 months.I have an active HIV, HBV, or HCV infection.You are allergic to pembrolizumab or enzalutamide or any ingredients in these medications.I have been treated with docetaxel or another chemotherapy for advanced prostate cancer.I have cancer that has spread to my brain or spinal cord.You have fainted or lost consciousness in the past year.I have either never taken abiraterone, took it without my cancer getting worse, or my cancer got worse after 8+ weeks on abiraterone.I am on hormone therapy for cancer, and my testosterone levels are low.I have received an organ or tissue transplant from another person.I have another cancer that is getting worse or was treated in the last 3 years.My cancer has spread, as shown by bone scans or CT/MRI.I have received a monoclonal antibody treatment for cancer before.I have had treatment with radium or similar for prostate cancer.I have been treated for an autoimmune disease in the last 2 years.I have been treated with specific immune therapy for cancer.I have been treated with specific prostate cancer medications, but not abiraterone acetate.My blood pressure is either below 86 or above 170/105 mmHg.My prostate cancer is confirmed and not of the small cell type.I have not had a live vaccine in the last 30 days.I have an immune system disorder or am on long-term steroids.I had major surgery, excluding prostate biopsy, within the last 28 days and haven't fully recovered.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Enzalutamide
- Group 2: Pembrolizumab + Enzalutamide
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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