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Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC
EU CTIS ID: 2022-500785-10-00
What this study is testing
1. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS) 2. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to 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)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
- 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)
- Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
You likely can't join if
- Known additional malignancy that is progressing or has required active treatment in the last 3 years
- Active autoimmune disease that has required systemic treatment in past 2 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
- Known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
- History of seizure or any condition that may predispose to seizure
See the full eligibility criteria
- Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
- 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)
- Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- Known additional malignancy that is progressing or has required active treatment in the last 3 years
- Active autoimmune disease that has required systemic treatment in past 2 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
- Known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
- History of seizure or any condition that may predispose to seizure
- Received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- United Kingdom
- Argentina
- Canada
- Israel
- Colombia
- Brazil
- Japan
- Australia
- Puerto Rico
- United States
- Chile
- Russian Federation
- Korea, Republic of
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; United Kingdom; Argentina; Canada; Israel; Colombia and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.