Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Registration Number
- 2022-500785-10-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Male
- Target Recruitment
- 420
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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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) 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
Name Time Method Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST) Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
Prostate-specific Antigen (PSA) Response Rate Prostate-specific Antigen (PSA) Response Rate
Prostate-specific Antigen (PSA) Undetectable Rate Prostate-specific Antigen (PSA) Undetectable Rate
Objective Response Rate (ORR) 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) Objective Response Rate (ORR) 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)
Duration of Response (DOR) 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) Duration of Response (DOR) 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)
Time to Prostate-specific Antigen (PSA) Progression Time to Prostate-specific Antigen (PSA) Progression
Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of 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) Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of 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)
Time to Pain Progression (TTPP) Time to Pain Progression (TTPP)
Time to First Symptomatic Skeletal-Related Event (SSRE) Time to First Symptomatic Skeletal-Related Event (SSRE)
Number of Participants Who Experienced At Least One Adverse Event (AE) Number of Participants Who Experienced At Least One Adverse Event (AE)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE
Trial Locations
- Locations (77)
Complex Oncological Center Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Provita Centrum Medyczne Sp. z o.o.
🇵🇱Tomaszow Mazowiecki, Poland
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
🇵🇱Koszalin, Poland
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
🇵🇱Konin, Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
🇵🇱Bydgoszcz, Poland
Stichting Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Stichting Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Medical Center Haaglanden
🇳🇱's-Gravenhage, Netherlands
Stichting Sint Franciscus Vlietland Groep
🇳🇱Rotterdam, Netherlands
Stichting Ziekenhuisgroep Twente
🇳🇱Almelo, Netherlands
Scroll for more (67 remaining)Complex Oncological Center Plovdiv EOOD🇧🇬Plovdiv, BulgariaAntonetta TomovaSite contact+359886347493info@drtomova.com