186
Participants
Start Date
May 25, 2021
Primary Completion Date
October 31, 2022
Study Completion Date
September 10, 2025
Pembrolizumab
Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
Enzalutamide
Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
Androgen Deprivation Therapy (ADT)
Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
Placebo
Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
Peking University First Hospital ( Site 0800), Beijing
Beijing Cancer Hospital ( Site 0802), Beijing
Harbin Medical University Cancer Hospital ( Site 0822), Harbin
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0807 ), Shanghai
Nanjing Drum Tower Hospital ( Site 0811), Nanjing
Tianjin Medical University Cancer Institute & Hospital ( Site 0804 ), Tianjin
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0808), Hangzhou
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 0830), Hangzhou
Zhejiang Provincial People's Hospital ( Site 0809), Hangzhou
Ningbo First Hospital-Urology (0835), Ningbo
The First Affiliated Hospital of Wenzhou Medical University ( Site 0834), Wenzhou
The First Affiliated Hospital of Nanchang University ( Site 0821), Nanchang
The First Affiliated Hospital of Xiamen University (Site 0816), Xiamen
Chongqing Cancer Hospital ( Site 0815), Chongqing
Hunan Cancer Hospital ( Site 0817), Changsha
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0829), Wuhan
Hubei Cancer Hospital ( Site 0833), Wuhan
Henan Cancer Hospital ( Site 0818), Zhengzhou
Sun Yat-Sen University Cancer Center ( Site 0825), Guangzhou
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0638), Guangzhou
Sun Yat Sen Memorial Hospital (Site # 0819), Guangzhou
Southern Medical University Nanfang Hospital ( Site 0838), Guangzhou
The Second Affiliated Hosp of Xi'an Jiaotong Univ College of Medicine ( Site 0831), Xi'an
The first affiliated Hospital of Xi an Jiaotong University ( Site # 0812), Xi’an
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