Spots Global Cancer Trial Database for Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
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Trial Identification
Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
Official Title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)
Study ID: NCT04934722
Study Description
Brief Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of Amendment 4, the study is being stopped for futility. All the prespecified interim analysis after interim analysis (IA1) and final analysis of the study described the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.
Detailed Description: The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Peking University First Hospital ( Site 0800), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0802), Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 0815), Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University (Site 0816), Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 0825), Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0638), Guangzhou, Guangdong, China
Sun Yat Sen Memorial Hospital (Site # 0819), Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0838), Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0822), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 0818), Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0829), Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0833), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0817), Changsha, Hunan, China
Nanjing Drum Tower Hospital ( Site 0811), Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 0821), Nanchang, Jiangxi, China
The Second Affiliated Hosp of Xi'an Jiaotong Univ College of Medicine ( Site 0831), XI An, Shaanxi, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0807 ), Shanghai, Shanghai, China
The first affiliated Hospital of Xi an Jiaotong University ( Site # 0812), XI An, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0804 ), Tianjin, Tianjin, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0808), Hangzhou, Zhejiang, China
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 0830), Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital ( Site 0809), Hangzhou, Zhejiang, China
Ningbo First Hospital-Urology (0835), Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0834), Wenzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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