A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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.
With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.
The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants enrolled in the global study, 21 were also enrolled in the China extension study for MK-3475-921 (NCT04907227).
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Mobile, Alabama 36604, United States
Los Angeles, California 90033, United States
Newport Beach, California 92663, United States
Grand Rapids, Michigan 49503, United States
Hackensack, New Jersey 07601, United States
Berazategui, Buenos Aires B1884BBF, Argentina
Buenos Aires, C1012AAR, Argentina
Macquarie University, New South Wales 2109, Australia
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Itajaí, Santa Catarina 88301-215, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Rimouski, Quebec G5L 5T1, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Santiago, Region M. de Santiago 8420383, Chile
Beijing, Beijing Municipality 100071, China
Guangzhou, Guangdong 510230, China
Hangzhou, Zhejiang 310009, China
Bogotá, Bogota D.C. 111321, Colombia
Valledupar, Cesar Department 200001, Colombia
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Nuremberg, Bavaria 90419, Germany
Beer Yaakov-Zerifin, 7030001, Israel
Chelyabinsk, Chelyabinsk Oblast 454087, Russia
Krasnoyarsk, Krasnoyarsk Krai 660133, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603074, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Saint Petersburg, Sankt-Peterburg 198255, Russia
Tomsk, Tomsk Oblast 634050, Russia
Tainen, Tainan 704, Taiwan
Bristol, Bristol, City of BS2 8ED, United Kingdom
Cambridge, Cambridgeshire CB2 0QQ, United Kingdom