Clinical trial NCT03834506: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Programmed Cell Death 1 (PD 1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL 1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL 2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 1030
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
* Has 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)
* Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<2.0 nM)
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
* Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
* Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
* Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
* Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
* Has an active infection (including tuberculosis) requiring systemic therapy
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
* Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
* Has hypersensitivity to docetaxel or polysorbate 80
* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
* Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
* Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
* Has received a live vaccine within 30 days prior to randomization
* Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
* Has received prior treatment with ketoconazole for prostate cancer
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
* Has a "superscan" bone scan
* Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 36.5 months
measure: 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)
timeFrame: Up to approximately 28 months
Secondary outcomes:
measure: Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
timeFrame: Up to approximately 28 months
measure: Prostate-specific Antigen (PSA) Response Rate
timeFrame: Up to 36.5 months
measure: 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)
timeFrame: Up to 36.5 months
measure: 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)
timeFrame: Up to 36.5 months
measure: Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm (AQA) Score
timeFrame: Up to 36.5 months
measure: Time to First Symptomatic Skeletal-related Event (SSRE)
timeFrame: Up to 36.5 months
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to 36.5 months
measure: 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)
timeFrame: Up to 36.5 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 30 months
measure: Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
timeFrame: Up to approximately 27 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 0065)
state: Alabama
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0069)
state: California
city: Los Angeles
country: United States
facility: University of Southern California Norris Comprehensive Cancer Center ( Site 0061)
state: California
city: Newport Beach
country: United States
facility: USC Norris Oncology Hematology Newport Beach ( Site 0093)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco ( Site 0023)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0022)
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center ( Site 0038)
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0080)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0026)
state: Georgia
city: Chicago
country: United States
facility: Mount Sinai Hospital Medical Center ( Site 0042)
state: Illinois
city: Merrillville
country: United States
facility: Methodist Hospital- Merriillville ( Site 0008)
state: Indiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0077)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0039)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan ( Site 0013)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0057)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0016)
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists ( Site 0034)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0092)
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
state: New Jersey
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY ( Site 0060)
state: New York
city: Durham
country: United States
facility: Duke Cancer Center ( Site 0010)
state: North Carolina
city: Salisbury
country: United States
facility: W. G. Bill Hefner VA Medical Center ( Site 0029)
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0036)
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University ( Site 0031)
state: Oregon
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center ( Site 0070)
state: South Carolina
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0006)
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute ( Site 0052)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0086)
state: Virginia
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas ( Site 1000)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Diagnostico Urologico ( Site 1008)
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 1006)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 1002)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 1004)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 1010)
city: Cordoba
country: Argentina
facility: CEMAIC ( Site 1014)
city: Kogarah
country: Australia
facility: St George Hospital ( Site 0157)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University ( Site 0151)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital ( Site 0153)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 0148)
state: New South Wales
city: Redcliffe
country: Australia
facility: Redcliffe Hospital ( Site 0161)
state: Queensland
city: Tugun
country: Australia
facility: John Flynn Hospital & Medical Centre ( Site 0164)
state: Queensland
city: Nedlands
country: Australia
facility: Hollywood Private Hospital ( Site 0163)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universitat Graz ( Site 0374)
state: Steiermark
city: Salzburg
country: Austria
facility: SCRI-CCCIT GesmbH ( Site 0371)
city: Wien
country: Austria
facility: Medizinische Universitaet Wien ( Site 0375)
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 1038)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 1026)
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital ( Site 0120)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0117)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0108)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0107)
state: Ontario
city: Rimouski
country: Canada
facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 1041)
state: Araucania
city: Temuco
country: Chile
facility: Rey y Oreilly Limitada ( Site 1048)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 1049)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1047)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)
state: Valparaiso
city: Beijing
country: China
facility: Peking University First Hospital ( Site 1303)
state: Beijing
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital ( Site 1307)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 1305)
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 1319)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital ( Site 1323)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 1326)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 1321)
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 1329)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1320)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital ( Site 1312)
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 1300)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 1301)
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital ( Site 1310)
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 1066)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Biomelab S A S ( Site 1067)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 1073)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 1057)
state: Cordoba
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 1061)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 1072)
state: Risaralda
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 1064)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 1065)
state: Valle Del Cauca
city: Saint Quentin
country: France
facility: C.H. de Saint Quentin ( Site 0481)
state: Aisne
city: Strasbourg
country: France
facility: Clinique Sainte Anne ( Site 0431)
state: Alsace
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin ( Site 0434)
state: Auvergne
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0422)
state: Auvergne
city: Marseille
country: France
facility: Institut Paoli Calmettes. ( Site 0419)
state: Bouches-du-Rhone
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0423)
state: Doubs
city: Brest
country: France
facility: CHU de Brest -Site Hopital Morvan ( Site 0441)
state: Finistere
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 0421)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)
state: Haute-Garonne
city: Suresnes
country: France
facility: Hopital Foch ( Site 0428)
state: Hauts-de-Seine
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 0448)
state: Loire-Atlantique
city: Orleans
country: France
facility: Centre Hospitalier Regional du Orleans ( Site 0430)
state: Loiret
city: Nancy
country: France
facility: Centre D Oncologie de Gentilly ( Site 0432)
state: Meurthe-et-Moselle
city: Pierre Benite
country: France
facility: C.H.U. Lyon Sud ( Site 0436)
state: Rhone
city: Amiens
country: France
facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)
state: Somme
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0416)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0447)
state: Vaucluse
city: Paris
country: France
facility: Institut Mutualiste Montsouris ( Site 0446)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum in Mannheim ( Site 0314)
state: Baden-Wurttemberg
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie ( Site 0309)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 0307)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar ( Site 0300)
state: Bayern
city: Nuernberg
country: Germany
facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg ( Site 0302)
state: Bayern
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen ( Site 0345)
state: Niedersachsen
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen ( Site 0308)
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes ( Site 0348)
state: Saarland
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0305)
state: Thuringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0301)
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 0727)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0730)
city: Limerick
country: Ireland
facility: Mid Western Cancer Centre ( Site 0728)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0548)
city: Beer Yaakov-Zerifin
country: Israel
facility: Assaf Harofeh MC ( Site 0547)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0543)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0546)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0544)
city: Petach-Tikwa
country: Israel
facility: Rabin Medical Center ( Site 0545)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0541)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0542)
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)
state: Milano
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro ( Site 0458)
city: Modena
country: Italy
facility: A.O. Universitaria di Modena ( Site 0454)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara ( Site 0451)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0702)
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 0703)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)
state: Ehime
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0701)
state: Ishikawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 0705)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0706)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0715)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0714)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0713)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 0708)
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 0720)
state: Shizuoka
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 0717)
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0704)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0718)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0721)
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital ( Site 0719)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0711)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0709)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0710)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0174)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0175)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0171)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0176)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0172)
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden ( Site 0477)
state: Fryslan
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei ( Site 0485)
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center ( Site 0470)
state: Gelderland
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum ( Site 0487)
state: Limburg
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis ( Site 1200)
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis ( Site 0472)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: Ziekenhuis Hilversum ( Site 0466)
state: Noord-Holland
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente ( Site 0469)
state: Overijssel
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep ( Site 0484)
state: Zuid-Holland
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis ( Site 1201)
state: Zuid-Holland
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
state: Chelyabinskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Radiology ( Site 0559)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 0562)
state: Moskva
city: Moscow
country: Russian Federation
facility: National Medical Research Radiological Center ( Site 0556)
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)
state: Nizhegorodskaya Oblast
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 0568)
state: Omskaya Oblast
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0571)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 0588)
state: Sankt-Peterburg
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)
state: Tomskaya Oblast
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 0330)
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Consorci Sanitari Parc Tauli ( Site 0335)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 0336)
state: Cantabria
city: Girona
country: Spain
facility: Hospital Josep Trueta ( Site 0321)
state: Gerona
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0333)
city: Barcelona
country: Spain
facility: Hospital Clinic ( Site 0323)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 0328)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 0324)
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro ( Site 0322)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 0337)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 0329)
city: Tainen
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0134)
state: Tainan
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0132)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0133)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0131)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0135)
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust ( Site 0540)
state: Cambridgeshire
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 0532)
state: Devon
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital ( Site 0539)
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital ( Site 0526)
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 0536)
state: Hertfordshire
city: London
country: United Kingdom
facility: Barts Cancer Institute ( Site 0483)
state: London, City Of
city: Stoke-on-Trent
country: United Kingdom
facility: University of North Midlands NHS Foundation Trust ( Site 0527)
state: Staffordshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Petrylak DP, Ratta R, Gafanov R, Facchini G, Piulats JM, Kramer G, Flaig TW, Chandana SR, Li B, Burgents J, Fizazi K. KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Sep;17(25):3291-3299. doi: 10.2217/fon-2020-1133. Epub 2021 Jun 8.