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)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pembrolizumab+Docetaxel On Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by intravenous (IV) infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months). Participants also receive pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years). |
Biological: Pembrolizumab
IV infusion
Other Names:
Drug: Docetaxel
IV infusion
Other Names:
Drug: Prednisone
Oral tablets
Drug: Dexamethasone
Oral tablets
Other Names:
|
| Placebo Comparator: Placebo+Docetaxel On Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by IV infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months). Participants also receive placebo by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years). |
Drug: Docetaxel
IV infusion
Other Names:
Drug: Prednisone
Oral tablets
Drug: Placebo
IV infusion
Other Names:
Drug: Dexamethasone
Oral tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) [Up to approximately 28 months]
Time from randomization to death due to any cause
- 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 [Up to approximately 28 months]
Time from randomization to radiographic progression, or death due to any cause, whichever occurs first
Secondary Outcome Measures
- Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST) [Up to approximately 28 months]
Time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first
- Prostate-specific Antigen (PSA) Response Rate [Up to approximately 28 months]
Percentage of participants in the analysis population who have a negative change (decrease) in PSA level of ≥50% measured twice ≥3 weeks apart
- 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 [Up to approximately 28 months]
Percentage of participants in the analysis population who have a best overall response of either confirmed Complete Response (CR) or a confirmed Partial Response (PR) per PCWG-modified RECIST 1.1
- 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 [Up to approximately 28 months]
Time from first documented evidence of confirmed Complete Response (CR) or Partial Response (PR) per PCWG-modified RECIST 1.1 until disease progression or death from any cause, whichever occurs first
- 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 (Analgesic Quantification Algorithm [AQA] Score) [Up to approximately 28 months]
Time from randomization to pain progression. In this study, pain progression will be assessed by participant responses to Item 3 of the BPI-SF and participant AQA Scores which are both assessed by participants daily for 7 consecutive days
- Time to First Symptomatic Skeletal-related Event (SSRE) [Up to approximately 28 months]
Time from randomization to the first SSRE. SSRE is defined as radiation to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathological fracture, spinal cord compression, or surgery to bone
- Time to Prostate-specific Antigen (PSA) Progression [Up to approximately 28 months]
Time from randomization to PSA progression. PSA progression date is defined as the date of 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline
- 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 [Up to approximately 28 months]
Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1
- Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 28 months]
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
- Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [Up to approximately 28 months]
The number of participants who discontinue study treatment due to an AE will be presented
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama, Mitchell Cancer Institute ( Site 0065) | Mobile | Alabama | United States | 36604 |
| 2 | St. Joseph Heritage Healthcare ( Site 0069) | Fullerton | California | United States | 92835 |
| 3 | University of Southern California Norris Comprehensive Cancer Center ( Site 0061) | Los Angeles | California | United States | 90033 |
| 4 | USC Norris Oncology Hematology Newport Beach ( Site 0093) | Newport Beach | California | United States | 92663 |
| 5 | University of California San Francisco ( Site 0023) | San Francisco | California | United States | 94158 |
| 6 | University of Colorado Cancer Center ( Site 0022) | Aurora | Colorado | United States | 80045 |
| 7 | Yale Cancer Center ( Site 0038) | New Haven | Connecticut | United States | 06510 |
| 8 | Moffitt Cancer Center ( Site 0080) | Tampa | Florida | United States | 33612 |
| 9 | Georgia Cancer Center at Augusta University ( Site 0026) | Augusta | Georgia | United States | 30912 |
| 10 | Mount Sinai Hospital Medical Center ( Site 0042) | Chicago | Illinois | United States | 60608 |
| 11 | Methodist Hospital- Merriillville ( Site 0008) | Merrillville | Indiana | United States | 46410 |
| 12 | Karmanos Cancer Institute ( Site 0077) | Detroit | Michigan | United States | 48201 |
| 13 | Henry Ford Health System ( Site 0039) | Detroit | Michigan | United States | 48202-2608 |
| 14 | Cancer & Hematology Centers of Western Michigan ( Site 0013) | Grand Rapids | Michigan | United States | 49503 |
| 15 | Washington University School of Medicine ( Site 0057) | Saint Louis | Missouri | United States | 63110 |
| 16 | St. Vincent Frontier Cancer Center ( Site 0016) | Billings | Montana | United States | 59102 |
| 17 | Nebraska Cancer Specialists ( Site 0034) | Omaha | Nebraska | United States | 68130 |
| 18 | Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas | Nevada | United States | 89169 |
| 19 | John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004) | Hackensack | New Jersey | United States | 07601 |
| 20 | Associated Medical Professionals of NY ( Site 0060) | Syracuse | New York | United States | 13210 |
| 21 | Duke Cancer Center ( Site 0010) | Durham | North Carolina | United States | 27710 |
| 22 | W. G. Bill Hefner VA Medical Center ( Site 0029) | Salisbury | North Carolina | United States | 28144 |
| 23 | University Hospitals Cleveland Medical Center ( Site 0036) | Cleveland | Ohio | United States | 44106 |
| 24 | Oregon Health Sciences University ( Site 0031) | Portland | Oregon | United States | 97239 |
| 25 | Carolina Urologic Research Center ( Site 0070) | Myrtle Beach | South Carolina | United States | 29572 |
| 26 | Inova Schar Cancer Institute ( Site 0006) | Fairfax | Virginia | United States | 22031-4867 |
| 27 | Virginia Cancer Institute ( Site 0052) | Richmond | Virginia | United States | 23230 |
| 28 | Blue Ridge Cancer Care ( Site 0086) | Roanoke | Virginia | United States | 24014 |
| 29 | Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) | Berazategui | Buenos Aires | Argentina | B1884BBF |
| 30 | Instituto de Investigaciones Clinicas ( Site 1000) | Mar del Plata | Buenos Aires | Argentina | B7600FZN |
| 31 | Centro de Diagnostico Urologico ( Site 1008) | Buenos Aires | Caba | Argentina | C1120AAT |
| 32 | Hospital Britanico de Buenos Aires ( Site 1006) | Buenos Aires | Caba | Argentina | C1280AEB |
| 33 | Sanatorio Parque ( Site 1002) | Rosario | Santa Fe | Argentina | S2000DSV |
| 34 | Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011) | Buenos Aires | Argentina | C1012AAR | |
| 35 | Hospital Aleman ( Site 1004) | Buenos Aires | Argentina | C1118AAT | |
| 36 | Instituto Medico Alexander Fleming ( Site 1010) | Buenos Aires | Argentina | C1426ANZ | |
| 37 | CEMAIC ( Site 1014) | Cordoba | Argentina | X5008HHW | |
| 38 | St George Hospital ( Site 0157) | Kogarah | New South Wales | Australia | 2217 |
| 39 | Macquarie University ( Site 0151) | Macquarie University | New South Wales | Australia | 2109 |
| 40 | Port Macquarie Base Hospital ( Site 0153) | Port Macquarie | New South Wales | Australia | 2444 |
| 41 | Calvary Mater Newcastle ( Site 0148) | Waratah | New South Wales | Australia | 2298 |
| 42 | Redcliffe Hospital ( Site 0161) | Redcliffe | Queensland | Australia | 4020 |
| 43 | John Flynn Hospital & Medical Centre ( Site 0164) | Tugun | Queensland | Australia | 4224 |
| 44 | Hollywood Private Hospital ( Site 0163) | Nedlands | Western Australia | Australia | 6009 |
| 45 | Ordensklinikum Linz GmbH Elisabethinen ( Site 0373) | Linz | Oberosterreich | Austria | 4020 |
| 46 | Medizinische Universitat Graz ( Site 0374) | Graz | Steiermark | Austria | 8036 |
| 47 | SCRI-CCCIT GesmbH ( Site 0371) | Salzburg | Austria | 5020 | |
| 48 | Medizinische Universitaet Wien ( Site 0375) | Wien | Austria | 1090 | |
| 49 | Hospital de Caridade de Ijui ( Site 1038) | Ijui | Rio Grande Do Sul | Brazil | 98700-000 |
| 50 | Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021) | Porto Alegre | Rio Grande Do Sul | Brazil | 90610-000 |
| 51 | Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035) | Itajai | Santa Catarina | Brazil | 88301-215 |
| 52 | Hospital de Base de Sao Jose de Rio Preto ( Site 1022) | Sao Jose do Rio Preto | Sao Paulo | Brazil | 15090-000 |
| 53 | A.C. Camargo Cancer Center ( Site 1026) | Sao Paulo | Brazil | 01509-900 | |
| 54 | Nova Scotia Health Authority QEII-HSC ( Site 0114) | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 55 | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116) | Hamilton | Ontario | Canada | L8V5C2 |
| 56 | Grand River Hospital ( Site 0120) | Kitchener | Ontario | Canada | N2G 1G3 |
| 57 | Lakeridge Health ( Site 0117) | Oshawa | Ontario | Canada | L1G 2B9 |
| 58 | Sunnybrook Research Institute ( Site 0108) | Toronto | Ontario | Canada | M4N 3M5 |
| 59 | Princess Margaret Cancer Centre ( Site 0107) | Toronto | Ontario | Canada | M5G 2M9 |
| 60 | CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) | Rimouski | Quebec | Canada | G5L 5T1 |
| 61 | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105) | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 62 | CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103) | Quebec | Canada | G1R 2J6 | |
| 63 | Centro Investigación del Cáncer James Lind ( Site 1041) | Temuco | Araucania | Chile | 4780000 |
| 64 | Rey y Oreilly Limitada ( Site 1048) | Temuco | Araucania | Chile | 4810148 |
| 65 | Fundacion Arturo Lopez Perez ( Site 1049) | Santiago | Region M. De Santiago | Chile | 7500921 |
| 66 | Pontificia Universidad Catolica de Chile ( Site 1047) | Santiago | Region M. De Santiago | Chile | 8330032 |
| 67 | Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) | Santiago | Region M. De Santiago | Chile | 8420383 |
| 68 | Centro de Investigaciones Clinicas Vina del Mar ( Site 1042) | Vina del Mar | Valparaiso | Chile | 2540488 |
| 69 | Peking University First Hospital ( Site 1303) | Beijing | Beijing | China | 100034 |
| 70 | The Fifth Medical Center of PLA General Hospital ( Site 1307) | Beijing | Beijing | China | 100071 |
| 71 | Beijing Cancer Hospital ( Site 1305) | Beijing | Beijing | China | 100142 |
| 72 | The First Affiliated Hospital of Xiamen University ( Site 1319) | Xiamen | Fujian | China | 361003 |
| 73 | Sun Yat Sen Memorial Hospital ( Site 1323) | Guangzhou | Guangdong | China | 510220 |
| 74 | The First Affiliated Hospital of Guangzhou Medical University ( Site 1330) | Guangzhou | Guangdong | China | 510230 |
| 75 | Harbin Medical University Cancer Hospital ( Site 1326) | Harbin | Heilongjiang | China | 150081 |
| 76 | Henan Cancer Hospital ( Site 1321) | Zhengzhou | Henan | China | 450008 |
| 77 | Hubei Cancer Hospital ( Site 1329) | Wuhan | Hubei | China | 430079 |
| 78 | Hunan Cancer Hospital ( Site 1320) | Changsha | Hunan | China | 410013 |
| 79 | Nanjing Drum Tower Hospital ( Site 1312) | Nanjing | Jiangsu | China | 210008 |
| 80 | Fudan University Shanghai Cancer Center ( Site 1300) | Shanghai | Shanghai | China | 200032 |
| 81 | Zhongshan Hospital Fudan University ( Site 1301) | Shanghai | Shanghai | China | 200032 |
| 82 | The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309) | Hangzhou | Zhejiang | China | 310009 |
| 83 | Zhejiang Provincial People's Hospital ( Site 1310) | Hangzhou | Zhejiang | China | 310014 |
| 84 | Hospital Pablo Tobon Uribe ( Site 1066) | Medellin | Antioquia | Colombia | 050034 |
| 85 | Biomelab S A S ( Site 1067) | Barranquilla | Atlantico | Colombia | 080002 |
| 86 | Clinica de la Costa Ltda. ( Site 1073) | Barranquilla | Atlantico | Colombia | 080020 |
| 87 | Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068) | Valledupar | Cesar | Colombia | 200001 |
| 88 | Oncomedica S.A. ( Site 1057) | Monteria | Cordoba | Colombia | 230002 |
| 89 | Instituto Nacional de Cancerologia E.S.E ( Site 1061) | Bogota | Distrito Capital De Bogota | Colombia | 110321 |
| 90 | Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062) | Bogota | Distrito Capital De Bogota | Colombia | 111321 |
| 91 | Oncologos del Occidente S.A. ( Site 1072) | Pereira | Risaralda | Colombia | 660001 |
| 92 | Centro Medico Imbanaco de Cali S.A ( Site 1064) | Cali | Valle Del Cauca | Colombia | 760042 |
| 93 | Hemato Oncologos S.A. ( Site 1065) | Cali | Valle Del Cauca | Colombia | 760042 |
| 94 | C.H. de Saint Quentin ( Site 0481) | Saint Quentin | Aisne | France | 02321 |
| 95 | Clinique Sainte Anne ( Site 0431) | Strasbourg | Alsace | France | 67000 |
| 96 | Centre Jean Perrin ( Site 0434) | Clermont-Ferrand | Auvergne | France | 63011 |
| 97 | Centre Leon Berard ( Site 0422) | Lyon | Auvergne | France | 69373 |
| 98 | Institut Paoli Calmettes. ( Site 0419) | Marseille | Bouches-du-Rhone | France | 13009 |
| 99 | CHU Jean Minjoz ( Site 0423) | Besancon | Doubs | France | 25000 |
| 100 | CHU de Brest -Site Hopital Morvan ( Site 0441) | Brest | Finistere | France | 29200 |
| 101 | Institut Bergonie ( Site 0421) | Bordeaux | Gironde | France | 33076 |
| 102 | Institut Claudius Regaud IUCT Oncopole ( Site 0418) | Toulouse | Haute-Garonne | France | 31059 |
| 103 | Hopital Foch ( Site 0428) | Suresnes | Hauts-de-Seine | France | 92151 |
| 104 | Institut De Cancerologie De L Ouest ( Site 0448) | Saint Herblain | Loire-Atlantique | France | 44805 |
| 105 | Centre Hospitalier Regional du Orleans ( Site 0430) | Orleans | Loiret | France | 45100 |
| 106 | Centre D Oncologie de Gentilly ( Site 0432) | Nancy | Meurthe-et-Moselle | France | 54100 |
| 107 | C.H.U. Lyon Sud ( Site 0436) | Pierre Benite | Rhone | France | 69310 |
| 108 | CHU Amiens Picardie Site Sud Amiens ( Site 0438) | Amiens | Somme | France | 80000 |
| 109 | Institut Gustave Roussy ( Site 0416) | Villejuif | Val-de-Marne | France | 94800 |
| 110 | Institut Sainte Catherine ( Site 0447) | Avignon | Vaucluse | France | 84000 |
| 111 | Institut Mutualiste Montsouris ( Site 0446) | Paris | France | 75014 | |
| 112 | Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) | Freiburg | Baden-Wurttemberg | Germany | 79106 |
| 113 | Universitaetsklinikum in Mannheim ( Site 0314) | Mannheim | Baden-Wurttemberg | Germany | 68167 |
| 114 | Studienpraxis Urologie ( Site 0309) | Nuertingen | Baden-Wurttemberg | Germany | 72622 |
| 115 | Universitaetsklinik fuer Urologie ( Site 0307) | Tuebingen | Baden-Wurttemberg | Germany | 72076 |
| 116 | Klinikum Rechts der Isar ( Site 0300) | Muenchen | Bayern | Germany | 81675 |
| 117 | Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318) | Nuernberg | Bayern | Germany | 90419 |
| 118 | Universitaetsklinikum Wuerzburg ( Site 0302) | Wuerzburg | Bayern | Germany | 97080 |
| 119 | Universitaetsklinikum Goettingen ( Site 0345) | Goettingen | Niedersachsen | Germany | 37075 |
| 120 | Uniklinik RWTH Aachen ( Site 0308) | Aachen | Nordrhein-Westfalen | Germany | 52074 |
| 121 | Universitaetsklinikum des Saarlandes ( Site 0348) | Homburg | Saarland | Germany | 66421 |
| 122 | Universitaetsklinikum Jena ( Site 0305) | Jena | Thuringen | Germany | 07747 |
| 123 | Charite Universitaetsmedizin Berlin ( Site 0301) | Berlin | Germany | 10117 | |
| 124 | Cork University Hospital ( Site 0727) | Cork | Ireland | T12 YE02 | |
| 125 | Tallaght University Hospital ( Site 0730) | Dublin | Ireland | D24 NROA | |
| 126 | Mid Western Cancer Centre ( Site 0728) | Limerick | Ireland | ||
| 127 | Soroka Medical Center ( Site 0548) | Beer Sheva | Israel | 8410101 | |
| 128 | Assaf Harofeh MC ( Site 0547) | Beer Yaakov-Zerifin | Israel | 7030001 | |
| 129 | Rambam Medical Center ( Site 0543) | Haifa | Israel | 3109601 | |
| 130 | Hadassah Ein Kerem Medical Center ( Site 0546) | Jerusalem | Israel | 9112001 | |
| 131 | Meir Medical Center ( Site 0544) | Kfar Saba | Israel | 4428164 | |
| 132 | Rabin Medical Center ( Site 0545) | Petach-Tikwa | Israel | 4941492 | |
| 133 | Chaim Sheba Medical Center ( Site 0541) | Ramat Gan | Israel | 5262000 | |
| 134 | Sourasky Medical Center ( Site 0542) | Tel Aviv | Israel | 6423906 | |
| 135 | Istituto Clinico Humanitas Research Hospital ( Site 0452) | Rozzano | Milano | Italy | 20089 |
| 136 | Azienda Ospedaliera Cannizzaro ( Site 0458) | Catania | Italy | 95126 | |
| 137 | A.O. Universitaria di Modena ( Site 0454) | Modena | Italy | 41100 | |
| 138 | Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457) | Napoli | Italy | 80131 | |
| 139 | Azienda Ospedaliera San Camillo Forlanini ( Site 0455) | Roma | Italy | 00152 | |
| 140 | Azienda Ospedaliera Santa Maria Terni ( Site 0456) | Terni | Italy | 05100 | |
| 141 | Presidio Ospedaliero Santa Chiara ( Site 0451) | Trento | Italy | 38122 | |
| 142 | National Cancer Center Hospital East ( Site 0702) | Kashiwa | Chiba | Japan | 277-8577 |
| 143 | Toho University Sakura Medical Center ( Site 0703) | Sakura | Chiba | Japan | 285-8741 |
| 144 | National Hospital Organization Shikoku Cancer Center ( Site 0716) | Matsuyama | Ehime | Japan | 791-0280 |
| 145 | Kanazawa University Hospital ( Site 0701) | Kanazawa | Ishikawa | Japan | 920-8641 |
| 146 | Kitasato University Hospital ( Site 0705) | Sagamihara | Kanagawa | Japan | 252-0375 |
| 147 | Yokohama City University Medical Center ( Site 0706) | Yokohama | Kanagawa | Japan | 232-0024 |
| 148 | Nara Medical University Hospital ( Site 0715) | Kashihara | Nara | Japan | 634-8522 |
| 149 | Kindai University Hospital ( Site 0714) | Osakasayama | Osaka | Japan | 589-8511 |
| 150 | Osaka University Hospital ( Site 0713) | Suita | Osaka | Japan | 565-0871 |
| 151 | Saitama Medical University International Medical Center ( Site 0708) | Hidaka | Saitama | Japan | 1932 |
| 152 | Dokkyo Medical University Saitama Medical Center ( Site 0707) | Koshigaya | Saitama | Japan | 343-8555 |
| 153 | Hamamatsu University Hospital ( Site 0720) | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 154 | Yamaguchi University Hospital ( Site 0717) | Ube | Yamaguchi | Japan | 755-8505 |
| 155 | Chiba Cancer Center ( Site 0704) | Chiba | Japan | 260-8717 | |
| 156 | Kyushu University Hospital ( Site 0718) | Fukuoka | Japan | 812-8582 | |
| 157 | University of Miyazaki Hospital ( Site 0721) | Miyazaki | Japan | 889-1692 | |
| 158 | Nagasaki University Hospital ( Site 0719) | Nagasaki | Japan | 852-8501 | |
| 159 | Toranomon Hospital ( Site 0711) | Tokyo | Japan | 105-8470 | |
| 160 | Nippon Medical School Hospital ( Site 0709) | Tokyo | Japan | 113-8603 | |
| 161 | Keio University Hospital ( Site 0710) | Tokyo | Japan | 160-8582 | |
| 162 | National Cancer Center ( Site 0174) | Goyang-si | Kyonggi-do | Korea, Republic of | 10408 |
| 163 | Seoul National University Bundang Hospital ( Site 0175) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13620 |
| 164 | Seoul National University Hospital ( Site 0171) | Seoul | Korea, Republic of | 03080 | |
| 165 | Asan Medical Center ( Site 0176) | Seoul | Korea, Republic of | 05505 | |
| 166 | Samsung Medical Center ( Site 0172) | Seoul | Korea, Republic of | 06351 | |
| 167 | Medisch Centrum Leeuwarden ( Site 0477) | Leeuwarden | Fryslan | Netherlands | 8934 AD |
| 168 | Ziekenhuis Gelderse Vallei ( Site 0485) | Ede | Gelderland | Netherlands | 6746 RP |
| 169 | Radboud University Medical Center ( Site 0470) | Nijmegen | Gelderland | Netherlands | 6525 GA |
| 170 | VieCuri Medisch Centrum ( Site 0487) | Venlo | Limburg | Netherlands | 5912 BL |
| 171 | Jeroen Bosch Ziekenhuis ( Site 1200) | Den Bosch | Noord-Brabant | Netherlands | 5223 GZ |
| 172 | Catharina Ziekenhuis ( Site 0472) | Eindhoven | Noord-Brabant | Netherlands | 5623 EJ |
| 173 | Antoni van Leeuwenhoek Ziekenhuis ( Site 0480) | Amsterdam | Noord-Holland | Netherlands | 1066 CX |
| 174 | Ziekenhuis Hilversum ( Site 0466) | Hilversum | Noord-Holland | Netherlands | 1213 XZ |
| 175 | Ziekenhuisgroep Twente ( Site 0469) | Hengelo | Overijssel | Netherlands | 7555 DL |
| 176 | Reinier de Graaf Groep ( Site 0484) | Delft | Zuid-Holland | Netherlands | 2625 AD |
| 177 | Hagaziekenhuis ( Site 1201) | Den Haag | Zuid-Holland | Netherlands | 2545 AA |
| 178 | Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) | Chelyabinsk | Chelyabinskaya Oblast | Russian Federation | 454087 |
| 179 | Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660133 |
| 180 | SBIH City clinical hospital named after D.D. Pletniov ( Site 0575) | Moscow | Moskva | Russian Federation | 105077 |
| 181 | Russian Scientific Center of Radiology ( Site 0559) | Moscow | Moskva | Russian Federation | 117485 |
| 182 | Central Clinical Hospital with Polyclinic ( Site 0562) | Moscow | Moskva | Russian Federation | 121359 |
| 183 | National Medical Research Radiological Center ( Site 0556) | Moscow | Moskva | Russian Federation | 125284 |
| 184 | Volga District Medical Center Federal Medical and Biological Agency ( Site 0572) | Nizhny Novgorod | Nizhegorodskaya Oblast | Russian Federation | 603074 |
| 185 | Omsk Clinical Oncology Dispensary ( Site 0568) | Omsk | Omskaya Oblast | Russian Federation | 644013 |
| 186 | SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) | Samara | Samarskaya Oblast | Russian Federation | 443031 |
| 187 | Clinical Research Center of specialized types medical care-Oncology ( Site 0570) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197758 |
| 188 | Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197758 |
| 189 | SPb SBHI City Clinical Oncological Dispensary ( Site 0571) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 198255 |
| 190 | Leningrad Regional Oncology Center ( Site 0588) | Saint-Petersburg | Sankt-Peterburg | Russian Federation | 188663 |
| 191 | Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579) | Tomsk | Tomskaya Oblast | Russian Federation | 634050 |
| 192 | Instituto Catalan de Oncologia - ICO ( Site 0330) | L Hospitalet De Llobregat | Barcelona | Spain | 08908 |
| 193 | Hospital Consorci Sanitari Parc Tauli ( Site 0335) | Sabadell | Barcelona | Spain | 08208 |
| 194 | Hospital Universitario Marques de Valdecilla ( Site 0336) | Santander | Cantabria | Spain | 39008 |
| 195 | Hospital Josep Trueta ( Site 0321) | Girona | Gerona | Spain | 17007 |
| 196 | Hospital del Mar ( Site 0333) | Barcelona | Spain | 08003 | |
| 197 | Hospital Clinic ( Site 0323) | Barcelona | Spain | 08036 | |
| 198 | Hospital Universitario Ramon y Cajal ( Site 0328) | Madrid | Spain | 28034 | |
| 199 | Hospital Clinico San Carlos ( Site 0324) | Madrid | Spain | 28040 | |
| 200 | Hospital Universitario HM Sanchinarro ( Site 0322) | Madrid | Spain | 28050 | |
| 201 | Hospital Universitario Virgen de la Victoria ( Site 0337) | Malaga | Spain | 29016 | |
| 202 | Hospital Virgen del Rocio ( Site 0329) | Sevilla | Spain | 41013 | |
| 203 | National Cheng Kung University Hospital ( Site 0134) | Tainen | Tainan | Taiwan | 704 |
| 204 | China Medical University Hospital ( Site 0132) | Taichung | Taiwan | 40447 | |
| 205 | Taichung Veterans General Hospital ( Site 0133) | Taichung | Taiwan | 40705 | |
| 206 | National Taiwan University Hospital ( Site 0131) | Taipei | Taiwan | 10048 | |
| 207 | Taipei Veterans General Hospital ( Site 0135) | Taipei | Taiwan | 11217 | |
| 208 | University Hospitals Bristol NHS Foundation Trust ( Site 0530) | Bristol | Bristol, City Of | United Kingdom | BS2 8ED |
| 209 | Cambridge University Hospitals NHS Trust ( Site 0540) | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
| 210 | Torbay Hospital ( Site 0532) | Torquay | Devon | United Kingdom | TQ2 7AA |
| 211 | Weston Park Hospital ( Site 0539) | Sheffield | England | United Kingdom | S10 2SJ |
| 212 | Royal Marsden Hospital ( Site 0526) | Sutton | England | United Kingdom | SM2 5PT |
| 213 | Mount Vernon Cancer Centre ( Site 0536) | Northwood | Hertfordshire | United Kingdom | HA6 2RN |
| 214 | Barts Cancer Institute ( Site 0483) | London | London, City Of | United Kingdom | EC1A 7BE |
| 215 | University of North Midlands NHS Foundation Trust ( Site 0527) | Stoke-on-Trent | Staffordshire | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 3475-921
- MK-3475-921
- KEYNOTE-921
- JAPAC-CTI
- 2018-004116-22