Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

994

Participants

Timeline

Start Date

June 9, 2017

Primary Completion Date

December 14, 2020

Study Completion Date

December 28, 2025

Conditions
Renal Cell Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Placebo

IV infusion

Trial Locations (251)

112

Taipei Veterans General Hospital ( Site 0201), Taipei

333

Chang Gung Medical Foundation. Linkou ( Site 0203), Taoyuan District

407

Taichung Veterans General Hospital ( Site 0204), Taichung

2109

Macquarie University Hospital ( Site 0700), Macquarie Park

2217

Saint George Hospital [Kogarah, Australia] ( Site 0707), Kogarah

3128

Box Hill Hospital ( Site 0701), Box Hill

3350

Ballarat Health Services ( Site 0705), Ballarat

3550

Bendigo Cancer Centre ( Site 0704), Bendigo

5037

Adelaide Cancer Centre ( Site 0703), Kurralta Park

6150

Fiona Stanley Hospital ( Site 0702), Murdoch

10002

National Taiwan University Hospital ( Site 0202), Taipei

10043

Ospedale San Luigi Gonzaga ( Site 2010), Orbassano

10117

Campus Charite Mitte ( Site 2120), Berlin

10408

National Cancer Center ( Site 0304), Goyang-si

10461

Montefiore Medical Center ( Site 0009), The Bronx

13005

Hopital La Timone ( Site 2204), Marseille

13125

Helios Klinikum Berlin Buch ( Site 2125), Berlin

17007

Hospital de Girona Dr. Josep Trueta ( Site 1806), Girona

18045

St. Luke's University Health Network ( Site 0042), Easton

19104

Abramson Cancer Center ( Site 0010), Philadelphia

20007

Georgetown University Medical Center ( Site 0002), Washington D.C.

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005), Milan

20141

Istituto Europeo di Oncologia ( Site 2000), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 2118), Hamburg

20521

TYKS ( Site 2302), Turku

20850

Maryland Oncology Hematology, P.A. ( Site 8020), Rockville

21237

Weinberg Cancer Institute at Franklin Square ( Site 0046), Baltimore

23502

Virginia Oncology Associates ( Site 8011), Norfolk

23538

Universitaetsklinikum Schleswig Holstein ( Site 2109), Lübeck

25000

CHU Besancon - Hopital Jean Minjoz ( Site 2200), Besançon

27710

Duke University ( Site 0037), Durham

28007

Hospital Universitario Gregorio Maranon ( Site 1801), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 1800), Madrid

29010

Hospital Universitario Virgen de la Victoria ( Site 1808), Málaga

29414

Charleston Hematology Oncology Associates PA ( Site 8000), Charleston

29425

Medical University of South Carolina ( Site 0033), Charleston

30060

Northwest Georgia Oncology Centers PC ( Site 0014), Marietta

31008

Clinica Universitaria de Navarra ( Site 1803), Pamplona

31059

Institut Claudius Regaud IUCT Oncopole ( Site 2201), Toulouse

32503

Woodlands Medical Specialists, PA ( Site 8021), Pensacola

33075

Hopital Saint Andre ( Site 2202), Bordeaux

33486

Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035), Boca Raton

33520

TAYS ( Site 2301), Tampere

34205

Manatee Medical Research Institute ( Site 0039), Bradenton

34295

CHU Saint-Eloi ( Site 2203), Montpellier

35042

Centre Eugene Marquis ( Site 2209), Rennes

37209

Urology Associates [Nashville, TN] ( Site 0063), Nashville

40225

Universitatsklinikum Dusseldorf ( Site 2108), Düsseldorf

40447

China Medical University Hospital ( Site 0200), Taichung

40620

Keski-Suomen keskussairaala ( Site 2303), Jyväskylä

41125

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006), Modena

44805

Centre Rene Gauducheau ICO ( Site 2207), Saint-Herblain

45122

Universitaetsklinikum Essen ( Site 2116), Essen

45242

Oncology Hematology Care, Inc. ( Site 8008), Cincinnati

46009

Instituto Valenciano de Oncologia ( Site 1804), Valencia

46026

Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809), Valencia

47014

Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012), Meldola

48073

Quest Research Institute ( Site 0036), Royal Oak

48109

University of Michigan ( Site 0045), Ann Arbor

48201

Karmanos Cancer Institute ( Site 0013), Detroit

48202

Henry Ford Hospital ( Site 0032), Detroit

49055

ICO Centre Paul Papin ( Site 2208), Angers

52100

Medical Oncology Ospedale San Donato ( Site 2004), Arezzo

52242

University of Iowa Hospital and Clinics ( Site 0031), Iowa City

53127

Universitaetsklinikum Bonn ( Site 2110), Bonn

53792

University of Wisconsin Carbone Cancer Center ( Site 0019), Madison

54292

Krankenhaus der Barmherzigen Brueder Trier ( Site 2117), Trier

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111), Mainz

55404

Minnesota Oncology Specialist, PA ( Site 8002), Minneapolis

55426

Park Nicollet Frauenshuh Cancer Center ( Site 0020), Saint Louis Park

55435

Fairview Southdale Medical Oncology Clinic ( Site 0041), Edina

57105

Avera Cancer Institute ( Site 0023), Sioux Falls

59102

St. Vincent Healthcare Frontier Cancer Center ( Site 0008), Billings

60590

Universitaetsklinikum Frankfurt ( Site 2121), Frankfurt

60714

Illinois Cancer Specialists ( Site 8001), Niles

68130

Nebraska Cancer Specialists ( Site 0012), Omaha

69310

Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212), Pierre-Bénite

70112

University Medical Center New Orleans ( Site 0053), New Orleans

72076

Universitaetsklinikum Tuebingen ( Site 2100), Tübingen

72622

Studienpraxis Urologie ( Site 2115), Nürtingen

74146

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052), Tulsa

75246

Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019), Dallas

75390

UT Southwestern Medical Center ( Site 0003), Dallas

75702

Texas Oncology-Tyler ( Site 8005), Tyler

75908

Hopital Europeen Georges Pompidou ( Site 2206), Paris

76210

Texas Oncology-Denton South ( Site 8016), Denton

76712

Texas Oncology-Waco ( Site 8012), Waco

77024

Texas Oncology-Memorial City ( Site 8015), Houston

77030

MD Anderson Cancer Center ( Site 0065), Houston

UTHealth/Memorial Hermann Cancer Center ( Site 0001), Houston

78229

CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026), San Antonio

78731

Texas Oncology-Austin Central ( Site 8003), Austin

79106

Universitaetsklinikum Freiburg ( Site 2119), Freiburg im Breisgau

80012

Rocky Mountain Cancer Center ( Site 8010), Aurora

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003), Napoli

84106

IHO Corporation- Utah Cancer Specialists ( Site 0055), Salt Lake City

85016

Arizona Oncology Associates, PC- HAL ( Site 8018), Phoenix

87106

University of New Mexico Cancer Center ( Site 0043), Albuquerque

89148

Comprehensive Cancer Centers of Nevada ( Site 8013), Las Vegas

90033

USC Norris Comprehensive Cancer Center ( Site 0038), Los Angeles

90220

Oulun yliopistollinen sairaala - OYS ( Site 2304), Oulu

91054

Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102), Erlangen

93105

Sansum Clinic Research ( Site 8014), Santa Barbara

94158

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056), San Francisco

94305

Stanford Cancer Center ( Site 0028), Stanford

97223

Northwest Cancer Specialists, P.C. ( Site 8006), Tigard

98109

SCCA/UW ( Site 0029), Seattle

98201

Providence Regional Cancer Partnership ( Site 0016), Everett

98405

Northwest Medical Specialties, PLLC ( Site 0034), Tacoma

98902

Yakima Valley Memorial Hospital North Star Lodge ( Site 8017), Yakima

99202

Cancer Care Northwest ( Site 0021), Spokane

99208

Medical Oncology Associates (Summit Cancer Centers) ( Site 0005), Spokane

110131

Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803), Bogotá

110221

Administradora Country SA - Clinica del Country ( Site 0808), Bogotá

111161

Instituto Nacional de Cancerologia E.S.E ( Site 0807), Bogota

115478

N.N. Blokhin NMRCO ( Site 1206), Moscow

117997

Russian Scientific Center of Roentgenoradiology ( Site 1201), Moscow

125284

National Medical Research Radiology Centre ( Site 1200), Moscow

153040

Ivanovo Regional Oncology Dispensary ( Site 1204), Ivanovo

183057

Bayandin Murmansk Regional Clinical Hospital ( Site 1214), Murmansk

197758

Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205), Saint Petersburg

200001

Sociedad de Hematologia y Oncologia del Cesar ( Site 0809), Valledupar

230002

Oncomedica S.A. ( Site 0801), Montería

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217), Ufa

450083

Clinical Hospital Bashkirsky Medical State University ( Site 1202), Ufa

634028

Tomsk Scientific Research Institute of Oncology ( Site 1208), Tomsk

644013

Omsk Clinical Oncology Dispensary ( Site 1209), Omsk

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210), Krasnoyarsk

661002

Oncologos del Occidente S.A. ( Site 0800), Pereira

1240000

Centro Oncologico Antofagasta ( Site 0914), Antofagasta

1710216

Hospital Regional de La Serena ( Site 0907), La Serena

2520598

Oncocentro ( Site 0900), Viña del Mar

2820000

Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910), Rancagua

4810469

Sociedad de Investigaciones Medicas Limitadas ( Site 0913), Temuco

7500006

Health and Care Chile ( Site 0901), Santiago

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0902), Santiago

7630372

Iram Cancer Research ( Site 0909), Santiago

7850000

Hospital Militar de Santiago ( Site 0911), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 0904), Santiago

8380455

Instituto Nacional del Cancer ( Site 0912), Santiago

8380456

Hospital Clinico Universidad de Chile ( Site 0905), Santiago

50010-3014

McFarland Clinic ( Site 0025), Ames

02215

Beth Israel Deaconess Medical Ctr. ( Site 0044), Boston

Dana-Farber Cancer Institute (Boston) ( Site 0007), Boston

08903

Rutgers Cancer Institute of New Jersey ( Site 0059), New Brunswick

75460-5004

Texas Oncology- Paris ( Site 8004), Paris

R8500ACE

Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102), Viedma

S2000DSV

Sanatorio Parque ( Site 1104), Rosario

C1012AAR

Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113), Buenos Aires

C1093AAS

Fundacion Favaloro ( Site 1110), Buenos Aires

C1426ANZ

Instituto Medico Alexander Fleming ( Site 1105), Buenos Aires

F5300COE

Centro Oncologico Riojano Integral ( Site 1101), La Rioja

M5500AYB

Centro Oncologico de Integracion Regional. COIR ( Site 1109), Mendoza

S2000CVB

Sanatorio Britanico ( Site 1106), Rosario

S2000KZE

Instituto de Oncologia de Rosario ( Site 1100), Rosario

T4000IAK

Centro Medico San Roque ( Site 1108), San Miguel de Tucumán

80510-130

Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012), Curitiba

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 1013), Natal

95070-560

Universidade de Caxias do Sul ( Site 1004), Caxias do Sul

95900-000

Hospital Bruno Born ( Site 1015), Lajeado

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001), Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao ( Site 1000), Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002), Barretos

17210-120

Fundacao Dr Amaral Carvalho ( Site 1005), Jaú

01246-000

Instituto do Cancer de Sao Paulo - ICESP ( Site 1010), São Paulo

08270-120

Casa de Saude Santa Marcelina ( Site 1006), São Paulo

14048-900

Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016), Ribeirão Preto

38408-150

COT Centro Oncologico do Triangulo Ltda ( Site 1014), Uberlândia

R3E 0V9

CancerCare Manitoba ( Site 0119), Winnipeg

E1C 8X3

Dr. Leon Richard Oncology Centre ( Site 0106), Moncton

L6R 3J7

William Osler Health System ( Site 0115), Brampton

L8V 5C2

Juravinski Cancer Centre ( Site 0117), Hamilton

N6A 4L6

London Regional Cancer Program - London HSC ( Site 0107), London

L1G 2B9

Lakeridge Health ( Site 0108), Oshawa

L2S 0A9

Niagara Health System - St. Catharines ( Site 0120), St. Catharines

G7H 5H6

CIUSSS du Saguenay-Lac-St-Jean ( Site 0113), Chicoutimi

G6V 3Z1

CISSS-CA Hotel Dieu de Levis ( Site 0111), Lévis

H1T 2M4

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118), Montreal

J7Z 5T3

St-Jerome Medical Research Inc ( Site 0103), Saint-Jérôme

S4T 7T1

Allan Blair Cancer Centre ( Site 0116), Regina

S7N 4H4

Saskatoon Cancer Centre ( Site 0105), Saskatoon

050034

Hospital Pablo Tobon Uribe. ( Site 0805), Medellín

080020

Clinica de la Costa Ltda. ( Site 0804), Barranquilla

625 00

FN Brno. ( Site 1501), Brno

741 01

Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506), Nový Jičín

775 20

Fakultni nemocnice Olomouc ( Site 1502), Olomouc

708 52

Fakultni nemocnice Ostrava ( Site 1507), Ostrava

140 59

Thomayerova nemocnice ( Site 1505), Prague

150 06

Fakultni nemocnice v Motole ( Site 1504), Prague

180 81

Nemocnice Na Bulovce ( Site 1503), Prague

00290

HYKS ( Site 2300), Helsinki

06189

Centre Antoine Lacassagne ( Site 2211), Nice

01307

Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113), Dresden

07747

Universitaetsklinikum Jena. ( Site 2104), Jena

D04 Y8V0

Beaumont Hospital ( Site 1611), Dublin

St Vincents University Hospital ( Site 1610), Dublin

X91 ER8E

University Hospital Waterford ( Site 1614), Waterford

00144

Istituto Nazionale Tumori Regina Elena ( Site 2009), Roma

466-8560

Nagoya University Hospital ( Site 0431), Nagoya

060-8543

Sapporo Medical University Hospital ( Site 0424), Sapporo

761-0793

Kagawa University Hospital ( Site 0419), Kita-gun

981-8501

Japan Community Health care Organization Sendai Hospital ( Site 0430), Sendai

634-8522

Nara Medical University Hospital ( Site 0416), Kashihara

591-8025

Osaka Rosai Hospital ( Site 0418), Sakai

589-8511

Kindai University Hospital ( Site 0411), Sayama

350-1298

Saitama Medical University International Medical Center ( Site 0404), Hidaka

755-8505

Yamaguchi University Hospital ( Site 0406), Ube

010-8543

Akita University Hospital ( Site 0433), Akita

812-0033

Harasanshin Hospital ( Site 0402), Fukuoka

812-8582

Kyushu University Hospital ( Site 0413), Fukuoka

860-8556

Kumamoto University Hospital ( Site 0434), Kumamoto

381-8551

Nagano Municipal Hospital ( Site 0429), Nagano

951-8520

Niigata University Medical & Dental Hospital ( Site 0421), Niigata

541-8567

Osaka International Cancer Institute ( Site 0401), Osaka

545-8586

Osaka City University Hospital ( Site 0428), Osaka

105-8470

Toranomon Hospital ( Site 0426), Tokyo

113-8603

Nippon Medical School Hospital ( Site 0400), Tokyo

160-8582

Keio University Hospital ( Site 0407), Tokyo

930-0194

Toyama University Hospital ( Site 0432), Toyama

4819 EV

Amphia Ziekenhuis Breda ( Site 1901), Breda

6229 HX

Maastricht Universitair Medisch Centrum - MUMC ( Site 1902), Maastricht

3045 PM

Franciscus Gasthuis ( Site 1903), Rotterdam

05-135

Mazowiecki Szpital Onkologiczny ( Site 1316), Wieliszew

83-400

Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322), Kościerzyna

36-200

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309), Brzozów

41-902

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307), Bytom

80-219

Wojewodzkie Centrum Onkologii Copernicus ( Site 1304), Gdansk

81-519

Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302), Gdynia

44-101

Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323), Gliwice

62-500

Przychodnia Lekarska Komed ( Site 1306), Konin

31-115

Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310), Krakow

20-090

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315), Lublin

05-400

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324), Otwock

60-569

Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311), Poznan

87-100

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305), Torun

02-793

Centrum Medyczne Onkologii I Hipertermii ( Site 1321), Warsaw

04-141

Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300), Warsaw

03080

Seoul National University Hospital ( Site 0302), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0303), Seoul

05505

Asan Medical Center ( Site 0300), Seoul

06351

Samsung Medical Center ( Site 0301), Seoul

06080

Hospital Universitario Infanta Cristina ( Site 1805), Badajoz

08026

Hospital de la Santa Creu i Sant Pau ( Site 1807), Barcelona

ST4 6QG

North Staffordshire Hospital in Stoke-on-Trent ( Site 1601), Stoke-on-Trent

EH4 2XU

Western General Hospital ( Site 1600), Edinburgh

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 1605), Glasgow

NW3 2QG

Royal Free Hospital ( Site 1609), London

SW17 0QT

St George s Healthcare Trust ( Site 1608), London

W6 8RF

Charing Cross Hospital ( Site 1607), London

M20 4BX

The Christie NHS Foundation Trust ( Site 1602), Manchester

TS4 3BW

The James Cook University Hospital ( Site 1606), Middlesbrough

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03142334 - Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) | Biotech Hunter | Biotech Hunter