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)

June 28, 2023 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be assigned to receive study treatment until disease recurrence, unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the participant, noncompliance with study treatment or procedural requirements, administrative reasons requiring cessation of treatment, or until the participant has received 17 cycles of study treatment (approximately 1 year). Each cycle is 3 weeks long.

With Protocol Amendment 02 (dated 04 Sep 2019), the secondary study objectives for the evaluation of pharmacokinetic (PK) parameters and the presence of pembrolizumab antidrug antibodies (ADA) were reclassified as tertiary study objectives.

Study Type

Interventional

Enrollment (Actual)

994

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1012AAR
        • Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
      • Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro ( Site 1110)
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Medico Alexander Fleming ( Site 1105)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral ( Site 1101)
      • Mendoza, Argentina, M5500AYB
        • Centro Oncologico de Integracion Regional. COIR ( Site 1109)
      • Rosario, Argentina, S2000CVB
        • Sanatorio Britanico ( Site 1106)
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario ( Site 1100)
      • Tucuman, Argentina, T4000IAK
        • Centro Medico San Roque ( Site 1108)
    • Rio Negro
      • Viedma, Rio Negro, Argentina, R8500ACE
        • Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque ( Site 1104)
  • Australia
      • Ballarat, Australia, 3350
        • Ballarat Health Services ( Site 0705)
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Saint George Hospital [Kogarah, Australia] ( Site 0707)
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University Hospital ( Site 0700)
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre ( Site 0703)
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Cancer Centre ( Site 0704)
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital ( Site 0701)
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital ( Site 0702)
  • Brazil
      • Ribeirao Preto, Brazil, 14048-900
        • Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
      • Uberlandia, Brazil, 38408-150
        • COT Centro Oncologico do Triangulo Ltda ( Site 1014)
    • PR
      • Curitiba, PR, Brazil, 80510-130
        • Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
    • RS
      • Lajeado, RS, Brazil, 95900-000
        • Hospital Bruno Born ( Site 1015)
      • Porto Alegre, RS, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao ( Site 1000)
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Cancer ( Site 1013)
    • Rio Grande Do Sul
      • Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
        • Universidade de Caxias do Sul ( Site 1004)
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
      • Sao Paulo, SP, Brazil, 08270-120
        • Casa de Saude Santa Marcelina ( Site 1006)
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
      • Jau, Sao Paulo, Brazil, 17210-120
        • Fundacao Dr Amaral Carvalho ( Site 1005)
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba ( Site 0119)
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dr. Leon Richard Oncology Centre ( Site 0106)
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System ( Site 0115)
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre ( Site 0117)
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program - London HSC ( Site 0107)
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health ( Site 0108)
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Niagara Health System - St. Catharines ( Site 0120)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
      • Lévis, Quebec, Canada, G6V 3Z1
        • CISSS-CA Hotel Dieu de Levis ( Site 0111)
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
      • St-Jerome, Quebec, Canada, J7Z 5T3
        • St-Jerome Medical Research Inc ( Site 0103)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre ( Site 0116)
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre ( Site 0105)
  • Chile
      • Antofagasta, Chile, 1240000
        • Centro Oncologico Antofagasta ( Site 0914)
      • La Serena, Chile, 1710216
        • Hospital Regional de La Serena ( Site 0907)
      • Rancagua, Chile, 2820000
        • Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
      • Santiago, Chile, 7500006
        • Health and Care Chile ( Site 0901)
      • Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez FALP ( Site 0902)
      • Santiago, Chile, 7630372
        • Iram Cancer Research ( Site 0909)
      • Santiago, Chile, 7850000
        • Hospital Militar de Santiago ( Site 0911)
      • Santiago, Chile, 8330032
        • Pontificia Universidad Catolica de Chile ( Site 0904)
      • Santiago, Chile, 8380456
        • Hospital Clinico Universidad de Chile ( Site 0905)
      • Temuco, Chile, 4810469
        • Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
      • Vina del Mar, Chile, 2520598
        • Oncocentro ( Site 0900)
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8380455
        • Instituto Nacional del Cancer ( Site 0912)
  • Colombia
      • Bogota, Colombia, 110131
        • Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
      • Bogota, Colombia, 110221
        • Administradora Country SA - Clinica del Country ( Site 0808)
      • Monteria, Colombia, 230002
        • Oncomedica S.A. ( Site 0801)
    • Antioquia
      • Medellin, Antioquia, Colombia, 050034
        • Hospital Pablo Tobon Uribe. ( Site 0805)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 0804)
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111161
        • Instituto Nacional de Cancerologia E.S.E ( Site 0807)
    • Risaralda
      • Pereira, Risaralda, Colombia, 661002
        • Oncologos del Occidente S.A. ( Site 0800)
  • Czechia
      • Brno, Czechia, 625 00
        • FN Brno. ( Site 1501)
      • Novy Jicin, Czechia, 741 01
        • Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
      • Olomouc, Czechia, 775 20
        • Fakultni nemocnice Olomouc ( Site 1502)
      • Ostrava, Czechia, 708 52
        • Fakultni nemocnice Ostrava ( Site 1507)
      • Praha 4, Czechia, 140 59
        • Thomayerova nemocnice ( Site 1505)
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole ( Site 1504)
      • Praha 8, Czechia, 180 81
        • Nemocnice Na Bulovce ( Site 1503)
  • Finland
      • Helsinki, Finland, 00290
        • HYKS ( Site 2300)
      • Jyvaskyla, Finland, 40620
        • Keski-Suomen keskussairaala ( Site 2303)
      • Oulu, Finland, 90220
        • Oulun yliopistollinen sairaala - OYS ( Site 2304)
      • Tampere, Finland, 33520
        • TAYS ( Site 2301)
      • Turku, Finland, 20521
        • TYKS ( Site 2302)
  • France
      • Angers, France, 49055
        • ICO Centre Paul Papin ( Site 2208)
      • Besancon, France, 25000
        • CHU Besancon - Hopital Jean Minjoz ( Site 2200)
      • Bordeaux, France, 33075
        • Hopital Saint Andre ( Site 2202)
      • Marseille, France, 13005
        • Hopital La Timone ( Site 2204)
      • Montpellier, France, 34295
        • CHU Saint-Eloi ( Site 2203)
      • Nice, France, 06189
        • Centre Antoine Lacassagne ( Site 2211)
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou ( Site 2206)
      • Pierre Benite, France, 69310
        • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
      • Rennes, France, 35042
        • Centre Eugene Marquis ( Site 2209)
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau ICO ( Site 2207)
      • Toulouse, France, 31059
        • Institut Claudius Regaud IUCT Oncopole ( Site 2201)
  • Germany
      • Berlin, Germany, 10117
        • Campus Charite Mitte ( Site 2120)
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin Buch ( Site 2125)
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn ( Site 2110)
      • Dresden, Germany, 01307
        • Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
      • Dusseldorf, Germany, 40225
        • Universitatsklinikum Dusseldorf ( Site 2108)
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
      • Essen, Germany, 45122
        • Universitaetsklinikum Essen ( Site 2116)
      • Frankfurt, Germany, 60590
        • Universitaetsklinikum Frankfurt ( Site 2121)
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg ( Site 2119)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena. ( Site 2104)
      • Luebeck, Germany, 23538
        • Universitaetsklinikum Schleswig Holstein ( Site 2109)
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
      • Nuertingen, Germany, 72622
        • Studienpraxis Urologie ( Site 2115)
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen ( Site 2100)
  • Ireland
      • Dublin, Ireland, D04 Y8V0
        • Beaumont Hospital ( Site 1611)
      • Dublin, Ireland, D04 Y8V0
        • St Vincents University Hospital ( Site 1610)
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford ( Site 1614)
  • Italy
      • Arezzo, Italy, 52100
        • Medical Oncology Ospedale San Donato ( Site 2004)
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia ( Site 2000)
      • Modena, Italy, 41125
        • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena ( Site 2009)
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Ospedale San Luigi Gonzaga ( Site 2010)
  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital ( Site 0433)
      • Fukuoka, Japan, 812-0033
        • Harasanshin Hospital ( Site 0402)
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital ( Site 0413)
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital ( Site 0434)
      • Nagano, Japan, 381-8551
        • Nagano Municipal Hospital ( Site 0429)
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital ( Site 0421)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 0401)
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital ( Site 0428)
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital ( Site 0426)
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital ( Site 0400)
      • Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 0407)
      • Toyama, Japan, 930-0194
        • Toyama University Hospital ( Site 0432)
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital ( Site 0431)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital ( Site 0424)
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Kagawa University Hospital ( Site 0419)
    • Miyagi
      • Sendai, Miyagi, Japan, 981-8501
        • Japan Community Health care Organization Sendai Hospital ( Site 0430)
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Nara Medical University Hospital ( Site 0416)
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital ( Site 0411)
      • Sakai, Osaka, Japan, 591-8025
        • Osaka Rosai Hospital ( Site 0418)
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center ( Site 0404)
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital ( Site 0406)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 0302)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 0303)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 0300)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 0301)
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 0304)
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis Breda ( Site 1901)
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
      • Rotterdam, Netherlands, 3045 PM
        • Franciscus Gasthuis ( Site 1903)
  • Poland
      • Brzozow, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
      • Bytom, Poland, 41-902
        • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
      • Gdansk, Poland, 80-219
        • Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
      • Gdynia, Poland, 81-519
        • Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
      • Gliwice, Poland, 44-101
        • Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
      • Konin, Poland, 62-500
        • Przychodnia Lekarska Komed ( Site 1306)
      • Krakow, Poland, 31-115
        • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
      • Poznan, Poland, 60-569
        • Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
      • Warszawa, Poland, 02-793
        • Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
      • Warszawa, Poland, 04-141
        • Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
    • Mazowieckie
      • Wieliszew, Mazowieckie, Poland, 05-135
        • Mazowiecki Szpital Onkologiczny ( Site 1316)
    • Pomorskie
      • Koscierzyna, Pomorskie, Poland, 83-400
        • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary ( Site 1204)
      • Krasnoyarsk, Russian Federation, 660133
        • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin NMRCO ( Site 1206)
      • Moscow, Russian Federation, 117997
        • Russian Scientific Center of Roentgenoradiology ( Site 1201)
      • Moscow, Russian Federation, 125284
        • National Medical Research Radiology Centre ( Site 1200)
      • Murmansk, Russian Federation, 183057
        • Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
      • Omsk, Russian Federation, 644013
        • Omsk Clinical Oncology Dispensary ( Site 1209)
      • Saint Petersburg, Russian Federation, 197758
        • Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
      • Tomsk, Russian Federation, 634028
        • Tomsk Scientific Research Institute of Oncology ( Site 1208)
      • Ufa, Russian Federation, 450054
        • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
      • Ufa, Russian Federation, 450083
        • Clinical Hospital Bashkirsky Medical State University ( Site 1202)
  • Spain
      • Badajoz, Spain, 06080
        • Hospital Universitario Infanta Cristina ( Site 1805)
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau ( Site 1807)
      • Girona, Spain, 17007
        • Hospital de Girona Dr. Josep Trueta ( Site 1806)
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Maranon ( Site 1801)
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal ( Site 1800)
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria ( Site 1808)
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra ( Site 1803)
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia ( Site 1804)
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0200)
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital ( Site 0204)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 0202)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 0201)
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation. Linkou ( Site 0203)
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital ( Site 1600)
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre ( Site 1605)
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital ( Site 1609)
      • London, United Kingdom, SW17 0QT
        • St George s Healthcare Trust ( Site 1608)
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital ( Site 1607)
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust ( Site 1602)
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital ( Site 1606)
    • Staffordshire
      • Stoke-On-Trent, Staffordshire, United Kingdom, ST4 6QG
        • North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC- HAL ( Site 8018)
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center ( Site 0038)
      • San Francisco, California, United States, 94158
        • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic Research ( Site 8014)
      • Stanford, California, United States, 94305
        • Stanford Cancer Center ( Site 0028)
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center ( Site 8010)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center ( Site 0002)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
      • Bradenton, Florida, United States, 34205
        • Manatee Medical Research Institute ( Site 0039)
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA ( Site 8021)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC ( Site 0014)
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists ( Site 8001)
    • Iowa
      • Ames, Iowa, United States, 50010-3014
        • McFarland Clinic ( Site 0025)
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 0031)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans ( Site 0053)
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Weinberg Cancer Institute at Franklin Square ( Site 0046)
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, P.A. ( Site 8020)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Ctr. ( Site 0044)
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute (Boston) ( Site 0007)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 0045)
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute ( Site 0013)
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital ( Site 0032)
      • Royal Oak, Michigan, United States, 48073
        • Quest Research Institute ( Site 0036)
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Medical Oncology Clinic ( Site 0041)
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Specialist, PA ( Site 8002)
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Frauenshuh Cancer Center ( Site 0020)
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists ( Site 0012)
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada ( Site 8013)
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey ( Site 0059)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center ( Site 0043)
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center ( Site 0009)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University ( Site 0037)
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc. ( Site 8008)
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Northwest Cancer Specialists, P.C. ( Site 8006)
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • St. Luke's University Health Network ( Site 0042)
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center ( Site 0010)
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates PA ( Site 8000)
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina ( Site 0033)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute ( Site 0023)
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates [Nashville, TN] ( Site 0063)
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology-Austin Central ( Site 8003)
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center ( Site 0003)
      • Denton, Texas, United States, 76210
        • Texas Oncology-Denton South ( Site 8016)
      • Houston, Texas, United States, 77024
        • Texas Oncology-Memorial City ( Site 8015)
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center ( Site 0065)
      • Houston, Texas, United States, 77030
        • UTHealth/Memorial Hermann Cancer Center ( Site 0001)
      • Paris, Texas, United States, 75460-5004
        • Texas Oncology- Paris ( Site 8004)
      • San Antonio, Texas, United States, 78229
        • CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Tyler ( Site 8005)
      • Waco, Texas, United States, 76712
        • Texas Oncology-Waco ( Site 8012)
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • IHO Corporation- Utah Cancer Specialists ( Site 0055)
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates ( Site 8011)
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership ( Site 0016)
      • Seattle, Washington, United States, 98109
        • SCCA/UW ( Site 0029)
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest ( Site 0021)
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC ( Site 0034)
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center ( Site 0019)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
  • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment
  • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment

  • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:

    1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
    2. High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0
    3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤1 year from nephrectomy (metachronous)
  • Has received no prior systemic therapy for advanced RCC
  • Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins
  • Must have undergone a nephrectomy and/or metastasectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to randomization
  • Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan ≤28 days from randomization
  • Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available)
  • Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
  • Has adequate organ function

Exclusion Criteria:

  • Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization
  • Has received prior radiotherapy for RCC
  • Has pre-existing brain or bone metastatic lesions
  • Has residual thrombus post nephrectomy in the vena renalis or vena cava
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed
  • Has a known additional malignancy that is progressing or required active treatment ≤3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a history of, or is currently on, dialysis
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has known active hepatitis B or hepatitis C virus infection
  • Has a known history of active tuberculosis (Bacillus tuberculosis)
  • Has had a prior solid organ transplant
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
  • Is pregnant or breastfeeding, or 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 received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
  • Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be ≤ Grade 1 or at Baseline) from AEs due to previously administered agents
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Placebo Comparator: Placebo
Participants receive placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
Drug: Placebo
IV infusion
Other Names:
  • saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS) as Assessed by the Investigator
Time Frame: Up to approximately 42 months (database cutoff date 14 Dec 2020)
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
Up to approximately 42 months (database cutoff date 14 Dec 2020)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 72 months
OS was defined as the time from randomization to death due to any cause.
Up to approximately 72 months
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
Number of Participants Who Discontinued Study Drug Due to an AE
Time Frame: Up to approximately 12 months
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
Up to approximately 12 months
First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
Time Frame: Up to approximately 72 months
DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Up to approximately 72 months
Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
Time Frame: Up to approximately 72 months
DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator.
Up to approximately 72 months
Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 72 months
EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
Up to approximately 72 months
DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
Time Frame: Up to approximately 72 months
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
Up to approximately 72 months
OS According to Participant PD-L1 Expression Status (Positive, Negative)
Time Frame: Up to approximately 72 months
OS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
Up to approximately 72 months
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
Time Frame: Baseline and Week 52
The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.
Baseline and Week 52
Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
Time Frame: Baseline and Week 52
The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. The change from baseline in the FKSI-DRS index score will be presented.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2017

Primary Completion (Actual)

December 14, 2020

Study Completion (Estimated)

December 28, 2025

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-564
  • 2016-004351-75 (EudraCT Number)
  • 173704 (Registry Identifier: JAPAC-CTI)
  • MK-3475-564 (Other Identifier: Merck)
  • KEYNOTE-564 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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