AzTrials
AzTrials

Renal Cell CarcinomaPhase 3NCT03142334

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)

A Phase 3 study testing Pembrolizumab in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 251 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
994 participants
Where
251 sitesin 21 countries
Study dates
9 Jun 2017to 4 Feb 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
  • High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

251 sites in 21 countries.

251 sites in 21 countries

United States62 sites

  • University of New Mexico Cancer Center ( Site 0043)

    Albuquerque, New Mexico, 87106

  • McFarland Clinic ( Site 0025)

    Ames, Iowa, 50010-3014

  • University of Michigan ( Site 0045)

    Ann Arbor, Michigan, 48109

  • Rocky Mountain Cancer Center ( Site 8010)

    Aurora, Colorado, 80012

  • Texas Oncology-Austin Central ( Site 8003)

    Austin, Texas, 78731

  • Weinberg Cancer Institute at Franklin Square ( Site 0046)

    Baltimore, Maryland, 21237

  • St. Vincent Healthcare Frontier Cancer Center ( Site 0008)

    Billings, Montana, 59102

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

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Ctr. ( Site 0044)

    Boston, Massachusetts, 02215

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

    Boston, Massachusetts, 02215

  • Manatee Medical Research Institute ( Site 0039)

    Bradenton, Florida, 34205

  • Charleston Hematology Oncology Associates PA ( Site 8000)

    Charleston, South Carolina, 29414

  • Medical University of South Carolina ( Site 0033)

    Charleston, South Carolina, 29425

  • Oncology Hematology Care, Inc. ( Site 8008)

    Cincinnati, Ohio, 45242

  • Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)

    Dallas, Texas, 75246

  • UT Southwestern Medical Center ( Site 0003)

    Dallas, Texas, 75390

  • Texas Oncology-Denton South ( Site 8016)

    Denton, Texas, 76210

  • Karmanos Cancer Institute ( Site 0013)

    Detroit, Michigan, 48201

  • Henry Ford Hospital ( Site 0032)

    Detroit, Michigan, 48202

  • Duke University ( Site 0037)

    Durham, North Carolina, 27710

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

    Easton, Pennsylvania, 18045

  • Fairview Southdale Medical Oncology Clinic ( Site 0041)

    Edina, Minnesota, 55435

  • Providence Regional Cancer Partnership ( Site 0016)

    Everett, Washington, 98201

  • Texas Oncology-Memorial City ( Site 8015)

    Houston, Texas, 77024

  • MD Anderson Cancer Center ( Site 0065)

    Houston, Texas, 77030

  • UTHealth/Memorial Hermann Cancer Center ( Site 0001)

    Houston, Texas, 77030

  • University of Iowa Hospital and Clinics ( Site 0031)

    Iowa City, Iowa, 52242

  • Comprehensive Cancer Centers of Nevada ( Site 8013)

    Las Vegas, Nevada, 89148

  • USC Norris Comprehensive Cancer Center ( Site 0038)

    Los Angeles, California, 90033

  • University of Wisconsin Carbone Cancer Center ( Site 0019)

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers PC ( Site 0014)

    Marietta, Georgia, 30060

  • Minnesota Oncology Specialist, PA ( Site 8002)

    Minneapolis, Minnesota, 55404

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

    Nashville, Tennessee, 37209

  • Rutgers Cancer Institute of New Jersey ( Site 0059)

    New Brunswick, New Jersey, 08903

  • University Medical Center New Orleans ( Site 0053)

    New Orleans, Louisiana, 70112

  • Illinois Cancer Specialists ( Site 8001)

    Niles, Illinois, 60714

  • Virginia Oncology Associates ( Site 8011)

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists ( Site 0012)

    Omaha, Nebraska, 68130

  • Texas Oncology- Paris ( Site 8004)

    Paris, Texas, 75460-5004

  • Woodlands Medical Specialists, PA ( Site 8021)

    Pensacola, Florida, 32503

  • Abramson Cancer Center ( Site 0010)

    Philadelphia, Pennsylvania, 19104

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

    Phoenix, Arizona, 85016

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

    Rockville, Maryland, 20850

  • Quest Research Institute ( Site 0036)

    Royal Oak, Michigan, 48073

  • Park Nicollet Frauenshuh Cancer Center ( Site 0020)

    Saint Louis Park, Minnesota, 55426

  • IHO Corporation- Utah Cancer Specialists ( Site 0055)

    Salt Lake City, Utah, 84106

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

    San Antonio, Texas, 78229

  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)

    San Francisco, California, 94158

  • Sansum Clinic Research ( Site 8014)

    Santa Barbara, California, 93105

  • SCCA/UW ( Site 0029)

    Seattle, Washington, 98109

  • Avera Cancer Institute ( Site 0023)

    Sioux Falls, South Dakota, 57105

  • Cancer Care Northwest ( Site 0021)

    Spokane, Washington, 99202

  • Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)

    Spokane, Washington, 99208

  • Stanford Cancer Center ( Site 0028)

    Stanford, California, 94305

  • Northwest Medical Specialties, PLLC ( Site 0034)

    Tacoma, Washington, 98405

  • Montefiore Medical Center ( Site 0009)

    The Bronx, New York, 10461

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

    Tigard, Oregon, 97223

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

    Tulsa, Oklahoma, 74146

  • Texas Oncology-Tyler ( Site 8005)

    Tyler, Texas, 75702

  • Texas Oncology-Waco ( Site 8012)

    Waco, Texas, 76712

  • Georgetown University Medical Center ( Site 0002)

    Washington D.C., District of Columbia, 20007

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

    Yakima, Washington, 98902

Other trials in United States

Japan21 sites

  • Akita University Hospital ( Site 0433)

    Akita, 010-8543

  • Harasanshin Hospital ( Site 0402)

    Fukuoka, 812-0033

  • Kyushu University Hospital ( Site 0413)

    Fukuoka, 812-8582

  • Saitama Medical University International Medical Center ( Site 0404)

    Hidaka, Saitama, 350-1298

  • Nara Medical University Hospital ( Site 0416)

    Kashihara, Nara, 634-8522

  • Kagawa University Hospital ( Site 0419)

    Kita-gun, Kagawa-ken, 761-0793

  • Kumamoto University Hospital ( Site 0434)

    Kumamoto, 860-8556

  • Nagano Municipal Hospital ( Site 0429)

    Nagano, 381-8551

  • Nagoya University Hospital ( Site 0431)

    Nagoya, Aichi-ken, 466-8560

  • Niigata University Medical & Dental Hospital ( Site 0421)

    Niigata, 951-8520

  • Osaka International Cancer Institute ( Site 0401)

    Osaka, 541-8567

  • Osaka City University Hospital ( Site 0428)

    Osaka, 545-8586

  • Osaka Rosai Hospital ( Site 0418)

    Sakai, Osaka, 591-8025

  • Sapporo Medical University Hospital ( Site 0424)

    Sapporo, Hokkaido, 060-8543

  • Kindai University Hospital ( Site 0411)

    Sayama, Osaka, 589-8511

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

    Sendai, Miyagi, 981-8501

  • Toranomon Hospital ( Site 0426)

    Tokyo, 105-8470

  • Nippon Medical School Hospital ( Site 0400)

    Tokyo, 113-8603

  • Keio University Hospital ( Site 0407)

    Tokyo, 160-8582

  • Toyama University Hospital ( Site 0432)

    Toyama, 930-0194

  • Yamaguchi University Hospital ( Site 0406)

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Germany16 sites

  • Campus Charite Mitte ( Site 2120)

    Berlin, 10117

  • Helios Klinikum Berlin Buch ( Site 2125)

    Berlin, 13125

  • Universitaetsklinikum Bonn ( Site 2110)

    Bonn, 53127

  • Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)

    Dresden, 01307

  • Universitatsklinikum Dusseldorf ( Site 2108)

    Düsseldorf, 40225

  • Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)

    Erlangen, 91054

  • Universitaetsklinikum Essen ( Site 2116)

    Essen, 45122

  • Universitaetsklinikum Frankfurt ( Site 2121)

    Frankfurt, 60590

  • Universitaetsklinikum Freiburg ( Site 2119)

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)

    Hamburg, 20246

  • Universitaetsklinikum Jena. ( Site 2104)

    Jena, 07747

  • Universitaetsklinikum Schleswig Holstein ( Site 2109)

    Lübeck, 23538

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

    Mainz, 55131

  • Studienpraxis Urologie ( Site 2115)

    Nürtingen, 72622

  • Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)

    Trier, 54292

  • Universitaetsklinikum Tuebingen ( Site 2100)

    Tübingen, 72076

Other trials in Germany

Poland15 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)

    Brzozów, 36-200

  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)

    Bytom, 41-902

  • Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)

    Gdansk, 80-219

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

    Gdynia, 81-519

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

    Gliwice, 44-101

  • Przychodnia Lekarska Komed ( Site 1306)

    Konin, 62-500

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

    Kościerzyna, Pomeranian Voivodeship, 83-400

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

    Krakow, 31-115

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

    Lublin, 20-090

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

    Otwock, 05-400

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

    Poznan, 60-569

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

    Torun, 87-100

  • Centrum Medyczne Onkologii I Hipertermii ( Site 1321)

    Warsaw, 02-793

  • Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)

    Warsaw, 04-141

  • Mazowiecki Szpital Onkologiczny ( Site 1316)

    Wieliszew, Masovian Voivodeship, 05-135

Other trials in Poland

Canada13 sites

  • William Osler Health System ( Site 0115)

    Brampton, Ontario, L6R 3J7

  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)

    Chicoutimi, Quebec, G7H 5H6

  • Juravinski Cancer Centre ( Site 0117)

    Hamilton, Ontario, L8V 5C2

  • CISSS-CA Hotel Dieu de Levis ( Site 0111)

    Lévis, Quebec, G6V 3Z1

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

    London, Ontario, N6A 4L6

  • Dr. Leon Richard Oncology Centre ( Site 0106)

    Moncton, New Brunswick, E1C 8X3

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

    Montreal, Quebec, H1T 2M4

  • Lakeridge Health ( Site 0108)

    Oshawa, Ontario, L1G 2B9

  • Allan Blair Cancer Centre ( Site 0116)

    Regina, Saskatchewan, S4T 7T1

  • St-Jerome Medical Research Inc ( Site 0103)

    Saint-Jérôme, Quebec, J7Z 5T3

  • Saskatoon Cancer Centre ( Site 0105)

    Saskatoon, Saskatchewan, S7N 4H4

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

    St. Catharines, Ontario, L2S 0A9

  • CancerCare Manitoba ( Site 0119)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Brazil12 sites

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

    Barretos, São Paulo, 14784-400

  • Universidade de Caxias do Sul ( Site 1004)

    Caxias do Sul, Rio Grande do Sul, 95070-560

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

    Curitiba, Paraná, 80510-130

  • Fundacao Dr Amaral Carvalho ( Site 1005)

    Jaú, São Paulo, 17210-120

  • Hospital Bruno Born ( Site 1015)

    Lajeado, Rio Grande do Sul, 95900-000

  • Liga Norte Riograndense Contra o Cancer ( Site 1013)

    Natal, Rio Grande do Norte, 59075-740

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao ( Site 1000)

    Porto Alegre, Rio Grande do Sul, 91350-200

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

    Ribeirão Preto, 14048-900

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

    São Paulo, São Paulo, 01246-000

  • Casa de Saude Santa Marcelina ( Site 1006)

    São Paulo, São Paulo, 08270-120

  • COT Centro Oncologico do Triangulo Ltda ( Site 1014)

    Uberlândia, 38408-150

Other trials in Brazil

Chile12 sites

  • Centro Oncologico Antofagasta ( Site 0914)

    Antofagasta, 1240000

  • Hospital Regional de La Serena ( Site 0907)

    La Serena, 1710216

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

    Rancagua, 2820000

  • Instituto Nacional del Cancer ( Site 0912)

    Santiago, Santiago Metropolitan, 8380455

  • Health and Care Chile ( Site 0901)

    Santiago, 7500006

  • Fundacion Arturo Lopez Perez FALP ( Site 0902)

    Santiago, 7500921

  • Iram Cancer Research ( Site 0909)

    Santiago, 7630372

  • Hospital Militar de Santiago ( Site 0911)

    Santiago, 7850000

  • Pontificia Universidad Catolica de Chile ( Site 0904)

    Santiago, 8330032

  • Hospital Clinico Universidad de Chile ( Site 0905)

    Santiago, 8380456

  • Sociedad de Investigaciones Medicas Limitadas ( Site 0913)

    Temuco, 4810469

  • Oncocentro ( Site 0900)

    Viña del Mar, 2520598

Other trials in Chile

France11 sites

  • ICO Centre Paul Papin ( Site 2208)

    Angers, 49055

  • CHU Besancon - Hopital Jean Minjoz ( Site 2200)

    Besançon, 25000

  • Hopital Saint Andre ( Site 2202)

    Bordeaux, 33075

  • Hopital La Timone ( Site 2204)

    Marseille, 13005

  • CHU Saint-Eloi ( Site 2203)

    Montpellier, 34295

  • Centre Antoine Lacassagne ( Site 2211)

    Nice, 06189

  • Hopital Europeen Georges Pompidou ( Site 2206)

    Paris, 75908

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)

    Pierre-Bénite, 69310

  • Centre Eugene Marquis ( Site 2209)

    Rennes, 35042

  • Centre Rene Gauducheau ICO ( Site 2207)

    Saint-Herblain, 44805

  • Institut Claudius Regaud IUCT Oncopole ( Site 2201)

    Toulouse, 31059

Other trials in France

Russia11 sites

  • Ivanovo Regional Oncology Dispensary ( Site 1204)

    Ivanovo, 153040

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)

    Krasnoyarsk, 660133

  • N.N. Blokhin NMRCO ( Site 1206)

    Moscow, 115478

  • Russian Scientific Center of Roentgenoradiology ( Site 1201)

    Moscow, 117997

  • National Medical Research Radiology Centre ( Site 1200)

    Moscow, 125284

  • Bayandin Murmansk Regional Clinical Hospital ( Site 1214)

    Murmansk, 183057

  • Omsk Clinical Oncology Dispensary ( Site 1209)

    Omsk, 644013

  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)

    Saint Petersburg, 197758

  • Tomsk Scientific Research Institute of Oncology ( Site 1208)

    Tomsk, 634028

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)

    Ufa, 450054

  • Clinical Hospital Bashkirsky Medical State University ( Site 1202)

    Ufa, 450083

Other trials in Russia

Argentina10 sites

  • Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)

    Buenos Aires, C1012AAR

  • Fundacion Favaloro ( Site 1110)

    Buenos Aires, C1093AAS

  • Instituto Medico Alexander Fleming ( Site 1105)

    Buenos Aires, C1426ANZ

  • Centro Oncologico Riojano Integral ( Site 1101)

    La Rioja, F5300COE

  • Centro Oncologico de Integracion Regional. COIR ( Site 1109)

    Mendoza, M5500AYB

  • Sanatorio Parque ( Site 1104)

    Rosario, Santa Fe Province, S2000DSV

  • Sanatorio Britanico ( Site 1106)

    Rosario, S2000CVB

  • Instituto de Oncologia de Rosario ( Site 1100)

    Rosario, S2000KZE

  • Centro Medico San Roque ( Site 1108)

    San Miguel de Tucumán, T4000IAK

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

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Spain9 sites

  • Hospital Universitario Infanta Cristina ( Site 1805)

    Badajoz, 06080

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

    Barcelona, 08026

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

    Girona, 17007

  • Hospital Universitario Gregorio Maranon ( Site 1801)

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal ( Site 1800)

    Madrid, 28034

  • Hospital Universitario Virgen de la Victoria ( Site 1808)

    Málaga, 29010

  • Clinica Universitaria de Navarra ( Site 1803)

    Pamplona, 31008

  • Instituto Valenciano de Oncologia ( Site 1804)

    Valencia, 46009

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

    Valencia, 46026

Other trials in Spain

Colombia8 sites

  • Clinica de la Costa Ltda. ( Site 0804)

    Barranquilla, Atlántico, 080020

  • Instituto Nacional de Cancerologia E.S.E ( Site 0807)

    Bogota, Cundinamarca, 111161

  • Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)

    Bogotá, 110131

  • Administradora Country SA - Clinica del Country ( Site 0808)

    Bogotá, 110221

  • Hospital Pablo Tobon Uribe. ( Site 0805)

    Medellín, Antioquia, 050034

  • Oncomedica S.A. ( Site 0801)

    Montería, 230002

  • Oncologos del Occidente S.A. ( Site 0800)

    Pereira, Risaralda Department, 661002

  • Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Italy8 sites

  • Medical Oncology Ospedale San Donato ( Site 2004)

    Arezzo, 52100

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

    Meldola, 47014

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

    Milan, 20133

  • Istituto Europeo di Oncologia ( Site 2000)

    Milan, 20141

  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)

    Modena, 41125

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)

    Naples, 80131

  • Ospedale San Luigi Gonzaga ( Site 2010)

    Orbassano, Torino, 10043

  • Istituto Nazionale Tumori Regina Elena ( Site 2009)

    Roma, 00144

Other trials in Italy

United Kingdom8 sites

  • Western General Hospital ( Site 1600)

    Edinburgh, EH4 2XU

  • The Beatson West of Scotland Cancer Centre ( Site 1605)

    Glasgow, G12 0YN

  • Royal Free Hospital ( Site 1609)

    London, NW3 2QG

  • St George s Healthcare Trust ( Site 1608)

    London, SW17 0QT

  • Charing Cross Hospital ( Site 1607)

    London, W6 8RF

  • The Christie NHS Foundation Trust ( Site 1602)

    Manchester, M20 4BX

  • The James Cook University Hospital ( Site 1606)

    Middlesbrough, TS4 3BW

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

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

Australia7 sites

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About this study

Official title: 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.

Read the 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.

Being tested
Pembrolizumab, Placebo
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Adjuvant
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®, SCH 900475

    IV infusion

  • PlaceboDrug

    Also called saline solution

    IV infusion

Study groups in NCT03142334
Study groupRoleWhat they receive
PembrolizumabExperimentalParticipants 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).
Receives: Biological: Pembrolizumab
PlaceboPlacebo comparatorParticipants 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).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival (DFS) as Assessed by the Investigator

    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).

    Measured: Up to approximately 42 months (database cutoff date 14 Dec 2020)

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 72 months

  2. Number of Participants Who Experienced an Adverse Event (AE)

    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.

    Measured: 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)

  3. Number of Participants Who Discontinued Study Drug Due to an AE

    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.

    Measured: Up to approximately 12 months

  4. First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator

    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.

    Measured: Up to approximately 72 months

  5. Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator

    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.

    Measured: Up to approximately 72 months

  6. Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)

    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.

    Measured: Up to approximately 72 months

  7. DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator

    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.

    Measured: Up to approximately 72 months

  8. OS According to Participant PD-L1 Expression Status (Positive, Negative)

    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.

    Measured: Up to approximately 72 months

  9. Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score

    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.

    Measured: Baseline and Week 52

  10. Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score

    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.

    Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start9 Jun 2017
  3. Primary completion14 Dec 2020
  4. Study completion4 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
994 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03142334
Sponsor's protocol ID
3475-564
Other IDs
173704, MK-3475-564, KEYNOTE-564, U1111-1275-8289, 2022-501251-81-00, 2016-004351-75, 2016
Status last verified
Mar 2026
First submitted
3 May 2017
Last updated
10 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695.

    PubMed 38631003

  • Choueiri TK, Tomczak P, Park SH, Venugopal B, Symeonides S, Hajek J, Ferguson T, Chang YH, Lee JL, Haas N, Sawrycki P, Sarwar N, Gross-Goupil M, Thiery-Vuillemin A, Mahave M, Kimura G, Perini RF, Saretsky TL, Bhattacharya R, Xu L, Powles T. Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma. Oncologist. 2024 Feb 2;29(2):142-150. doi: 10.1093/oncolo/oyad231.

    PubMed 37589219

  • Powles T, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Gurney H, Chang YH, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Burgents JE, Xu L, Imai K, Quinn DI, Choueiri TK; KEYNOTE-564 Investigators. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1133-1144. doi: 10.1016/S1470-2045(22)00487-9.

    PubMed 36055304

  • Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Chang YH, Hajek J, Symeonides SN, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Gurney H, Chevreau C, Melichar B, Kopyltsov E, Alva A, Burke JM, Doshi G, Topart D, Oudard S, Hammers H, Kitamura H, Bedke J, Perini RF, Zhang P, Imai K, Willemann-Rogerio J, Quinn DI, Powles T; KEYNOTE-564 Investigators. Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. N Engl J Med. 2021 Aug 19;385(8):683-694. doi: 10.1056/NEJMoa2106391.

    PubMed 34407342

  • Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

    PubMed 33526329

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 251 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 251 sites in United States, Japan, Germany, Poland, Canada and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) as Assessed by the Investigator (time frame: Up to approximately 42 months (database cutoff date 14 Dec 2020)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03142334, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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