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, 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)
7 other identifiers
interventional
994
21 countries
251
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2017
Longer than P75 for phase_3
251 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2020
CompletedResults Posted
Study results publicly available
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2026
CompletedMarch 10, 2026
March 1, 2026
3.5 years
May 3, 2017
November 29, 2021
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
Up to approximately 42 months (database cutoff date 14 Dec 2020)
Secondary Outcomes (10)
Overall Survival (OS)
Up to approximately 72 months
Number of Participants Who Experienced an Adverse Event (AE)
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
Up to approximately 12 months
First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
Up to approximately 72 months
Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
Up to approximately 72 months
- +5 more secondary outcomes
Study Arms (2)
Pembrolizumab
EXPERIMENTALParticipants 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).
Placebo
PLACEBO 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (251)
Arizona Oncology Associates, PC- HAL ( Site 8018)
Phoenix, Arizona, 85016, United States
USC Norris Comprehensive Cancer Center ( Site 0038)
Los Angeles, California, 90033, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
San Francisco, California, 94158, United States
Sansum Clinic Research ( Site 8014)
Santa Barbara, California, 93105, United States
Stanford Cancer Center ( Site 0028)
Stanford, California, 94305, United States
Rocky Mountain Cancer Center ( Site 8010)
Aurora, Colorado, 80012, United States
Georgetown University Medical Center ( Site 0002)
Washington D.C., District of Columbia, 20007, United States
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
Boca Raton, Florida, 33486, United States
Manatee Medical Research Institute ( Site 0039)
Bradenton, Florida, 34205, United States
Woodlands Medical Specialists, PA ( Site 8021)
Pensacola, Florida, 32503, United States
Northwest Georgia Oncology Centers PC ( Site 0014)
Marietta, Georgia, 30060, United States
Illinois Cancer Specialists ( Site 8001)
Niles, Illinois, 60714, United States
McFarland Clinic ( Site 0025)
Ames, Iowa, 50010-3014, United States
University of Iowa Hospital and Clinics ( Site 0031)
Iowa City, Iowa, 52242, United States
University Medical Center New Orleans ( Site 0053)
New Orleans, Louisiana, 70112, United States
Weinberg Cancer Institute at Franklin Square ( Site 0046)
Baltimore, Maryland, 21237, United States
Maryland Oncology Hematology, P.A. ( Site 8020)
Rockville, Maryland, 20850, United States
Beth Israel Deaconess Medical Ctr. ( Site 0044)
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute (Boston) ( Site 0007)
Boston, Massachusetts, 02215, United States
University of Michigan ( Site 0045)
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute ( Site 0013)
Detroit, Michigan, 48201, United States
Henry Ford Hospital ( Site 0032)
Detroit, Michigan, 48202, United States
Quest Research Institute ( Site 0036)
Royal Oak, Michigan, 48073, United States
Fairview Southdale Medical Oncology Clinic ( Site 0041)
Edina, Minnesota, 55435, United States
Minnesota Oncology Specialist, PA ( Site 8002)
Minneapolis, Minnesota, 55404, United States
Park Nicollet Frauenshuh Cancer Center ( Site 0020)
Saint Louis Park, Minnesota, 55426, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
Billings, Montana, 59102, United States
Nebraska Cancer Specialists ( Site 0012)
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada ( Site 8013)
Las Vegas, Nevada, 89148, United States
Rutgers Cancer Institute of New Jersey ( Site 0059)
New Brunswick, New Jersey, 08903, United States
University of New Mexico Cancer Center ( Site 0043)
Albuquerque, New Mexico, 87106, United States
Montefiore Medical Center ( Site 0009)
The Bronx, New York, 10461, United States
Duke University ( Site 0037)
Durham, North Carolina, 27710, United States
Oncology Hematology Care, Inc. ( Site 8008)
Cincinnati, Ohio, 45242, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
Tulsa, Oklahoma, 74146, United States
Northwest Cancer Specialists, P.C. ( Site 8006)
Tigard, Oregon, 97223, United States
St. Luke's University Health Network ( Site 0042)
Easton, Pennsylvania, 18045, United States
Abramson Cancer Center ( Site 0010)
Philadelphia, Pennsylvania, 19104, United States
Charleston Hematology Oncology Associates PA ( Site 8000)
Charleston, South Carolina, 29414, United States
Medical University of South Carolina ( Site 0033)
Charleston, South Carolina, 29425, United States
Avera Cancer Institute ( Site 0023)
Sioux Falls, South Dakota, 57105, United States
Urology Associates [Nashville, TN] ( Site 0063)
Nashville, Tennessee, 37209, United States
Texas Oncology-Austin Central ( Site 8003)
Austin, Texas, 78731, United States
Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
Dallas, Texas, 75246, United States
UT Southwestern Medical Center ( Site 0003)
Dallas, Texas, 75390, United States
Texas Oncology-Denton South ( Site 8016)
Denton, Texas, 76210, United States
Texas Oncology-Memorial City ( Site 8015)
Houston, Texas, 77024, United States
MD Anderson Cancer Center ( Site 0065)
Houston, Texas, 77030, United States
UTHealth/Memorial Hermann Cancer Center ( Site 0001)
Houston, Texas, 77030, United States
Texas Oncology- Paris ( Site 8004)
Paris, Texas, 75460-5004, United States
CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
San Antonio, Texas, 78229, United States
Texas Oncology-Tyler ( Site 8005)
Tyler, Texas, 75702, United States
Texas Oncology-Waco ( Site 8012)
Waco, Texas, 76712, United States
IHO Corporation- Utah Cancer Specialists ( Site 0055)
Salt Lake City, Utah, 84106, United States
Virginia Oncology Associates ( Site 8011)
Norfolk, Virginia, 23502, United States
Providence Regional Cancer Partnership ( Site 0016)
Everett, Washington, 98201, United States
SCCA/UW ( Site 0029)
Seattle, Washington, 98109, United States
Cancer Care Northwest ( Site 0021)
Spokane, Washington, 99202, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
Spokane, Washington, 99208, United States
Northwest Medical Specialties, PLLC ( Site 0034)
Tacoma, Washington, 98405, United States
Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
Yakima, Washington, 98902, United States
University of Wisconsin Carbone Cancer Center ( Site 0019)
Madison, Wisconsin, 53792, United States
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
Viedma, Río Negro Province, R8500ACE, Argentina
Sanatorio Parque ( Site 1104)
Rosario, Santa Fe Province, S2000DSV, Argentina
Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
Buenos Aires, C1012AAR, Argentina
Fundacion Favaloro ( Site 1110)
Buenos Aires, C1093AAS, Argentina
Instituto Medico Alexander Fleming ( Site 1105)
Buenos Aires, C1426ANZ, Argentina
Centro Oncologico Riojano Integral ( Site 1101)
La Rioja, F5300COE, Argentina
Centro Oncologico de Integracion Regional. COIR ( Site 1109)
Mendoza, M5500AYB, Argentina
Sanatorio Britanico ( Site 1106)
Rosario, S2000CVB, Argentina
Instituto de Oncologia de Rosario ( Site 1100)
Rosario, S2000KZE, Argentina
Centro Medico San Roque ( Site 1108)
San Miguel de Tucumán, T4000IAK, Argentina
Saint George Hospital [Kogarah, Australia] ( Site 0707)
Kogarah, New South Wales, 2217, Australia
Macquarie University Hospital ( Site 0700)
Macquarie Park, New South Wales, 2109, Australia
Adelaide Cancer Centre ( Site 0703)
Kurralta Park, South Australia, 5037, Australia
Bendigo Cancer Centre ( Site 0704)
Bendigo, Victoria, 3550, Australia
Box Hill Hospital ( Site 0701)
Box Hill, Victoria, 3128, Australia
Fiona Stanley Hospital ( Site 0702)
Murdoch, Western Australia, 6150, Australia
Ballarat Health Services ( Site 0705)
Ballarat, 3350, Australia
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
Curitiba, Paraná, 80510-130, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 1013)
Natal, Rio Grande do Norte, 59075-740, Brazil
Universidade de Caxias do Sul ( Site 1004)
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital Bruno Born ( Site 1015)
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Nossa Senhora da Conceicao ( Site 1000)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
Barretos, São Paulo, 14784-400, Brazil
Fundacao Dr Amaral Carvalho ( Site 1005)
Jaú, São Paulo, 17210-120, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
São Paulo, São Paulo, 01246-000, Brazil
Casa de Saude Santa Marcelina ( Site 1006)
São Paulo, São Paulo, 08270-120, Brazil
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
Ribeirão Preto, 14048-900, Brazil
COT Centro Oncologico do Triangulo Ltda ( Site 1014)
Uberlândia, 38408-150, Brazil
CancerCare Manitoba ( Site 0119)
Winnipeg, Manitoba, R3E 0V9, Canada
Dr. Leon Richard Oncology Centre ( Site 0106)
Moncton, New Brunswick, E1C 8X3, Canada
William Osler Health System ( Site 0115)
Brampton, Ontario, L6R 3J7, Canada
Juravinski Cancer Centre ( Site 0117)
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program - London HSC ( Site 0107)
London, Ontario, N6A 4L6, Canada
Lakeridge Health ( Site 0108)
Oshawa, Ontario, L1G 2B9, Canada
Niagara Health System - St. Catharines ( Site 0120)
St. Catharines, Ontario, L2S 0A9, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
Chicoutimi, Quebec, G7H 5H6, Canada
CISSS-CA Hotel Dieu de Levis ( Site 0111)
Lévis, Quebec, G6V 3Z1, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
Montreal, Quebec, H1T 2M4, Canada
St-Jerome Medical Research Inc ( Site 0103)
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Allan Blair Cancer Centre ( Site 0116)
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre ( Site 0105)
Saskatoon, Saskatchewan, S7N 4H4, Canada
Instituto Nacional del Cancer ( Site 0912)
Santiago, Santiago Metropolitan, 8380455, Chile
Centro Oncologico Antofagasta ( Site 0914)
Antofagasta, 1240000, Chile
Hospital Regional de La Serena ( Site 0907)
La Serena, 1710216, Chile
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
Rancagua, 2820000, Chile
Health and Care Chile ( Site 0901)
Santiago, 7500006, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0902)
Santiago, 7500921, Chile
Iram Cancer Research ( Site 0909)
Santiago, 7630372, Chile
Hospital Militar de Santiago ( Site 0911)
Santiago, 7850000, Chile
Pontificia Universidad Catolica de Chile ( Site 0904)
Santiago, 8330032, Chile
Hospital Clinico Universidad de Chile ( Site 0905)
Santiago, 8380456, Chile
Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
Temuco, 4810469, Chile
Oncocentro ( Site 0900)
Viña del Mar, 2520598, Chile
Hospital Pablo Tobon Uribe. ( Site 0805)
Medellín, Antioquia, 050034, Colombia
Clinica de la Costa Ltda. ( Site 0804)
Barranquilla, Atlántico, 080020, Colombia
Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
Valledupar, Cesar Department, 200001, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0807)
Bogota, Cundinamarca, 111161, Colombia
Oncologos del Occidente S.A. ( Site 0800)
Pereira, Risaralda Department, 661002, Colombia
Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
Bogotá, 110131, Colombia
Administradora Country SA - Clinica del Country ( Site 0808)
Bogotá, 110221, Colombia
Oncomedica S.A. ( Site 0801)
Montería, 230002, Colombia
FN Brno. ( Site 1501)
Brno, 625 00, Czechia
Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
Nový Jičín, 741 01, Czechia
Fakultni nemocnice Olomouc ( Site 1502)
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava ( Site 1507)
Ostrava, 708 52, Czechia
Thomayerova nemocnice ( Site 1505)
Prague, 140 59, Czechia
Fakultni nemocnice v Motole ( Site 1504)
Prague, 150 06, Czechia
Nemocnice Na Bulovce ( Site 1503)
Prague, 180 81, Czechia
HYKS ( Site 2300)
Helsinki, 00290, Finland
Keski-Suomen keskussairaala ( Site 2303)
Jyväskylä, 40620, Finland
Oulun yliopistollinen sairaala - OYS ( Site 2304)
Oulu, 90220, Finland
TAYS ( Site 2301)
Tampere, 33520, Finland
TYKS ( Site 2302)
Turku, 20521, Finland
ICO Centre Paul Papin ( Site 2208)
Angers, 49055, France
CHU Besancon - Hopital Jean Minjoz ( Site 2200)
Besançon, 25000, France
Hopital Saint Andre ( Site 2202)
Bordeaux, 33075, France
Hopital La Timone ( Site 2204)
Marseille, 13005, France
CHU Saint-Eloi ( Site 2203)
Montpellier, 34295, France
Centre Antoine Lacassagne ( Site 2211)
Nice, 06189, France
Hopital Europeen Georges Pompidou ( Site 2206)
Paris, 75908, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
Pierre-Bénite, 69310, France
Centre Eugene Marquis ( Site 2209)
Rennes, 35042, France
Centre Rene Gauducheau ICO ( Site 2207)
Saint-Herblain, 44805, France
Institut Claudius Regaud IUCT Oncopole ( Site 2201)
Toulouse, 31059, France
Campus Charite Mitte ( Site 2120)
Berlin, 10117, Germany
Helios Klinikum Berlin Buch ( Site 2125)
Berlin, 13125, Germany
Universitaetsklinikum Bonn ( Site 2110)
Bonn, 53127, Germany
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
Dresden, 01307, Germany
Universitatsklinikum Dusseldorf ( Site 2108)
Düsseldorf, 40225, Germany
Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
Erlangen, 91054, Germany
Universitaetsklinikum Essen ( Site 2116)
Essen, 45122, Germany
Universitaetsklinikum Frankfurt ( Site 2121)
Frankfurt, 60590, Germany
Universitaetsklinikum Freiburg ( Site 2119)
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
Hamburg, 20246, Germany
Universitaetsklinikum Jena. ( Site 2104)
Jena, 07747, Germany
Universitaetsklinikum Schleswig Holstein ( Site 2109)
Lübeck, 23538, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
Mainz, 55131, Germany
Studienpraxis Urologie ( Site 2115)
Nürtingen, 72622, Germany
Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
Trier, 54292, Germany
Universitaetsklinikum Tuebingen ( Site 2100)
Tübingen, 72076, Germany
Beaumont Hospital ( Site 1611)
Dublin, D04 Y8V0, Ireland
St Vincents University Hospital ( Site 1610)
Dublin, D04 Y8V0, Ireland
University Hospital Waterford ( Site 1614)
Waterford, X91 ER8E, Ireland
Ospedale San Luigi Gonzaga ( Site 2010)
Orbassano, Torino, 10043, Italy
Medical Oncology Ospedale San Donato ( Site 2004)
Arezzo, 52100, Italy
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
Meldola, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
Milan, 20133, Italy
Istituto Europeo di Oncologia ( Site 2000)
Milan, 20141, Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
Modena, 41125, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
Naples, 80131, Italy
Istituto Nazionale Tumori Regina Elena ( Site 2009)
Roma, 00144, Italy
Nagoya University Hospital ( Site 0431)
Nagoya, Aichi-ken, 466-8560, Japan
Sapporo Medical University Hospital ( Site 0424)
Sapporo, Hokkaido, 060-8543, Japan
Kagawa University Hospital ( Site 0419)
Kita-gun, Kagawa-ken, 761-0793, Japan
Japan Community Health care Organization Sendai Hospital ( Site 0430)
Sendai, Miyagi, 981-8501, Japan
Nara Medical University Hospital ( Site 0416)
Kashihara, Nara, 634-8522, Japan
Osaka Rosai Hospital ( Site 0418)
Sakai, Osaka, 591-8025, Japan
Kindai University Hospital ( Site 0411)
Sayama, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center ( Site 0404)
Hidaka, Saitama, 350-1298, Japan
Yamaguchi University Hospital ( Site 0406)
Ube, Yamaguchi, 755-8505, Japan
Akita University Hospital ( Site 0433)
Akita, 010-8543, Japan
Harasanshin Hospital ( Site 0402)
Fukuoka, 812-0033, Japan
Kyushu University Hospital ( Site 0413)
Fukuoka, 812-8582, Japan
Kumamoto University Hospital ( Site 0434)
Kumamoto, 860-8556, Japan
Nagano Municipal Hospital ( Site 0429)
Nagano, 381-8551, Japan
Niigata University Medical & Dental Hospital ( Site 0421)
Niigata, 951-8520, Japan
Osaka International Cancer Institute ( Site 0401)
Osaka, 541-8567, Japan
Osaka City University Hospital ( Site 0428)
Osaka, 545-8586, Japan
Toranomon Hospital ( Site 0426)
Tokyo, 105-8470, Japan
Nippon Medical School Hospital ( Site 0400)
Tokyo, 113-8603, Japan
Keio University Hospital ( Site 0407)
Tokyo, 160-8582, Japan
Toyama University Hospital ( Site 0432)
Toyama, 930-0194, Japan
Amphia Ziekenhuis Breda ( Site 1901)
Breda, 4819 EV, Netherlands
Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
Maastricht, 6229 HX, Netherlands
Franciscus Gasthuis ( Site 1903)
Rotterdam, 3045 PM, Netherlands
Mazowiecki Szpital Onkologiczny ( Site 1316)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
Kościerzyna, Pomeranian Voivodeship, 83-400, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
Brzozów, 36-200, Poland
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
Bytom, 41-902, Poland
Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
Gdansk, 80-219, Poland
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
Gdynia, 81-519, Poland
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
Gliwice, 44-101, Poland
Przychodnia Lekarska Komed ( Site 1306)
Konin, 62-500, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
Krakow, 31-115, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
Lublin, 20-090, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
Otwock, 05-400, Poland
Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
Poznan, 60-569, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
Torun, 87-100, Poland
Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
Warsaw, 02-793, Poland
Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
Warsaw, 04-141, Poland
Ivanovo Regional Oncology Dispensary ( Site 1204)
Ivanovo, 153040, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
Krasnoyarsk, 660133, Russia
N.N. Blokhin NMRCO ( Site 1206)
Moscow, 115478, Russia
Russian Scientific Center of Roentgenoradiology ( Site 1201)
Moscow, 117997, Russia
National Medical Research Radiology Centre ( Site 1200)
Moscow, 125284, Russia
Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
Murmansk, 183057, Russia
Omsk Clinical Oncology Dispensary ( Site 1209)
Omsk, 644013, Russia
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
Saint Petersburg, 197758, Russia
Tomsk Scientific Research Institute of Oncology ( Site 1208)
Tomsk, 634028, Russia
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
Ufa, 450054, Russia
Clinical Hospital Bashkirsky Medical State University ( Site 1202)
Ufa, 450083, Russia
National Cancer Center ( Site 0304)
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Hospital ( Site 0302)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 0303)
Seoul, 03722, South Korea
Asan Medical Center ( Site 0300)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 0301)
Seoul, 06351, South Korea
Hospital Universitario Infanta Cristina ( Site 1805)
Badajoz, 06080, Spain
Hospital de la Santa Creu i Sant Pau ( Site 1807)
Barcelona, 08026, Spain
Hospital de Girona Dr. Josep Trueta ( Site 1806)
Girona, 17007, Spain
Hospital Universitario Gregorio Maranon ( Site 1801)
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal ( Site 1800)
Madrid, 28034, Spain
Hospital Universitario Virgen de la Victoria ( Site 1808)
Málaga, 29010, Spain
Clinica Universitaria de Navarra ( Site 1803)
Pamplona, 31008, Spain
Instituto Valenciano de Oncologia ( Site 1804)
Valencia, 46009, Spain
Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
Valencia, 46026, Spain
China Medical University Hospital ( Site 0200)
Taichung, 40447, Taiwan
Taichung Veterans General Hospital ( Site 0204)
Taichung, 407, Taiwan
National Taiwan University Hospital ( Site 0202)
Taipei, 10002, Taiwan
Taipei Veterans General Hospital ( Site 0201)
Taipei, 112, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0203)
Taoyuan District, 333, Taiwan
North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Western General Hospital ( Site 1600)
Edinburgh, EH4 2XU, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1605)
Glasgow, G12 0YN, United Kingdom
Royal Free Hospital ( Site 1609)
London, NW3 2QG, United Kingdom
St George s Healthcare Trust ( Site 1608)
London, SW17 0QT, United Kingdom
Charing Cross Hospital ( Site 1607)
London, W6 8RF, United Kingdom
The Christie NHS Foundation Trust ( Site 1602)
Manchester, M20 4BX, United Kingdom
The James Cook University Hospital ( Site 1606)
Middlesbrough, TS4 3BW, United Kingdom
Related Publications (5)
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.
PMID: 38631003RESULTChoueiri 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.
PMID: 37589219DERIVEDPowles 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.
PMID: 36055304DERIVEDChoueiri 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.
PMID: 34407342DERIVEDMarconi 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.
PMID: 33526329DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 5, 2017
Study Start
June 9, 2017
Primary Completion
December 14, 2020
Study Completion
February 4, 2026
Last Updated
March 10, 2026
Results First Posted
December 28, 2021
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf