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)

NCT ID: NCT03142334

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 994 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2025-12-28

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.

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

Interventions

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Placebo

IV infusion

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; SCH 900475; saline solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Arizona Oncology Associates, PC- HAL ( Site 8018)

Phoenix, Arizona, United States

USC Norris Comprehensive Cancer Center ( Site 0038)

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)

San Francisco, California, United States

Sansum Clinic Research ( Site 8014)

Santa Barbara, California, United States

Stanford Cancer Center ( Site 0028)

Stanford, California, United States

Rocky Mountain Cancer Center ( Site 8010)

Aurora, Colorado, United States

Georgetown University Medical Center ( Site 0002)

Washington D.C., District of Columbia, United States

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

Boca Raton, Florida, United States

Manatee Medical Research Institute ( Site 0039)

Bradenton, Florida, United States

Woodlands Medical Specialists, PA ( Site 8021)

Pensacola, Florida, United States

Northwest Georgia Oncology Centers PC ( Site 0014)

Marietta, Georgia, United States

Illinois Cancer Specialists ( Site 8001)

Niles, Illinois, United States

McFarland Clinic ( Site 0025)

Ames, Iowa, United States

University of Iowa Hospital and Clinics ( Site 0031)

Iowa City, Iowa, United States

University Medical Center New Orleans ( Site 0053)

New Orleans, Louisiana, United States

Weinberg Cancer Institute at Franklin Square ( Site 0046)

Baltimore, Maryland, United States

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

Rockville, Maryland, United States

Beth Israel Deaconess Medical Ctr. ( Site 0044)

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

University of Michigan ( Site 0045)

Ann Arbor, Michigan, United States

Karmanos Cancer Institute ( Site 0013)

Detroit, Michigan, United States

Henry Ford Hospital ( Site 0032)

Detroit, Michigan, United States

Quest Research Institute ( Site 0036)

Royal Oak, Michigan, United States

Fairview Southdale Medical Oncology Clinic ( Site 0041)

Edina, Minnesota, United States

Minnesota Oncology Specialist, PA ( Site 8002)

Minneapolis, Minnesota, United States

Park Nicollet Frauenshuh Cancer Center ( Site 0020)

Saint Louis Park, Minnesota, United States

St. Vincent Healthcare Frontier Cancer Center ( Site 0008)

Billings, Montana, United States

Nebraska Cancer Specialists ( Site 0012)

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada ( Site 8013)

Las Vegas, Nevada, United States

Rutgers Cancer Institute of New Jersey ( Site 0059)

New Brunswick, New Jersey, United States

University of New Mexico Cancer Center ( Site 0043)

Albuquerque, New Mexico, United States

Montefiore Medical Center ( Site 0009)

The Bronx, New York, United States

Duke University ( Site 0037)

Durham, North Carolina, United States

Oncology Hematology Care, Inc. ( Site 8008)

Cincinnati, Ohio, United States

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

Tulsa, Oklahoma, United States

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

Tigard, Oregon, United States

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

Easton, Pennsylvania, United States

Abramson Cancer Center ( Site 0010)

Philadelphia, Pennsylvania, United States

Charleston Hematology Oncology Associates PA ( Site 8000)

Charleston, South Carolina, United States

Medical University of South Carolina ( Site 0033)

Charleston, South Carolina, United States

Avera Cancer Institute ( Site 0023)

Sioux Falls, South Dakota, United States

Urology Associates [Nashville, TN] ( Site 0063)

Nashville, Tennessee, United States

Texas Oncology-Austin Central ( Site 8003)

Austin, Texas, United States

Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0003)

Dallas, Texas, United States

Texas Oncology-Denton South ( Site 8016)

Denton, Texas, United States

Texas Oncology-Memorial City ( Site 8015)

Houston, Texas, United States

MD Anderson Cancer Center ( Site 0065)

Houston, Texas, United States

UTHealth/Memorial Hermann Cancer Center ( Site 0001)

Houston, Texas, United States

Texas Oncology- Paris ( Site 8004)

Paris, Texas, United States

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

San Antonio, Texas, United States

Texas Oncology-Tyler ( Site 8005)

Tyler, Texas, United States

Texas Oncology-Waco ( Site 8012)

Waco, Texas, United States

IHO Corporation- Utah Cancer Specialists ( Site 0055)

Salt Lake City, Utah, United States

Virginia Oncology Associates ( Site 8011)

Norfolk, Virginia, United States

Providence Regional Cancer Partnership ( Site 0016)

Everett, Washington, United States

SCCA/UW ( Site 0029)

Seattle, Washington, United States

Cancer Care Northwest ( Site 0021)

Spokane, Washington, United States

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

Spokane, Washington, United States

Northwest Medical Specialties, PLLC ( Site 0034)

Tacoma, Washington, United States

Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)

Yakima, Washington, United States

University of Wisconsin Carbone Cancer Center ( Site 0019)

Madison, Wisconsin, United States

Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)

Viedma, Río Negro Province, Argentina

Sanatorio Parque ( Site 1104)

Rosario, Santa Fe Province, Argentina

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

Buenos Aires, , Argentina

Fundacion Favaloro ( Site 1110)

Buenos Aires, , Argentina

Instituto Medico Alexander Fleming ( Site 1105)

Buenos Aires, , Argentina

Centro Oncologico Riojano Integral ( Site 1101)

La Rioja, , Argentina

Centro Oncologico de Integracion Regional. COIR ( Site 1109)

Mendoza, , Argentina

Sanatorio Britanico ( Site 1106)

Rosario, , Argentina

Instituto de Oncologia de Rosario ( Site 1100)

Rosario, , Argentina

Centro Medico San Roque ( Site 1108)

San Miguel de Tucumán, , Argentina

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

Kogarah, New South Wales, Australia

Macquarie University Hospital ( Site 0700)

Macquarie Park, New South Wales, Australia

Adelaide Cancer Centre ( Site 0703)

Kurralta Park, South Australia, Australia

Bendigo Cancer Centre ( Site 0704)

Bendigo, Victoria, Australia

Box Hill Hospital ( Site 0701)

Box Hill, Victoria, Australia

Fiona Stanley Hospital ( Site 0702)

Murdoch, Western Australia, Australia

Ballarat Health Services ( Site 0705)

Ballarat, , Australia

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

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 1013)

Natal, Rio Grande do Norte, Brazil

Universidade de Caxias do Sul ( Site 1004)

Caxias do Sul, Rio Grande do Sul, Brazil

Hospital Bruno Born ( Site 1015)

Lajeado, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao ( Site 1000)

Porto Alegre, Rio Grande do Sul, Brazil

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

Barretos, São Paulo, Brazil

Fundacao Dr Amaral Carvalho ( Site 1005)

Jaú, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

Casa de Saude Santa Marcelina ( Site 1006)

São Paulo, São Paulo, Brazil

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

Ribeirão Preto, , Brazil

COT Centro Oncologico do Triangulo Ltda ( Site 1014)

Uberlândia, , Brazil

CancerCare Manitoba ( Site 0119)

Winnipeg, Manitoba, Canada

Dr. Leon Richard Oncology Centre ( Site 0106)

Moncton, New Brunswick, Canada

William Osler Health System ( Site 0115)

Brampton, Ontario, Canada

Juravinski Cancer Centre ( Site 0117)

Hamilton, Ontario, Canada

London Regional Cancer Program - London HSC ( Site 0107)

London, Ontario, Canada

Lakeridge Health ( Site 0108)

Oshawa, Ontario, Canada

Niagara Health System - St. Catharines ( Site 0120)

St. Catharines, Ontario, Canada

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

Chicoutimi, Quebec, Canada

CISSS-CA Hotel Dieu de Levis ( Site 0111)

Lévis, Quebec, Canada

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

Montreal, Quebec, Canada

St-Jerome Medical Research Inc ( Site 0103)

Saint-Jérôme, Quebec, Canada

Allan Blair Cancer Centre ( Site 0116)

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre ( Site 0105)

Saskatoon, Saskatchewan, Canada

Instituto Nacional del Cancer ( Site 0912)

Santiago, Santiago Metropolitan, Chile

Centro Oncologico Antofagasta ( Site 0914)

Antofagasta, , Chile

Hospital Regional de La Serena ( Site 0907)

La Serena, , Chile

Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)

Rancagua, , Chile

Health and Care Chile ( Site 0901)

Santiago, , Chile

Fundacion Arturo Lopez Perez FALP ( Site 0902)

Santiago, , Chile

Iram Cancer Research ( Site 0909)

Santiago, , Chile

Hospital Militar de Santiago ( Site 0911)

Santiago, , Chile

Pontificia Universidad Catolica de Chile ( Site 0904)

Santiago, , Chile

Hospital Clinico Universidad de Chile ( Site 0905)

Santiago, , Chile

Sociedad de Investigaciones Medicas Limitadas ( Site 0913)

Temuco, , Chile

Oncocentro ( Site 0900)

Viña del Mar, , Chile

Hospital Pablo Tobon Uribe. ( Site 0805)

Medellín, Antioquia, Colombia

Clinica de la Costa Ltda. ( Site 0804)

Barranquilla, Atlántico, Colombia

Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)

Valledupar, Cesar Department, Colombia

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

Bogota, Cundinamarca, Colombia

Oncologos del Occidente S.A. ( Site 0800)

Pereira, Risaralda Department, Colombia

Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)

Bogotá, , Colombia

Administradora Country SA - Clinica del Country ( Site 0808)

Bogotá, , Colombia

Oncomedica S.A. ( Site 0801)

Montería, , Colombia

FN Brno. ( Site 1501)

Brno, , Czechia

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

Nový Jičín, , Czechia

Fakultni nemocnice Olomouc ( Site 1502)

Olomouc, , Czechia

Fakultni nemocnice Ostrava ( Site 1507)

Ostrava, , Czechia

Thomayerova nemocnice ( Site 1505)

Prague, , Czechia

Fakultni nemocnice v Motole ( Site 1504)

Prague, , Czechia

Nemocnice Na Bulovce ( Site 1503)

Prague, , Czechia

HYKS ( Site 2300)

Helsinki, , Finland

Keski-Suomen keskussairaala ( Site 2303)

Jyväskylä, , Finland

Oulun yliopistollinen sairaala - OYS ( Site 2304)

Oulu, , Finland

TAYS ( Site 2301)

Tampere, , Finland

TYKS ( Site 2302)

Turku, , Finland

ICO Centre Paul Papin ( Site 2208)

Angers, , France

CHU Besancon - Hopital Jean Minjoz ( Site 2200)

Besançon, , France

Hopital Saint Andre ( Site 2202)

Bordeaux, , France

Hopital La Timone ( Site 2204)

Marseille, , France

CHU Saint-Eloi ( Site 2203)

Montpellier, , France

Centre Antoine Lacassagne ( Site 2211)

Nice, , France

Hopital Europeen Georges Pompidou ( Site 2206)

Paris, , France

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

Pierre-Bénite, , France

Centre Eugene Marquis ( Site 2209)

Rennes, , France

Centre Rene Gauducheau ICO ( Site 2207)

Saint-Herblain, , France

Institut Claudius Regaud IUCT Oncopole ( Site 2201)

Toulouse, , France

Campus Charite Mitte ( Site 2120)

Berlin, , Germany

Helios Klinikum Berlin Buch ( Site 2125)

Berlin, , Germany

Universitaetsklinikum Bonn ( Site 2110)

Bonn, , Germany

Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)

Dresden, , Germany

Universitatsklinikum Dusseldorf ( Site 2108)

Düsseldorf, , Germany

Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)

Erlangen, , Germany

Universitaetsklinikum Essen ( Site 2116)

Essen, , Germany

Universitaetsklinikum Frankfurt ( Site 2121)

Frankfurt, , Germany

Universitaetsklinikum Freiburg ( Site 2119)

Freiburg im Breisgau, , Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)

Hamburg, , Germany

Universitaetsklinikum Jena. ( Site 2104)

Jena, , Germany

Universitaetsklinikum Schleswig Holstein ( Site 2109)

Lübeck, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)

Mainz, , Germany

Studienpraxis Urologie ( Site 2115)

Nürtingen, , Germany

Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)

Trier, , Germany

Universitaetsklinikum Tuebingen ( Site 2100)

Tübingen, , Germany

Beaumont Hospital ( Site 1611)

Dublin, , Ireland

St Vincents University Hospital ( Site 1610)

Dublin, , Ireland

University Hospital Waterford ( Site 1614)

Waterford, , Ireland

Ospedale San Luigi Gonzaga ( Site 2010)

Orbassano, Torino, Italy

Medical Oncology Ospedale San Donato ( Site 2004)

Arezzo, , Italy

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

Meldola, , Italy

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

Milan, , Italy

Istituto Europeo di Oncologia ( Site 2000)

Milan, , Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)

Modena, , Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)

Napoli, , Italy

Istituto Nazionale Tumori Regina Elena ( Site 2009)

Roma, , Italy

Nagoya University Hospital ( Site 0431)

Nagoya, Aichi-ken, Japan

Sapporo Medical University Hospital ( Site 0424)

Sapporo, Hokkaido, Japan

Kagawa University Hospital ( Site 0419)

Kita-gun, Kagawa-ken, Japan

Japan Community Health care Organization Sendai Hospital ( Site 0430)

Sendai, Miyagi, Japan

Nara Medical University Hospital ( Site 0416)

Kashihara, Nara, Japan

Osaka Rosai Hospital ( Site 0418)

Sakai, Osaka, Japan

Kindai University Hospital ( Site 0411)

Sayama, Osaka, Japan

Saitama Medical University International Medical Center ( Site 0404)

Hidaka, Saitama, Japan

Yamaguchi University Hospital ( Site 0406)

Ube, Yamaguchi, Japan

Akita University Hospital ( Site 0433)

Akita, , Japan

Harasanshin Hospital ( Site 0402)

Fukuoka, , Japan

Kyushu University Hospital ( Site 0413)

Fukuoka, , Japan

Kumamoto University Hospital ( Site 0434)

Kumamoto, , Japan

Nagano Municipal Hospital ( Site 0429)

Nagano, , Japan

Niigata University Medical & Dental Hospital ( Site 0421)

Niigata, , Japan

Osaka International Cancer Institute ( Site 0401)

Osaka, , Japan

Osaka City University Hospital ( Site 0428)

Osaka, , Japan

Toranomon Hospital ( Site 0426)

Tokyo, , Japan

Nippon Medical School Hospital ( Site 0400)

Tokyo, , Japan

Keio University Hospital ( Site 0407)

Tokyo, , Japan

Toyama University Hospital ( Site 0432)

Toyama, , Japan

Amphia Ziekenhuis Breda ( Site 1901)

Breda, , Netherlands

Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)

Maastricht, , Netherlands

Franciscus Gasthuis ( Site 1903)

Rotterdam, , Netherlands

Mazowiecki Szpital Onkologiczny ( Site 1316)

Wieliszew, Masovian Voivodeship, Poland

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

Kościerzyna, Pomeranian Voivodeship, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)

Brzozów, , Poland

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)

Bytom, , Poland

Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)

Gdansk, , Poland

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

Gdynia, , Poland

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

Gliwice, , Poland

Przychodnia Lekarska Komed ( Site 1306)

Konin, , Poland

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

Krakow, , Poland

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

Lublin, , Poland

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

Otwock, , Poland

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

Poznan, , Poland

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

Torun, , Poland

Centrum Medyczne Onkologii I Hipertermii ( Site 1321)

Warsaw, , Poland

Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)

Warsaw, , Poland

Ivanovo Regional Oncology Dispensary ( Site 1204)

Ivanovo, , Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)

Krasnoyarsk, , Russia

N.N. Blokhin NMRCO ( Site 1206)

Moscow, , Russia

Russian Scientific Center of Roentgenoradiology ( Site 1201)

Moscow, , Russia

National Medical Research Radiology Centre ( Site 1200)

Moscow, , Russia

Bayandin Murmansk Regional Clinical Hospital ( Site 1214)

Murmansk, , Russia

Omsk Clinical Oncology Dispensary ( Site 1209)

Omsk, , Russia

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

Saint Petersburg, , Russia

Tomsk Scientific Research Institute of Oncology ( Site 1208)

Tomsk, , Russia

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

Ufa, , Russia

Clinical Hospital Bashkirsky Medical State University ( Site 1202)

Ufa, , Russia

National Cancer Center ( Site 0304)

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Hospital ( Site 0302)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 0303)

Seoul, , South Korea

Asan Medical Center ( Site 0300)

Seoul, , South Korea

Samsung Medical Center ( Site 0301)

Seoul, , South Korea

Hospital Universitario Infanta Cristina ( Site 1805)

Badajoz, , Spain

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

Barcelona, , Spain

Hospital de Girona Dr. Josep Trueta ( Site 1806)

Girona, , Spain

Hospital Universitario Gregorio Maranon ( Site 1801)

Madrid, , Spain

Hospital Universitario Ramon y Cajal ( Site 1800)

Madrid, , Spain

Hospital Universitario Virgen de la Victoria ( Site 1808)

Málaga, , Spain

Clinica Universitaria de Navarra ( Site 1803)

Pamplona, , Spain

Instituto Valenciano de Oncologia ( Site 1804)

Valencia, , Spain

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

Valencia, , Spain

China Medical University Hospital ( Site 0200)

Taichung, , Taiwan

Taichung Veterans General Hospital ( Site 0204)

Taichung, , Taiwan

National Taiwan University Hospital ( Site 0202)

Taipei, , Taiwan

Taipei Veterans General Hospital ( Site 0201)

Taipei, , Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0203)

Taoyuan District, , Taiwan

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

Stoke-on-Trent, Staffordshire, United Kingdom

Western General Hospital ( Site 1600)

Edinburgh, , United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 1605)

Glasgow, , United Kingdom

Royal Free Hospital ( Site 1609)

London, , United Kingdom

St George s Healthcare Trust ( Site 1608)

London, , United Kingdom

Charing Cross Hospital ( Site 1607)

London, , United Kingdom

The Christie NHS Foundation Trust ( Site 1602)

Manchester, , United Kingdom

The James Cook University Hospital ( Site 1606)

Middlesbrough, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Canada; Chile; Colombia; Czechia; Finland; France; Germany; Ireland; Italy; Japan; Netherlands; Poland; Russia; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: RESULT

PMID: 38631003 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37589219 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36055304 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34407342 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33526329 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26135&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

173704

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-3475-564

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-564

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1275-8289

Identifier Type: OTHER

Identifier Source: secondary_id

2016-004351-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-564

Identifier Type: -

Identifier Source: org_study_id