Clinical trial NCT03142334: Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Adjuvant
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-05-05
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease-free Survival (DFS) as Assessed by the Investigator
timeFrame: Up to approximately 42 months (database cutoff date 14 Dec 2020)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 72 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: 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)
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to approximately 12 months
measure: First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
timeFrame: Up to approximately 72 months
measure: Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
timeFrame: Up to approximately 72 months
measure: Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 72 months
measure: DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
timeFrame: Up to approximately 72 months
measure: OS According to Participant PD-L1 Expression Status (Positive, Negative)
timeFrame: Up to approximately 72 months
measure: Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC- HAL ( Site 8018)
state: Arizona
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center ( Site 0038)
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic Research ( Site 8014)
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center ( Site 0028)
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center ( Site 8010)
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0002)
state: District of Columbia
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
state: Florida
city: Bradenton
country: United States
facility: Manatee Medical Research Institute ( Site 0039)
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA ( Site 8021)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 0014)
state: Georgia
city: Niles
country: United States
facility: Illinois Cancer Specialists ( Site 8001)
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic ( Site 0025)
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0031)
state: Iowa
city: New Orleans
country: United States
facility: University Medical Center New Orleans ( Site 0053)
state: Louisiana
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square ( Site 0046)
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A. ( Site 8020)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Ctr. ( Site 0044)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (Boston) ( Site 0007)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 0045)
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0013)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0032)
state: Michigan
city: Royal Oak
country: United States
facility: Quest Research Institute ( Site 0036)
state: Michigan
city: Edina
country: United States
facility: Fairview Southdale Medical Oncology Clinic ( Site 0041)
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Specialist, PA ( Site 8002)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center ( Site 0020)
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists ( Site 0012)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 8013)
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0059)
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center ( Site 0043)
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 0009)
state: New York
city: Durham
country: United States
facility: Duke University ( Site 0037)
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. ( Site 8008)
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
state: Oklahoma
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C. ( Site 8006)
state: Oregon
city: Easton
country: United States
facility: St. Luke's University Health Network ( Site 0042)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center ( Site 0010)
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates PA ( Site 8000)
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina ( Site 0033)
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute ( Site 0023)
state: South Dakota
city: Nashville
country: United States
facility: Urology Associates [Nashville, TN] ( Site 0063)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Central ( Site 8003)
state: Texas
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 0003)
state: Texas
city: Denton
country: United States
facility: Texas Oncology-Denton South ( Site 8016)
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City ( Site 8015)
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center ( Site 0065)
state: Texas
city: Houston
country: United States
facility: UTHealth/Memorial Hermann Cancer Center ( Site 0001)
state: Texas
city: Paris
country: United States
facility: Texas Oncology- Paris ( Site 8004)
state: Texas
city: San Antonio
country: United States
facility: CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler ( Site 8005)
state: Texas
city: Waco
country: United States
facility: Texas Oncology-Waco ( Site 8012)
state: Texas
city: Salt Lake City
country: United States
facility: IHO Corporation- Utah Cancer Specialists ( Site 0055)
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates ( Site 8011)
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership ( Site 0016)
state: Washington
city: Seattle
country: United States
facility: SCCA/UW ( Site 0029)
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest ( Site 0021)
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC ( Site 0034)
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center ( Site 0019)
state: Wisconsin
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
state: Rio Negro
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 1104)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 1110)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 1105)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 1101)
city: Mendoza
country: Argentina
facility: Centro Oncologico de Integracion Regional. COIR ( Site 1109)
city: Rosario
country: Argentina
facility: Sanatorio Britanico ( Site 1106)
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario ( Site 1100)
city: Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 1108)
city: Kogarah
country: Australia
facility: Saint George Hospital [Kogarah, Australia] ( Site 0707)
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital ( Site 0700)
state: New South Wales
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre ( Site 0703)
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Cancer Centre ( Site 0704)
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital ( Site 0701)
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital ( Site 0702)
state: Western Australia
city: Ballarat
country: Australia
facility: Ballarat Health Services ( Site 0705)
city: Curitiba
country: Brazil
facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
state: PR
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 1013)
state: Rio Grande Do Norte
city: Caxias do Sul
country: Brazil
facility: Universidade de Caxias do Sul ( Site 1004)
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born ( Site 1015)
state: RS
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 1000)
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
state: Sao Paulo
city: Jau
country: Brazil
facility: Fundacao Dr Amaral Carvalho ( Site 1005)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
state: SP
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina ( Site 1006)
state: SP
city: Ribeirao Preto
country: Brazil
facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
city: Uberlandia
country: Brazil
facility: COT Centro Oncologico do Triangulo Ltda ( Site 1014)
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0119)
state: Manitoba
city: Moncton
country: Canada
facility: Dr. Leon Richard Oncology Centre ( Site 0106)
state: New Brunswick
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0115)
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre ( Site 0117)
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program - London HSC ( Site 0107)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0108)
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System - St. Catharines ( Site 0120)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
state: Quebec
city: Lévis
country: Canada
facility: CISSS-CA Hotel Dieu de Levis ( Site 0111)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
state: Quebec
city: St-Jerome
country: Canada
facility: St-Jerome Medical Research Inc ( Site 0103)
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre ( Site 0116)
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre ( Site 0105)
state: Saskatchewan
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer ( Site 0912)
state: Region Metropolitana
city: Antofagasta
country: Chile
facility: Centro Oncologico Antofagasta ( Site 0914)
city: La Serena
country: Chile
facility: Hospital Regional de La Serena ( Site 0907)
city: Rancagua
country: Chile
facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
city: Santiago
country: Chile
facility: Health and Care Chile ( Site 0901)
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0902)
city: Santiago
country: Chile
facility: Iram Cancer Research ( Site 0909)
city: Santiago
country: Chile
facility: Hospital Militar de Santiago ( Site 0911)
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0904)
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile ( Site 0905)
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 0900)
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe. ( Site 0805)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 0804)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
state: Cesar
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0807)
state: Cundinamarca
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 0800)
state: Risaralda
city: Bogota
country: Colombia
facility: Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 0808)
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0801)
city: Brno
country: Czechia
facility: FN Brno. ( Site 1501)
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 1502)
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava ( Site 1507)
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice ( Site 1505)
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole ( Site 1504)
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce ( Site 1503)
city: Helsinki
country: Finland
facility: HYKS ( Site 2300)
city: Jyvaskyla
country: Finland
facility: Keski-Suomen keskussairaala ( Site 2303)
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala - OYS ( Site 2304)
city: Tampere
country: Finland
facility: TAYS ( Site 2301)
city: Turku
country: Finland
facility: TYKS ( Site 2302)
city: Angers
country: France
facility: ICO Centre Paul Papin ( Site 2208)
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz ( Site 2200)
city: Bordeaux
country: France
facility: Hopital Saint Andre ( Site 2202)
city: Marseille
country: France
facility: Hopital La Timone ( Site 2204)
city: Montpellier
country: France
facility: CHU Saint-Eloi ( Site 2203)
city: Nice
country: France
facility: Centre Antoine Lacassagne ( Site 2211)
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou ( Site 2206)
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 2209)
city: Saint Herblain
country: France
facility: Centre Rene Gauducheau ICO ( Site 2207)
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 2201)
city: Berlin
country: Germany
facility: Campus Charite Mitte ( Site 2120)
city: Berlin
country: Germany
facility: Helios Klinikum Berlin Buch ( Site 2125)
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 2110)
city: Dresden
country: Germany
facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf ( Site 2108)
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 2116)
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 2121)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 2119)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
city: Jena
country: Germany
facility: Universitaetsklinikum Jena. ( Site 2104)
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein ( Site 2109)
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie ( Site 2115)
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 2100)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 1611)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 1610)
city: Waterford
country: Ireland
facility: University Hospital Waterford ( Site 1614)
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga ( Site 2010)
state: Torino
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 2004)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 2000)
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena ( Site 2009)
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 0431)
state: Aichi
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 0424)
state: Hokkaido
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 0419)
state: Kagawa
city: Sendai
country: Japan
facility: Japan Community Health care Organization Sendai Hospital ( Site 0430)
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0416)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0411)
state: Osaka
city: Sakai
country: Japan
facility: Osaka Rosai Hospital ( Site 0418)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 0404)
state: Saitama
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 0406)
state: Yamaguchi
city: Akita
country: Japan
facility: Akita University Hospital ( Site 0433)
city: Fukuoka
country: Japan
facility: Harasanshin Hospital ( Site 0402)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0413)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 0434)
city: Nagano
country: Japan
facility: Nagano Municipal Hospital ( Site 0429)
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital ( Site 0421)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0401)
city: Osaka
country: Japan
facility: Osaka City University Hospital ( Site 0428)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0426)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0400)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0407)
city: Toyama
country: Japan
facility: Toyama University Hospital ( Site 0432)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0304)
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0302)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0303)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0300)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0301)
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda ( Site 1901)
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis ( Site 1903)
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny ( Site 1316)
state: Mazowieckie
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
state: Pomorskie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
city: Bytom
country: Poland
facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 1306)
city: Krakow
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
city: Warszawa
country: Poland
facility: Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary ( Site 1204)
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 1206)
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology ( Site 1201)
city: Moscow
country: Russian Federation
facility: National Medical Research Radiology Centre ( Site 1200)
city: Murmansk
country: Russian Federation
facility: Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 1209)
city: Saint Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology ( Site 1208)
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
city: Ufa
country: Russian Federation
facility: Clinical Hospital Bashkirsky Medical State University ( Site 1202)
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina ( Site 1805)
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau ( Site 1807)
city: Girona
country: Spain
facility: Hospital de Girona Dr. Josep Trueta ( Site 1806)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon ( Site 1801)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1800)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 1808)
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra ( Site 1803)
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia ( Site 1804)
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0200)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0204)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0202)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0201)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0203)
city: Stoke-On-Trent
country: United Kingdom
facility: North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
state: Staffordshire
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1600)
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 1605)
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 1609)
city: London
country: United Kingdom
facility: St George s Healthcare Trust ( Site 1608)
city: London
country: United Kingdom
facility: Charing Cross Hospital ( Site 1607)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1602)
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital ( Site 1606)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.