Back to resultsSafety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
Primary Purpose
Renal Cell Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Adjuvant
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:
- 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
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
Sites / Locations
- Arizona Oncology Associates, PC- HAL ( Site 8018)
- USC Norris Comprehensive Cancer Center ( Site 0038)
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
- Sansum Clinic Research ( Site 8014)
- Stanford Cancer Center ( Site 0028)
- Rocky Mountain Cancer Center ( Site 8010)
- Georgetown University Medical Center ( Site 0002)
- Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
- Manatee Medical Research Institute ( Site 0039)
- Woodlands Medical Specialists, PA ( Site 8021)
- Northwest Georgia Oncology Centers PC ( Site 0014)
- Illinois Cancer Specialists ( Site 8001)
- McFarland Clinic ( Site 0025)
- University of Iowa Hospital and Clinics ( Site 0031)
- University Medical Center New Orleans ( Site 0053)
- Weinberg Cancer Institute at Franklin Square ( Site 0046)
- Maryland Oncology Hematology, P.A. ( Site 8020)
- Beth Israel Deaconess Medical Ctr. ( Site 0044)
- Dana-Farber Cancer Institute (Boston) ( Site 0007)
- University of Michigan ( Site 0045)
- Karmanos Cancer Institute ( Site 0013)
- Henry Ford Hospital ( Site 0032)
- Quest Research Institute ( Site 0036)
- Fairview Southdale Medical Oncology Clinic ( Site 0041)
- Minnesota Oncology Specialist, PA ( Site 8002)
- Park Nicollet Frauenshuh Cancer Center ( Site 0020)
- St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
- Nebraska Cancer Specialists ( Site 0012)
- Comprehensive Cancer Centers of Nevada ( Site 8013)
- Rutgers Cancer Institute of New Jersey ( Site 0059)
- University of New Mexico Cancer Center ( Site 0043)
- Montefiore Medical Center ( Site 0009)
- Duke University ( Site 0037)
- Oncology Hematology Care, Inc. ( Site 8008)
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
- Northwest Cancer Specialists, P.C. ( Site 8006)
- St. Luke's University Health Network ( Site 0042)
- Abramson Cancer Center ( Site 0010)
- Charleston Hematology Oncology Associates PA ( Site 8000)
- Medical University of South Carolina ( Site 0033)
- Avera Cancer Institute ( Site 0023)
- Urology Associates [Nashville, TN] ( Site 0063)
- Texas Oncology-Austin Central ( Site 8003)
- Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
- UT Southwestern Medical Center ( Site 0003)
- Texas Oncology-Denton South ( Site 8016)
- Texas Oncology-Memorial City ( Site 8015)
- MD Anderson Cancer Center ( Site 0065)
- UTHealth/Memorial Hermann Cancer Center ( Site 0001)
- Texas Oncology- Paris ( Site 8004)
- CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
- Texas Oncology-Tyler ( Site 8005)
- Texas Oncology-Waco ( Site 8012)
- IHO Corporation- Utah Cancer Specialists ( Site 0055)
- Virginia Oncology Associates ( Site 8011)
- Providence Regional Cancer Partnership ( Site 0016)
- SCCA/UW ( Site 0029)
- Cancer Care Northwest ( Site 0021)
- Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
- Northwest Medical Specialties, PLLC ( Site 0034)
- Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
- University of Wisconsin Carbone Cancer Center ( Site 0019)
- Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
- Sanatorio Parque ( Site 1104)
- Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
- Fundacion Favaloro ( Site 1110)
- Instituto Medico Alexander Fleming ( Site 1105)
- Centro Oncologico Riojano Integral ( Site 1101)
- Centro Oncologico de Integracion Regional. COIR ( Site 1109)
- Sanatorio Britanico ( Site 1106)
- Instituto de Oncologia de Rosario ( Site 1100)
- Centro Medico San Roque ( Site 1108)
- Saint George Hospital [Kogarah, Australia] ( Site 0707)
- Macquarie University Hospital ( Site 0700)
- Adelaide Cancer Centre ( Site 0703)
- Bendigo Cancer Centre ( Site 0704)
- Box Hill Hospital ( Site 0701)
- Fiona Stanley Hospital ( Site 0702)
- Ballarat Health Services ( Site 0705)
- Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
- Liga Norte Riograndense Contra o Cancer ( Site 1013)
- Universidade de Caxias do Sul ( Site 1004)
- Hospital Bruno Born ( Site 1015)
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
- Hospital Nossa Senhora da Conceicao ( Site 1000)
- Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
- Fundacao Dr Amaral Carvalho ( Site 1005)
- Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
- Casa de Saude Santa Marcelina ( Site 1006)
- Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
- COT Centro Oncologico do Triangulo Ltda ( Site 1014)
- CancerCare Manitoba ( Site 0119)
- Dr. Leon Richard Oncology Centre ( Site 0106)
- William Osler Health System ( Site 0115)
- Juravinski Cancer Centre ( Site 0117)
- London Regional Cancer Program - London HSC ( Site 0107)
- Lakeridge Health ( Site 0108)
- Niagara Health System - St. Catharines ( Site 0120)
- CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
- CISSS-CA Hotel Dieu de Levis ( Site 0111)
- CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
- St-Jerome Medical Research Inc ( Site 0103)
- Allan Blair Cancer Centre ( Site 0116)
- Saskatoon Cancer Centre ( Site 0105)
- Instituto Nacional del Cancer ( Site 0912)
- Centro Oncologico Antofagasta ( Site 0914)
- Hospital Regional de La Serena ( Site 0907)
- Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
- Health and Care Chile ( Site 0901)
- Fundacion Arturo Lopez Perez FALP ( Site 0902)
- Iram Cancer Research ( Site 0909)
- Hospital Militar de Santiago ( Site 0911)
- Pontificia Universidad Catolica de Chile ( Site 0904)
- Hospital Clinico Universidad de Chile ( Site 0905)
- Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
- Oncocentro ( Site 0900)
- Hospital Pablo Tobon Uribe. ( Site 0805)
- Clinica de la Costa Ltda. ( Site 0804)
- Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
- Instituto Nacional de Cancerologia E.S.E ( Site 0807)
- Oncologos del Occidente S.A. ( Site 0800)
- Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
- Administradora Country SA - Clinica del Country ( Site 0808)
- Oncomedica S.A. ( Site 0801)
- FN Brno. ( Site 1501)
- Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
- Fakultni nemocnice Olomouc ( Site 1502)
- Fakultni nemocnice Ostrava ( Site 1507)
- Thomayerova nemocnice ( Site 1505)
- Fakultni nemocnice v Motole ( Site 1504)
- Nemocnice Na Bulovce ( Site 1503)
- HYKS ( Site 2300)
- Keski-Suomen keskussairaala ( Site 2303)
- Oulun yliopistollinen sairaala - OYS ( Site 2304)
- TAYS ( Site 2301)
- TYKS ( Site 2302)
- ICO Centre Paul Papin ( Site 2208)
- CHU Besancon - Hopital Jean Minjoz ( Site 2200)
- Hopital Saint Andre ( Site 2202)
- Hopital La Timone ( Site 2204)
- CHU Saint-Eloi ( Site 2203)
- Centre Antoine Lacassagne ( Site 2211)
- Hopital Europeen Georges Pompidou ( Site 2206)
- Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
- Centre Eugene Marquis ( Site 2209)
- Centre Rene Gauducheau ICO ( Site 2207)
- Institut Claudius Regaud IUCT Oncopole ( Site 2201)
- Campus Charite Mitte ( Site 2120)
- Helios Klinikum Berlin Buch ( Site 2125)
- Universitaetsklinikum Bonn ( Site 2110)
- Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
- Universitatsklinikum Dusseldorf ( Site 2108)
- Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
- Universitaetsklinikum Essen ( Site 2116)
- Universitaetsklinikum Frankfurt ( Site 2121)
- Universitaetsklinikum Freiburg ( Site 2119)
- Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
- Universitaetsklinikum Jena. ( Site 2104)
- Universitaetsklinikum Schleswig Holstein ( Site 2109)
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
- Studienpraxis Urologie ( Site 2115)
- Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
- Universitaetsklinikum Tuebingen ( Site 2100)
- Beaumont Hospital ( Site 1611)
- St Vincents University Hospital ( Site 1610)
- University Hospital Waterford ( Site 1614)
- Ospedale San Luigi Gonzaga ( Site 2010)
- Medical Oncology Ospedale San Donato ( Site 2004)
- Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
- Istituto Europeo di Oncologia ( Site 2000)
- Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
- Istituto Nazionale Tumori Regina Elena ( Site 2009)
- Nagoya University Hospital ( Site 0431)
- Sapporo Medical University Hospital ( Site 0424)
- Kagawa University Hospital ( Site 0419)
- Japan Community Health care Organization Sendai Hospital ( Site 0430)
- Nara Medical University Hospital ( Site 0416)
- Kindai University Hospital ( Site 0411)
- Osaka Rosai Hospital ( Site 0418)
- Saitama Medical University International Medical Center ( Site 0404)
- Yamaguchi University Hospital ( Site 0406)
- Akita University Hospital ( Site 0433)
- Harasanshin Hospital ( Site 0402)
- Kyushu University Hospital ( Site 0413)
- Kumamoto University Hospital ( Site 0434)
- Nagano Municipal Hospital ( Site 0429)
- Niigata University Medical & Dental Hospital ( Site 0421)
- Osaka International Cancer Institute ( Site 0401)
- Osaka City University Hospital ( Site 0428)
- Toranomon Hospital ( Site 0426)
- Nippon Medical School Hospital ( Site 0400)
- Keio University Hospital ( Site 0407)
- Toyama University Hospital ( Site 0432)
- National Cancer Center ( Site 0304)
- Seoul National University Hospital ( Site 0302)
- Severance Hospital Yonsei University Health System ( Site 0303)
- Asan Medical Center ( Site 0300)
- Samsung Medical Center ( Site 0301)
- Amphia Ziekenhuis Breda ( Site 1901)
- Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
- Franciscus Gasthuis ( Site 1903)
- Mazowiecki Szpital Onkologiczny ( Site 1316)
- Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
- Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
- Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
- Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
- Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
- Przychodnia Lekarska Komed ( Site 1306)
- Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
- Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
- Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
- Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
- Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
- Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
- Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
- Ivanovo Regional Oncology Dispensary ( Site 1204)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
- N.N. Blokhin NMRCO ( Site 1206)
- Russian Scientific Center of Roentgenoradiology ( Site 1201)
- National Medical Research Radiology Centre ( Site 1200)
- Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
- Omsk Clinical Oncology Dispensary ( Site 1209)
- Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
- Tomsk Scientific Research Institute of Oncology ( Site 1208)
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
- Clinical Hospital Bashkirsky Medical State University ( Site 1202)
- Hospital Universitario Infanta Cristina ( Site 1805)
- Hospital de la Santa Creu i Sant Pau ( Site 1807)
- Hospital de Girona Dr. Josep Trueta ( Site 1806)
- Hospital Universitario Gregorio Maranon ( Site 1801)
- Hospital Universitario Ramon y Cajal ( Site 1800)
- Hospital Universitario Virgen de la Victoria ( Site 1808)
- Clinica Universitaria de Navarra ( Site 1803)
- Instituto Valenciano de Oncologia ( Site 1804)
- Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
- China Medical University Hospital ( Site 0200)
- Taichung Veterans General Hospital ( Site 0204)
- National Taiwan University Hospital ( Site 0202)
- Taipei Veterans General Hospital ( Site 0201)
- Chang Gung Medical Foundation. Linkou ( Site 0203)
- North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
- Western General Hospital ( Site 1600)
- The Beatson West of Scotland Cancer Centre ( Site 1605)
- Royal Free Hospital ( Site 1609)
- St George s Healthcare Trust ( Site 1608)
- Charing Cross Hospital ( Site 1607)
- The Christie NHS Foundation Trust ( Site 1602)
- The James Cook University Hospital ( Site 1606)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pembrolizumab
Placebo
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator.
Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)
EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
OS According to Participant PD-L1 Expression Status (Positive, Negative)
OS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.
Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. The change from baseline in the FKSI-DRS index score will be presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03142334
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Adjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
994 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®, SCH 900475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline solution
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS) as Assessed by the Investigator
Description
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).
Time Frame
Up to approximately 42 months (database cutoff date 14 Dec 2020)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 72 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
Time Frame
Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
Title
Number of Participants Who Discontinued Study Drug Due to an AE
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
Time Frame
Up to approximately 12 months
Title
First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
Description
DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Time Frame
Up to approximately 72 months
Title
Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
Description
DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator.
Time Frame
Up to approximately 72 months
Title
Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)
Description
EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 72 months
Title
DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
Description
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
Time Frame
Up to approximately 72 months
Title
OS According to Participant PD-L1 Expression Status (Positive, Negative)
Description
OS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative.
Time Frame
Up to approximately 72 months
Title
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
Description
The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.
Time Frame
Baseline and Week 52
Title
Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
Description
The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. The change from baseline in the FKSI-DRS index score will be presented.
Time Frame
Baseline and Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC- HAL ( Site 8018)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center ( Site 0038)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Sansum Clinic Research ( Site 8014)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford Cancer Center ( Site 0028)
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Center ( Site 8010)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Georgetown University Medical Center ( Site 0002)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Manatee Medical Research Institute ( Site 0039)
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Woodlands Medical Specialists, PA ( Site 8021)
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC ( Site 0014)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Cancer Specialists ( Site 8001)
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
McFarland Clinic ( Site 0025)
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010-3014
Country
United States
Facility Name
University of Iowa Hospital and Clinics ( Site 0031)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University Medical Center New Orleans ( Site 0053)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Weinberg Cancer Institute at Franklin Square ( Site 0046)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Maryland Oncology Hematology, P.A. ( Site 8020)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Beth Israel Deaconess Medical Ctr. ( Site 0044)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute (Boston) ( Site 0007)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan ( Site 0045)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute ( Site 0013)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital ( Site 0032)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Quest Research Institute ( Site 0036)
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Fairview Southdale Medical Oncology Clinic ( Site 0041)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Minnesota Oncology Specialist, PA ( Site 8002)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Park Nicollet Frauenshuh Cancer Center ( Site 0020)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Nebraska Cancer Specialists ( Site 0012)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 8013)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0059)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico Cancer Center ( Site 0043)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Montefiore Medical Center ( Site 0009)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Duke University ( Site 0037)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oncology Hematology Care, Inc. ( Site 8008)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. ( Site 8006)
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
St. Luke's University Health Network ( Site 0042)
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Abramson Cancer Center ( Site 0010)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Charleston Hematology Oncology Associates PA ( Site 8000)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Medical University of South Carolina ( Site 0033)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Avera Cancer Institute ( Site 0023)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Urology Associates [Nashville, TN] ( Site 0063)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Texas Oncology-Austin Central ( Site 8003)
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center ( Site 0003)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology-Denton South ( Site 8016)
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Texas Oncology-Memorial City ( Site 8015)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
MD Anderson Cancer Center ( Site 0065)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UTHealth/Memorial Hermann Cancer Center ( Site 0001)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology- Paris ( Site 8004)
City
Paris
State/Province
Texas
ZIP/Postal Code
75460-5004
Country
United States
Facility Name
CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology-Tyler ( Site 8005)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology-Waco ( Site 8012)
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
IHO Corporation- Utah Cancer Specialists ( Site 0055)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Oncology Associates ( Site 8011)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Providence Regional Cancer Partnership ( Site 0016)
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
SCCA/UW ( Site 0029)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Cancer Care Northwest ( Site 0021)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Northwest Medical Specialties, PLLC ( Site 0034)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center ( Site 0019)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
City
Viedma
State/Province
Rio Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Sanatorio Parque ( Site 1104)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Fundacion Favaloro ( Site 1110)
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming ( Site 1105)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral ( Site 1101)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Centro Oncologico de Integracion Regional. COIR ( Site 1109)
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Sanatorio Britanico ( Site 1106)
City
Rosario
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario ( Site 1100)
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro Medico San Roque ( Site 1108)
City
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Saint George Hospital [Kogarah, Australia] ( Site 0707)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Macquarie University Hospital ( Site 0700)
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Adelaide Cancer Centre ( Site 0703)
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Bendigo Cancer Centre ( Site 0704)
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Box Hill Hospital ( Site 0701)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Fiona Stanley Hospital ( Site 0702)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ballarat Health Services ( Site 0705)
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Facility Name
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
City
Curitiba
State/Province
PR
ZIP/Postal Code
80510-130
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 1013)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Universidade de Caxias do Sul ( Site 1004)
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95070-560
Country
Brazil
Facility Name
Hospital Bruno Born ( Site 1015)
City
Lajeado
State/Province
RS
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 1000)
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundacao Dr Amaral Carvalho ( Site 1005)
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Casa de Saude Santa Marcelina ( Site 1006)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
City
Ribeirao Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
COT Centro Oncologico do Triangulo Ltda ( Site 1014)
City
Uberlandia
ZIP/Postal Code
38408-150
Country
Brazil
Facility Name
CancerCare Manitoba ( Site 0119)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Dr. Leon Richard Oncology Centre ( Site 0106)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
William Osler Health System ( Site 0115)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Juravinski Cancer Centre ( Site 0117)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program - London HSC ( Site 0107)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Lakeridge Health ( Site 0108)
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Niagara Health System - St. Catharines ( Site 0120)
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
CISSS-CA Hotel Dieu de Levis ( Site 0111)
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
St-Jerome Medical Research Inc ( Site 0103)
City
St-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Allan Blair Cancer Centre ( Site 0116)
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre ( Site 0105)
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Instituto Nacional del Cancer ( Site 0912)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Centro Oncologico Antofagasta ( Site 0914)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Facility Name
Hospital Regional de La Serena ( Site 0907)
City
La Serena
ZIP/Postal Code
1710216
Country
Chile
Facility Name
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
City
Rancagua
ZIP/Postal Code
2820000
Country
Chile
Facility Name
Health and Care Chile ( Site 0901)
City
Santiago
ZIP/Postal Code
7500006
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0902)
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Iram Cancer Research ( Site 0909)
City
Santiago
ZIP/Postal Code
7630372
Country
Chile
Facility Name
Hospital Militar de Santiago ( Site 0911)
City
Santiago
ZIP/Postal Code
7850000
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0904)
City
Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile ( Site 0905)
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Oncocentro ( Site 0900)
City
Vina del Mar
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Hospital Pablo Tobon Uribe. ( Site 0805)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Clinica de la Costa Ltda. ( Site 0804)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 0807)
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111161
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 0800)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
661002
Country
Colombia
Facility Name
Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
City
Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Administradora Country SA - Clinica del Country ( Site 0808)
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0801)
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
FN Brno. ( Site 1501)
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc ( Site 1502)
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava ( Site 1507)
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Thomayerova nemocnice ( Site 1505)
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Fakultni nemocnice v Motole ( Site 1504)
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Nemocnice Na Bulovce ( Site 1503)
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
HYKS ( Site 2300)
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Keski-Suomen keskussairaala ( Site 2303)
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
Facility Name
Oulun yliopistollinen sairaala - OYS ( Site 2304)
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
TAYS ( Site 2301)
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
TYKS ( Site 2302)
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
ICO Centre Paul Papin ( Site 2208)
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHU Besancon - Hopital Jean Minjoz ( Site 2200)
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Hopital Saint Andre ( Site 2202)
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital La Timone ( Site 2204)
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Saint-Eloi ( Site 2203)
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Antoine Lacassagne ( Site 2211)
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Europeen Georges Pompidou ( Site 2206)
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Eugene Marquis ( Site 2209)
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Rene Gauducheau ICO ( Site 2207)
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 2201)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Campus Charite Mitte ( Site 2120)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Helios Klinikum Berlin Buch ( Site 2125)
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 2110)
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf ( Site 2108)
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Essen ( Site 2116)
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 2121)
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Freiburg ( Site 2119)
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Jena. ( Site 2104)
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinikum Schleswig Holstein ( Site 2109)
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Studienpraxis Urologie ( Site 2115)
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen ( Site 2100)
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Beaumont Hospital ( Site 1611)
City
Dublin
ZIP/Postal Code
D04 Y8V0
Country
Ireland
Facility Name
St Vincents University Hospital ( Site 1610)
City
Dublin
ZIP/Postal Code
D04 Y8V0
Country
Ireland
Facility Name
University Hospital Waterford ( Site 1614)
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Ospedale San Luigi Gonzaga ( Site 2010)
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Medical Oncology Ospedale San Donato ( Site 2004)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia ( Site 2000)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
City
Modena
ZIP/Postal Code
41125
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena ( Site 2009)
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Nagoya University Hospital ( Site 0431)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Sapporo Medical University Hospital ( Site 0424)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kagawa University Hospital ( Site 0419)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Japan Community Health care Organization Sendai Hospital ( Site 0430)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-8501
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0416)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0411)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Rosai Hospital ( Site 0418)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 0404)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 0406)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Akita University Hospital ( Site 0433)
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Harasanshin Hospital ( Site 0402)
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0413)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 0434)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Nagano Municipal Hospital ( Site 0429)
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital ( Site 0421)
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0401)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka City University Hospital ( Site 0428)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Toranomon Hospital ( Site 0426)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0400)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital ( Site 0407)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Toyama University Hospital ( Site 0432)
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
National Cancer Center ( Site 0304)
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0302)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0303)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0300)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0301)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Amphia Ziekenhuis Breda ( Site 1901)
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Franciscus Gasthuis ( Site 1903)
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Mazowiecki Szpital Onkologiczny ( Site 1316)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
City
Koscierzyna
State/Province
Pomorskie
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 1306)
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Ivanovo Regional Oncology Dispensary ( Site 1204)
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
N.N. Blokhin NMRCO ( Site 1206)
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology ( Site 1201)
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
National Medical Research Radiology Centre ( Site 1200)
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
City
Murmansk
ZIP/Postal Code
183057
Country
Russian Federation
Facility Name
Omsk Clinical Oncology Dispensary ( Site 1209)
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tomsk Scientific Research Institute of Oncology ( Site 1208)
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Clinical Hospital Bashkirsky Medical State University ( Site 1202)
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
Hospital Universitario Infanta Cristina ( Site 1805)
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau ( Site 1807)
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital de Girona Dr. Josep Trueta ( Site 1806)
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon ( Site 1801)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1800)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 1808)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinica Universitaria de Navarra ( Site 1803)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Instituto Valenciano de Oncologia ( Site 1804)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
China Medical University Hospital ( Site 0200)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0204)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0202)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0201)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0203)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
City
Stoke-On-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Western General Hospital ( Site 1600)
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre ( Site 1605)
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Free Hospital ( Site 1609)
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St George s Healthcare Trust ( Site 1608)
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital ( Site 1607)
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust ( Site 1602)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The James Cook University Hospital ( Site 1606)
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
36055304
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. Erratum In: Lancet Oncol. 2023 Jan;24(1):e10.
Results Reference
derived
PubMed Identifier
34407342
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.
Results Reference
derived
PubMed Identifier
33526329
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.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-564&&kw=3475-564
Description
Plain Language Summary
Learn more about this trial
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)
We'll reach out to this number within 24 hrs