A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Registration Number
- NCT05239728
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.
The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1800
-
Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
-
Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
- 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, ≤2 years from nephrectomy (metachronous)
-
Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
-
Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
-
Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
-
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 pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
-
Has adequate organ function
- Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
- Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
- Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
- Has preexisting brain or bone metastatic lesions
- Has received prior systemic therapy for RCC
- Has received prior radiotherapy for RCC
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
- 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 history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection, requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
- Has had an allogenic tissue/solid organ transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Pembrolizumab Placebo Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks). Placebo + Pembrolizumab Pembrolizumab Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks). Belzutifan + Pembrolizumab Pembrolizumab Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks). Belzutifan + Pembrolizumab Belzutifan Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks).
- Primary Outcome Measures
Name Time Method Disease-Free Survival (DFS) Up to approximately 54 months DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience at Least One Adverse Event (AE) Up to approximately 66 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score Baseline (Day 1) and up to approximately 36 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of participants with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score Baseline (Day 1) and up to approximately 36 months The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score Baseline (Day 1) and up to approximately 36 months The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher score indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score Baseline (Day 1) and up to approximately 36 months The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. 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. Change from baseline in the score of FKSI-DRS Items 1-9 will be presented.
Overall Survival (OS) Up to approximately 89 months OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 54 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued the study due to an AE will be reported.
Disease Recurrence-Specific Survival 1 (DRSS1) Up to approximately 54 months 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.
Disease Recurrence-Specific Survival 2 (DRSS2) Up to approximately 54 months 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 investigator.
Trial Locations
- Locations (285)
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
🇺🇸Columbus, Ohio, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
🇺🇸Los Angeles, California, United States
UT Southwestern Medical Center ( Site 3529)
🇺🇸Dallas, Texas, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)
🇺🇸Boston, Massachusetts, United States
Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)
🇺🇸La Jolla, California, United States
City of Hope Comprehensive Cancer Center ( Site 3567)
🇺🇸Duarte, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)
🇺🇸Orange, California, United States
St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 3562)
🇺🇸Grand Junction, Colorado, United States
Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)
🇺🇸Seattle, Washington, United States
Georgetown University Medical Center ( Site 3534)
🇺🇸Washington, District of Columbia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)
🇺🇸Marietta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 3526)
🇺🇸Fort Wayne, Indiana, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 3571)
🇺🇸Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan ( Site 3502)
🇺🇸Grand Rapids, Michigan, United States
Dana-Farber Cancer Institute-GU ( Site 3505)
🇺🇸Boston, Massachusetts, United States
Washington University-Internal Medicine/Oncology ( Site 3531)
🇺🇸Saint Louis, Missouri, United States
Monter Cancer Center ( Site 3560)
🇺🇸Lake Success, New York, United States
Englewood Hospital and Medical Center ( Site 3557)
🇺🇸Englewood, New Jersey, United States
Icahn School of Medicine at Mount Sinai ( Site 3539)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 3568)
🇺🇸New York, New York, United States
University of Rochester Medical Center ( Site 3528)
🇺🇸Rochester, New York, United States
MidLantic urology ( Site 3501)
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Hospital São Carlos-Oncocentro Ce ( Site 0104)
🇧🇷Fortaleza, Ceara, Brazil
ONCOCENTRO APYS-ACEREY ( Site 0301)
🇨🇱Viña del Mar, Valparaiso, Chile
Zhejiang Provincial People's Hospital-Urology ( Site 0426)
🇨🇳Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)
🇨🇿Brno, Brno-mesto, Czechia
Universitaetsklinikum Tuebingen ( Site 1002)
🇩🇪Tübingen, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
🇩🇪Munich, Bayern, Germany
Universitaetsklinikum Essen ( Site 1004)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Helios Klinikum Berlin-Buch ( Site 1011)
🇩🇪Berlin, Germany
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)
🇭🇺Debrecen, Hungary
Seoul National University Bundang Hospital-Urology ( Site 2602)
🇰🇷Seongnam, Kyonggi-do, Korea, Republic of
City Hospital, Nottingham University Hospitals ( Site 3303)
🇬🇧Nottingham, England, United Kingdom
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35
🇺🇸Miami, Florida, United States
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0402)
🇨🇳Guangzhou, Guangdong, China
Hubei Cancer Hospital-Urinary surgery ( Site 0419)
🇨🇳Wuhan, Hubei, China
Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)
🇩🇪Homburg, Saarland, Germany
Tallaght University Hospital ( Site 1402)
🇮🇪Dublin 24, Dublin, Ireland
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)
🇧🇷Natal, Rio Grande Do Norte, Brazil
Centro de Oncología Personalizada ( Site 1911)
🇲🇽Culiacán, Sinaloa, Mexico
Fiona Stanley Hospital-Medical Oncology ( Site 0004)
🇦🇺Murdoch, Western Australia, Australia
St. Vincent's University Hospital ( Site 1401)
🇮🇪Dublin 4, Dublin, Ireland
Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)
🇫🇷Angers, Maine-et-Loire, France
Urology Associates ( Site 3512)
🇺🇸Nashville, Tennessee, United States
Rutgers Cancer Institute of New Jersey ( Site 3541)
🇺🇸New Brunswick, New Jersey, United States
Clinica de la Costa S.A.S. ( Site 0506)
🇨🇴Barranquilla, Atlantico, Colombia
Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)
🇬🇷Athens, Attiki, Greece
Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)
🇬🇷Thessaloniki, Greece
Soroka Medical Center ( Site 1505)
🇮🇱Be'er Sheva, Israel
Hadassah Medical Center-Oncology ( Site 1506)
🇮🇱Jerusalem, Israel
Toho University Sakura Medical Center ( Site 1718)
🇯🇵Sakura, Chiba, Japan
Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
St. Vincent Frontier Cancer Center-Research ( Site 3506)
🇺🇸Billings, Montana, United States
Austin Health-Cancer Clinical Trials Centre ( Site 0005)
🇦🇺Heidelberg, Victoria, Australia
Clínica Puerto Montt ( Site 0309)
🇨🇱Puerto Montt, Los Lagos, Chile
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)
🇭🇺Budapest, Pest, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)
🇭🇺Kaposvár, Somogy, Hungary
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)
🇮🇪Dublin, Ireland
Rambam Health Care Campus-Oncology ( Site 1502)
🇮🇱Haifa, Israel
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)
🇮🇹Roma, Lazio, Italy
University Malaya Medical Centre ( Site 1804)
🇲🇾Lembah Pantai, Kuala Lumpur, Malaysia
McGill University Health Centre ( Site 3709)
🇨🇦Montréal, Quebec, Canada
Bell Land General Hospital ( Site 1710)
🇯🇵Sakai, Osaka, Japan
Kagoshima University Hospital ( Site 1719)
🇯🇵Kagoshima, Japan
Tergooiziekenhuizen, locatie Hilversum ( Site 3102)
🇳🇱Hilversum, Noord-Holland, Netherlands
Haaglanden MC - locatie Antoniushove ( Site 3117)
🇳🇱Leidschendam, Zuid-Holland, Netherlands
The West Clinic, PLLC dba West Cancer Center ( Site 3522)
🇺🇸Germantown, Tennessee, United States
Rabin Medical Center-Oncology ( Site 1503)
🇮🇱Petah-Tikva, Israel
Sheba Medical Center-ONCOLOGY ( Site 1504)
🇮🇱Ramat Gan, Israel
Sourasky Medical Center-Oncology ( Site 1501)
🇮🇱Tel Aviv, Israel
Fujita Health University ( Site 1709)
🇯🇵Toyoake, Aichi, Japan
National Cancer Center Hospital East ( Site 1704)
🇯🇵Kashiwa, Chiba, Japan
Hokkaido University Hospital ( Site 1701)
🇯🇵Sapporo, Hokkaido, Japan
Kanagawa cancer center ( Site 1703)
🇯🇵Yokohama, Kanagawa, Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 1717)
🇯🇵Tokyo, Japan
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)
🇳🇱Breda, Noord-Brabant, Netherlands
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2401)
🇷🇴Craiova, Dolj, Romania
Chulalongkorn University ( Site 3005)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital ( Site 3001)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Toranomon Hospital ( Site 1706)
🇯🇵Minato-ku, Tokyo, Japan
Osaka University Hospital ( Site 1711)
🇯🇵Suita, Osaka, Japan
National Cancer Centre Singapore ( Site 3601)
🇸🇬Singapore, Central Singapore, Singapore
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)
🇵🇱Tarnow, Malopolskie, Poland
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 2312)
🇵🇱Poznań, Wielkopolskie, Poland
BRCR Global Mexico - Guadalajara-Research ( Site 1908)
🇲🇽Guadalajara, Jalisco, Mexico
Sarawak General Hospital-Radiotherapy Unit ( Site 1805)
🇲🇾Kuching, Sarawak, Malaysia
Hamamatsu University Hospital ( Site 1708)
🇯🇵Hamamatsu, Shizuoka, Japan
Kumamoto University ( Site 1716)
🇯🇵Kumamoto, Japan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1
🇲🇽Mexico City, Distrito Federal, Mexico
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
National University Hospital ( Site 3602)
🇸🇬Singapore, South West, Singapore
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)
🇹🇷Istanbul- Fatih, Istanbul, Turkey
Filios Alta Medicina ( Site 1903)
🇲🇽Monterrey, Nuevo Leon, Mexico
Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)
🇳🇱Hoofddorp, Noord-Holland, Netherlands
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)
🇵🇱Siedlce, Mazowieckie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)
🇵🇱Koszalin, Zachodniopomorskie, Poland
Cabinet Medical Oncomed ( Site 2403)
🇷🇴Timișoara, Timis, Romania
Taichung Veterans General Hospital ( Site 2902)
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital ( Site 2903)
🇨🇳Taipei, Taiwan
St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)
🇳🇱Utrecht, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)
🇳🇱Utrecht, Netherlands
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Radiology Therapeutic Center-Oncology ( Site 2404)
🇷🇴Otopeni, Ilfov, Romania
The Christie NHS Foundation Trust ( Site 3301)
🇬🇧Manchester, England, United Kingdom
Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)
🇹🇷Yenimahalle, Ankara, Turkey
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)
🇮🇹Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)
🇮🇹Milan, Lombardia, Italy
Fox Chase Cancer Center-GU Oncology ( Site 3535)
🇺🇸Philadelphia, Pennsylvania, United States
Sanford Cancer Center ( Site 3551)
🇺🇸Sioux Falls, South Dakota, United States
Inova Schar Cancer Institute ( Site 3525)
🇺🇸Fairfax, Virginia, United States
University of Texas MD Anderson Cancer Center-Urology ( Site 3569)
🇺🇸Houston, Texas, United States
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002)
🇦🇺Blacktown, New South Wales, Australia
Tamworth Hospital-North West Cancer Centre ( Site 0006)
🇦🇺North Tamworth, New South Wales, Australia
Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)
🇦🇺Elizabeth Vale, South Australia, Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)
🇦🇺Macquarie University, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
🇦🇺Brisbane, Queensland, Australia
Instituto do Câncer e Transplante de Curitiba ( Site 0102)
🇧🇷Curitiba, Parana, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)
🇧🇬Panagyurishte, Pazardzhik, Bulgaria
Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)
🇧🇬Plovdiv, Bulgaria
Hospital de Clínicas de Ribeirão Preto ( Site 0112)
🇧🇷Ribeirão Preto, Sao Paulo, Brazil
MHAT Serdika-Second Department of Medical Oncology ( Site 0203)
🇧🇬Sofia, Sofia (stolitsa), Bulgaria
BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)
🇧🇷Sao Paulo, Brazil
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)
🇨🇦Montreal, Quebec, Canada
Tom Baker Cancer Center ( Site 3706)
🇨🇦Calgary, Alberta, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)
🇨🇦Vancouver, British Columbia, Canada
James Lind Centro de Investigación del Cáncer ( Site 0307)
🇨🇱Temuco, Araucania, Chile
Princess Margaret Cancer Centre ( Site 3703)
🇨🇦Toronto, Ontario, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)
🇨🇦Hamilton, Ontario, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
🇨🇦Quebec, Canada
Oncocentro Valdivia ( Site 0312)
🇨🇱Valdivia, Los Rios, Chile
FALP-UIDO ( Site 0302)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0305)
🇨🇱Santiago, Region M. De Santiago, Chile
Oncovida ( Site 0306)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradford Hill Norte ( Site 0303)
🇨🇱Antofagasta, Chile
Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 0438)
🇨🇳Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 0435)
🇨🇳Beijing, Beijing, China
Peking University First Hospital-Urology ( Site 0407)
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital ( Site 0414)
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0445)
🇨🇳Fuzhou, Fujian, China
First Medical Center of Chinese PLA General Hospital ( Site 0415)
🇨🇳Beijing, Beijing, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417)
🇨🇳Guangzhou, Guangdong, China
Second Affiliated hospital of Anhui Medical University-Urology ( Site 0416)
🇨🇳Hefei, Anhui, China
Wuhan Union Hospital ( Site 0430)
🇨🇳Wuhan, Hubei, China
Army Medical Center of People's Liberation Army ( Site 0439)
🇨🇳Chongqing, Chongqing, China
Beijing Cancer hospital-Urinary Surgery ( Site 0406)
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0403)
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital-Urology ( Site 0441)
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital ( Site 0421)
🇨🇳Changsha, Hunan, China
Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0423)
🇨🇳Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
🇨🇳NanJing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 0443)
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University ( Site 0432)
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)
🇨🇳Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center-Urology department ( Site 0401)
🇨🇳Shanghai, Shanghai, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)
🇨🇳Shanghai, Shanghai, China
Huadong Hospital Affiliated to Fudan University ( Site 0405)
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University-Urology Surgery ( Site 0410)
🇨🇳Cheng Du, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0422)
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0425)
🇨🇳Wenzhou, Zhejiang, China
Ningbo First Hospital-Urology ( Site 0433)
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital, Zhejiang University ( Site 0428)
🇨🇳Hangzhou, Zhejiang, China
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)
🇨🇴Valledupar, Cesar, Colombia
Oncomédica S.A.S ( Site 0501)
🇨🇴Monteria, Cordoba, Colombia
Administradora Country S.A. - Clinica del Country ( Site 0504)
🇨🇴Bogotá, Distrito Capital De Bogota, Colombia
Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)
🇨🇿Prague, Praha 4, Czechia
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)
🇨🇿Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)
🇨🇿Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)
🇨🇿Olomouc, Olomoucky Kraj, Czechia
Oulun yliopistollinen sairaala ( Site 0802)
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)
🇨🇿Praha, Praha 5, Czechia
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)
🇨🇿Hradec Kralove, Czechia
Tampereen yliopistollinen sairaala ( Site 0805)
🇫🇮Tampere, Pirkanmaa, Finland
Turku University Hospital ( Site 0801)
🇫🇮Turku, Varsinais-Suomi, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)
🇫🇮Helsinki, Uusimaa, Finland
Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)
🇫🇮Kuopio, Pohjois-Savo, Finland
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903)
🇫🇷Strasbourg, Alsace, France
CHU Besançon-Medical oncology ( Site 0904)
🇫🇷Besançon, Doubs, France
ROC37 ( Site 0910)
🇫🇷Chambray Les Tours, Centre, France
Gustave Roussy ( Site 0907)
🇫🇷Villejuif, Ile-de-France, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)
🇫🇷Rennes, Ille-et-Vilaine, France
Hôpital Saint-Louis ( Site 0905)
🇫🇷Paris, France
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)
🇫🇷Paris, France
Universitätsklinikum Aachen ( Site 1024)
🇩🇪Aachen, Nordrhein-Westfalen, Germany
CENTRE LEON BERARD-Medical oncology ( Site 0902)
🇫🇷Lyon, Rhone-Alpes, France
Universitaetsklinikum Duesseldorf ( Site 1017)
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Hegau-Bodensee-Klinikum Singen ( Site 1016)
🇩🇪Singen, Baden-Wurttemberg, Germany
Universitätsklinikum Bonn ( Site 1006)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie (
🇩🇪Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Jena ( Site 1007)
🇩🇪Jena, Thuringen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)
🇩🇪Münster, Nordrhein-Westfalen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)
🇩🇪Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)
🇩🇪Dresden, Sachsen, Germany
SRH Wald-Klinikum Gera ( Site 1015)
🇩🇪Gera, Thuringen, Germany
Metropolitan Hospital-2nd Oncology Dept ( Site 1104)
🇬🇷Athens, Attiki, Greece
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)
🇩🇪Hamburg, Germany
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)
🇬🇷Chaidari, Attiki, Greece
European Interbalkan Medical Center-Oncology Department ( Site 1105)
🇬🇷Thessaloniki, Greece
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)
🇭🇺Szeged, Csongrad, Hungary
Cork University Hospital ( Site 1404)
🇮🇪Cork, Ireland
Ospedale San Raffaele-Oncologia Medica ( Site 1606)
🇮🇹Milano, Lombardia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)
🇮🇹Orbassano, Piemonte, Italy
Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)
🇮🇹Terni, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)
🇮🇹Firenze, Toscana, Italy
A.O.U.C. Policlinico di Bari ( Site 1607)
🇮🇹Bari, Puglia, Italy
Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)
🇮🇹Arezzo, Italy
IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)
🇮🇹Bologna, Italy
Ehime University Hospital ( Site 1714)
🇯🇵Toon, Ehime, Japan
Nara Medical University Hospital ( Site 1712)
🇯🇵Kashihara, Nara, Japan
Sapporo Medical University Hospital ( Site 1702)
🇯🇵Sapporo, Hokkaido, Japan
Toyama University Hospital ( Site 1713)
🇯🇵Toyoma, Toyama, Japan
Kyushu University Hospital ( Site 1715)
🇯🇵Fukuoka, Japan
Okayama University Hospital ( Site 1720)
🇯🇵Okayama, Japan
Keio university hospital ( Site 1707)
🇯🇵Tokyo, Japan
Nippon Medical School Hospital ( Site 1705)
🇯🇵Tokyo, Japan
Asan Medical Center-Oncology ( Site 2601)
🇰🇷Songpagu, Seoul, Korea, Republic of
National Cancer Center-Center for Urologic Cancer ( Site 2604)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Wakayama Medical University Hospital ( Site 1721)
🇯🇵Wakayama, Japan
Samsung Medical Center ( Site 2603)
🇰🇷Seoul, Korea, Republic of
Hospital Pulau Pinang ( Site 1806)
🇲🇾George Town, Pulau Pinang, Malaysia
INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)
🇲🇽Mexico City, Distrito Federal, Mexico
iCan Oncology Center Centro Medico AVE ( Site 1901)
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)
🇲🇽Guadalajara, Jalisco, Mexico
Terapias Integrales del Riñon SA de CV ( Site 1910)
🇲🇽Guadalajara, Jalisco, Mexico
Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)
🇲🇽Santiago de Queretaro, Queretaro, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1904)
🇲🇽Oaxaca, Mexico
BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)
🇲🇽Santiago de Querétaro, Queretaro, Mexico
Maastricht UMC+ ( Site 3104)
🇳🇱Maastricht, Limburg, Netherlands
Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)
🇳🇱Arnhem, Gelderland, Netherlands
Radboudumc ( Site 3120)
🇳🇱Nijmegen, Gelderland, Netherlands
Oncocenter ( Site 1909)
🇲🇽Puebla, Mexico
Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)
🇳🇱Eindhoven, Noord-Brabant, Netherlands
University Medical Center Groningen ( Site 3121)
🇳🇱Groningen, Netherlands
Amsterdam UMC, locatie AMC ( Site 3105)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Isala, locatie Zwolle-Oncology ( Site 3111)
🇳🇱Zwolle, Overijssel, Netherlands
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)
🇳🇱Den Haag, Zuid-Holland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)
🇳🇱Schiedam, Zuid-Holland, Netherlands
MICS Centrum Medyczne Torun ( Site 2305)
🇵🇱Torun, Kujawsko-pomorskie, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)
🇵🇱Wrocław, Dolnoslaskie, Poland
Auckland City Hospital-Cancer & Blood Research ( Site 2003)
🇳🇿Auckland, New Zealand
Przychodnia Lekarska KOMED ( Site 2304)
🇵🇱Konin, Wielkopolskie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)
🇵🇱Przemysl, Podkarpackie, Poland
Luxmed Onkologia sp. z o. o. ( Site 2303)
🇵🇱Warszawa, Mazowieckie, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)
🇵🇱Szczecin, Zachodniopomorskie, Poland
Cardiomed SRL Cluj-Napoca ( Site 2406)
🇷🇴Cluj-Napoca, Cluj, Romania
Institut Català d'Oncologia (ICO) - Girona ( Site 2707)
🇪🇸Girona, Gerona, Spain
Centrul medical Focus ( Site 2407)
🇷🇴București, Bucuresti, Romania
Sahlgrenska Universitetssjukhuset ( Site 2801)
🇸🇪Gothenburg, Vastra Gotalands Lan, Sweden
China Medical University Hospital-Department of Urology ( Site 2907)
🇨🇳Taichung, Taiwan
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)
🇷🇴Florești, Cluj, Romania
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)
🇪🇸Barcelona, Spain
Karolinska Universitetssjukhuset Solna ( Site 2802)
🇸🇪Stockholm, Stockholms Lan, Sweden
Tri-Service General Hospital ( Site 2908)
🇨🇳Taipei City, Taipei, Taiwan
Fundación Instituto Valenciano de Oncología ( Site 2705)
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Lucus Augusti-Oncology ( Site 2706)
🇪🇸Lugo, Spain
Kaohsiung Veterans General Hospital ( Site 2901)
🇨🇳Kaohsiung, Taiwan
Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)
🇪🇸Malaga, Spain
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)
🇸🇪Uppsala, Uppsala Lan, Sweden
Faculty of Medicine Siriraj Hospital ( Site 3002)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
National Taiwan University Hospital ( Site 2904)
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)
🇨🇳Taoyuan, Taiwan
Songklanagarind hospital ( Site 3004)
🇹🇭Hatyai, Songkhla, Thailand
Hacettepe Universitesi-oncology hospital ( Site 3203)
🇹🇷Ankara, Turkey
Ankara University Hospital Cebeci ( Site 3209)
🇹🇷Ankara, Turkey
Ege University Medicine of Faculty-Medical Oncology ( Site 3202)
🇹🇷Izmir, Turkey
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)
🇬🇧London, London, City Of, United Kingdom
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)
🇹🇷Adana, Turkey
Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)
🇹🇷Ankara, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)
🇹🇷Istanbul, Turkey
Royal Free Hospital ( Site 3304)
🇬🇧London, England, United Kingdom
Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)
🇬🇧Glasgow, Glasgow City, United Kingdom
Charing Cross Hospital ( Site 3302)
🇬🇧London, Hammersmith And Fulham, United Kingdom
Singleton Hospital ( Site 3306)
🇬🇧Swansea, Wales, United Kingdom
Victoria Hospital & Children's Hospital - London Health Scie-London Regional Cancer Program ( Site 3
🇨🇦London, Ontario, Canada
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 2703)
🇪🇸Madrid, Spain
Mayo Clinic in Arizona - Phoenix ( Site 3554)
🇺🇸Phoenix, Arizona, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)
🇺🇸Omaha, Nebraska, United States
University of Colorado Anschutz Medical Campus ( Site 3514)
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center ( Site 3540)
🇺🇸Tampa, Florida, United States
Stanford Cancer Center ( Site 3523)
🇺🇸Palo Alto, California, United States