Back to resultsA Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Primary Purpose
Carcinoma, Renal Cell
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Belzutifan
Pembrolizumab/Quavonlimab
Lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Hypoxia inducible factor (HIF), Hypoxia inducible factor 1B (HIF-1B), Hypoxia inducible factor 2 alpha (HIF-2 alpha)
Eligibility Criteria
Inclusion Criteria:
- Has histologically confirmed diagnosis of RCC with clear cell component.
- Has received no prior systemic therapy for advanced ccRCC
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
- Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function.
- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
- Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
- Has clinically significant cardiac disease within 12 months from first dose of study intervention
- Has a history of interstitial lung disease
- Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
- Has preexisting gastrointestinal or non-gastrointestinal fistula
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B
- Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
- Has clinically significant history of bleeding within 3 months prior to randomization
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- The University of Alabama at Birmingham ( Site 0010)Recruiting
- UC San Diego ( Site 0050)Recruiting
- Cedars Sinai Medical Center ( Site 0027)Recruiting
- University of California Irvine ( Site 0029)Recruiting
- UCLA Hematology Oncology Santa Monica ( Site 0048)Recruiting
- Hartford Hospital ( Site 0024)Recruiting
- Advent Health Hematology & Oncology ( Site 0003)
- University Cancer & Blood Center, LLC ( Site 0057)
- Emory University Winship Cancer Institute ( Site 0012)Recruiting
- Rush University Medical Center ( Site 0040)Recruiting
- Parkview Cancer Institute ( Site 0088)Recruiting
- Norton Cancer Institute - St. Matthews ( Site 0065)
- Ochsner Medical Center ( Site 0049)Recruiting
- New England Cancer Specialists ( Site 0082)Recruiting
- Massachusetts General Hospital ( Site 0094)Recruiting
- Beth Israel Deaconess Medical Center ( Site 0089)Recruiting
- Dana Farber Cancer Institute ( Site 0093)Recruiting
- Lahey Hospital & Medical Center ( Site 0090)Recruiting
- Henry Ford Hospital ( Site 0038)
- Cancer & Hematology Centers of Western Michigan ( Site 0018)Recruiting
- HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)Recruiting
- Regions Hospital ( Site 0095)
- University of Mississippi Medical Center ( Site 0037)
- Dartmouth Hitchcock Medical Center ( Site 0075)
- Roswell Park Cancer Institute ( Site 0032)Recruiting
- R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)Recruiting
- Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
- Oregon Health & Science University ( Site 0071)Recruiting
- Ralph H. Johnson VA Center ( Site 0073)
- University of Tennessee Medical Center Knoxville ( Site 0019)Recruiting
- Vanderbilt University Medical Center ( Site 0069)Recruiting
- UTSW Medical Center ( Site 0015)Recruiting
- Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)Recruiting
- Liverpool Hospital ( Site 4006)
- Macquarie University ( Site 4007)
- Lyell McEwin Hospital ( Site 4004)
- Monash Health ( Site 4008)
- Fiona Stanley Hospital ( Site 4009)
- Oncocentro Ceara ( Site 0309)
- Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
- Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
- Liga Norte Riograndense Contra o Cancer ( Site 0308)
- Hospital de Clinicas de Porto Alegre ( Site 0310)
- Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
- BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
- A.C. Camargo Cancer Center ( Site 0301)
- Tom Baker Cancer Centre ( Site 0119)
- BC Cancer - Vancouver Center ( Site 0120)
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
- Sunnybrook Research Institute ( Site 0116)
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
- Centro Investigacion Cancer James Lind ( Site 0402)
- IC La Serena Research ( Site 0403)
- Servicios Medicos Urumed ( Site 0405)
- Fundacion Arturo Lopez Perez ( Site 0400)
- Bradfordhill-Clinical Area ( Site 0401)
- Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)Recruiting
- Peking University First Hospital ( Site 6011)Recruiting
- Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)Recruiting
- Chongqing University Cancer Hospital ( Site 6009)Recruiting
- The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)Recruiting
- The First Affiliated hospital of Xiamen University-Urology ( Site 6001)Recruiting
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)Recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)Recruiting
- The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)Recruiting
- Guangzhou First People's Hospital ( Site 6007)Recruiting
- Harbin Medical University Cancer Hospital-urology ( Site 6015)Recruiting
- Henan Cancer Hospital-Urology ( Site 6006)Recruiting
- Wuhan Union Hospital ( Site 6002)Recruiting
- Hunan Cancer Hospital ( Site 6020)Recruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( SRecruiting
- The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)Recruiting
- The First Affiliated Hospital of Nanchang University ( Site 6019)Recruiting
- Jiangxi Provincial Cancer Hospital ( Site 6042)Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)Recruiting
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)Recruiting
- Shanghai Tenth People's Hospital ( Site 6023)Recruiting
- West China Hospital Sichuan University-Urology Surgery ( Site 6016)Recruiting
- Tianjin Medical University Cancer Institute and Hospital ( Site 6029)Recruiting
- The Second Hospital of Tianjin Medical University ( Site 6032)Recruiting
- The First Affiliated Hospital, Zhejiang University ( Site 6024)Recruiting
- The First Hospital of Jiaxing ( Site 6033)Recruiting
- Ningbo First Hospital-Urology ( Site 6028)Recruiting
- The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)Recruiting
- Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
- Clinica de la Costa S.A.S. ( Site 0502)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
- Administradora Country SA - Clinica del Country ( Site 0504)
- Instituto Nacional de Cancerología E.S.E. ( Site 0503)
- Oncólogos del Occidente S.A ( Site 0501)
- Fundacion Cardiovascular de Colombia ( Site 0506)
- Klinicki Bolnicki Centar Zagreb ( Site 3200)
- Klinički Bolnički Centar Split ( Site 3202)
- Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
- Masarykuv onkologicky ustav ( Site 2203)
- Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
- Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
- Fakultni nemocnice Ostrava ( Site 2208)
- Fakultni nemocnice Olomouc ( Site 2200)
- Fakultni Thomayerova nemocnice ( Site 2201)
- 2 LF UK a FN Motol ( Site 2207)
- Herlev Hospital ( Site 1700)
- Odense University Hospital ( Site 1701)
- TAYS ( Site 1801)
- Kuopion Yliopistollinen Sairaala ( Site 1803)
- HYKS ( Site 1800)
- TYKS ( Site 1802)
- Institut Paoli Calmettes ( Site 1206)
- CHU Jean Minjoz ( Site 1205)Recruiting
- Institut Claudius Regaud ( Site 1214)
- Clinique Francois Chenieux ( Site 1209)Recruiting
- CHU Angers ( Site 1200)
- Clinique Ambroise Pare Beuvry ( Site 1213)
- CH Lyon Sud Hospices Civils de Lyon ( Site 1203)Recruiting
- Gustave Roussy ( Site 1207)
- Hopital Tenon ( Site 1212)
- Universitaetsklinik fuer Urologie ( Site 1300)
- Helios Kliniken Schwerin GmbH ( Site 1302)
- Charite Universitaetsmedizin Berlin ( Site 1301)
- Centro Medico Integral de Cancerologia CEMIC ( Site 0701)
- Oncomedica ( Site 0700)
- Grupo Angeles SA ( Site 0705)
- Sanatorio Nuestra Senora del Pilar ( Site 0702)
- Medi-K Cayala ( Site 0703)
- Centro Regional de Sub Especialidades Medicas SA ( Site 0704)
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)
- Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)
- Markusovszky Egyetemi Oktatokorhaz ( Site 2303)
- Orszagos Onkologiai Intezet ( Site 2304)
- Debreceni Egyetem Klinikai Kozpont ( Site 2301)
- Beaumont Hospital ( Site 6101)
- Tallaght University Hospital ( Site 6100)
- Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)
- Ospedale San Raffaele-Oncologia Medica ( Site 1417)
- Fondazione Policlinico Universitario A. Gemelli ( Site 1414)
- Azienda Ospedaliera Policlinico di Bari ( Site 1411)
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)
- Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)
- Azienda Ospedaliera S. Maria di Terni ( Site 1410)
- Fujita Health University ( Site 5003)
- Chiba cancer center ( Site 5021)
- National Cancer Center Hospital East ( Site 5000)
- Ehime University Hospital ( Site 5020)
- Sapporo Medical University Hospital ( Site 5008)
- Hokkaido University Hospital ( Site 5013)
- Kanagawa cancer center ( Site 5016)
- Nara Medical University Hospital ( Site 5002)
- Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
- Osaka University Hospital ( Site 5012)
- Saitama Medical University International Medical Center ( Site 5015)
- Hamamatsu University School of Medicine University Hospital ( Site 5004)
- Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)
- Toranomon Hospital ( Site 5001)
- Toyama University Hospital ( Site 5014)
- Kyushu University Hospital ( Site 5005)
- Kumamoto University ( Site 5022)
- Niigata University Medical & Dental Hospital ( Site 5024)
- Okayama University Hospital ( Site 5017)
- Tokushima University Hospital-Department of Urology ( Site 5019)
- Nippon Medical School Hospital ( Site 5006)
- Tokyo Women's Medical University Adachi Medical Center ( Site 5023)
- Keio university hospital ( Site 5011)
- National Cancer Center ( Site 4202)
- Chungnam National University Hospital ( Site 4205)
- Korea University Anam Hospital ( Site 4206)
- Seoul National University Hospital ( Site 4201)
- Severance Hospital Yonsei University Health System ( Site 4204)
- Asan Medical Center ( Site 4203)
- Samsung Medical Center ( Site 4200)
- Hospital Sultan Ismail ( Site 4303)
- Institut Kanser Negara - National Cancer Institute ( Site 4302)
- Hospital Kuala Lumpur ( Site 4301)
- Universiti Malaya Medical Centre ( Site 4300)
- Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)
- I CAN Oncology SA de SV ( Site 0601)
- Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)
- Instituto Nacional de Cancerologia ( Site 0602)
- Centro de Investigacion Clinica de Oaxaca ( Site 0605)
- Akershus universitetssykehus ( Site 2000)Recruiting
- Soerlandet sykehus HF Kristiansand ( Site 2007)
- Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)
- Sykehuset Østfold HF Kalnes ( Site 2003)
- St. Olavs Hospital HF ( Site 2005)
- Oslo Universitetssykehus Radiumhospitalet ( Site 2001)
- Manila Doctors Hospital ( Site 4601)
- The Medical City ( Site 4602)
- Cardinal Santos Medical Center ( Site 4603)
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)
- Radomskie Centrum Onkologii ( Site 2418)
- Luxmed Onkologia sp. z o. o. ( Site 2412)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)
- Przychodnia Lekarska KOMED ( Site 2419)
- Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)
- Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)
- Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)
- Policlinica Oncomed SRL ( Site 2506)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 2503)
- Altay Regional Oncology Dispensary ( Site 2610)
- Ivanovo Regional Oncology Dispensary ( Site 2615)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)
- The Loginov Moscow Clinical Scientific Center ( Site 2604)
- Moscow Oncological Clinical Dispensary #1 ( Site 2619)
- Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)
- FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)
- City clinical oncological dispensary ( Site 2605)
- Klinicki centar Srbije. ( Site 3333)
- Klinicki centar Nis ( Site 3322)Recruiting
- Institut za onkologiju Vojvodine ( Site 3311)
- Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)
- Wits Clinical Research ( Site 3012)
- Sandton Oncology Medical Group PTY LTD ( Site 3000)
- Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)
- Life Wilgers Hospital ( Site 3004)
- Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)
- Vaal Triangle Oncology Centre ( Site 3010)
- Groote Schuur Hospital ( Site 3011)
- Cape Town Oncology Trials Pty Ltd ( Site 3006)
- Cancercare Rondebosch Oncology ( Site 3005)
- Instituto Catalan de Oncologia - ICO ( Site 1502)
- Hospital Universitario Marques de Valdecilla ( Site 1501)
- Institut Català d'Oncologia (ICO) - Girona ( Site 1500)
- Hospital Clinico San Carlos ( Site 1503)
- Hospital Universitario 12 de Octubre ( Site 1505)
- Hospital Universitario Virgen de la Victoria ( Site 1504)
- Lanssjukhuset Ryhov ( Site 2103)
- Karolinska Universitetssjukhuset Solna ( Site 2100)
- Akademiska Sjukhuset ( Site 2105)
- Norrlands Universitetssjukhus ( Site 2106)
- Sahlgrenska Universitetssjukhuset ( Site 2102)
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)
- Taichung Veterans General Hospital ( Site 4403)
- National Cheng Kung University Hospital ( Site 4404)
- National Taiwan University Hospital ( Site 4401)
- Taipei Veterans General Hospital ( Site 4402)
- Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)
- Ramathibodi Hospital. ( Site 4500)
- Siriraj Hospital ( Site 4501)
- Ankara Universitesi Tip Fakultesi ( Site 2902)
- Hacettepe Universitesi Tıp Fakultesi ( Site 2903)
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)
- Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)
- Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)
- Cherkasy Regional Oncology Dispensary ( Site 2704)
- Chernihiv Medical Center of Modern Oncology ( Site 2709)
- MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 2710)
- Clinical oncology dispensary of Dnipro ( Site 2700)
- Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)
- Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)
- Regional Oncology Center of Kharkiv ( Site 2708)
- Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)
- Kyiv City Clinical Oncology Center ( Site 2706)
- Lviv State Regional Oncological Center ( Site 2712)
- Addenbrookes Hospital ( Site 3110)
- Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
- Mount Vernon Cancer Centre ( Site 3101)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Pembrolizumab + Belzutifan + Lenvatinib
Pembrolizumab/Quavonlimab + Lenvatinib
Pembrolizumab + Lenvatinib
Arm Description
Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Participants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR based on RECIST 1.1 will be presented.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
ORR is defined as the percentage of participants who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 will be presented.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR based on RECIST 1.1 will be presented.
Number of Participants Who Experienced At least One Adverse Event (AE)
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. The number of participants who experience at least one AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE
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. The number of participants who discontinue study treatment due to an AE will be presented.
Full Information
NCT ID
NCT04736706
First Posted
January 29, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04736706
Brief Title
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Official Title
An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
October 29, 2026 (Anticipated)
Study Completion Date
October 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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 goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Hypoxia inducible factor (HIF), Hypoxia inducible factor 1B (HIF-1B), Hypoxia inducible factor 2 alpha (HIF-2 alpha)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1653 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Belzutifan + Lenvatinib
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Arm Title
Pembrolizumab/Quavonlimab + Lenvatinib
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Arm Title
Pembrolizumab + Lenvatinib
Arm Type
Active Comparator
Arm Description
Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 400 mg administered Q6W via IV infusion
Intervention Type
Drug
Intervention Name(s)
Belzutifan
Other Intervention Name(s)
MK-6482, PT2977, WELIREG™
Intervention Description
Belzutifan 120 mg administered QD via oral tablet
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Quavonlimab
Other Intervention Name(s)
MK-1308A
Intervention Description
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080, LENVIMA®
Intervention Description
Lenvatinib 20 mg administered QD via oral capsule
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR based on RECIST 1.1 will be presented.
Time Frame
Up to approximately 46 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 66 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Description
ORR is defined as the percentage of participants who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 will be presented.
Time Frame
Up to approximately 46 months
Title
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Description
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR based on RECIST 1.1 will be presented.
Time Frame
Up to approximately 66 months
Title
Number of Participants Who Experienced At least One Adverse Event (AE)
Description
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. The number of participants who experience at least one AE will be presented.
Time Frame
Up to approximately 66 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 66 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has histologically confirmed diagnosis of RCC with clear cell component.
Has received no prior systemic therapy for advanced ccRCC
Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function.
Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
Has clinically significant cardiac disease within 12 months from first dose of study intervention
Has a history of interstitial lung disease
Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
Has preexisting gastrointestinal or non-gastrointestinal fistula
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B
Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
Has clinically significant history of bleeding within 3 months prior to randomization
Has had an allogenic tissue/solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
The University of Alabama at Birmingham ( Site 0010)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
205-934-3411
Facility Name
UC San Diego ( Site 0050)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
858-657-7516
Facility Name
Cedars Sinai Medical Center ( Site 0027)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-423-3713
Facility Name
University of California Irvine ( Site 0029)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-456-8000
Facility Name
UCLA Hematology Oncology Santa Monica ( Site 0048)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-633-8400
Facility Name
Hartford Hospital ( Site 0024)
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
860-972-4700
Facility Name
Advent Health Hematology & Oncology ( Site 0003)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Cancer & Blood Center, LLC ( Site 0057)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Completed
Facility Name
Emory University Winship Cancer Institute ( Site 0012)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-778-1900
Facility Name
Rush University Medical Center ( Site 0040)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-942-3732
Facility Name
Parkview Cancer Institute ( Site 0088)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
833-724-8326
Facility Name
Norton Cancer Institute - St. Matthews ( Site 0065)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Completed
Facility Name
Ochsner Medical Center ( Site 0049)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
504-842-3910
Facility Name
New England Cancer Specialists ( Site 0082)
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
207-303-3300
Facility Name
Massachusetts General Hospital ( Site 0094)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-724-4000
Facility Name
Beth Israel Deaconess Medical Center ( Site 0089)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-667-7000
Facility Name
Dana Farber Cancer Institute ( Site 0093)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-632-3000
Facility Name
Lahey Hospital & Medical Center ( Site 0090)
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
781-744-8400
Facility Name
Henry Ford Hospital ( Site 0038)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
Cancer & Hematology Centers of Western Michigan ( Site 0018)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
616-885-1462
Facility Name
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
952-993-6705
Facility Name
Regions Hospital ( Site 0095)
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Completed
Facility Name
University of Mississippi Medical Center ( Site 0037)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Completed
Facility Name
Dartmouth Hitchcock Medical Center ( Site 0075)
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Completed
Facility Name
Roswell Park Cancer Institute ( Site 0032)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
716-845-3159
Facility Name
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-734-8919
Facility Name
Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University ( Site 0071)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-494-1080
Facility Name
Ralph H. Johnson VA Center ( Site 0073)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Completed
Facility Name
University of Tennessee Medical Center Knoxville ( Site 0019)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-305-8780
Facility Name
Vanderbilt University Medical Center ( Site 0069)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-936-8422
Facility Name
UTSW Medical Center ( Site 0015)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-648-7097
Facility Name
Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-436-6245
Facility Name
Liverpool Hospital ( Site 4006)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Macquarie University ( Site 4007)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Lyell McEwin Hospital ( Site 4004)
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Monash Health ( Site 4008)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Fiona Stanley Hospital ( Site 4009)
City
Murdock
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Oncocentro Ceara ( Site 0309)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
City
Cachoeiro de Itapemirim
State/Province
Espirito Santo
ZIP/Postal Code
29308-014
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130090
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 0308)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Clinicas de Porto Alegre ( Site 0310)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
A.C. Camargo Cancer Center ( Site 0301)
City
Sao Paulo
ZIP/Postal Code
01525-001
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Tom Baker Cancer Centre ( Site 0119)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
BC Cancer - Vancouver Center ( Site 0120)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sunnybrook Research Institute ( Site 0116)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Centro Investigacion Cancer James Lind ( Site 0402)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
IC La Serena Research ( Site 0403)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Servicios Medicos Urumed ( Site 0405)
City
Rancagua
State/Province
Lbtdr Gen Bernardo O Higgins
ZIP/Postal Code
2852424
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Fundacion Arturo Lopez Perez ( Site 0400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Bradfordhill-Clinical Area ( Site 0401)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
010-87788029
Facility Name
Peking University First Hospital ( Site 6011)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13910688432
Facility Name
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13911233048
Facility Name
Chongqing University Cancer Hospital ( Site 6009)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13883029913
Facility Name
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13235907575
Facility Name
The First Affiliated hospital of Xiamen University-Urology ( Site 6001)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0592-2132222
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13922735659
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13600054833
Facility Name
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0592-2132222
Facility Name
Guangzhou First People's Hospital ( Site 6007)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13922231881
Facility Name
Harbin Medical University Cancer Hospital-urology ( Site 6015)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0451-86298192
Facility Name
Henan Cancer Hospital-Urology ( Site 6006)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0371-65588237
Facility Name
Wuhan Union Hospital ( Site 6002)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 027-85726300
Facility Name
Hunan Cancer Hospital ( Site 6020)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0731-89762271
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613605171690
Facility Name
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 18994392817
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 6019)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13879103861
Facility Name
Jiangxi Provincial Cancer Hospital ( Site 6042)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13870628187
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18149480558
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613801931604
Facility Name
Shanghai Tenth People's Hospital ( Site 6023)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-66300588
Facility Name
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13881749152
Facility Name
Tianjin Medical University Cancer Institute and Hospital ( Site 6029)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23340123
Facility Name
The Second Hospital of Tianjin Medical University ( Site 6032)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022 6073 5857
Facility Name
The First Affiliated Hospital, Zhejiang University ( Site 6024)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613957120101
Facility Name
The First Hospital of Jiaxing ( Site 6033)
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13957391616
Facility Name
Ningbo First Hospital-Urology ( Site 6028)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0574-87085146
Facility Name
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13626582653
Facility Name
Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Clinica de la Costa S.A.S. ( Site 0502)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Administradora Country SA - Clinica del Country ( Site 0504)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Instituto Nacional de Cancerología E.S.E. ( Site 0503)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Oncólogos del Occidente S.A ( Site 0501)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Fundacion Cardiovascular de Colombia ( Site 0506)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
68017
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Klinicki Bolnicki Centar Zagreb ( Site 3200)
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Klinički Bolnički Centar Split ( Site 3202)
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
City
Zagreb
State/Province
Zagrebacka Zupanija
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Masarykuv onkologicky ustav ( Site 2203)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
City
Brno
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
City
Novy Jicin
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
741 01
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Ostrava ( Site 2208)
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Olomouc ( Site 2200)
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni Thomayerova nemocnice ( Site 2201)
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
2 LF UK a FN Motol ( Site 2207)
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Herlev Hospital ( Site 1700)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Odense University Hospital ( Site 1701)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
TAYS ( Site 1801)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Kuopion Yliopistollinen Sairaala ( Site 1803)
City
Kuopio
State/Province
Pohjois-Savo
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
HYKS ( Site 1800)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
TYKS ( Site 1802)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Institut Paoli Calmettes ( Site 1206)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Jean Minjoz ( Site 1205)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33370632403
Facility Name
Institut Claudius Regaud ( Site 1214)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Clinique Francois Chenieux ( Site 1209)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87039
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33555454800
Facility Name
CHU Angers ( Site 1200)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Clinique Ambroise Pare Beuvry ( Site 1213)
City
Beuvry
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
62660
Country
France
Individual Site Status
Completed
Facility Name
CH Lyon Sud Hospices Civils de Lyon ( Site 1203)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33478864324
Facility Name
Gustave Roussy ( Site 1207)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Tenon ( Site 1212)
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinik fuer Urologie ( Site 1300)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Helios Kliniken Schwerin GmbH ( Site 1302)
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19049
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Charite Universitaetsmedizin Berlin ( Site 1301)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Centro Medico Integral de Cancerologia CEMIC ( Site 0701)
City
Salcaja
State/Province
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Oncomedica ( Site 0700)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Grupo Angeles SA ( Site 0705)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Sanatorio Nuestra Senora del Pilar ( Site 0702)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Medi-K Cayala ( Site 0703)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Centro Regional de Sub Especialidades Medicas SA ( Site 0704)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Markusovszky Egyetemi Oktatokorhaz ( Site 2303)
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Orszagos Onkologiai Intezet ( Site 2304)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 2301)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Beaumont Hospital ( Site 6101)
City
Dublin
ZIP/Postal Code
D09 V2N0
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
Tallaght University Hospital ( Site 6100)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 1417)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli ( Site 1414)
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Policlinico di Bari ( Site 1411)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera S. Maria di Terni ( Site 1410)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fujita Health University ( Site 5003)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Completed
Facility Name
Chiba cancer center ( Site 5021)
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Completed
Facility Name
National Cancer Center Hospital East ( Site 5000)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Ehime University Hospital ( Site 5020)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Sapporo Medical University Hospital ( Site 5008)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hokkaido University Hospital ( Site 5013)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kanagawa cancer center ( Site 5016)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nara Medical University Hospital ( Site 5002)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka University Hospital ( Site 5012)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saitama Medical University International Medical Center ( Site 5015)
City
Hidaka-city
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hamamatsu University School of Medicine University Hospital ( Site 5004)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Toranomon Hospital ( Site 5001)
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Toyama University Hospital ( Site 5014)
City
Toyoma
State/Province
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kyushu University Hospital ( Site 5005)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kumamoto University ( Site 5022)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Niigata University Medical & Dental Hospital ( Site 5024)
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Completed
Facility Name
Okayama University Hospital ( Site 5017)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokushima University Hospital-Department of Urology ( Site 5019)
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nippon Medical School Hospital ( Site 5006)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Women's Medical University Adachi Medical Center ( Site 5023)
City
Tokyo
ZIP/Postal Code
123-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Keio university hospital ( Site 5011)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center ( Site 4202)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chungnam National University Hospital ( Site 4205)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Korea University Anam Hospital ( Site 4206)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital ( Site 4201)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital Yonsei University Health System ( Site 4204)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center ( Site 4203)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center ( Site 4200)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sultan Ismail ( Site 4303)
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Institut Kanser Negara - National Cancer Institute ( Site 4302)
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Hospital Kuala Lumpur ( Site 4301)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Universiti Malaya Medical Centre ( Site 4300)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
I CAN Oncology SA de SV ( Site 0601)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)
City
Santiago de Queretaro
State/Province
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Instituto Nacional de Cancerologia ( Site 0602)
City
Cdmx
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Centro de Investigacion Clinica de Oaxaca ( Site 0605)
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Akershus universitetssykehus ( Site 2000)
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
47 67 96 00 00
Facility Name
Soerlandet sykehus HF Kristiansand ( Site 2007)
City
Kristiansand
State/Province
Aust-Agder
ZIP/Postal Code
4615
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
Sykehuset Østfold HF Kalnes ( Site 2003)
City
Gralum
State/Province
Ostfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
St. Olavs Hospital HF ( Site 2005)
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
Oslo Universitetssykehus Radiumhospitalet ( Site 2001)
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
Manila Doctors Hospital ( Site 4601)
City
Manila
State/Province
National Capital Region
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Completed
Facility Name
The Medical City ( Site 4602)
City
Pasig City
State/Province
National Capital Region
ZIP/Postal Code
1605
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
Cardinal Santos Medical Center ( Site 4603)
City
San Juan
State/Province
National Capital Region
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Radomskie Centrum Onkologii ( Site 2418)
City
Radom
State/Province
Mazowieckie
ZIP/Postal Code
26-600
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Luxmed Onkologia sp. z o. o. ( Site 2412)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Przychodnia Lekarska KOMED ( Site 2419)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)
City
Alba Iulia
State/Province
Alba
ZIP/Postal Code
510007
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200746
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Policlinica Oncomed SRL ( Site 2506)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40256495403
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 2503)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Altay Regional Oncology Dispensary ( Site 2610)
City
Barnaul
State/Province
Altayskiy Kray
ZIP/Postal Code
656045
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Ivanovo Regional Oncology Dispensary ( Site 2615)
City
Ivanovo
State/Province
Ivanovskaya Oblast
ZIP/Postal Code
153040
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
The Loginov Moscow Clinical Scientific Center ( Site 2604)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Moscow Oncological Clinical Dispensary #1 ( Site 2619)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603074
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
City clinical oncological dispensary ( Site 2605)
City
Sankt-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Klinicki centar Srbije. ( Site 3333)
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
112106
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Klinicki centar Nis ( Site 3322)
City
Nis
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+381631049653
Facility Name
Institut za onkologiju Vojvodine ( Site 3311)
City
Sremska Kamenica
State/Province
Sremski Okrug
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Wits Clinical Research ( Site 3012)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Sandton Oncology Medical Group PTY LTD ( Site 3000)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Life Wilgers Hospital ( Site 3004)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0040
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Vaal Triangle Oncology Centre ( Site 3010)
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1939
Country
South Africa
Individual Site Status
Completed
Facility Name
Groote Schuur Hospital ( Site 3011)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Cape Town Oncology Trials Pty Ltd ( Site 3006)
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Cancercare Rondebosch Oncology ( Site 3005)
City
Rondebosch
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 1502)
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1501)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Institut Català d'Oncologia (ICO) - Girona ( Site 1500)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico San Carlos ( Site 1503)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario 12 de Octubre ( Site 1505)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 1504)
City
Malaga
ZIP/Postal Code
29016
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Lanssjukhuset Ryhov ( Site 2103)
City
Jonkoping
State/Province
Jonkopings Lan
ZIP/Postal Code
551 85
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 2100)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Akademiska Sjukhuset ( Site 2105)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Norrlands Universitetssjukhus ( Site 2106)
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Completed
Facility Name
Sahlgrenska Universitetssjukhuset ( Site 2102)
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taichung Veterans General Hospital ( Site 4403)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Cheng Kung University Hospital ( Site 4404)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Taiwan University Hospital ( Site 4401)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taipei Veterans General Hospital ( Site 4402)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Ramathibodi Hospital. ( Site 4500)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Siriraj Hospital ( Site 4501)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Ankara Universitesi Tip Fakultesi ( Site 2902)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Hacettepe Universitesi Tıp Fakultesi ( Site 2903)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 2704)
City
Cherkasy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Chernihiv Medical Center of Modern Oncology ( Site 2709)
City
Chernihiv
State/Province
Chernihivska Oblast
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Completed
Facility Name
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 2710)
City
Dnipropetrovsk
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Clinical oncology dispensary of Dnipro ( Site 2700)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76008
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Regional Oncology Center of Kharkiv ( Site 2708)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61037
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Clinical Oncology Center ( Site 2706)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Lviv State Regional Oncological Center ( Site 2712)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Addenbrookes Hospital ( Site 3110)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Mount Vernon Cancer Centre ( Site 3101)
City
Northwood
State/Province
London, City Of
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Active, not recruiting
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
Links:
URL
https://merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=6482-012&&kw=6482-012
Description
Plain Language Summary
Learn more about this trial
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
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