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)

March 11, 2024 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1653

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital ( Site 4006)
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University ( Site 4007)
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital ( Site 4004)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health ( Site 4008)
    • Western Australia
      • Murdock, Western Australia, Australia, 6150
        • Fiona Stanley Hospital ( Site 4009)
  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
      • Sao Paulo, Brazil, 01321-001
        • BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
      • Sao Paulo, Brazil, 01525-001
        • A.C. Camargo Cancer Center ( Site 0301)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135-237
        • Oncocentro Ceara ( Site 0309)
    • Espirito Santo
      • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308-014
        • Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Cancer ( Site 0308)
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre ( Site 0310)
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
    • Alberta
      • Calgary, Alberta, Canada, T4N 4N2
        • Tom Baker Cancer Centre ( Site 0119)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver Center ( Site 0120)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0116)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Centro Investigacion Cancer James Lind ( Site 0402)
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • IC La Serena Research ( Site 0403)
    • Lbtdr Gen Bernardo O Higgins
      • Rancagua, Lbtdr Gen Bernardo O Higgins, Chile, 2852424
        • Servicios Medicos Urumed ( Site 0405)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez ( Site 0400)
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0401)
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital ( Site 6011)
      • Beijing, Beijing, China, 100142
        • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing University Cancer Hospital ( Site 6009)
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated hospital of Xiamen University-Urology ( Site 6001)
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital ( Site 6007)
      • Guangzhou, Guangdong, China, 510289
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital-urology ( Site 6015)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital-Urology ( Site 6006)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital ( Site 6002)
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital Central South University ( Site 6034)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 6020)
    • Jiangsu
      • NanJing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 6019)
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Cancer Hospital ( Site 6042)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital ( Site 6023)
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • West China Hospital Sichuan University-Urology Surgery ( Site 6016)
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital ( Site 6029)
      • Tianjin, Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University ( Site 6032)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University ( Site 6024)
      • Jiaxing, Zhejiang, China, 314001
        • The First Hospital of Jiaxing ( Site 6033)
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital-Urology ( Site 6028)
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050024
        • Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 0502)
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • Administradora Country SA - Clinica del Country ( Site 0504)
      • Bogotá, Distrito Capital De Bogota, Colombia, 110411
        • Instituto Nacional de Cancerología E.S.E. ( Site 0503)
    • Risaralda
      • Pereira, Risaralda, Colombia, 660001
        • Oncólogos del Occidente S.A ( Site 0501)
    • Santander
      • Piedecuesta, Santander, Colombia, 68017
        • Fundacion Cardiovascular de Colombia ( Site 0506)
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki Bolnicki Centar Zagreb ( Site 3200)
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinički Bolnički Centar Split ( Site 3202)
    • Zagrebacka Zupanija
      • Zagreb, Zagrebacka Zupanija, Croatia, 10000
        • Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
  • Czechia
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc ( Site 2200)
      • Praha 4, Czechia, 140 59
        • Fakultni Thomayerova nemocnice ( Site 2201)
      • Praha 5, Czechia, 150 06
        • 2 LF UK a FN Motol ( Site 2207)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Masarykuv onkologicky ustav ( Site 2203)
    • Jihomoravsky Kraj
      • Brno, Jihomoravsky Kraj, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
    • Moravskoslezsky Kraj
      • Novy Jicin, Moravskoslezsky Kraj, Czechia, 741 01
        • Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • Fakultni nemocnice Ostrava ( Site 2208)
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital ( Site 1700)
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Odense University Hospital ( Site 1701)
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • TAYS ( Site 1801)
    • Pohjois-Savo
      • Kuopio, Pohjois-Savo, Finland, 70210
        • Kuopion Yliopistollinen Sairaala ( Site 1803)
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • HYKS ( Site 1800)
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • TYKS ( Site 1802)
  • France
      • Paris, France, 75020
        • Hopital Tenon ( Site 1212)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Institut Paoli Calmettes ( Site 1206)
    • Doubs
      • Besancon, Doubs, France, 25000
        • CHU Jean Minjoz ( Site 1205)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Institut Claudius Regaud ( Site 1214)
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87039
        • Clinique Francois Chenieux ( Site 1209)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • CHU Angers ( Site 1200)
    • Nord-Pas-de-Calais
      • Beuvry, Nord-Pas-de-Calais, France, 62660
        • Clinique Ambroise Pare Beuvry ( Site 1213)
    • Rhone
      • Pierre Benite, Rhone, France, 69310
        • CH Lyon Sud Hospices Civils de Lyon ( Site 1203)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Gustave Roussy ( Site 1207)
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin ( Site 1301)
    • Baden-Wurttemberg
      • Tuebingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinik fuer Urologie ( Site 1300)
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19049
        • Helios Kliniken Schwerin GmbH ( Site 1302)
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Oncomedica ( Site 0700)
      • Guatemala, Guatemala, 01015
        • Grupo Angeles SA ( Site 0705)
      • Guatemala, Guatemala, 01015
        • Sanatorio Nuestra Senora del Pilar ( Site 0702)
      • Guatemala, Guatemala, 01016
        • Medi-K Cayala ( Site 0703)
      • Quetzaltenango, Guatemala, 09001
        • Centro Regional de Sub Especialidades Medicas SA ( Site 0704)
    • Quetzaltenango
      • Salcaja, Quetzaltenango, Guatemala, 09002
        • Centro Medico Integral de Cancerologia CEMIC ( Site 0701)
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ( Site 2304)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 2301)
    • Bacs-Kiskun
      • Kecskemét, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)
    • Bekes
      • Gyula, Bekes, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz ( Site 2303)
  • Ireland
      • Dublin, Ireland, D09 V2N0
        • Beaumont Hospital ( Site 6101)
      • Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital ( Site 6100)
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliera Policlinico di Bari ( Site 1411)
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)
      • Terni, Italy, 05100
        • Azienda Ospedaliera S. Maria di Terni ( Site 1410)
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele-Oncologia Medica ( Site 1417)
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli ( Site 1414)
  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital ( Site 5005)
      • Kumamoto, Japan, 860-8556
        • Kumamoto University ( Site 5022)
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital ( Site 5024)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 5017)
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital-Department of Urology ( Site 5019)
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital ( Site 5006)
      • Tokyo, Japan, 160-8582
        • Keio university hospital ( Site 5011)
      • Tokyo, Japan, 123-8558
        • Tokyo Women's Medical University Adachi Medical Center ( Site 5023)
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Fujita Health University ( Site 5003)
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Chiba cancer center ( Site 5021)
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 5000)
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 5020)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital ( Site 5008)
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 5013)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa cancer center ( Site 5016)
    • Nara
      • Kashihara, Nara, Japan, 634-0813
        • Nara Medical University Hospital ( Site 5002)
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital ( Site 5012)
    • Saitama
      • Hidaka-city, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center ( Site 5015)
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine University Hospital ( Site 5004)
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital ( Site 5001)
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Toyama University Hospital ( Site 5014)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital ( Site 4206)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 4201)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 4204)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 4203)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 4200)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 4202)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, Korea, Republic of, 35015
        • Chungnam National University Hospital ( Site 4205)
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur ( Site 4301)
      • Kuala Lumpur, Malaysia, 59100
        • Universiti Malaya Medical Centre ( Site 4300)
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Hospital Sultan Ismail ( Site 4303)
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
        • Institut Kanser Negara - National Cancer Institute ( Site 4302)
  • Mexico
      • Cdmx, Mexico, 14080
        • Instituto Nacional de Cancerologia ( Site 0602)
      • Oaxaca, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca ( Site 0605)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • I CAN Oncology SA de SV ( Site 0601)
    • Queretaro
      • Santiago de Queretaro, Queretaro, Mexico, 76000
        • Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)
  • Norway
      • Oslo, Norway, 0379
        • Oslo Universitetssykehus Radiumhospitalet ( Site 2001)
    • Akershus
      • Lorenskog, Akershus, Norway, 1478
        • Akershus universitetssykehus ( Site 2000)
    • Aust-Agder
      • Kristiansand, Aust-Agder, Norway, 4615
        • Soerlandet sykehus HF Kristiansand ( Site 2007)
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)
    • Ostfold
      • Gralum, Ostfold, Norway, 1714
        • Sykehuset Østfold HF Kalnes ( Site 2003)
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7030
        • St. Olavs Hospital HF ( Site 2005)
  • Philippines
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • Manila Doctors Hospital ( Site 4601)
      • Pasig City, National Capital Region, Philippines, 1605
        • The Medical City ( Site 4602)
      • San Juan, National Capital Region, Philippines, 1502
        • Cardinal Santos Medical Center ( Site 4603)
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)
    • Mazowieckie
      • Radom, Mazowieckie, Poland, 26-600
        • Radomskie Centrum Onkologii ( Site 2418)
      • Warszawa, Mazowieckie, Poland, 01-748
        • Luxmed Onkologia sp. z o. o. ( Site 2412)
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)
    • Wielkopolskie
      • Konin, Wielkopolskie, Poland, 62-500
        • Przychodnia Lekarska KOMED ( Site 2419)
      • Poznan, Wielkopolskie, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)
    • Zachodniopomorskie
      • Koszalin, Zachodniopomorskie, Poland, 75-581
        • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)
  • Romania
      • Bucuresti, Romania, 022548
        • S.C.Focus Lab Plus S.R.L ( Site 2503)
    • Alba
      • Alba Iulia, Alba, Romania, 510007
        • Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)
    • Timis
      • Timisoara, Timis, Romania, 300239
        • Policlinica Oncomed SRL ( Site 2506)
  • Russian Federation
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russian Federation, 656045
        • Altay Regional Oncology Dispensary ( Site 2610)
    • Ivanovskaya Oblast
      • Ivanovo, Ivanovskaya Oblast, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary ( Site 2615)
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
        • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)
    • Moskva
      • Moscow, Moskva, Russian Federation, 111123
        • The Loginov Moscow Clinical Scientific Center ( Site 2604)
      • Moscow, Moskva, Russian Federation, 129090
        • Moscow Oncological Clinical Dispensary #1 ( Site 2619)
    • Nizhegorodskaya Oblast
      • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603081
        • Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)
      • Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603074
        • FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)
      • Sankt-Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • City clinical oncological dispensary ( Site 2605)
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 112106
        • Klinicki centar Srbije. ( Site 3333)
    • Nisavski Okrug
      • Nis, Nisavski Okrug, Serbia, 18000
        • Klinicki centar Nis ( Site 3322)
    • Sremski Okrug
      • Sremska Kamenica, Sremski Okrug, Serbia, 21204
        • Institut za onkologiju Vojvodine ( Site 3311)
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 3012)
      • Johannesburg, Gauteng, South Africa, 2196
        • Sandton Oncology Medical Group PTY LTD ( Site 3000)
      • Pretoria, Gauteng, South Africa, 0002
        • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)
      • Pretoria, Gauteng, South Africa, 0040
        • Life Wilgers Hospital ( Site 3004)
      • Pretoria, Gauteng, South Africa, 0181
        • Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)
      • Vereeniging, Gauteng, South Africa, 1939
        • Vaal Triangle Oncology Centre ( Site 3010)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital ( Site 3011)
      • Kraaifontein, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials Pty Ltd ( Site 3006)
      • Rondebosch, Western Cape, South Africa, 7700
        • Cancercare Rondebosch Oncology ( Site 3005)
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos ( Site 1503)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 1505)
      • Malaga, Spain, 29016
        • Hospital Universitario Virgen de la Victoria ( Site 1504)
    • Barcelona
      • L Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Instituto Catalan de Oncologia - ICO ( Site 1502)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla ( Site 1501)
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Institut Català d'Oncologia (ICO) - Girona ( Site 1500)
  • Sweden
    • Jonkopings Lan
      • Jonkoping, Jonkopings Lan, Sweden, 551 85
        • Lanssjukhuset Ryhov ( Site 2103)
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna ( Site 2100)
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Akademiska Sjukhuset ( Site 2105)
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 901 85
        • Norrlands Universitetssjukhus ( Site 2106)
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset ( Site 2102)
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital ( Site 4403)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 4404)
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital ( Site 4401)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 4402)
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)
  • Thailand
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
        • Ramathibodi Hospital. ( Site 4500)
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Siriraj Hospital ( Site 4501)
  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Universitesi Tip Fakultesi ( Site 2902)
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tıp Fakultesi ( Site 2903)
      • Edirne, Turkey, 22030
        • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)
      • Istanbul, Turkey, 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)
      • Izmir, Turkey, 35040
        • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)
      • Izmir, Turkey, 35340
        • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)
  • Ukraine
    • Cherkaska Oblast
      • Cherkasy, Cherkaska Oblast, Ukraine, 18009
        • Cherkasy Regional Oncology Dispensary ( Site 2704)
    • Chernihivska Oblast
      • Chernihiv, Chernihivska Oblast, Ukraine, 14029
        • Chernihiv Medical Center of Modern Oncology ( Site 2709)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
        • Clinical oncology dispensary of Dnipro ( Site 2700)
      • Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine, 49005
        • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2710)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
        • Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61000
        • Regional Oncology Center of Kharkiv ( Site 2708)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61037
        • Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03115
        • Kyiv City Clinical Oncology Center ( Site 2706)
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79031
        • Lviv State Regional Oncological Center ( Site 2712)
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital ( Site 3110)
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
    • London, City Of
      • Northwood, London, City Of, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre ( Site 3101)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • The University of Alabama at Birmingham ( Site 0010)
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego ( Site 0050)
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center ( Site 0027)
      • Orange, California, United States, 92868
        • University of California Irvine ( Site 0029)
      • Santa Monica, California, United States, 90404
        • UCLA Hematology Oncology Santa Monica ( Site 0048)
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital ( Site 0024)
    • Florida
      • Orlando, Florida, United States, 32804
        • Advent Health Hematology & Oncology ( Site 0003)
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC ( Site 0057)
      • Atlanta, Georgia, United States, 30322
        • Emory University Winship Cancer Institute ( Site 0012)
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Rush University Medical Center ( Site 0040)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Cancer Institute ( Site 0088)
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute - St. Matthews ( Site 0065)
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center ( Site 0049)
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists ( Site 0082)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 0094)
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center ( Site 0089)
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute ( Site 0093)
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center ( Site 0090)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital ( Site 0038)
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan ( Site 0018)
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital ( Site 0095)
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center ( Site 0037)
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center ( Site 0075)
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Cancer Institute ( Site 0032)
      • Lake Success, New York, United States, 11042
        • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
      • New York, New York, United States, 10065
        • Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University ( Site 0071)
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Center ( Site 0073)
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center Knoxville ( Site 0019)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center ( Site 0069)
    • Texas
      • Dallas, Texas, United States, 75390
        • UTSW Medical Center ( Site 0015)
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Belzutifan + Lenvatinib
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.
Biological: Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Belzutifan
Belzutifan 120 mg administered QD via oral tablet
Other Names:
  • MK-6482
  • PT2977
  • WELIREG™
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Experimental: Pembrolizumab/Quavonlimab + Lenvatinib
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.
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Biological: Pembrolizumab/Quavonlimab
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Other Names:
  • MK-1308A
Active Comparator: Pembrolizumab + Lenvatinib
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.
Biological: Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
Overall Survival (OS)
Time Frame: Up to approximately 66 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 66 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Time Frame: Up to approximately 66 months
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.
Up to approximately 66 months
Number of Participants Who Experienced At least One Adverse Event (AE)
Time Frame: Up to approximately 66 months
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.
Up to approximately 66 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 66 months
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.
Up to approximately 66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Estimated)

October 29, 2026

Study Completion (Estimated)

October 29, 2026

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6482-012
  • MK-6482-012 (Other Identifier: Merck)
  • jRCT2031210435 (Registry Identifier: jRCT(Japan Registry of Clinical Trials))
  • PHRR210911-003887 (Registry Identifier: Philippine Health Research Registry (PHRR))
  • 2020-002216-52 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Renal Cell

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe