AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT04736706

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)

A Phase 3 study testing Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 262 sites in 35 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,688 participants
Where
262 sitesin 35 countries
Study dates
14 Apr 2021to 22 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

262 sites in 35 countries.

262 sites in 35 countries

United States33 sites

  • University Cancer & Blood Center, LLC ( Site 0057)

    Athens, Georgia, 30607

  • Emory University Winship Cancer Institute ( Site 0012)

    Atlanta, Georgia, 30322

  • The University of Alabama at Birmingham ( Site 0010)

    Birmingham, Alabama, 35294-3300

  • Massachusetts General Hospital ( Site 0094)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center ( Site 0089)

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute ( Site 0093)

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute ( Site 0032)

    Buffalo, New York, 14263

  • Lahey Hospital & Medical Center ( Site 0090)

    Burlington, Massachusetts, 01805

  • Ralph H. Johnson VA Center ( Site 0073)

    Charleston, South Carolina, 29401

  • Rush University Medical Center ( Site 0040)

    Chicago, Illinois, 60607

  • UTSW Medical Center ( Site 0015)

    Dallas, Texas, 75390

  • Henry Ford Hospital ( Site 0038)

    Detroit, Michigan, 48202

  • Parkview Cancer Institute ( Site 0088)

    Fort Wayne, Indiana, 46845

  • Cancer & Hematology Centers of Western Michigan ( Site 0018)

    Grand Rapids, Michigan, 49503

  • Hartford Hospital ( Site 0024)

    Hartford, Connecticut, 06102

  • University of Mississippi Medical Center ( Site 0037)

    Jackson, Mississippi, 39216

  • University of Tennessee Medical Center Knoxville ( Site 0019)

    Knoxville, Tennessee, 37920

  • UC San Diego ( Site 0050)

    La Jolla, California, 92037

  • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Medical Center ( Site 0075)

    Lebanon, New Hampshire, 03756

  • Cedars Sinai Medical Center ( Site 0027)

    Los Angeles, California, 90048

  • Norton Cancer Institute - St. Matthews ( Site 0065)

    Louisville, Kentucky, 40207

  • Vanderbilt University Medical Center ( Site 0069)

    Nashville, Tennessee, 37232

  • Ochsner Medical Center ( Site 0049)

    New Orleans, Louisiana, 70121

  • Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)

    New York, New York, 10065

  • University of California Irvine ( Site 0029)

    Orange, California, 92868

  • Advent Health Hematology & Oncology ( Site 0003)

    Orlando, Florida, 32804

  • Oregon Health & Science University ( Site 0071)

    Portland, Oregon, 97239

  • HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

    Saint Louis Park, Minnesota, 55426

  • Regions Hospital ( Site 0095)

    Saint Paul, Minnesota, 55101

  • UCLA Hematology Oncology Santa Monica ( Site 0048)

    Santa Monica, California, 90404

  • New England Cancer Specialists ( Site 0082)

    Scarborough, Maine, 04074

  • Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)

    Wenatchee, Washington, 98801

Other trials in United States

China30 sites

  • Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)

    Beijing, Beijing Municipality, 100021

  • Peking University First Hospital ( Site 6011)

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)

    Beijing, Beijing Municipality, 100142

  • The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)

    Bengbu, Anhui, 233004

  • Xiangya Hospital Central South University ( Site 6034)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 6020)

    Changsha, Hunan, 410013

  • West China Hospital Sichuan University-Urology Surgery ( Site 6016)

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital ( Site 6009)

    Chongging, Chongqing Municipality, 400030

  • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)

    Fuzhou, Fujian, 350005

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 6036)

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital ( Site 6007)

    Guangzhou, Guangdong, 510180

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)

    Guangzhou, Guangdong, 510289

  • The First Affiliated Hospital Zhejiang University School of Medicine ( Site 6024)

    Hangzhou, Zhejiang, 310003

  • Harbin Medical University Cancer Hospital-urology ( Site 6015)

    Harbin, Heilongjiang, 150000

  • The First Hospital of Jiaxing ( Site 6033)

    Jiaxing, Zhejiang, 314001

  • Jiangxi Provincial Cancer Hospital ( Site 6042)

    Nanchang, Jiangxi, 330029

  • The First Affiliated Hospital of Nanchang University ( Site 6019)

    Nanchang, Jiangxi, 330052

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 6022)

    Nanjing, Jiangsu, 210008

  • Ningbo First Hospital-Urology ( Site 6028)

    Ningbo, Zhejiang, 315010

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)

    Shanghai, Shanghai Municipality, 200001

  • Shanghai Tenth People's Hospital ( Site 6023)

    Shanghai, Shanghai Municipality, 200072

  • The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)

    Suzhou, Jiangsu, 215004

  • Tianjin Medical University Cancer Institute and Hospital ( Site 6029)

    Tianjin, Tianjin Municipality, 300060

  • The Second Hospital of Tianjin Medical University ( Site 6032)

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 6002)

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University ( Site 6001)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital-Urology ( Site 6006)

    Zhengzhou, Henan, 450008

Other trials in China

Japan23 sites

  • Tokyo Women's Medical University Adachi Medical Center ( Site 5023)

    Adachi City, Tokyo, 123-8558

  • Nippon Medical School Hospital ( Site 5006)

    Bunkyo, Tokyo, 113-8603

  • Institute of Science Tokyo Hospital ( Site 5009)

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba Cancer Center ( Site 5021)

    Chiba, 260-8717

  • Kyushu University Hospital ( Site 5005)

    Fukuoka, 812-8582

  • Hamamatsu University Hospital ( Site 5004)

    Hamamatsu, Shizuoka, 431-3192

  • Saitama Medical University International Medical Center ( Site 5015)

    Hidaka, Saitama, 350-1298

  • Nara Medical University Hospital ( Site 5002)

    Kashihara, Nara, 634-0813

  • National Cancer Center Hospital East ( Site 5000)

    Kashiwa, Chiba, 277-8577

  • Kumamoto University Hospital ( Site 5022)

    Kumamoto, 860-8556

  • Toranomon Hospital ( Site 5001)

    Minato-ku, Tokyo, 105-8470

  • Niigata University Medical & Dental Hospital ( Site 5024)

    Niigata, 951-8520

  • Okayama University Hospital ( Site 5017)

    Okayama, 700-8558

  • Sapporo Medical University Hospital ( Site 5008)

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital ( Site 5013)

    Sapporo, Hokkaido, 060-8648

  • Kindai University Hospital ( Site 5010)

    Sayama, Osaka, 589-8511

  • The University of Osaka Hospital ( Site 5012)

    Suita, Osaka, 565-0871

  • Tokushima University Hospital ( Site 5019)

    Tokushima, 770-8503

  • Keio University Hospital ( Site 5011)

    Tokyo, 160-8582

  • Ehime University Hospital ( Site 5020)

    Tōon, Ehime, 791-0295

  • Toyama University Hospital ( Site 5014)

    Toyama, 930-0194

  • Fujita Health University Hospital ( Site 5003)

    Toyoake, Aichi-ken, 470-1192

  • Kanagawa Cancer Center ( Site 5016)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Africa10 sites

  • Cancercare Rondebosch Oncology ( Site 3005)

    Cape Town, Western Cape, 7700

  • Groote Schuur Hospital ( Site 3011)

    Cape Town, Western Cape, 7925

  • Wits Clinical Research ( Site 3012)

    Johannesburg, Gauteng, 2193

  • Sandton Oncology Medical Group PTY LTD ( Site 3000)

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials Pty Ltd ( Site 3006)

    Kraaifontein, Western Cape, 7570

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)

    Port Elizabeth, Eastern Cape, 6045

  • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)

    Pretoria, Gauteng, 0002

  • Life Wilgers Hospital ( Site 3004)

    Pretoria, Gauteng, 0040

  • Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)

    Pretoria, Gauteng, 0181

  • Vaal Triangle Oncology Centre ( Site 3010)

    Vereeniging, Gauteng, 1939

Other trials in South Africa

Ukraine10 sites

  • Cherkasy Regional Oncology Dispensary ( Site 2704)

    Cherkasy, Cherkasy Oblast, 18009

  • Chernihiv Medical Center of Modern Oncology ( Site 2709)

    Chernihiv, Chernihiv Oblast, 14029

  • Clinical oncology dispensary of Dnipro ( Site 2700)

    Dnipro, Dnipropetrovsk Oblast, 49055

  • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2710)

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49005

  • Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Regional Oncology Center of Kharkiv ( Site 2708)

    Kharkiv, Kharkiv Oblast, 61000

  • Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)

    Kharkiv, Kharkiv Oblast, 61037

  • Kyiv City Clinical Oncology Center ( Site 2706)

    Kyiv, Kyivska Oblast, 03115

  • Lviv State Regional Oncological Center ( Site 2712)

    Lviv, Lviv Oblast, 79031

Other trials in Ukraine

France9 sites

  • CHU Angers ( Site 1200)

    Angers, Maine-et-Loire, 49933

  • CHU Jean Minjoz ( Site 1205)

    Besançon, Doubs, 25000

  • Clinique Ambroise Pare Beuvry ( Site 1213)

    Beuvry, Hauts-de-France, 62660

  • Clinique Francois Chenieux ( Site 1209)

    Limoges, Haute-Vienne, 87039

  • Institut Paoli Calmettes ( Site 1206)

    Marseille, Bouches-du-Rhone, 13272

  • Hopital Tenon ( Site 1212)

    Paris, 75020

  • CH Lyon Sud Hospices Civils de Lyon ( Site 1203)

    Pierre-Bénite, Rhone, 69310

  • Institut Claudius Regaud ( Site 1214)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 1207)

    Villejuif, Île-de-France Region, 94800

Other trials in France

Russia9 sites

  • Altay Regional Oncology Dispensary ( Site 2610)

    Barnaul, Altayskiy Kray, 656045

  • Ivanovo Regional Oncology Dispensary ( Site 2615)

    Ivanovo, Ivanovo Oblast, 153040

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • The Loginov Moscow Clinical Scientific Center ( Site 2604)

    Moscow, Moscow, 111123

  • City Clinical Hospital n.a. S.S.Yudin ( Site 2619)

    Moscow, Moscow, 115446

  • FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603074

  • Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)

    Saint Petersburg, Sankt-Peterburg, 197758

  • City clinical oncological dispensary ( Site 2605)

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

Brazil8 sites

  • Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)

    Belo Horizonte, Minas Gerais, 30130090

  • Centro de Pesquisas Clinicas em Oncologia ( Site 0306)

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Oncocentro Ceara ( Site 0309)

    Fortaleza, Ceará, 60135-237

  • Liga Norte Riograndense Contra o Cancer ( Site 0308)

    Natal, Rio Grande do Norte, 59075-740

  • Hospital de Clinicas de Porto Alegre ( Site 0310)

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)

    São Paulo, 01246-000

  • BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)

    São Paulo, 01321-001

  • A.C. Camargo Cancer Center ( Site 0301)

    São Paulo, 01525-001

Other trials in Brazil

Colombia7 sites

  • Clinica de la Costa S.A.S. ( Site 0502)

    Barranquilla, Atlántico, 080020

  • Instituto Nacional de Cancerología E.S.E. ( Site 0503)

    Bogota, Cundinamarca, 111511

  • Administradora Country SA - Clinica del Country ( Site 0504)

    Bogotá, Bogota D.C., 110221

  • Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)

    Medellín, Antioquia, 050024

  • Oncólogos del Occidente S.A ( Site 0501)

    Pereira, Risaralda Department, 660001

  • Fundacion Cardiovascular de Colombia ( Site 0506)

    Piedecuesta, Santander Department, 68017

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Czechia7 sites

  • Masarykuv onkologicky ustav ( Site 2203)

    Brno, Brno-mesto, 656 53

  • Fakultni nemocnice u sv. Anny v Brne ( Site 2205)

    Brno, South Moravian, 656 91

  • Nemocnice AGEL Novy Jicin a.s. ( Site 2202)

    Nový Jičín, Moravian-Silesian Region, 741 01

  • Fakultni nemocnice Olomouc ( Site 2200)

    Olomouc, 77900

  • Fakultni nemocnice Ostrava ( Site 2208)

    Ostrava, Moravian-Silesian Region, 708 52

  • Fakultni Thomayerova nemocnice ( Site 2201)

    Prague, 140 59

  • 2 LF UK a FN Motol ( Site 2207)

    Prague, 150 06

Other trials in Czechia

Italy7 sites

  • Azienda Ospedaliera Policlinico di Bari ( Site 1411)

    Bari, 70124

  • Ospedale San Raffaele-Oncologia Medica ( Site 1417)

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)

    Milan, 20133

  • Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)

    Modena, Emilia-Romagna, 41125

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)

    Naples, 80131

  • Fondazione Policlinico Universitario A. Gemelli ( Site 1414)

    Rome, Roma, 00168

  • Azienda Ospedaliera S. Maria di Terni ( Site 1410)

    Terni, 05100

Other trials in Italy

Poland7 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Przychodnia Lekarska KOMED ( Site 2419)

    Konin, Greater Poland Voivodeship, 62-500

  • Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 2407)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)

    Poznan, Greater Poland Voivodeship, 60-569

  • Radomskie Centrum Onkologii ( Site 2418)

    Radom, Masovian Voivodeship, 26-600

  • Luxmed Onkologia sp. z o. o. ( Site 2412)

    Warsaw, Masovian Voivodeship, 01-748

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

South Korea7 sites

  • Chungnam National University Hospital ( Site 4205)

    Daejeon, Taejon-Kwangyokshi, 35015

  • National Cancer Center ( Site 4202)

    Goyang-si, Kyonggi-do, 10408

  • Korea University Anam Hospital ( Site 4206)

    Seoul, 02841

  • Seoul National University Hospital ( Site 4201)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 4204)

    Seoul, 03722

  • Asan Medical Center ( Site 4203)

    Seoul, 05505

  • Samsung Medical Center ( Site 4200)

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Ankara Universitesi Tip Fakultesi ( Site 2902)

    Ankara, 06100

  • Hacettepe Universitesi Tıp Fakultesi ( Site 2903)

    Ankara, 06100

  • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)

    Edirne, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)

    Istanbul, 34098

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)

    Izmir, 35040

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)

    Izmir, 35340

Other trials in Turkey (Türkiye)

Guatemala6 sites

  • MEDI-K ( Site 0703)

    Guatemala City, 01009

  • Oncomedica ( Site 0700)

    Guatemala City, 01010

  • Grupo Angeles SA ( Site 0705)

    Guatemala City, 01015

  • Sanatorio Nuestra Senora del Pilar ( Site 0702)

    Guatemala City, 01015

  • Centro Regional de Sub Especialidades Medicas SA ( Site 0704)

    Quetzaltenango, 09001

  • Centro Medico Integral de Cancerologia CEMIC ( Site 0701)

    Salcajá, Departamento de Quetzaltenango, 09002

Other trials in Guatemala

Hungary6 sites

  • Orszagos Onkologiai Intezet ( Site 2304)

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont ( Site 2301)

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)

    Gyula, Bekes County, 5700

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)

    Kecskemét, Bács-Kiskun county, 6000

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Markusovszky Egyetemi Oktatokorhaz ( Site 2303)

    Szombathely, Vas County, 9700

Other trials in Hungary

Norway6 sites

  • Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)

    Bergen, Hordaland, 5021

  • Sykehuset Østfold HF Kalnes ( Site 2003)

    Grålum, Østfold fylke, 1714

  • Soerlandet sykehus HF Kristiansand ( Site 2007)

    Kristiansand, Aust-Agder, 4615

  • Akershus universitetssykehus ( Site 2000)

    Lorenskog, Akershus, 1478

  • Oslo Universitetssykehus Radiumhospitalet ( Site 2001)

    Oslo, 0379

  • St. Olavs Hospital HF ( Site 2005)

    Trondheim, Sor-Trondelag, 7030

Other trials in Norway

Spain6 sites

  • Instituto Catalan de Oncologia - ICO ( Site 1502)

    Barcelona, Catalonia, 08908

  • Institut Català d'Oncologia (ICO) - Girona ( Site 1500)

    Girona, Gerona, 17007

  • Hospital Clinico San Carlos ( Site 1503)

    Madrid, 28040

  • Hospital Universitario 12 de Octubre ( Site 1505)

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria ( Site 1504)

    Málaga, 29016

  • Hospital Universitario Marques de Valdecilla ( Site 1501)

    Santander, Cantabria, 39008

Other trials in Spain

Taiwan6 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)

    Kaohsiung City, 833

  • Taichung Veterans General Hospital ( Site 4403)

    Taichung, 40705

  • National Cheng Kung University Hospital ( Site 4404)

    Tainan, 704

  • National Taiwan University Hospital ( Site 4401)

    Taipei, 100

  • Taipei Veterans General Hospital ( Site 4402)

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)

    Taoyuan, 333

Other trials in Taiwan

Australia5 sites

  • Monash Health ( Site 4008)

    Clayton, Victoria, 3168

  • Lyell McEwin Hospital ( Site 4004)

    Elizabeth Vale, South Australia, 5112

  • Liverpool Hospital ( Site 4006)

    Liverpool, New South Wales, 2170

  • Macquarie University ( Site 4007)

    Macquarie University, New South Wales, 2109

  • Fiona Stanley Hospital ( Site 4009)

    Murdock, Western Australia, 6150

Other trials in Australia

Canada5 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0119)

    Calgary, Alberta, T2N 5G2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)

    Hamilton, Ontario, L8V 5C2

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0112)

    Québec, Quebec, G1J 1Z4

  • Sunnybrook Research Institute ( Site 0116)

    Toronto, Ontario, M4N 3M5

  • BC Cancer - Vancouver Center ( Site 0120)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Chile5 sites

  • IC La Serena Research ( Site 0403)

    La Serena, Coquimbo Region, 1720430

  • Servicios Medicos Urumed ( Site 0405)

    Rancagua, Lbtdr Gen Bernardo O Higgins, 2852424

  • Fundacion Arturo Lopez Perez ( Site 0400)

    Santiago, Region M. de Santiago, 7500921

  • Bradfordhill-Clinical Area ( Site 0401)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigacion Cancer James Lind ( Site 0402)

    Temuco, Araucania, 4800827

Other trials in Chile

Mexico5 sites

  • Antiguo hospital civil de Guadalajara Fray Antonio Alcalde ( Site 0610)

    Guadalajara, Jalisco, 44280

  • Instituto Nacional de Cancerologia ( Site 0602)

    Mexico City, Mexico City, 14080

  • I CAN Oncology SA de SV ( Site 0601)

    Monterrey, Nuevo León, 64710

  • Centro de Investigacion Clinica de Oaxaca ( Site 0605)

    Oaxaca City, 68020

  • Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)

    Querétaro City, Querétaro, 76000

Other trials in Mexico

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset ( Site 2102)

    Gothenburg, Västra Götaland County, 413 45

  • Lanssjukhuset Ryhov ( Site 2103)

    Jönköping, Jönköping County, 551 85

  • Karolinska Universitetssjukhuset Solna ( Site 2100)

    Stockholm, Stockholm County, 171 76

  • Norrlands Universitetssjukhus ( Site 2106)

    Umeå, Västerbotten County, 901 85

  • Akademiska Sjukhuset ( Site 2105)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Finland4 sites

  • HYKS ( Site 1800)

    Helsinki, Uusimaa, 00290

  • Kuopion Yliopistollinen Sairaala ( Site 1803)

    Kuopio, Northern Savonia, 70210

  • TAYS ( Site 1801)

    Tampere, Pirkanmaa, 33520

  • TYKS ( Site 1802)

    Turku, Southwest Finland, 20520

Other trials in Finland

Malaysia4 sites

  • Hospital Sultan Ismail ( Site 4303)

    Johor Bahru, Johor, 81100

  • Hospital Kuala Lumpur ( Site 4301)

    Kuala Lumpur, 50586

  • Universiti Malaya Medical Centre ( Site 4300)

    Kuala Lumpur, 59100

  • Institut Kanser Negara - National Cancer Institute ( Site 4302)

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Romania4 sites

  • Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)

    Alba Iulia, Alba, 510007

  • Memorial Healthcare International ( Site 2503)

    Bucharest, Bucharest, 013823

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)

    Craiova, Dolj, 200746

  • Policlinica Oncomed SRL ( Site 2506)

    Timișoara, Timiș County, 300239

Other trials in Romania

Croatia3 sites

  • Klinički Bolnički Centar Split ( Site 3202)

    Split, Split-Dalmatia County, 21000

  • Klinicki Bolnicki Centar Zagreb ( Site 3200)

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)

    Zagreb, Zagreb County, 10000

Other trials in Croatia

Germany3 sites

  • Charite Universitaetsmedizin Berlin ( Site 1301)

    Berlin, 10117

  • Helios Kliniken Schwerin GmbH ( Site 1302)

    Schwerin, Mecklenburg-Vorpommern, 19049

  • Universitaetsklinik fuer Urologie ( Site 1300)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Philippines3 sites

  • Manila Doctors Hospital ( Site 4601)

    Manila, National Capital Region, 1000

  • The Medical City ( Site 4602)

    Pasig, National Capital Region, 1605

  • Cardinal Santos Medical Center ( Site 4603)

    San Juan City, National Capital Region, 1502

Other trials in Philippines

Serbia3 sites

  • Klinicki centar Srbije. ( Site 3333)

    Belgrade, Beograd, 112106

  • Institut za onkologiju Vojvodine ( Site 3311)

    Kamenitz, Sremski Okrug, 21204

  • Klinicki centar Nis ( Site 3322)

    Niš, Nisavski Okrug, 18000

Other trials in Serbia

United Kingdom3 sites

  • Addenbrookes Hospital ( Site 3110)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)

    London, London, City of, EC1A 7BE

  • Mount Vernon Cancer Centre ( Site 3101)

    Northwood, London, City of, HA6 2RN

Other trials in United Kingdom

Denmark2 sites

  • Herlev Hospital ( Site 1700)

    Herlev, Capital Region, 2730

  • Odense University Hospital ( Site 1701)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Ireland2 sites

  • Beaumont Hospital ( Site 6101)

    Dublin, D09 V2N0

  • Tallaght University Hospital ( Site 6100)

    Dublin, D24 NR0A

Other trials in Ireland

Thailand2 sites

  • Siriraj Hospital ( Site 4501)

    Bangkok, Bangkok, 10700

  • Ramathibodi Hospital ( Site 4500)

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

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)

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.

Being tested
Pembrolizumab, Belzutifan, Pembrolizumab/Quavonlimab, Lenvatinib
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)
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 400 mg administered Q6W via IV infusion

  • BelzutifanDrug

    Also called MK-6482, PT2977, WELIREG™

    Belzutifan 120 mg administered QD via oral tablet

  • Pembrolizumab/QuavonlimabBiological

    Also called MK-1308A

    Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

    Lenvatinib 20 mg administered QD via oral capsule

Study groups in NCT04736706
Study groupRoleWhat they receive
Pembrolizumab + Belzutifan + LenvatinibExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Belzutifan; Drug: Lenvatinib
Pembrolizumab/Quavonlimab + LenvatinibExperimentalParticipants 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.
Receives: Biological: Pembrolizumab/Quavonlimab; Drug: Lenvatinib
Pembrolizumab + LenvatinibActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 57 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 57 months

Secondary outcomes (4)

  1. 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.

    Measured: Up to approximately 57 months

  2. 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.

    Measured: Up to approximately 57 months

  3. 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.

    Measured: Up to approximately 72 months

  4. 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.

    Measured: Up to approximately 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start14 Apr 2021
  3. Primary completion4 Feb 2026
  4. Study completion22 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736706
Sponsor's protocol ID
6482-012
Other IDs
MK-6482-012, jRCT2031210435, PHRR210911-003887, 2022-502122-41-00, U1111-1283-3681, 2020-002216-52
Status last verified
Nov 2026
First submitted
29 Jan 2021
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Rini BI, Choueiri TK, Voss MH, Burotto M, Oldenburg J, Gurney HP, Ferguson TR, Hammers H, Albiges L, Urun Y, Romero Diaz RI, Ozguroglu M, Weber PY, Verzoni E, Porta C, Drakaki A, Guo J, Matsubara N, Chen A, Burgents JE, Rodriguez-Lopez KG, Powles TB. Pembrolizumab plus lenvatinib with belzutifan or quavonlimab as first-line therapy for advanced renal-cell carcinoma: randomized open-label phase 3 LITESPARK-012 study. Ann Oncol. 2026 Oct 25:S0923-7534(26)08071-3. doi: 10.1016/j.annonc.2026.10.1281. Online ahead of print.

    PubMed 42927856

  • Choueiri TK, Powles T, Voss MH, Plimack ER, Gurney H, Song Y, Perini RF, Rodriguez-Lopez K, Rini BI. LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2631-2640. doi: 10.2217/fon-2023-0283. Epub 2023 Oct 26.

    PubMed 37882432

  • Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.

    PubMed 36064785

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 262 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, China, Japan, South Africa, Ukraine and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 57 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736706, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in