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)
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)
7 other identifiers
interventional
1,653
34 countries
257
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Longer than P75 for phase_3
257 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedStudy Start
First participant enrolled
April 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 29, 2026
May 6, 2026
May 1, 2026
5.5 years
January 29, 2021
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to approximately 46 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Up to approximately 66 months
Secondary Outcomes (4)
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Up to approximately 46 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Up to approximately 66 months
Number of Participants Who Experienced At least One Adverse Event (AE)
Up to approximately 66 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 66 months
Study Arms (3)
Pembrolizumab + Belzutifan + Lenvatinib
EXPERIMENTALParticipants 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.
Pembrolizumab/Quavonlimab + Lenvatinib
EXPERIMENTALParticipants 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.
Pembrolizumab + Lenvatinib
ACTIVE 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.
Interventions
Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan 120 mg administered QD via oral tablet
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Lenvatinib 20 mg administered QD via oral capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.collaborator
- Merck Sharp & Dohme LLClead
Study Sites (262)
The University of Alabama at Birmingham ( Site 0010)
Birmingham, Alabama, 35294-3300, United States
UC San Diego ( Site 0050)
La Jolla, California, 92037, United States
Cedars Sinai Medical Center ( Site 0027)
Los Angeles, California, 90048, United States
University of California Irvine ( Site 0029)
Orange, California, 92868, United States
UCLA Hematology Oncology Santa Monica ( Site 0048)
Santa Monica, California, 90404, United States
Hartford Hospital ( Site 0024)
Hartford, Connecticut, 06102, United States
Advent Health Hematology & Oncology ( Site 0003)
Orlando, Florida, 32804, United States
University Cancer & Blood Center, LLC ( Site 0057)
Athens, Georgia, 30607, United States
Emory University Winship Cancer Institute ( Site 0012)
Atlanta, Georgia, 30322, United States
Rush University Medical Center ( Site 0040)
Chicago, Illinois, 60607, United States
Parkview Cancer Institute ( Site 0088)
Fort Wayne, Indiana, 46845, United States
Norton Cancer Institute - St. Matthews ( Site 0065)
Louisville, Kentucky, 40207, United States
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, 70121, United States
New England Cancer Specialists ( Site 0082)
Scarborough, Maine, 04074, United States
Massachusetts General Hospital ( Site 0094)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center ( Site 0089)
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute ( Site 0093)
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center ( Site 0090)
Burlington, Massachusetts, 01805, United States
Henry Ford Hospital ( Site 0038)
Detroit, Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan ( Site 0018)
Grand Rapids, Michigan, 49503, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital ( Site 0095)
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center ( Site 0037)
Jackson, Mississippi, 39216, United States
Dartmouth Hitchcock Medical Center ( Site 0075)
Lebanon, New Hampshire, 03756, United States
Roswell Park Cancer Institute ( Site 0032)
Buffalo, New York, 14263, United States
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
Lake Success, New York, 11042, United States
Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
New York, New York, 10065, United States
Oregon Health & Science University ( Site 0071)
Portland, Oregon, 97239, United States
Ralph H. Johnson VA Center ( Site 0073)
Charleston, South Carolina, 29401, United States
University of Tennessee Medical Center Knoxville ( Site 0019)
Knoxville, Tennessee, 37920, United States
Vanderbilt University Medical Center ( Site 0069)
Nashville, Tennessee, 37232, United States
UTSW Medical Center ( Site 0015)
Dallas, Texas, 75390, United States
Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)
Wenatchee, Washington, 98801, United States
Liverpool Hospital ( Site 4006)
Liverpool, New South Wales, 2170, Australia
Macquarie University ( Site 4007)
Macquarie University, New South Wales, 2109, Australia
Lyell McEwin Hospital ( Site 4004)
Elizabeth Vale, South Australia, 5112, Australia
Monash Health ( Site 4008)
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital ( Site 4009)
Murdock, Western Australia, 6150, Australia
Oncocentro Ceara ( Site 0309)
Fortaleza, Ceará, 60135-237, Brazil
Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
Belo Horizonte, Minas Gerais, 30130090, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0308)
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0310)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
São Paulo, 01246-000, Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
São Paulo, 01321-001, Brazil
A.C. Camargo Cancer Center ( Site 0301)
São Paulo, 01525-001, Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0119)
Calgary, Alberta, T2N 5G2, Canada
BC Cancer - Vancouver Center ( Site 0120)
Vancouver, British Columbia, V5Z 4E6, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
Hamilton, Ontario, L8V 5C2, Canada
Sunnybrook Research Institute ( Site 0116)
Toronto, Ontario, M4N 3M5, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0112)
Québec, Quebec, G1J 1Z4, Canada
Centro Investigacion Cancer James Lind ( Site 0402)
Temuco, Araucania, 4800827, Chile
IC La Serena Research ( Site 0403)
La Serena, Coquimbo Region, 1720430, Chile
Servicios Medicos Urumed ( Site 0405)
Rancagua, Lbtdr Gen Bernardo O Higgins, 2852424, Chile
Fundacion Arturo Lopez Perez ( Site 0400)
Santiago, Region M. de Santiago, 7500921, Chile
Bradfordhill-Clinical Area ( Site 0401)
Santiago, Region M. de Santiago, 8420383, Chile
The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)
Bengbu, Anhui, 233004, China
Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital ( Site 6011)
Beijing, Beijing Municipality, 100034, China
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital ( Site 6009)
Chongging, Chongqing Municipality, 400030, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Xiamen University ( Site 6001)
Xiamen, Fujian, 361003, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 6036)
Guangzhou, Guangdong, 510120, China
Guangzhou First People's Hospital ( Site 6007)
Guangzhou, Guangdong, 510180, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)
Guangzhou, Guangdong, 510289, China
Harbin Medical University Cancer Hospital-urology ( Site 6015)
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital-Urology ( Site 6006)
Zhengzhou, Henan, 450008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 6002)
Wuhan, Hubei, 430022, China
Xiangya Hospital Central South University ( Site 6034)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 6020)
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 6022)
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Suzhou, Jiangsu, 215004, China
Jiangxi Provincial Cancer Hospital ( Site 6042)
Nanchang, Jiangxi, 330029, China
The First Affiliated Hospital of Nanchang University ( Site 6019)
Nanchang, Jiangxi, 330052, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Xi'an, Shaanxi, 710061, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)
Shanghai, Shanghai Municipality, 200001, China
Shanghai Tenth People's Hospital ( Site 6023)
Shanghai, Shanghai Municipality, 200072, China
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital ( Site 6029)
Tianjin, Tianjin Municipality, 300060, China
The Second Hospital of Tianjin Medical University ( Site 6032)
Tianjin, Tianjin Municipality, 300211, China
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 6024)
Hangzhou, Zhejiang, 310003, China
The First Hospital of Jiaxing ( Site 6033)
Jiaxing, Zhejiang, 314001, China
Ningbo First Hospital-Urology ( Site 6028)
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
Wenzhou, Zhejiang, 325000, China
Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
Medellín, Antioquia, 050024, Colombia
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, 080020, Colombia
Administradora Country SA - Clinica del Country ( Site 0504)
Bogotá, Bogota D.C., 110221, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
Valledupar, Cesar Department, 200001, Colombia
Instituto Nacional de Cancerología E.S.E. ( Site 0503)
Bogota, Cundinamarca, 111511, Colombia
Oncólogos del Occidente S.A ( Site 0501)
Pereira, Risaralda Department, 660001, Colombia
Fundacion Cardiovascular de Colombia ( Site 0506)
Piedecuesta, Santander Department, 68017, Colombia
Klinicki Bolnicki Centar Zagreb ( Site 3200)
Zagreb, City of Zagreb, 10000, Croatia
Klinički Bolnički Centar Split ( Site 3202)
Split, Split-Dalmatia County, 21000, Croatia
Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
Zagreb, Zagreb County, 10000, Croatia
Masarykuv onkologicky ustav ( Site 2203)
Brno, Brno-mesto, 656 53, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
Nový Jičín, Moravian-Silesian Region, 741 01, Czechia
Fakultni nemocnice Ostrava ( Site 2208)
Ostrava, Moravian-Silesian Region, 708 52, Czechia
Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
Brno, South Moravian, 656 91, Czechia
Fakultni nemocnice Olomouc ( Site 2200)
Olomouc, 77900, Czechia
Fakultni Thomayerova nemocnice ( Site 2201)
Prague, 140 59, Czechia
2 LF UK a FN Motol ( Site 2207)
Prague, 150 06, Czechia
Herlev Hospital ( Site 1700)
Herlev, Capital Region, 2730, Denmark
Odense University Hospital ( Site 1701)
Odense, Region Syddanmark, 5000, Denmark
Kuopion Yliopistollinen Sairaala ( Site 1803)
Kuopio, Northern Savonia, 70210, Finland
TAYS ( Site 1801)
Tampere, Pirkanmaa, 33520, Finland
TYKS ( Site 1802)
Turku, Southwest Finland, 20520, Finland
HYKS ( Site 1800)
Helsinki, Uusimaa, 00290, Finland
Institut Paoli Calmettes ( Site 1206)
Marseille, Bouches-du-Rhone, 13272, France
CHU Jean Minjoz ( Site 1205)
Besançon, Doubs, 25000, France
Institut Claudius Regaud ( Site 1214)
Toulouse, Haute-Garonne, 31059, France
Clinique Francois Chenieux ( Site 1209)
Limoges, Haute-Vienne, 87039, France
Clinique Ambroise Pare Beuvry ( Site 1213)
Beuvry, Hauts-de-France, 62660, France
CHU Angers ( Site 1200)
Angers, Maine-et-Loire, 49933, France
CH Lyon Sud Hospices Civils de Lyon ( Site 1203)
Pierre-Bénite, Rhone, 69310, France
Hopital Tenon ( Site 1212)
Paris, 75020, France
Gustave Roussy ( Site 1207)
Villejuif, Île-de-France Region, 94800, France
Universitaetsklinik fuer Urologie ( Site 1300)
Tübingen, Baden-Wurttemberg, 72076, Germany
Helios Kliniken Schwerin GmbH ( Site 1302)
Schwerin, Mecklenburg-Vorpommern, 19049, Germany
Charite Universitaetsmedizin Berlin ( Site 1301)
Berlin, 10117, Germany
Centro Medico Integral de Cancerologia CEMIC ( Site 0701)
Salcajá, Departamento de Quetzaltenango, 09002, Guatemala
MEDI-K ( Site 0703)
Guatemala City, 01009, Guatemala
Oncomedica ( Site 0700)
Guatemala City, 01010, Guatemala
Grupo Angeles SA ( Site 0705)
Guatemala City, 01015, Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0702)
Guatemala City, 01015, Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 0704)
Quetzaltenango, 09001, Guatemala
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)
Gyula, Bekes County, 5700, Hungary
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)
Kecskemét, Bács-Kiskun county, 6000, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Markusovszky Egyetemi Oktatokorhaz ( Site 2303)
Szombathely, Vas County, 9700, Hungary
Orszagos Onkologiai Intezet ( Site 2304)
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2301)
Debrecen, 4032, Hungary
Beaumont Hospital ( Site 6101)
Dublin, D09 V2N0, Ireland
Tallaght University Hospital ( Site 6100)
Dublin, D24 NR0A, Ireland
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)
Modena, Emilia-Romagna, 41125, Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 1414)
Rome, Roma, 00168, Italy
Azienda Ospedaliera Policlinico di Bari ( Site 1411)
Bari, 70124, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1417)
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)
Milan, 20133, Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)
Naples, 80131, Italy
Azienda Ospedaliera S. Maria di Terni ( Site 1410)
Terni, 05100, Italy
Fujita Health University Hospital ( Site 5003)
Toyoake, Aichi-ken, 470-1192, Japan
National Cancer Center Hospital East ( Site 5000)
Kashiwa, Chiba, 277-8577, Japan
Ehime University Hospital ( Site 5020)
Tōon, Ehime, 791-0295, Japan
Sapporo Medical University Hospital ( Site 5008)
Sapporo, Hokkaido, 060-8543, Japan
Hokkaido University Hospital ( Site 5013)
Sapporo, Hokkaido, 060-8648, Japan
Kanagawa Cancer Center ( Site 5016)
Yokohama, Kanagawa, 241-8515, Japan
Nara Medical University Hospital ( Site 5002)
Kashihara, Nara, 634-0813, Japan
Kindai University Hospital ( Site 5010)
Sayama, Osaka, 589-8511, Japan
The University of Osaka Hospital ( Site 5012)
Suita, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center ( Site 5015)
Hidaka, Saitama, 350-1298, Japan
Hamamatsu University Hospital ( Site 5004)
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 5023)
Adachi City, Tokyo, 123-8558, Japan
Institute of Science Tokyo Hospital ( Site 5009)
Bunkyo-ku, Tokyo, 113-8519, Japan
Nippon Medical School Hospital ( Site 5006)
Bunkyo, Tokyo, 113-8603, Japan
Toranomon Hospital ( Site 5001)
Minato-ku, Tokyo, 105-8470, Japan
Chiba Cancer Center ( Site 5021)
Chiba, 260-8717, Japan
Kyushu University Hospital ( Site 5005)
Fukuoka, 812-8582, Japan
Kumamoto University Hospital ( Site 5022)
Kumamoto, 860-8556, Japan
Niigata University Medical & Dental Hospital ( Site 5024)
Niigata, 951-8520, Japan
Okayama University Hospital ( Site 5017)
Okayama, 700-8558, Japan
Tokushima University Hospital ( Site 5019)
Tokushima, 770-8503, Japan
Keio University Hospital ( Site 5011)
Tokyo, 160-8582, Japan
Toyama University Hospital ( Site 5014)
Toyama, 930-0194, Japan
Hospital Sultan Ismail ( Site 4303)
Johor Bahru, Johor, 81100, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 4302)
Putrajaya, Putrajaya, 62250, Malaysia
Hospital Kuala Lumpur ( Site 4301)
Kuala Lumpur, 50586, Malaysia
Universiti Malaya Medical Centre ( Site 4300)
Kuala Lumpur, 59100, Malaysia
Antiguo hospital civil de Guadalajara Fray Antonio Alcalde ( Site 0610)
Guadalajara, Jalisco, 44280, Mexico
Instituto Nacional de Cancerologia ( Site 0602)
Mexico City, Mexico City, 14080, Mexico
I CAN Oncology SA de SV ( Site 0601)
Monterrey, Nuevo León, 64710, Mexico
Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)
Querétaro City, Querétaro, 76000, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0605)
Oaxaca City, 68020, Mexico
Akershus universitetssykehus ( Site 2000)
Lorenskog, Akershus, 1478, Norway
Soerlandet sykehus HF Kristiansand ( Site 2007)
Kristiansand, Aust-Agder, 4615, Norway
Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)
Bergen, Hordaland, 5021, Norway
St. Olavs Hospital HF ( Site 2005)
Trondheim, Sor-Trondelag, 7030, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 2001)
Oslo, 0379, Norway
Sykehuset Østfold HF Kalnes ( Site 2003)
Grålum, Østfold fylke, 1714, Norway
Manila Doctors Hospital ( Site 4601)
Manila, National Capital Region, 1000, Philippines
The Medical City ( Site 4602)
Pasig, National Capital Region, 1605, Philippines
Cardinal Santos Medical Center ( Site 4603)
San Juan City, National Capital Region, 1502, Philippines
Przychodnia Lekarska KOMED ( Site 2419)
Konin, Greater Poland Voivodeship, 62-500, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)
Poznan, Greater Poland Voivodeship, 60-569, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Radomskie Centrum Onkologii ( Site 2418)
Radom, Masovian Voivodeship, 26-600, Poland
Luxmed Onkologia sp. z o. o. ( Site 2412)
Warsaw, Masovian Voivodeship, 01-748, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)
Warsaw, Masovian Voivodeship, 02-781, Poland
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 2407)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)
Alba Iulia, Alba, 510007, Romania
Memorial Healthcare International ( Site 2503)
Bucharest, Bucharest, 013823, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)
Craiova, Dolj, 200746, Romania
Policlinica Oncomed SRL ( Site 2506)
Timișoara, Timiș County, 300239, Romania
Altay Regional Oncology Dispensary ( Site 2610)
Barnaul, Altayskiy Kray, 656045, Russia
Ivanovo Regional Oncology Dispensary ( Site 2615)
Ivanovo, Ivanovo Oblast, 153040, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)
Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia
The Loginov Moscow Clinical Scientific Center ( Site 2604)
Moscow, Moscow, 111123, Russia
City Clinical Hospital n.a. S.S.Yudin ( Site 2619)
Moscow, Moscow, 115446, Russia
FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603074, Russia
Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
City clinical oncological dispensary ( Site 2605)
Saint Petersburg, Sankt-Peterburg, 198255, Russia
Klinicki centar Srbije. ( Site 3333)
Belgrade, Beograd, 112106, Serbia
Klinicki centar Nis ( Site 3322)
Niš, Nisavski Okrug, 18000, Serbia
Institut za onkologiju Vojvodine ( Site 3311)
Kamenitz, Sremski Okrug, 21204, Serbia
Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)
Port Elizabeth, Eastern Cape, 6045, South Africa
Wits Clinical Research ( Site 3012)
Johannesburg, Gauteng, 2193, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 3000)
Johannesburg, Gauteng, 2196, South Africa
Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)
Pretoria, Gauteng, 0002, South Africa
Life Wilgers Hospital ( Site 3004)
Pretoria, Gauteng, 0040, South Africa
Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)
Pretoria, Gauteng, 0181, South Africa
Vaal Triangle Oncology Centre ( Site 3010)
Vereeniging, Gauteng, 1939, South Africa
Cancercare Rondebosch Oncology ( Site 3005)
Cape Town, Western Cape, 7700, South Africa
Groote Schuur Hospital ( Site 3011)
Cape Town, Western Cape, 7925, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 3006)
Kraaifontein, Western Cape, 7570, South Africa
National Cancer Center ( Site 4202)
Goyang-si, Kyonggi-do, 10408, South Korea
Chungnam National University Hospital ( Site 4205)
Daejeon, Taejon-Kwangyokshi, 35015, South Korea
Korea University Anam Hospital ( Site 4206)
Seoul, 02841, South Korea
Seoul National University Hospital ( Site 4201)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 4204)
Seoul, 03722, South Korea
Asan Medical Center ( Site 4203)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 4200)
Seoul, 06351, South Korea
Hospital Universitario Marques de Valdecilla ( Site 1501)
Santander, Cantabria, 39008, Spain
Instituto Catalan de Oncologia - ICO ( Site 1502)
Barcelona, Catalonia, 08908, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 1500)
Girona, Gerona, 17007, Spain
Hospital Clinico San Carlos ( Site 1503)
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre ( Site 1505)
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria ( Site 1504)
Málaga, 29016, Spain
Lanssjukhuset Ryhov ( Site 2103)
Jönköping, Jönköping County, 551 85, Sweden
Karolinska Universitetssjukhuset Solna ( Site 2100)
Stockholm, Stockholm County, 171 76, Sweden
Akademiska Sjukhuset ( Site 2105)
Uppsala, Uppsala County, 751 85, Sweden
Norrlands Universitetssjukhus ( Site 2106)
Umeå, Västerbotten County, 901 85, Sweden
Sahlgrenska Universitetssjukhuset ( Site 2102)
Gothenburg, Västra Götaland County, 413 45, Sweden
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital ( Site 4403)
Taichung, 40705, Taiwan
National Cheng Kung University Hospital ( Site 4404)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 4401)
Taipei, 100, Taiwan
Taipei Veterans General Hospital ( Site 4402)
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)
Taoyuan, 333, Taiwan
Siriraj Hospital ( Site 4501)
Bangkok, Bangkok, 10700, Thailand
Ramathibodi Hospital ( Site 4500)
Ratchathewi, Bangkok, 10400, Thailand
Ankara Universitesi Tip Fakultesi ( Site 2902)
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tıp Fakultesi ( Site 2903)
Ankara, 06100, Turkey (Türkiye)
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)
Istanbul, 34098, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)
Izmir, 35040, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)
Izmir, 35340, Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 2704)
Cherkasy, Cherkasy Oblast, 18009, Ukraine
Chernihiv Medical Center of Modern Oncology ( Site 2709)
Chernihiv, Chernihiv Oblast, 14029, Ukraine
Clinical oncology dispensary of Dnipro ( Site 2700)
Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2710)
Dnipropetrovsk, Dnipropetrovsk Oblast, 49005, Ukraine
Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Regional Oncology Center of Kharkiv ( Site 2708)
Kharkiv, Kharkivs’ka Oblast’, 61000, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
Kyiv City Clinical Oncology Center ( Site 2706)
Kyiv, Kyivska Oblast, 03115, Ukraine
Lviv State Regional Oncological Center ( Site 2712)
Lviv, Lviv Oblast, 79031, Ukraine
Addenbrookes Hospital ( Site 3110)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
London, London, City of, EC1A 7BE, United Kingdom
Mount Vernon Cancer Centre ( Site 3101)
Northwood, London, City of, HA6 2RN, United Kingdom
Related Publications (2)
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.
PMID: 37882432DERIVEDGed 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.
PMID: 36064785DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 3, 2021
Study Start
April 14, 2021
Primary Completion (Estimated)
October 29, 2026
Study Completion (Estimated)
October 29, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf