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)

NCT ID: NCT04736706

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2026-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

Pembrolizumab 400 mg administered Q6W via IV infusion

Belzutifan

Intervention Type DRUG

Belzutifan 120 mg administered QD via oral tablet

Lenvatinib

Intervention Type DRUG

Lenvatinib 20 mg administered QD via oral capsule

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.

Group Type EXPERIMENTAL

Pembrolizumab/Quavonlimab

Intervention Type BIOLOGICAL

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

Lenvatinib

Intervention Type DRUG

Lenvatinib 20 mg administered QD via oral capsule

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.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

Pembrolizumab 400 mg administered Q6W via IV infusion

Lenvatinib

Intervention Type DRUG

Lenvatinib 20 mg administered QD via oral capsule

Interventions

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Pembrolizumab

Pembrolizumab 400 mg administered Q6W via IV infusion

Intervention Type BIOLOGICAL

Belzutifan

Belzutifan 120 mg administered QD via oral tablet

Intervention Type DRUG

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

Intervention Type BIOLOGICAL

Lenvatinib

Lenvatinib 20 mg administered QD via oral capsule

Intervention Type DRUG

Other Intervention Names

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MK-3475 KEYTRUDA® MK-6482 PT2977 WELIREG™ MK-1308A MK-7902 E7080 LENVIMA®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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The University of Alabama at Birmingham ( Site 0010)

Birmingham, Alabama, United States

Site Status

UC San Diego ( Site 0050)

La Jolla, California, United States

Site Status

Cedars Sinai Medical Center ( Site 0027)

Los Angeles, California, United States

Site Status

University of California Irvine ( Site 0029)

Orange, California, United States

Site Status

UCLA Hematology Oncology Santa Monica ( Site 0048)

Santa Monica, California, United States

Site Status

Hartford Hospital ( Site 0024)

Hartford, Connecticut, United States

Site Status

Advent Health Hematology & Oncology ( Site 0003)

Orlando, Florida, United States

Site Status

University Cancer & Blood Center, LLC ( Site 0057)

Athens, Georgia, United States

Site Status

Emory University Winship Cancer Institute ( Site 0012)

Atlanta, Georgia, United States

Site Status

Rush University Medical Center ( Site 0040)

Chicago, Illinois, United States

Site Status

Parkview Cancer Institute ( Site 0088)

Fort Wayne, Indiana, United States

Site Status

Norton Cancer Institute - St. Matthews ( Site 0065)

Louisville, Kentucky, United States

Site Status

Ochsner Medical Center ( Site 0049)

New Orleans, Louisiana, United States

Site Status

New England Cancer Specialists ( Site 0082)

Scarborough, Maine, United States

Site Status

Massachusetts General Hospital ( Site 0094)

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center ( Site 0089)

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute ( Site 0093)

Boston, Massachusetts, United States

Site Status

Lahey Hospital & Medical Center ( Site 0090)

Burlington, Massachusetts, United States

Site Status

Henry Ford Hospital ( Site 0038)

Detroit, Michigan, United States

Site Status

Cancer & Hematology Centers of Western Michigan ( Site 0018)

Grand Rapids, Michigan, United States

Site Status

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

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital ( Site 0095)

Saint Paul, Minnesota, United States

Site Status

University of Mississippi Medical Center ( Site 0037)

Jackson, Mississippi, United States

Site Status

Dartmouth Hitchcock Medical Center ( Site 0075)

Lebanon, New Hampshire, United States

Site Status

Roswell Park Cancer Institute ( Site 0032)

Buffalo, New York, United States

Site Status

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

Lake Success, New York, United States

Site Status

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

New York, New York, United States

Site Status

Oregon Health & Science University ( Site 0071)

Portland, Oregon, United States

Site Status

Ralph H. Johnson VA Center ( Site 0073)

Charleston, South Carolina, United States

Site Status

University of Tennessee Medical Center Knoxville ( Site 0019)

Knoxville, Tennessee, United States

Site Status

Vanderbilt University Medical Center ( Site 0069)

Nashville, Tennessee, United States

Site Status

UTSW Medical Center ( Site 0015)

Dallas, Texas, United States

Site Status

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

Wenatchee, Washington, United States

Site Status

Liverpool Hospital ( Site 4006)

Liverpool, New South Wales, Australia

Site Status

Macquarie University ( Site 4007)

Macquarie University, New South Wales, Australia

Site Status

Lyell McEwin Hospital ( Site 4004)

Elizabeth Vale, South Australia, Australia

Site Status

Monash Health ( Site 4008)

Clayton, Victoria, Australia

Site Status

Fiona Stanley Hospital ( Site 4009)

Murdock, Western Australia, Australia

Site Status

Oncocentro Ceara ( Site 0309)

Fortaleza, Ceará, Brazil

Site Status

Centro de Pesquisas Clinicas em Oncologia ( Site 0306)

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Site Status

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

Belo Horizonte, Minas Gerais, Brazil

Site Status

Liga Norte Riograndense Contra o Cancer ( Site 0308)

Natal, Rio Grande do Norte, Brazil

Site Status

Hospital de Clinicas de Porto Alegre ( Site 0310)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

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

São Paulo, , Brazil

Site Status

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

São Paulo, , Brazil

Site Status

A.C. Camargo Cancer Center ( Site 0301)

São Paulo, , Brazil

Site Status

Tom Baker Cancer Centre ( Site 0119)

Calgary, Alberta, Canada

Site Status

BC Cancer - Vancouver Center ( Site 0120)

Vancouver, British Columbia, Canada

Site Status

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)

Hamilton, Ontario, Canada

Site Status

Sunnybrook Research Institute ( Site 0116)

Toronto, Ontario, Canada

Site Status

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Site Status

IC La Serena Research ( Site 0403)

La Serena, Coquimbo Region, Chile

Site Status

Servicios Medicos Urumed ( Site 0405)

Rancagua, Lbtdr Gen Bernardo O Higgins, Chile

Site Status

Fundacion Arturo Lopez Perez ( Site 0400)

Santiago, Region M. de Santiago, Chile

Site Status

Bradfordhill-Clinical Area ( Site 0401)

Santiago, Region M. de Santiago, Chile

Site Status

Centro Investigacion Cancer James Lind ( Site 0402)

Temuco, Región de la Araucanía, Chile

Site Status

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

Bengbu, Anhui, China

Site Status

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

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital ( Site 6011)

Beijing, Beijing Municipality, China

Site Status

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

Beijing, Beijing Municipality, China

Site Status

Chongqing University Cancer Hospital ( Site 6009)

Chongqing, Chongqing Municipality, China

Site Status

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

Fuzhou, Fujian, China

Site Status

The First Affiliated hospital of Xiamen University-Urology ( Site 6001)

Xiamen, Fujian, China

Site Status

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Guangzhou First People's Hospital ( Site 6007)

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Harbin Medical University Cancer Hospital-urology ( Site 6015)

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital-Urology ( Site 6006)

Zhengzhou, Henan, China

Site Status

Wuhan Union Hospital ( Site 6002)

Wuhan, Hubei, China

Site Status

Xiangya Hospital Central South University ( Site 6034)

Changsha, Hunan, China

Site Status

Hunan Cancer Hospital ( Site 6020)

Changsha, Hunan, China

Site Status

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

Nanjing, Jiangsu, China

Site Status

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

Suzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University ( Site 6019)

Nanchang, Jiangxi, China

Site Status

Jiangxi Provincial Cancer Hospital ( Site 6042)

Nanchang, Jiangxi, China

Site Status

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

Xi'an, Shaanxi, China

Site Status

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

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Tenth People's Hospital ( Site 6023)

Shanghai, Shanghai Municipality, China

Site Status

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

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute and Hospital ( Site 6029)

Tianjin, Tianjin Municipality, China

Site Status

The Second Hospital of Tianjin Medical University ( Site 6032)

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital, Zhejiang University ( Site 6024)

Hangzhou, Zhejiang, China

Site Status

The First Hospital of Jiaxing ( Site 6033)

Jiaxing, Zhejiang, China

Site Status

Ningbo First Hospital-Urology ( Site 6028)

Ningbo, Zhejiang, China

Site Status

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

Wenzhou, Zhejiang, China

Site Status

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

Medellín, Antioquia, Colombia

Site Status

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

Barranquilla, Atlántico, Colombia

Site Status

Administradora Country SA - Clinica del Country ( Site 0504)

Bogotá, Bogota D.C., Colombia

Site Status

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

Bogotá, Bogota D.C., Colombia

Site Status

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

Valledupar, Cesar Department, Colombia

Site Status

Oncólogos del Occidente S.A ( Site 0501)

Pereira, Risaralda Department, Colombia

Site Status

Fundacion Cardiovascular de Colombia ( Site 0506)

Piedecuesta, Santander Department, Colombia

Site Status

Klinicki Bolnicki Centar Zagreb ( Site 3200)

Zagreb, City of Zagreb, Croatia

Site Status

Klinički Bolnički Centar Split ( Site 3202)

Split, Split-Dalmatia County, Croatia

Site Status

Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)

Zagreb, Zagreb County, Croatia

Site Status

Masarykuv onkologicky ustav ( Site 2203)

Brno, Brno-mesto, Czechia

Site Status

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

Nový Jičín, Moravskoslezský kraj, Czechia

Site Status

Fakultni nemocnice Ostrava ( Site 2208)

Ostrava, Moravskoslezský kraj, Czechia

Site Status

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

Brno, South Moravian, Czechia

Site Status

Fakultni nemocnice Olomouc ( Site 2200)

Olomouc, , Czechia

Site Status

Fakultni Thomayerova nemocnice ( Site 2201)

Prague, , Czechia

Site Status

2 LF UK a FN Motol ( Site 2207)

Prague, , Czechia

Site Status

Herlev Hospital ( Site 1700)

Herlev, Capital Region, Denmark

Site Status

Odense University Hospital ( Site 1701)

Odense, Region Syddanmark, Denmark

Site Status

Kuopion Yliopistollinen Sairaala ( Site 1803)

Kuopio, Northern Savonia, Finland

Site Status

TAYS ( Site 1801)

Tampere, Pirkanmaa, Finland

Site Status

TYKS ( Site 1802)

Turku, Southwest Finland, Finland

Site Status

HYKS ( Site 1800)

Helsinki, Uusimaa, Finland

Site Status

Institut Paoli Calmettes ( Site 1206)

Marseille, Bouches-du-Rhone, France

Site Status

CHU Jean Minjoz ( Site 1205)

Besançon, Doubs, France

Site Status

Institut Claudius Regaud ( Site 1214)

Toulouse, Haute-Garonne, France

Site Status

Clinique Francois Chenieux ( Site 1209)

Limoges, Haute-Vienne, France

Site Status

Clinique Ambroise Pare Beuvry ( Site 1213)

Beuvry, Hauts-de-France, France

Site Status

CHU Angers ( Site 1200)

Angers, Maine-et-Loire, France

Site Status

CH Lyon Sud Hospices Civils de Lyon ( Site 1203)

Pierre-Bénite, Rhone, France

Site Status

Gustave Roussy ( Site 1207)

Villejuif, Val-de-Marne, France

Site Status

Hopital Tenon ( Site 1212)

Paris, , France

Site Status

Universitaetsklinik fuer Urologie ( Site 1300)

Tübingen, Baden-Wurttemberg, Germany

Site Status

Helios Kliniken Schwerin GmbH ( Site 1302)

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

Charite Universitaetsmedizin Berlin ( Site 1301)

Berlin, , Germany

Site Status

Centro Medico Integral de Cancerologia CEMIC ( Site 0701)

Salcajá, Departamento de Quetzaltenango, Guatemala

Site Status

Oncomedica ( Site 0700)

Guatemala City, , Guatemala

Site Status

Grupo Angeles SA ( Site 0705)

Guatemala City, , Guatemala

Site Status

Sanatorio Nuestra Senora del Pilar ( Site 0702)

Guatemala City, , Guatemala

Site Status

Medi-K Cayala ( Site 0703)

Guatemala City, , Guatemala

Site Status

Centro Regional de Sub Especialidades Medicas SA ( Site 0704)

Quetzaltenango, , Guatemala

Site Status

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

Gyula, Bekes County, Hungary

Site Status

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

Kecskemét, Bács-Kiskun county, Hungary

Site Status

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

Markusovszky Egyetemi Oktatokorhaz ( Site 2303)

Szombathely, Vas County, Hungary

Site Status

Orszagos Onkologiai Intezet ( Site 2304)

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont ( Site 2301)

Debrecen, , Hungary

Site Status

Beaumont Hospital ( Site 6101)

Dublin, , Ireland

Site Status

Tallaght University Hospital ( Site 6100)

Dublin, , Ireland

Site Status

Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)

Modena, Emilia-Romagna, Italy

Site Status

Ospedale San Raffaele-Oncologia Medica ( Site 1417)

Milan, Lombardy, Italy

Site Status

Fondazione Policlinico Universitario A. Gemelli ( Site 1414)

Rome, Roma, Italy

Site Status

Azienda Ospedaliera Policlinico di Bari ( Site 1411)

Bari, , Italy

Site Status

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

Milan, , Italy

Site Status

Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)

Napoli, , Italy

Site Status

Azienda Ospedaliera S. Maria di Terni ( Site 1410)

Terni, , Italy

Site Status

Fujita Health University ( Site 5003)

Toyoake, Aichi-ken, Japan

Site Status

Chiba cancer center ( Site 5021)

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East ( Site 5000)

Kashiwa, Chiba, Japan

Site Status

Ehime University Hospital ( Site 5020)

Tōon, Ehime, Japan

Site Status

Sapporo Medical University Hospital ( Site 5008)

Sapporo, Hokkaido, Japan

Site Status

Hokkaido University Hospital ( Site 5013)

Sapporo, Hokkaido, Japan

Site Status

Kanagawa cancer center ( Site 5016)

Yokohama, Kanagawa, Japan

Site Status

Nara Medical University Hospital ( Site 5002)

Kashihara, Nara, Japan

Site Status

Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)

Sayama, Osaka, Japan

Site Status

Osaka University Hospital ( Site 5012)

Suita, Osaka, Japan

Site Status

Saitama Medical University International Medical Center ( Site 5015)

Hidaka, Saitama, Japan

Site Status

Hamamatsu University School of Medicine University Hospital ( Site 5004)

Hamamatsu, Shizuoka, Japan

Site Status

Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)

Bunkyō, Tokyo, Japan

Site Status

Toranomon Hospital ( Site 5001)

Minato-ku, Tokyo, Japan

Site Status

Toyama University Hospital ( Site 5014)

Toyoma, Toyama, Japan

Site Status

Kyushu University Hospital ( Site 5005)

Fukuoka, , Japan

Site Status

Kumamoto University ( Site 5022)

Kumamoto, , Japan

Site Status

Niigata University Medical & Dental Hospital ( Site 5024)

Niigata, , Japan

Site Status

Okayama University Hospital ( Site 5017)

Okayama, , Japan

Site Status

Tokushima University Hospital-Department of Urology ( Site 5019)

Tokushima, , Japan

Site Status

Nippon Medical School Hospital ( Site 5006)

Tokyo, , Japan

Site Status

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

Tokyo, , Japan

Site Status

Keio university hospital ( Site 5011)

Tokyo, , Japan

Site Status

Hospital Sultan Ismail ( Site 4303)

Johor Bahru, Johor, Malaysia

Site Status

Institut Kanser Negara - National Cancer Institute ( Site 4302)

Putrajaya, Putrajaya, Malaysia

Site Status

Hospital Kuala Lumpur ( Site 4301)

Kuala Lumpur, , Malaysia

Site Status

Universiti Malaya Medical Centre ( Site 4300)

Kuala Lumpur, , Malaysia

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)

Guadalajara, Jalisco, Mexico

Site Status

Instituto Nacional de Cancerologia ( Site 0602)

Mexico City, Mexico City, Mexico

Site Status

I CAN Oncology SA de SV ( Site 0601)

Monterrey, Nuevo León, Mexico

Site Status

Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)

Querétaro City, Querétaro, Mexico

Site Status

Centro de Investigacion Clinica de Oaxaca ( Site 0605)

Oaxaca City, , Mexico

Site Status

Akershus universitetssykehus ( Site 2000)

Lorenskog, Akershus, Norway

Site Status

Soerlandet sykehus HF Kristiansand ( Site 2007)

Kristiansand, Aust-Agder, Norway

Site Status

Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)

Bergen, Hordaland, Norway

Site Status

St. Olavs Hospital HF ( Site 2005)

Trondheim, Sor-Trondelag, Norway

Site Status

Oslo Universitetssykehus Radiumhospitalet ( Site 2001)

Oslo, , Norway

Site Status

Sykehuset Østfold HF Kalnes ( Site 2003)

Grålum, Østfold fylke, Norway

Site Status

Manila Doctors Hospital ( Site 4601)

Manila, National Capital Region, Philippines

Site Status

The Medical City ( Site 4602)

Pasig, National Capital Region, Philippines

Site Status

Cardinal Santos Medical Center ( Site 4603)

San Juan City, National Capital Region, Philippines

Site Status

Przychodnia Lekarska KOMED ( Site 2419)

Konin, Greater Poland Voivodeship, Poland

Site Status

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)

Poznan, Greater Poland Voivodeship, Poland

Site Status

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Radomskie Centrum Onkologii ( Site 2418)

Radom, Masovian Voivodeship, Poland

Site Status

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

Warsaw, Masovian Voivodeship, Poland

Site Status

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

Warsaw, Masovian Voivodeship, Poland

Site Status

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)

Koszalin, West Pomeranian Voivodeship, Poland

Site Status

Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)

Alba Iulia, Alba, Romania

Site Status

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

Craiova, Dolj, Romania

Site Status

Policlinica Oncomed SRL ( Site 2506)

Timișoara, Timiș County, Romania

Site Status

S.C.Focus Lab Plus S.R.L ( Site 2503)

Bucharest, , Romania

Site Status

Altay Regional Oncology Dispensary ( Site 2610)

Barnaul, Altayskiy Kray, Russia

Site Status

Ivanovo Regional Oncology Dispensary ( Site 2615)

Ivanovo, Ivanovo Oblast, Russia

Site Status

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)

Krasnoyarsk, Krasnoyarsk Krai, Russia

Site Status

The Loginov Moscow Clinical Scientific Center ( Site 2604)

Moscow, Moscow, Russia

Site Status

Moscow Oncological Clinical Dispensary #1 ( Site 2619)

Moscow, Moscow, Russia

Site Status

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

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Site Status

Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Site Status

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

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

City clinical oncological dispensary ( Site 2605)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Klinicki centar Srbije. ( Site 3333)

Belgrade, Beograd, Serbia

Site Status

Klinicki centar Nis ( Site 3322)

Niš, Nisavski Okrug, Serbia

Site Status

Institut za onkologiju Vojvodine ( Site 3311)

Kamenitz, Sremski Okrug, Serbia

Site Status

Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)

Port Elizabeth, Eastern Cape, South Africa

Site Status

Wits Clinical Research ( Site 3012)

Johannesburg, Gauteng, South Africa

Site Status

Sandton Oncology Medical Group PTY LTD ( Site 3000)

Johannesburg, Gauteng, South Africa

Site Status

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

Pretoria, Gauteng, South Africa

Site Status

Life Wilgers Hospital ( Site 3004)

Pretoria, Gauteng, South Africa

Site Status

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

Pretoria, Gauteng, South Africa

Site Status

Vaal Triangle Oncology Centre ( Site 3010)

Vereeniging, Gauteng, South Africa

Site Status

Groote Schuur Hospital ( Site 3011)

Cape Town, Western Cape, South Africa

Site Status

Cape Town Oncology Trials Pty Ltd ( Site 3006)

Kraaifontein, Western Cape, South Africa

Site Status

Cancercare Rondebosch Oncology ( Site 3005)

Rondebosch, Western Cape, South Africa

Site Status

National Cancer Center ( Site 4202)

Goyang-si, Kyonggi-do, South Korea

Site Status

Chungnam National University Hospital ( Site 4205)

Daejeon, Taejon-Kwangyokshi, South Korea

Site Status

Korea University Anam Hospital ( Site 4206)

Seoul, , South Korea

Site Status

Seoul National University Hospital ( Site 4201)

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System ( Site 4204)

Seoul, , South Korea

Site Status

Asan Medical Center ( Site 4203)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 4200)

Seoul, , South Korea

Site Status

Instituto Catalan de Oncologia - ICO ( Site 1502)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitario Marques de Valdecilla ( Site 1501)

Santander, Cantabria, Spain

Site Status

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

Girona, Gerona, Spain

Site Status

Hospital Clinico San Carlos ( Site 1503)

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre ( Site 1505)

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Victoria ( Site 1504)

Málaga, , Spain

Site Status

Lanssjukhuset Ryhov ( Site 2103)

Jönköping, Jönköping County, Sweden

Site Status

Karolinska Universitetssjukhuset Solna ( Site 2100)

Stockholm, Stockholm County, Sweden

Site Status

Akademiska Sjukhuset ( Site 2105)

Uppsala, Uppsala County, Sweden

Site Status

Norrlands Universitetssjukhus ( Site 2106)

Umeå, Västerbotten County, Sweden

Site Status

Sahlgrenska Universitetssjukhuset ( Site 2102)

Gothenburg, Västra Götaland County, Sweden

Site Status

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital ( Site 4403)

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital ( Site 4404)

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital ( Site 4401)

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital ( Site 4402)

Taipei, , Taiwan

Site Status

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

Taoyuan District, , Taiwan

Site Status

Ramathibodi Hospital. ( Site 4500)

Bangkok, Bangkok, Thailand

Site Status

Siriraj Hospital ( Site 4501)

Bangkok, Bangkok, Thailand

Site Status

Ankara Universitesi Tip Fakultesi ( Site 2902)

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Universitesi Tıp Fakultesi ( Site 2903)

Ankara, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)

Edirne, , Turkey (Türkiye)

Site Status

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)

Istanbul, , Turkey (Türkiye)

Site Status

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

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)

Izmir, , Turkey (Türkiye)

Site Status

Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)

Izmir, , Turkey (Türkiye)

Site Status

Cherkasy Regional Oncology Dispensary ( Site 2704)

Cherkasy, Cherkasy Oblast, Ukraine

Site Status

Chernihiv Medical Center of Modern Oncology ( Site 2709)

Chernihiv, Chernihiv Oblast, Ukraine

Site Status

Clinical oncology dispensary of Dnipro ( Site 2700)

Dnipro, Dnipropetrovsk Oblast, Ukraine

Site Status

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

Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

Site Status

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Regional Oncology Center of Kharkiv ( Site 2708)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

Kyiv City Clinical Oncology Center ( Site 2706)

Kyiv, Kyivska Oblast, Ukraine

Site Status

Lviv State Regional Oncological Center ( Site 2712)

Lviv, Lviv Oblast, Ukraine

Site Status

Addenbrookes Hospital ( Site 3110)

Cambridge, Cambridgeshire, United Kingdom

Site Status

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

London, England, United Kingdom

Site Status

Mount Vernon Cancer Centre ( Site 3101)

Northwood, London, City of, United Kingdom

Site Status

Countries

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United States Australia Brazil Canada Chile China Colombia Croatia Czechia Denmark Finland France Germany Guatemala Hungary Ireland Italy Japan Malaysia Mexico Norway Philippines Poland Romania Russia Serbia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37882432 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36064785 (View on PubMed)

Related Links

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Other Identifiers

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MK-6482-012

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031210435

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHRR210911-003887

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-002216-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6482-012

Identifier Type: -

Identifier Source: org_study_id

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