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)

Carcinoma, Renal Cell Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04736706
• Other study ID #: 6482-012
• Secondary ID: MK-6482-012jRCT2
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 14, 2021
• Est. completion date: October 29, 2026

Study information

• Verified date: March 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1653
• Est. completion date: October 29, 2026
• Est. primary completion date: October 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Biological:
• Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion

Drug:
• Belzutifan
Belzutifan 120 mg administered QD via oral tablet

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

Drug:
• Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	Eisai Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 66 months
Secondary	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.	Up to approximately 46 months
Secondary	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.	Up to approximately 66 months
Secondary	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.	Up to approximately 66 months
Secondary	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.	Up to approximately 66 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary