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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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