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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05239728
Other study ID # 6482-022
Secondary ID MK-6482-022LITES
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 15, 2022
Est. completion date September 28, 2029

Study information

Verified date April 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1800
Est. completion date September 28, 2029
Est. primary completion date October 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features - Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, =2 years from nephrectomy (metachronous) - Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants - Must have undergone a nephrectomy and/or metastasectomy =12 weeks prior to randomization - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization. - Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo - Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last - Has adequate organ function Exclusion Criteria: - Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization - Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen - Has clinically significant cardiovascular disease within 6 months from first dose of study intervention - Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis - Has preexisting brain or bone metastatic lesions - Has received prior systemic therapy for RCC - Has received prior radiotherapy for RCC - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years - Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection, requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection - Has had an allogenic tissue/solid organ transplant

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Biological:
Pembrolizumab
400 mg via IV infusion
Drug:
Placebo
Oral tablet

Locations

Country Name City State
Australia Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002) Blacktown New South Wales
Australia Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si Brisbane Queensland
Australia Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008) Elizabeth Vale South Australia
Australia Austin Health-Cancer Clinical Trials Centre ( Site 0005) Heidelberg Victoria
Australia Macquarie University-MQ Health Clinical Trials Unit ( Site 0003) Macquarie University New South Wales
Australia Fiona Stanley Hospital-Medical Oncology ( Site 0004) Murdoch Western Australia
Australia Tamworth Hospital-North West Cancer Centre ( Site 0006) North Tamworth New South Wales
Brazil Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105) Belo Horizonte Minas Gerais
Brazil Instituto do Câncer e Transplante de Curitiba ( Site 0102) Curitiba Parana
Brazil Hospital São Carlos-Oncocentro Ce ( Site 0104) Fortaleza Ceara
Brazil Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103) Natal Rio Grande Do Norte
Brazil Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101) Porto Alegre Rio Grande Do Sul
Brazil Hospital de Clínicas de Ribeirão Preto ( Site 0112) Ribeirão Preto Sao Paulo
Brazil BP - A Beneficencia Portuguesa de São Paulo ( Site 0111) Sao Paulo
Bulgaria MBAL Uni Hospital-Department of Medical Oncology ( Site 0204) Panagyurishte Pazardzhik
Bulgaria Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205) Plovdiv
Bulgaria MHAT Serdika-Second Department of Medical Oncology ( Site 0203) Sofia Sofia (stolitsa)
Canada Tom Baker Cancer Center ( Site 3706) Calgary Alberta
Canada Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710) Hamilton Ontario
Canada Victoria Hospital & Children's Hospital - London Health Scie-London Regional Cancer Program ( Site 3 London Ontario
Canada CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708) Montreal Quebec
Canada McGill University Health Centre ( Site 3709) Montréal Quebec
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3 Quebec
Canada Princess Margaret Cancer Centre ( Site 3703) Toronto Ontario
Canada BC Cancer Vancouver-Clinical Trials Unit ( Site 3707) Vancouver British Columbia
Chile Bradford Hill Norte ( Site 0303) Antofagasta
Chile Clínica Puerto Montt ( Site 0309) Puerto Montt Los Lagos
Chile Bradfordhill ( Site 0305) Santiago Region M. De Santiago
Chile FALP-UIDO ( Site 0302) Santiago Region M. De Santiago
Chile Oncovida ( Site 0306) Santiago Region M. De Santiago
Chile James Lind Centro de Investigación del Cáncer ( Site 0307) Temuco Araucania
Chile Oncocentro Valdivia ( Site 0312) Valdivia Los Rios
Chile ONCOCENTRO APYS-ACEREY ( Site 0301) Viña del Mar Valparaiso
China Beijing Cancer hospital-Urinary Surgery ( Site 0406) Beijing Beijing
China Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 0435) Beijing Beijing
China First Medical Center of Chinese PLA General Hospital ( Site 0415) Beijing Beijing
China Peking University First Hospital-Urology ( Site 0407) Beijing Beijing
China Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 0438) Bengbu Anhui
China Hunan Cancer Hospital ( Site 0421) Changsha Hunan
China West China Hospital of Sichuan University-Urology Surgery ( Site 0410) Cheng Du Sichuan
China Army Medical Center of People's Liberation Army ( Site 0439) Chongqing Chongqing
China Chongqing University Cancer Hospital ( Site 0414) Chongqing Chongqing
China The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0445) Fuzhou Fujian
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0402) Guangzhou Guangdong
China SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417) Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0403) Guangzhou Guangdong
China The First Affiliated Hospital, Zhejiang University ( Site 0428) Hangzhou Zhejiang
China Zhejiang Provincial People's Hospital-Urology ( Site 0426) Hangzhou Zhejiang
China Second Affiliated hospital of Anhui Medical University-Urology ( Site 0416) Hefei Anhui
China The First Affiliated Hospital of Nanchang University ( Site 0432) Nanchang Jiangxi
China The Second Affiliated Hospital of Nanchang University ( Site 0443) 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 0433) Ningbo Zhejiang
China Fudan University Shanghai Cancer Center-Urology department ( Site 0401) Shanghai Shanghai
China Huadong Hospital Affiliated to Fudan University ( Site 0405) Shanghai Shanghai
China Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418) Shanghai Shanghai
China Tianjin Medical University Cancer Institute and Hospital ( Site 0422) Tianjin Tianjin
China The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0425) Wenzhou Zhejiang
China Hubei Cancer Hospital-Urinary surgery ( Site 0419) Wuhan Hubei
China Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0423) Wuhan Hubei
China Wuhan Union Hospital ( Site 0430) Wuhan Hubei
China The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431) Xi'an Shaanxi
China Henan Cancer Hospital-Urology ( Site 0441) Zhengzhou Henan
Colombia Clinica de la Costa S.A.S. ( Site 0506) Barranquilla Atlantico
Colombia Administradora Country S.A. - Clinica del Country ( Site 0504) Bogotá Distrito Capital De Bogota
Colombia Oncomédica S.A.S ( Site 0501) Monteria Cordoba
Colombia Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505) Valledupar Cesar
Czechia Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603) Brno Brno-mesto
Czechia Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605) Brno Brno-mesto
Czechia Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604) Hradec Kralove
Czechia Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601) Olomouc Olomoucky Kraj
Czechia Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606) Ostrava Moravskoslezsky Kraj
Czechia Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602) Prague Praha 4
Czechia Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607) Praha Praha 5
Finland Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803) Helsinki Uusimaa
Finland Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804) Kuopio Pohjois-Savo
Finland Oulun yliopistollinen sairaala ( Site 0802) Oulu Pohjois-Pohjanmaa
Finland Tampereen yliopistollinen sairaala ( Site 0805) Tampere Pirkanmaa
Finland Turku University Hospital ( Site 0801) Turku Varsinais-Suomi
France Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901) Angers Maine-et-Loire
France CHU Besançon-Medical oncology ( Site 0904) Besançon Doubs
France ROC37 ( Site 0910) Chambray Les Tours Centre
France CENTRE LEON BERARD-Medical oncology ( Site 0902) Lyon Rhone-Alpes
France Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906) Paris
France Hôpital Saint-Louis ( Site 0905) Paris
France Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908) Rennes Ille-et-Vilaine
France Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903) Strasbourg Alsace
France Gustave Roussy ( Site 0907) Villejuif Ile-de-France
Germany Universitätsklinikum Aachen ( Site 1024) Aachen Nordrhein-Westfalen
Germany Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022) Berlin
Germany Helios Klinikum Berlin-Buch ( Site 1011) Berlin
Germany Universitätsklinikum Bonn ( Site 1006) Bonn Nordrhein-Westfalen
Germany Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021) Dresden Sachsen
Germany Universitaetsklinikum Duesseldorf ( Site 1017) Düsseldorf Nordrhein-Westfalen
Germany Universitaetsklinikum Essen ( Site 1004) Essen Nordrhein-Westfalen
Germany SRH Wald-Klinikum Gera ( Site 1015) Gera Thuringen
Germany Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie ( Halle Sachsen-Anhalt
Germany Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001) Hamburg
Germany Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020) Homburg Saarland
Germany Universitätsklinikum Jena ( Site 1007) Jena Thuringen
Germany klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit Munich Bayern
Germany Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005) Münster Nordrhein-Westfalen
Germany Hegau-Bodensee-Klinikum Singen ( Site 1016) Singen Baden-Wurttemberg
Germany Universitaetsklinikum Tuebingen ( Site 1002) Tübingen Baden-Wurttemberg
Greece Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102) Athens Attiki
Greece Metropolitan Hospital-2nd Oncology Dept ( Site 1104) Athens Attiki
Greece ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101) Chaidari Attiki
Greece Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103) Thessaloniki
Greece European Interbalkan Medical Center-Oncology Department ( Site 1105) Thessaloniki
Hungary Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316) Budapest Pest
Hungary Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310) Debrecen
Hungary Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321) Gyor Gyor-Moson-Sopron
Hungary Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311) Kaposvár Somogy
Hungary Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319) Szeged Csongrad
Ireland Cork University Hospital ( Site 1404) Cork
Ireland Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403) Dublin
Ireland Tallaght University Hospital ( Site 1402) Dublin 24 Dublin
Ireland St. Vincent's University Hospital ( Site 1401) Dublin 4 Dublin
Israel Soroka Medical Center ( Site 1505) Be'er Sheva
Israel Rambam Health Care Campus-Oncology ( Site 1502) Haifa
Israel Hadassah Medical Center-Oncology ( Site 1506) Jerusalem
Israel Rabin Medical Center-Oncology ( Site 1503) Petah-Tikva
Israel Sheba Medical Center-ONCOLOGY ( Site 1504) Ramat Gan
Israel Sourasky Medical Center-Oncology ( Site 1501) Tel Aviv
Italy Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610) Arezzo
Italy A.O.U.C. Policlinico di Bari ( Site 1607) Bari Puglia
Italy IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605) Bologna
Italy Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601) Firenze Toscana
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603) Meldola Emilia-Romagna
Italy Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608) Milan Lombardia
Italy Ospedale San Raffaele-Oncologia Medica ( Site 1606) Milano Lombardia
Italy Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602) Orbassano Piemonte
Italy Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604) Roma Lazio
Italy Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609) Terni
Japan Kyushu University Hospital ( Site 1715) Fukuoka
Japan Hamamatsu University Hospital ( Site 1708) Hamamatsu Shizuoka
Japan Kagoshima University Hospital ( Site 1719) Kagoshima
Japan Nara Medical University Hospital ( Site 1712) Kashihara Nara
Japan National Cancer Center Hospital East ( Site 1704) Kashiwa Chiba
Japan Kumamoto University ( Site 1716) Kumamoto
Japan Toranomon Hospital ( Site 1706) Minato-ku Tokyo
Japan Okayama University Hospital ( Site 1720) Okayama
Japan Bell Land General Hospital ( Site 1710) Sakai Osaka
Japan Toho University Sakura Medical Center ( Site 1718) Sakura Chiba
Japan Hokkaido University Hospital ( Site 1701) Sapporo Hokkaido
Japan Sapporo Medical University Hospital ( Site 1702) Sapporo Hokkaido
Japan Osaka University Hospital ( Site 1711) Suita Osaka
Japan Keio university hospital ( Site 1707) Tokyo
Japan Nippon Medical School Hospital ( Site 1705) Tokyo
Japan Tokyo Women's Medical University Adachi Medical Center ( Site 1717) Tokyo
Japan Ehime University Hospital ( Site 1714) Toon Ehime
Japan Fujita Health University ( Site 1709) Toyoake Aichi
Japan Toyama University Hospital ( Site 1713) Toyoma Toyama
Japan Wakayama Medical University Hospital ( Site 1721) Wakayama
Japan Kanagawa cancer center ( Site 1703) Yokohama Kanagawa
Korea, Republic of National Cancer Center-Center for Urologic Cancer ( Site 2604) Goyang-si Kyonggi-do
Korea, Republic of Seoul National University Bundang Hospital-Urology ( Site 2602) Seongnam Kyonggi-do
Korea, Republic of Samsung Medical Center ( Site 2603) Seoul
Korea, Republic of Asan Medical Center-Oncology ( Site 2601) Songpagu Seoul
Malaysia Hospital Pulau Pinang ( Site 1806) George Town Pulau Pinang
Malaysia Sarawak General Hospital-Radiotherapy Unit ( Site 1805) Kuching Sarawak
Malaysia University Malaya Medical Centre ( Site 1804) Lembah Pantai Kuala Lumpur
Mexico Centro de Oncología Personalizada ( Site 1911) Culiacán Sinaloa
Mexico BRCR Global Mexico - Guadalajara-Research ( Site 1908) Guadalajara Jalisco
Mexico Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906) Guadalajara Jalisco
Mexico Terapias Integrales del Riñon SA de CV ( Site 1910) Guadalajara Jalisco
Mexico INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902) Mexico City Distrito Federal
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1 Mexico City Distrito Federal
Mexico Filios Alta Medicina ( Site 1903) Monterrey Nuevo Leon
Mexico iCan Oncology Center Centro Medico AVE ( Site 1901) Monterrey Nuevo Leon
Mexico Centro de Investigacion Clinica de Oaxaca ( Site 1904) Oaxaca
Mexico Oncocenter ( Site 1909) Puebla
Mexico Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905) Santiago de Queretaro Queretaro
Mexico BRCR Global Mexico - Queretaro-SMIQ ( Site 1907) Santiago de Querétaro Queretaro
Netherlands Amsterdam UMC, locatie AMC ( Site 3105) Amsterdam Noord-Holland
Netherlands Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113) Arnhem Gelderland
Netherlands Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103) Breda Noord-Brabant
Netherlands Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108) Den Haag Zuid-Holland
Netherlands Maxima Medisch Centrum, locatie Eindhoven ( Site 3116) Eindhoven Noord-Brabant
Netherlands University Medical Center Groningen ( Site 3121) Groningen
Netherlands Tergooiziekenhuizen, locatie Hilversum ( Site 3102) Hilversum Noord-Holland
Netherlands Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107) Hoofddorp Noord-Holland
Netherlands Haaglanden MC - locatie Antoniushove ( Site 3117) Leidschendam Zuid-Holland
Netherlands Maastricht UMC+ ( Site 3104) Maastricht Limburg
Netherlands Radboudumc ( Site 3120) Nijmegen Gelderland
Netherlands Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101) Schiedam Zuid-Holland
Netherlands St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112) Utrecht
Netherlands Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106) Utrecht
Netherlands Isala, locatie Zwolle-Oncology ( Site 3111) Zwolle Overijssel
New Zealand Auckland City Hospital-Cancer & Blood Research ( Site 2003) Auckland
Poland Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307) Bydgoszcz Kujawsko-pomorskie
Poland Przychodnia Lekarska KOMED ( Site 2304) Konin Wielkopolskie
Poland Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302) Koszalin Zachodniopomorskie
Poland Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 2312) Poznan Wielkopolskie
Poland Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306) Przemysl Podkarpackie
Poland Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313) Siedlce Mazowieckie
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315) Szczecin Zachodniopomorskie
Poland Szpital Wojewódzki im. Swietego Lukasza SP ZOZ w Tarnowie ( Site 2311) Tarnow Malopolskie
Poland MICS Centrum Medyczne Torun ( Site 2305) Torun Kujawsko-pomorskie
Poland Luxmed Onkologia sp. z o. o. ( Site 2303) Warszawa Mazowieckie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Warszawa Mazowieckie
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu ( Site 2309) Wroclaw Dolnoslaskie
Romania Centrul medical Focus ( Site 2407) Bucure?ti Bucuresti
Romania Cardiomed SRL Cluj-Napoca ( Site 2406) Cluj-Napoca Cluj
Romania Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2401) Craiova Dolj
Romania Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405) Flore?ti Cluj
Romania Radiology Therapeutic Center-Oncology ( Site 2404) Otopeni Ilfov
Romania Cabinet Medical Oncomed ( Site 2403) Timi?oara Timis
Singapore National Cancer Centre Singapore ( Site 3601) Singapore Central Singapore
Singapore National University Hospital ( Site 3602) Singapore South West
Spain Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702) Barcelona
Spain Institut Català d'Oncologia (ICO) - Girona ( Site 2707) Girona Gerona
Spain Hospital Lucus Augusti-Oncology ( Site 2706) Lugo
Spain Hospital Clinico San Carlos-Oncology Department ( Site 2703) Madrid
Spain Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708) Madrid Madrid, Comunidad De
Spain Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710) Madrid Madrid, Comunidad De
Spain Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709) Malaga
Spain Fundación Instituto Valenciano de Oncología ( Site 2705) Valencia Valenciana, Comunitat
Sweden Sahlgrenska Universitetssjukhuset ( Site 2801) Gothenburg Vastra Gotalands Lan
Sweden Karolinska Universitetssjukhuset Solna ( Site 2802) Stockholm Stockholms Lan
Sweden Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803) Uppsala Uppsala Lan
Taiwan Kaohsiung Veterans General Hospital ( Site 2901) Kaohsiung
Taiwan Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905) Kaohsiung Niao Sung Dist Kaohsiung
Taiwan China Medical University Hospital-Department of Urology ( Site 2907) Taichung
Taiwan Taichung Veterans General Hospital ( Site 2902) Taichung
Taiwan National Taiwan University Hospital ( Site 2904) Taipei
Taiwan Taipei Veterans General Hospital ( Site 2903) Taipei
Taiwan Tri-Service General Hospital ( Site 2908) Taipei City Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906) Taoyuan
Thailand Chulalongkorn University ( Site 3005) Bangkok Krung Thep Maha Nakhon
Thailand Faculty of Medicine Siriraj Hospital ( Site 3002) Bangkok Krung Thep Maha Nakhon
Thailand Ramathibodi Hospital ( Site 3001) Bangkok Krung Thep Maha Nakhon
Thailand Songklanagarind hospital ( Site 3004) Hatyai Songkhla
Turkey Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208) Adana
Turkey Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207) Ankara
Turkey Ankara University Hospital Cebeci ( Site 3209) Ankara
Turkey Hacettepe Universitesi-oncology hospital ( Site 3203) Ankara
Turkey TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201) Istanbul
Turkey Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204) Istanbul- Fatih Istanbul
Turkey Ege University Medicine of Faculty-Medical Oncology ( Site 3202) Izmir
Turkey Ankara Bilkent Sehir Hastanesi-oncology ( Site 3206) Yenimahalle Ankara
United Kingdom Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305) Glasgow Glasgow City
United Kingdom Charing Cross Hospital ( Site 3302) London Hammersmith And Fulham
United Kingdom Royal Free Hospital ( Site 3304) London England
United Kingdom St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307) London London, City Of
United Kingdom The Christie NHS Foundation Trust ( Site 3301) Manchester England
United Kingdom City Hospital, Nottingham University Hospitals ( Site 3303) Nottingham England
United Kingdom Singleton Hospital ( Site 3306) Swansea Wales
United States University of Colorado Anschutz Medical Campus ( Site 3514) Aurora Colorado
United States MidLantic urology ( Site 3501) Bala-Cynwyd Pennsylvania
United States Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549) Baltimore Maryland
United States St. Vincent Frontier Cancer Center-Research ( Site 3506) Billings Montana
United States Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572) Boston Massachusetts
United States Dana-Farber Cancer Institute-GU ( Site 3505) Boston Massachusetts
United States Massachusetts General Hospital ( Site 3571) Boston Massachusetts
United States The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C Columbus Ohio
United States UT Southwestern Medical Center ( Site 3529) Dallas Texas
United States City of Hope Comprehensive Cancer Center ( Site 3567) Duarte California
United States Englewood Hospital and Medical Center ( Site 3557) Englewood New Jersey
United States Inova Schar Cancer Institute ( Site 3525) Fairfax Virginia
United States Parkview Research Center at Parkview Regional Medical Center ( Site 3526) Fort Wayne Indiana
United States The West Clinic, PLLC dba West Cancer Center ( Site 3522) Germantown Tennessee
United States St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 3562) Grand Junction Colorado
United States Cancer and Hematology Centers of Western Michigan ( Site 3502) Grand Rapids Michigan
United States University of Texas MD Anderson Cancer Center-Urology ( Site 3569) Houston Texas
United States Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516) La Jolla California
United States Monter Cancer Center ( Site 3560) Lake Success New York
United States UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro Los Angeles California
United States Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) Marietta Georgia
United States University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35 Miami Florida
United States Urology Associates ( Site 3512) Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey ( Site 3541) New Brunswick New Jersey
United States Icahn School of Medicine at Mount Sinai ( Site 3539) New York New York
United States Memorial Sloan Kettering Cancer Center ( Site 3568) New York New York
United States Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550) Omaha Nebraska
United States University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518) Orange California
United States Stanford Cancer Center ( Site 3523) Palo Alto California
United States Fox Chase Cancer Center-GU Oncology ( Site 3535) Philadelphia Pennsylvania
United States Mayo Clinic in Arizona - Phoenix ( Site 3554) Phoenix Arizona
United States University of Rochester Medical Center ( Site 3528) Rochester New York
United States Washington University-Internal Medicine/Oncology ( Site 3531) Saint Louis Missouri
United States Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524) Seattle Washington
United States Sanford Cancer Center ( Site 3551) Sioux Falls South Dakota
United States Moffitt Cancer Center ( Site 3540) Tampa Florida
United States Georgetown University Medical Center ( Site 3534) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Romania,  Singapore,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-Free Survival (DFS) DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented. Up to approximately 54 months
Secondary Overall Survival (OS) OS is defined as the time from randomization to death due to any cause. Up to approximately 89 months
Secondary Number of Participants Who Experience 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported. Up to approximately 66 weeks
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued the study due to an AE will be reported. Up to approximately 54 weeks
Secondary Disease Recurrence-Specific Survival 1 (DRSS1) DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event. Up to approximately 54 months
Secondary Disease Recurrence-Specific Survival 2 (DRSS2) DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by investigator. Up to approximately 54 months
Secondary Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of participants with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented. Baseline (Day 1) and up to approximately 36 months
Secondary Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. Baseline (Day 1) and up to approximately 36 months
Secondary Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher score indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. Baseline (Day 1) and up to approximately 36 months
Secondary Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. Change from baseline in the score of FKSI-DRS Items 1-9 will be presented. Baseline (Day 1) and up to approximately 36 months
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