A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Carcinoma, Renal Cell Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

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

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary