Melanoma Clinical Trial
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)
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).
Eligibility Criteria
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:
Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
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
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There are 276 Locations for this study
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Aurora Colorado, 80045, United States
Grand Junction Colorado, 81501, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Marietta Georgia, 30060, United States
Fort Wayne Indiana, 46845, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Grand Rapids Michigan, 49503, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59102, United States
Omaha Nebraska, 68130, United States
Englewood New Jersey, 07631, United States
New Brunswick New Jersey, 08903, United States
Lake Success New York, 11042, United States
New York New York, 10029, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Columbus Ohio, 43210, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57104, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37209, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States
Blacktown New South Wales, 2148, Australia
Macquarie University New South Wales, 2109, Australia
North Tamworth New South Wales, 2340, Australia
Brisbane Queensland, 4029, Australia
Elizabeth Vale South Australia, 5112, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Fortaleza Ceara, 60135, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Curitiba Parana, 80510, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Ribeirão Preto Sao Paulo, 14048, Brazil
Sao Paulo , 01321, Brazil
Panagyurishte Pazardzhik, 4500, Bulgaria
Sofia Sofia (stolitsa), 1301, Bulgaria
Plovdiv , 4004, Bulgaria
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montréal Quebec, H4A 3, Canada
Quebec , G1J 1, Canada
Temuco Araucania, 48008, Chile
Puerto Montt Los Lagos, 55002, Chile
Valdivia Los Rios, 51121, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 75100, Chile
Santiago Region M. De Santiago, 84203, Chile
Viña del Mar Valparaiso, 25205, Chile
Antofagasta , 12400, Chile
Bengbu Anhui, 23300, China
Hefei Anhui, 23000, China
Beijing Beijing, 10002, China
Beijing Beijing, 10003, China
Beijing Beijing, 10014, China
Beijing Beijing, 10085, China
Chongqing Chongqing, 40003, China
Chongqing Chongqing, 40004, China
Fuzhou Fujian, 35000, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51012, China
Guangzhou Guangdong, 51028, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41001, China
NanJing Jiangsu, 21000, China
Nanchang Jiangxi, 33000, China
Nanchang Jiangxi, 33000, China
Xi'an Shaanxi, 71006, China
Shanghai Shanghai, 20000, China
Shanghai Shanghai, 20000, China
Shanghai Shanghai, 20004, China
Cheng Du Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Ningbo Zhejiang, 31501, China
Wenzhou Zhejiang, 32500, China
Barranquilla Atlantico, 08002, Colombia
Valledupar Cesar, 20000, Colombia
Monteria Cordoba, 23000, Colombia
Bogotá Distrito Capital De Bogota, 11022, Colombia
Brno Brno-mesto, 656 5, Czechia
Brno Brno-mesto, 656 9, Czechia
Ostrava Moravskoslezsky Kraj, 708 5, Czechia
Olomouc Olomoucky Kraj, 779 0, Czechia
Prague Praha 4, 140 5, Czechia
Praha Praha 5, 150 0, Czechia
Hradec Kralove , 500 0, Czechia
Tampere Pirkanmaa, 33520, Finland
Oulu Pohjois-Pohjanmaa, 90220, Finland
Kuopio Pohjois-Savo, 70210, Finland
Helsinki Uusimaa, 00290, Finland
Turku Varsinais-Suomi, 20520, Finland
Strasbourg Alsace, 67200, France
Chambray Les Tours Centre, 37170, France
Besançon Doubs, 25000, France
Villejuif Ile-de-France, 94800, France
Rennes Ille-et-Vilaine, 35000, France
Angers Maine-et-Loire, 49933, France
Lyon Rhone-Alpes, 69008, France
Paris , 75010, France
Paris , 75015, France
Singen Baden-Wurttemberg, 78224, Germany
Tübingen Baden-Wurttemberg, 72076, Germany
Munich Bayern, 81675, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Bonn Nordrhein-Westfalen, 53127, Germany
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Essen Nordrhein-Westfalen, 45147, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Homburg Saarland, 66421, Germany
Halle Sachsen-Anhalt, 06120, Germany
Dresden Sachsen, 01307, Germany
Gera Thuringen, 07548, Germany
Jena Thuringen, 07747, Germany
Berlin , 10117, Germany
Berlin , 13125, Germany
Hamburg , 20246, Germany
Athens Attiki, 115 2, Greece
Athens Attiki, 185 4, Greece
Chaidari Attiki, 124 6, Greece
Thessaloniki , 546 4, Greece
Thessaloniki , 57001, Greece
Szeged Csongrad, 6725, Hungary
Gyor Gyor-Moson-Sopron, 9024, Hungary
Budapest Pest, 1122, Hungary
Kaposvár Somogy, 7400, Hungary
Debrecen , 4032, Hungary
Dublin 24 Dublin, D24 N, Ireland
Dublin 4 Dublin, , Ireland
Cork , T12 E, Ireland
Dublin , Dubli, Ireland
Be'er Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petah-Tikva , 49414, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Meldola Emilia-Romagna, 47014, Italy
Roma Lazio, 00168, Italy
Milano Lombardia, 20132, Italy
Milan Lombardia, 20133, Italy
Orbassano Piemonte, 10043, Italy
Bari Puglia, 70124, Italy
Firenze Toscana, 50134, Italy
Arezzo , 52100, Italy
Bologna , 40138, Italy
Terni , 05100, Italy
Toyoake Aichi, 470-1, Japan
Kashiwa Chiba, 277-8, Japan
Sakura Chiba, 285-8, Japan
Toon Ehime, 791-0, Japan
Sapporo Hokkaido, 060-8, Japan
Sapporo Hokkaido, 060-8, Japan
Yokohama Kanagawa, 241-8, Japan
Kashihara Nara, 634-0, Japan
Sakai Osaka, 599-8, Japan
Suita Osaka, 565-0, Japan
Hamamatsu Shizuoka, 431-3, Japan
Minato-ku Tokyo, 105-8, Japan
Toyoma Toyama, 930-0, Japan
Fukuoka , 812-8, Japan
Kagoshima , 890-8, Japan
Kumamoto , 860-8, Japan
Okayama , 700-8, Japan
Tokyo , 113-8, Japan
Tokyo , 123-8, Japan
Tokyo , 160-8, Japan
Wakayama , 641-8, Japan
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seongnam Kyonggi-do, 13620, Korea, Republic of
Songpagu Seoul, 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Lembah Pantai Kuala Lumpur, 59100, Malaysia
George Town Pulau Pinang, 10450, Malaysia
Kuching Sarawak, 93586, Malaysia
Mexico City Distrito Federal, 14070, Mexico
Mexico City Distrito Federal, 14080, Mexico
Guadalajara Jalisco, 44260, Mexico
Guadalajara Jalisco, 44280, Mexico
Guadalajara Jalisco, , Mexico
Monterrey Nuevo Leon, 64460, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Santiago de Queretaro Queretaro, 76000, Mexico
Santiago de Querétaro Queretaro, 76070, Mexico
Culiacán Sinaloa, 80040, Mexico
Oaxaca , 68020, Mexico
Puebla , 72530, Mexico
Arnhem Gelderland, 6815 , Netherlands
Nijmegen Gelderland, 6525 , Netherlands
Maastricht Limburg, 6229 , Netherlands
Breda Noord-Brabant, 4818 , Netherlands
Eindhoven Noord-Brabant, 5600 , Netherlands
Amsterdam Noord-Holland, 1105 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Hoofddorp Noord-Holland, 2134 , Netherlands
Zwolle Overijssel, 8025 , Netherlands
Den Haag Zuid-Holland, 2545 , Netherlands
Leidschendam Zuid-Holland, 2501 , Netherlands
Schiedam Zuid-Holland, 3118 , Netherlands
Groningen , 9700R, Netherlands
Utrecht , 3543 , Netherlands
Utrecht , 3584 , Netherlands
Auckland , 1023, New Zealand
Wrocław Dolnoslaskie, 50-55, Poland
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Torun Kujawsko-pomorskie, 87-10, Poland
Tarnow Malopolskie, 33-10, Poland
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 01-74, Poland
Warszawa Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Konin Wielkopolskie, 62-50, Poland
Poznań Wielkopolskie, 60-56, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Szczecin Zachodniopomorskie, 71-43, Poland
București Bucuresti, 02254, Romania
Cluj-Napoca Cluj, 40001, Romania
Florești Cluj, 40728, Romania
Craiova Dolj, 20074, Romania
Otopeni Ilfov, 07510, Romania
Timișoara Timis, 30023, Romania
Singapore Central Singapore, 16858, Singapore
Singapore South West, 11907, Singapore
Girona Gerona, 17007, Spain
Madrid Madrid, Comunidad De, 28034, Spain
Madrid Madrid, Comunidad De, 28041, Spain
Valencia Valenciana, Comunitat, 46009, Spain
Barcelona , 08035, Spain
Lugo , 27003, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Stockholm Stockholms Lan, 171 7, Sweden
Uppsala Uppsala Lan, 751 8, Sweden
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Taipei City Taipei, 114, Taiwan
Kaohsiung , 81362, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Taipei , 10022, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
Bangkok Krung Thep Maha Nakhon, 10330, Thailand
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Hatyai Songkhla, 90110, Thailand
Yenimahalle Ankara, 06200, Turkey
Istanbul- Fatih Istanbul, 34098, Turkey
Adana , 01250, Turkey
Ankara , 06010, Turkey
Ankara , 06100, Turkey
Ankara , 06230, Turkey
Istanbul , 34722, Turkey
Izmir , 35100, Turkey
London England, NW32Q, United Kingdom
Manchester England, M20 4, United Kingdom
Nottingham England, NG5 1, United Kingdom
Glasgow Glasgow City, G12 0, United Kingdom
London Hammersmith And Fulham, W6 8R, United Kingdom
London London, City Of, EC1A , United Kingdom
Swansea Wales, SA2 8, United Kingdom
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