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 More Info
La Jolla California, 92037, United States More Info
Los Angeles California, 90095, United States More Info
Orange California, 92868, United States More Info
Aurora Colorado, 80045, United States More Info
Grand Junction Colorado, 81501, United States More Info
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States More Info
Marietta Georgia, 30060, United States More Info
Fort Wayne Indiana, 46845, United States More Info
Baltimore Maryland, 21231, United States More Info
Boston Massachusetts, 02215, United States More Info
Grand Rapids Michigan, 49503, United States More Info
Saint Louis Missouri, 63110, United States More Info
Billings Montana, 59102, United States More Info
Omaha Nebraska, 68130, United States More Info
Englewood New Jersey, 07631, United States More Info
New Brunswick New Jersey, 08901, United States More Info
New York New York, 10029, United States More Info
New York New York, 10065, United States More Info
Rochester New York, 14642, United States More Info
Columbus Ohio, 43210, United States More Info
Philadelphia Pennsylvania, 19111, United States More Info
Germantown Tennessee, 38138, United States More Info
Houston Texas, 77030, United States More Info
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States More Info
Blacktown New South Wales, 2148, Australia More Info
Macquarie University New South Wales, 2109, Australia More Info
North Tamworth New South Wales, 2340, Australia More Info
Brisbane Queensland, 4029, Australia More Info
Elizabeth Vale South Australia, 5112, Australia More Info
Heidelberg Victoria, 3084, Australia More Info
Murdoch Western Australia, 6150, Australia More Info
Belo Horizonte Minas Gerais, 30130, Brazil More Info
Natal Rio Grande Do Norte, 59075, Brazil More Info
Porto Alegre Rio Grande Do Sul, 91350, Brazil More Info
Ribeirão Preto Sao Paulo, 14048, Brazil More Info
Sao Paulo , 01321, Brazil
Panagyurishte Pazardzhik, 4500, Bulgaria More Info
Sofia Sofia (stolitsa), 1301, Bulgaria More Info
Plovdiv , 4004, Bulgaria More Info
Vancouver British Columbia, V5Z 4, Canada More Info
Hamilton Ontario, L8V 5, Canada More Info
London Ontario, N6A 5, Canada More Info
Montreal Quebec, H1T 2, Canada
Quebec , G1J 1, Canada More Info
Bengbu Anhui, 23300, China More Info
Hefei Anhui, 23000, China More Info
Beijing Beijing, 10002, China More Info
Beijing Beijing, 10085, China More Info
Chongqing Chongqing, 40004, China More Info
Fuzhou Fujian, 35000, China More Info
Guangzhou Guangdong, 51006, China More Info
Guangzhou Guangdong, 51012, China More Info
Guangzhou Guangdong, 51012, China More Info
Wuhan Hubei, 43003, China More Info
Nanjing Jiangsu, 21000, China More Info
Nanchang Jiangxi, 33000, China More Info
Nanchang Jiangxi, 33000, China More Info
Xi'an Shaanxi, 71006, China More Info
Shanghai Shanghai, 20000, China More Info
Shanghai Shanghai, 20003, China More Info
Shanghai Shanghai, 20004, China More Info
Cheng Du Sichuan, 61004, China More Info
Tianjin Tianjin, 30006, China More Info
Hangzhou Zhejiang, 31000, China More Info
Hangzhou Zhejiang, 31001, China More Info
Wenzhou Zhejiang, 32500, China More Info
Valledupar Cesar, 20000, Colombia More Info
Bogotá Distrito Capital De Bogota, 11022, Colombia
Brno Brno-mesto, 602 0, Czechia
Brno Brno-mesto, 656 5, Czechia More Info
Ostrava Moravskoslezsky Kraj, 708 5, Czechia More Info
Olomouc Olomoucky Kraj, 779 0, Czechia More Info
Prague Praha 4, 140 5, Czechia More Info
Praha Praha 5, 150 0, Czechia More Info
Hradec Kralove , 500 0, Czechia More Info
Kuopio Pohjois-Savo, 70210, Finland More Info
Helsinki Uusimaa, 00290, Finland More Info
Strasbourg Alsace, 67033, France More Info
Rennes Ille-et-Vilaine, 35033, France More Info
Angers Maine-et-Loire, 49933, France More Info
Paris , 75015, France More Info
Munich Bayern, 81675, Germany More Info
Düsseldorf Nordrhein-Westfalen, 40225, Germany More Info
Münster Nordrhein-Westfalen, 48149, Germany More Info
Homburg Saarland, 66421, Germany
Halle Sachsen-Anhalt, 06120, Germany More Info
Dresden Sachsen, 01307, Germany More Info
Hamburg , 20246, Germany More Info
Thessaloniki , 546 4, Greece More Info
Thessaloniki , 57001, Greece
Szeged Csongrad, 6725, Hungary More Info
Gyor Gyor-Moson-Sopron, 9024, Hungary More Info
Budapest Pest, 1122, Hungary More Info
Kaposvár Somogy, 7400, Hungary More Info
Debrecen , 4032, Hungary More Info
Dublin , Dubli, Ireland More Info
Meldola Emilia-Romagna, 47014, Italy More Info
Roma Lazio, 00168, Italy More Info
Milan Lombardia, 20133, Italy More Info
Orbassano Piemonte, 10043, Italy More Info
Firenze Toscana, 50134, Italy More Info
Goyang-si Kyonggi-do, 10408, Korea, Republic of More Info
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Mexico City Distrito Federal, 14070, Mexico More Info
Mexico City Distrito Federal, 14080, Mexico More Info
Guadalajara Jalisco, 44280, Mexico More Info
Santiago de Queretaro Queretaro, 76000, Mexico More Info
Santiago de Querétaro Queretaro, 76070, Mexico More Info
Arnhem Gelderland, 6815 , Netherlands More Info
Breda Noord-Brabant, 4818 , Netherlands More Info
Eindhoven Noord-Brabant, 5600 , Netherlands More Info
Hilversum Noord-Holland, 1213 , Netherlands More Info
Hoofddorp Noord-Holland, 2134 , Netherlands More Info
Den Haag Zuid-Holland, 2545 , Netherlands More Info
Leidschendam Zuid-Holland, 2501 , Netherlands More Info
Schiedam Zuid-Holland, 3118 , Netherlands More Info
Utrecht , 3543 , Netherlands More Info
Utrecht , 3584 , Netherlands More Info
Wrocław Dolnoslaskie, 50-55, Poland More Info
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland More Info
Tarnow Malopolskie, 33-10, Poland More Info
Siedlce Mazowieckie, 08-11, Poland More Info
Warszawa Mazowieckie, 02-78, Poland More Info
Poznań Wielkopolskie, 60-56, Poland More Info
Koszalin Zachodniopomorskie, 75-58, Poland More Info
Szczecin Zachodniopomorskie, 71-43, Poland More Info
Florești Cluj, 40728, Romania More Info
Craiova Dolj, 20074, Romania More Info
Singapore Central Singapore, 16858, Singapore More Info
Madrid Madrid, Comunidad De, 28034, Spain More Info
Madrid Madrid, Comunidad De, 28041, Spain More Info
Valencia Valenciana, Comunitat, 46009, Spain More Info
Barcelona , 08035, Spain More Info
Malaga , 29010, Spain More Info
Stockholm Stockholms Lan, 171 7, Sweden More Info
Uppsala Uppsala Lan, 751 8, Sweden More Info
Gothenburg Vastra Gotalands Lan, 413 4, Sweden More Info
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan More Info
Taichung , 40447, Taiwan More Info
Bangkok Krung Thep Maha Nakhon, 10700, Thailand More Info
Istanbul- Fatih Istanbul, 34098, Turkey More Info
Adana , 01250, Turkey More Info
Istanbul , 34722, Turkey More Info
Nottingham England, NG5 1, United Kingdom More Info
Glasgow Glasgow City, G12 0, United Kingdom More Info
London London, City Of, EC1A , United Kingdom More Info
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