Melanoma Clinical Trial
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Eligibility Criteria
Inclusion Criteria:
Has histologically confirmed diagnosis of RCC with clear cell component.
Has received no prior systemic therapy for advanced ccRCC
Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function.
Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
Has clinically significant cardiac disease within 12 months from first dose of study intervention
Has a history of interstitial lung disease
Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
Has preexisting gastrointestinal or non-gastrointestinal fistula
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B
Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
Has clinically significant history of bleeding within 3 months prior to randomization
Has had an allogenic tissue/solid organ transplant
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There are 251 Locations for this study
Birmingham Alabama, 35294, United States More Info
Santa Monica California, 90404, United States More Info
Orlando Florida, 32804, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30322, United States More Info
Chicago Illinois, 60607, United States
Fort Wayne Indiana, 46845, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70121, United States
Scarborough Maine, 04074, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Burlington Massachusetts, 01805, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States More Info
Saint Louis Park Minnesota, 55426, United States
Saint Paul Minnesota, 55101, United States
Jackson Mississippi, 39216, United States
Lebanon New Hampshire, 03756, United States
Lake Success New York, 11042, United States More Info
New York New York, 10065, United States
Charleston South Carolina, 29401, United States
Knoxville Tennessee, 37920, United States More Info
Nashville Tennessee, 37232, United States More Info
Dallas Texas, 75390, United States
Wenatchee Washington, 98801, United States
Liverpool New South Wales, 2170, Australia
Macquarie University New South Wales, 2109, Australia
Elizabeth Vale South Australia, 5112, Australia
Clayton Victoria, 3168, Australia
Murdock Western Australia, 6150, Australia
Fortaleza Ceara, 60135, Brazil
Cachoeiro de Itapemirim Espirito Santo, 29308, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01525, Brazil
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M4N 3, Canada
Quebec , G1J 1, Canada
Temuco Araucania, 48008, Chile
La Serena Coquimbo, 17204, Chile
Rancagua Lbtdr Gen Bernardo O Higgins, 28524, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 84203, Chile
Beijing Beijing, 10002, China More Info
Beijing Beijing, 10014, China More Info
Fuzhou Fujian, 35000, China More Info
Xiamen Fujian, 36100, China More Info
Guangzhou Guangdong, 51012, China More Info
Guangzhou Guangdong, 51012, China More Info
Harbin Heilongjiang, 15008, China More Info
Nanjing Jiangsu, 21000, China More Info
Suzhou Jiangsu, 21500, China More Info
Nanchang Jiangxi, 33000, China More Info
Xi'an Shaanxi, 71006, China More Info
Shanghai Shanghai, 20000, China More Info
Cheng Du Sichuan, 61004, China More Info
Tianjin Tianjin, 30006, China More Info
Tianjin Tianjin, 30021, China More Info
Hangzhou Zhejiang, 31000, China More Info
Wenzhou Zhejiang, 32500, China More Info
Medellin Antioquia, 05002, Colombia
Barranquilla Atlantico, 08002, Colombia
Valledupar Cesar, 20000, Colombia
Bogota Distrito Capital De Bogota, 11022, Colombia
Bogotá Distrito Capital De Bogota, 11151, Colombia
Pereira Risaralda, 66000, Colombia
Piedecuesta Santander, 68017, Colombia
Zagreb Grad Zagreb, 10000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Zagreb Zagrebacka Zupanija, 10000, Croatia
Brno Brno-mesto, 656 5, Czechia
Brno Jihomoravsky Kraj, 656 9, Czechia
Novy Jicin Moravskoslezsky Kraj, 741 0, Czechia
Ostrava Moravskoslezsky Kraj, 708 5, Czechia
Olomouc , 779 0, Czechia
Praha 4 , 140 5, Czechia
Praha 5 , 150 0, Czechia
Herlev Hovedstaden, 2730, Denmark
Odense Syddanmark, 5000, Denmark
Tampere Pirkanmaa, 33520, Finland
Kuopio Pohjois-Savo, 70210, Finland
Helsinki Uusimaa, 00290, Finland
Turku Varsinais-Suomi, 20520, Finland
Marseille Bouches-du-Rhone, 13009, France
Besancon Doubs, 25000, France
Toulouse Haute-Garonne, 31059, France
Angers Maine-et-Loire, 49933, France
Beuvry Nord-Pas-de-Calais, 62660, France
Pierre Benite Rhone, 69310, France
Villejuif Val-de-Marne, 94800, France
Paris , 75020, France
Tuebingen Baden-Wurttemberg, 72076, Germany
Schwerin Mecklenburg-Vorpommern, 19049, Germany
Berlin , 10117, Germany
Salcaja Quetzaltenango, 09002, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01015, Guatemala
Guatemala , 01015, Guatemala
Guatemala , 01016, Guatemala
Quetzaltenango , 09001, Guatemala
Kecskemét Bacs-Kiskun, 6000, Hungary
Gyula Bekes, 5700, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Dublin , D09 V, Ireland
Dublin , D24 N, Ireland
Modena Emilia-Romagna, 41100, Italy
Milano Lombardia, 20132, Italy
Rome Roma, 00168, Italy
Bari , 70124, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Terni , 05100, Italy
Toyoake Aichi, 470-1, Japan
Chiba-shi Chiba, 260-8, Japan
Kashiwa Chiba, 277-8, Japan
Toon Ehime, 791-0, Japan
Sapporo Hokkaido, 060-8, Japan
Sapporo Hokkaido, 060-8, Japan
Yokohama Kanagawa, 241-8, Japan
Kashihara Nara, 634-8, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Hidaka-city Saitama, 350-1, Japan
Hamamatsu Shizuoka, 431-3, Japan
Bunkyō Tokyo, 113-8, Japan
Minato-ku Tokyo, 105-8, Japan
Toyoma Toyama, 930-0, Japan
Fukuoka , 812-8, Japan
Kumamoto , 860-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Tokushima , 770-8, Japan
Tokyo , 113-8, Japan
Tokyo , 123-8, Japan
Tokyo , 160-8, Japan
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Johor Bahru Johor, 81100, Malaysia
Putrajaya Wilayah Persekutuan Putrajaya, 62250, Malaysia
Kuala Lumpur , 50586, Malaysia
Kuala Lumpur , 59100, Malaysia
Guadalajara Jalisco, 44280, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Santiago de Queretaro Queretaro, 76000, Mexico
Cdmx , 14080, Mexico
Oaxaca , 68020, Mexico
Lorenskog Akershus, 1478, Norway
Kristiansand Aust-Agder, 4615, Norway
Bergen Hordaland, 5021, Norway
Gralum Ostfold, 1714, Norway
Trondheim Sor-Trondelag, 7030, Norway
Oslo , 0379, Norway
Manila National Capital Region, 1000, Philippines
Pasig City National Capital Region, 1605, Philippines
San Juan National Capital Region, 1502, Philippines
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Radom Mazowieckie, 26-60, Poland
Warszawa Mazowieckie, 01-74, Poland
Warszawa Mazowieckie, 02-78, Poland
Konin Wielkopolskie, 62-50, Poland
Poznan Wielkopolskie, 60-56, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Alba Iulia Alba, 51000, Romania
Craiova Dolj, 20074, Romania
Bucuresti , 02254, Romania
Barnaul Altayskiy Kray, 65604, Russian Federation
Ivanovo Ivanovskaya Oblast, 15304, Russian Federation
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Moscow Moskva, 11112, Russian Federation
Moscow Moskva, 12909, Russian Federation
Nizhniy Novgorod Nizhegorodskaya Oblast, 60308, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Sankt-Petersburg Sankt-Peterburg, 19825, Russian Federation
Belgrade Beograd, 11210, Serbia
Nis Nisavski Okrug, 18000, Serbia
Sremska Kamenica Sremski Okrug, 21204, Serbia
Port Elizabeth Eastern Cape, 6045, South Africa
Johannesburg Gauteng, 2193, South Africa
Johannesburg Gauteng, 2196, South Africa
Pretoria Gauteng, 0002, South Africa
Pretoria Gauteng, 0040, South Africa
Pretoria Gauteng, 0181, South Africa
Vereeniging Gauteng, 1939, South Africa
Cape Town Western Cape, 7925, South Africa
Kraaifontein Western Cape, 7570, South Africa
Rondebosch Western Cape, 7700, South Africa
L Hospitalet De Llobregat Barcelona, 08908, Spain
Santander Cantabria, 39008, Spain
Girona Gerona, 17007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29016, Spain
Jonkoping Jonkopings Lan, 551 8, Sweden
Stockholm Stockholms Lan, 171 7, Sweden
Uppsala Uppsala Lan, 751 8, Sweden
Umea Vasterbottens Lan, 901 8, Sweden
Goteborg Vastra Gotalands Lan, 413 4, Sweden
Kaohsiung , 833, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Ankara , 06100, Turkey
Ankara , 06100, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34722, Turkey
Izmir , 35040, Turkey
Izmir , 35340, Turkey
Cherkasy Cherkaska Oblast, 18009, Ukraine
Chernihiv Chernihivska Oblast, 14029, Ukraine
Dnipropetrovsk Dnipropetrovska Oblast, 49005, Ukraine
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76008, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kharkiv Kharkivska Oblast, 61000, Ukraine
Kharkiv Kharkivska Oblast, 61037, Ukraine
Kyiv Kyivska Oblast, 03115, Ukraine
Lviv Lvivska Oblast, 79031, Ukraine
Cambridge Cambridgeshire, CB2 0, United Kingdom
London England, EC1A , United Kingdom
Northwood London, City Of, HA6 2, United Kingdom
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