Melanoma Clinical Trial
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Summary
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.
The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.
Eligibility Criteria
Inclusion Criteria:
Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC.
A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
Adequately controlled blood pressure.
Adequate organ function.
Exclusion Criteria:
A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Clinically significant cardiac disease within 6 months of first dose of study intervention.
Prolongation of QTc interval to >480 ms.
Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
Moderate to severe hepatic impairment.
History of significant bleeding within 3 months before randomization.
History of solid organ transplantation.
Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
Prior treatment with lenvatinib.
Prior treatment with cabozantinib.
Currently participating in a study of an investigational agent or using an investigational device.
Active infection requiring systemic therapy.
History of human immunodeficiency virus (HIV) infection.
History of hepatitis B or known active hepatitis C infection.
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There are 179 Locations for this study
Chandler Arizona, 85224, United States
Los Angeles California, 90048, United States
Los Angeles California, 90404, United States
Orange California, 92868, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60607, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46845, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70112, United States
Burlington Massachusetts, 01805, United States
Grand Rapids Michigan, 49503, United States
Saint Louis Park Minnesota, 55426, United States
Jackson Mississippi, 39213, United States
Lincoln Nebraska, 68510, United States
New Brunswick New Jersey, 08901, United States
Lake Success New York, 11042, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Allentown Pennsylvania, 18103, United States
Dallas Texas, 75390, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Roanoke Virginia, 24014, United States
Seattle Washington, 98109, United States
Wenatchee Washington, 98801, United States
Caba Buenos Aires, C1120, Argentina
Ciudad autónoma de Buenos Aires Buenos Aires, 1280, Argentina
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
Rosario Santa Fe, 2000, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1419, Argentina
St Leonards New South Wales, 2065, Australia
Elizabeth Vale South Australia, 5112, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3000, Australia
Linz Oberosterreich, 4020, Austria
Graz Steiermark, 8036, Austria
Vienna Wien, 1160, Austria
Wien , 1020, Austria
Wien , 1090, Austria
Anderlecht Bruxelles-Capitale, Region De, 1070, Belgium
Brussels Bruxelles-Capitale, Region De, 1200, Belgium
Charleroi Hainaut, 6000, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Liege , 4000, Belgium
Natal Rio Grande Do Norte, 59151, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01321, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Moncton New Brunswick, E1C 6, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Greenfield Park Quebec, J4V 2, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1J 1, Canada
Temuco Araucania, 47800, Chile
Santiago Region M. De Santiago, 84203, Chile
Medellin Antioquia, 05003, Colombia
Valledupar Cesar, 20000, Colombia
Bogotá Cundinamarca, 11151, Colombia
Piedecuesta Santander, 68101, Colombia
Brno Brno-mesto, 656 5, Czechia
České Budějovice Jihocesky Kraj, 370 0, Czechia
Prague Praha 4, 140 5, Czechia
Praha Praha 5, 150 0, Czechia
Hradec Kralove , 500 0, Czechia
Tampere Pirkanmaa, 33520, Finland
Helsinki Uusimaa, 00290, Finland
Turku Varsinais-Suomi, 20520, Finland
Reims Ain, 51726, France
Nice Alpes-Maritimes, 06189, France
Strasbourg Alsace, 67200, France
Bordeaux Gironde, 33075, France
Toulouse Haute-Garonne, 31059, France
Limoges Haute-Vienne, 87039, France
Saint Herblain Loire-Atlantique, 44805, France
Angers Maine-et-Loire, 49055, France
Paris , 75020, France
Freiburg Baden-Wurttemberg, 79106, Germany
Heidelberg Baden-Wurttemberg, 69120, Germany
Nuremberg Bayern, 90419, Germany
Frankfurt am Main Hessen, 60590, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Homburg/ Saar Saarland, 66421, Germany
Halle Sachsen-Anhalt, 06120, Germany
Erfurt Thuringen, 99089, Germany
Berlin , 10117, Germany
Berlin , 13125, Germany
Patras Achaia, 26504, Greece
Athens Attiki, 115 2, Greece
Athens Attiki, 151 2, Greece
Chaidari Attiki, 124 6, Greece
Thessaloniki , 570 0, Greece
Dublin 7 Dublin, D07 R, Ireland
Dublin , D24NR, Ireland
Dublin , Dubli, Ireland
Meldola Forli-Cesena, 47014, Italy
Rozzano Milano, 20089, Italy
Orbassano Torino, 10043, Italy
Arezzo , 52100, Italy
Bari , 70124, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Pavia , 27100, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Verona , 37126, Italy
Toyoake Aichi, 470-1, Japan
Kashiwa Chiba, 27785, Japan
Sakura Chiba, 285-8, Japan
Sapporo Hokkaido, 060-8, Japan
Kobe Hyogo, 650-0, Japan
Yokohama Kanagawa, 23600, Japan
Kashihara Nara, 634-8, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Hamamatsu Shizuoka, 431-3, Japan
Bunkyo-ku Tokyo, 11385, Japan
Minato-ku Tokyo, 105-8, Japan
Fukuoka , 812-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Tokyo , 113-8, Japan
Tokyo , 123-8, Japan
Tokyo , 160-8, Japan
Hwasun Jeonranamdo, 58128, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Leeuwarden Fryslan, 8934 , Netherlands
Sittard-Geleen Limburg, 6162 , Netherlands
Breda Noord-Brabant, 4818 , Netherlands
Amsterdam Noord-Holland, 1066 , Netherlands
Den Haag Zuid-Holland, 2545 , Netherlands
Rotterdam Zuid-Holland, GD 30, Netherlands
Schiedam Zuid-Holland, 3118 , Netherlands
Utrecht , 3584C, Netherlands
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Krakow Malopolskie, 31-11, Poland
Warszawa Mazowieckie, 02-78, Poland
Poznan Wielkopolskie, 60-56, Poland
Cluj Napoca Cluj, 40001, Romania
Cluj Napoca Cluj, 40001, Romania
Craiova Dolj, 20054, Romania
Ivanovo Ivanovskaya Oblast, 15304, Russian Federation
Krasnogorsk Moskovskaya Oblast, 14344, Russian Federation
Moscow Moskovskaya Oblast, 12120, Russian Federation
Moscow Moskva, 11928, Russian Federation
Moscow Moskva, 12513, Russian Federation
Volzhsky Volgogradskaya Oblast, 40412, Russian Federation
Yaroslavl Yaroslavskaya Oblast, 15005, Russian Federation
A Coruna La Coruna, 15006, Spain
Madrid Madrid, Comunidad De, 28041, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Sevilla , 41013, Spain
Geneva Geneve, 1211, Switzerland
Chur Grisons, 7000, Switzerland
Bellinzona Ticino, 6500, Switzerland
Zuerich Zurich, 8001, Switzerland
Aberdeen Aberdeen City, AB25 , United Kingdom
Bath Bath And North East Somerset, BA1 3, United Kingdom
Nottingham England, NG5 1, United Kingdom
Southend Essex, SS0 0, United Kingdom
London London, City Of, W6 8R, United Kingdom
Northwood London, City Of, HA6 2, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
Swansea Wales, SA2 8, United Kingdom
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