[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508333":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":58,"centralContacts":62,"locations":63,"responsibleParty":225,"collaborators":227,"id":230,"slug":231,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":62,"eligibilityCriteria":236,"healthyVolunteers":232,"sex":237,"minAge":238,"maxAge":62,"enrollmentInfo":239,"targetDuration":62,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":254,"whyStopped":62,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":263,"locationsCount":264},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Pembrolizumab + Belzutifan + Lenvatinib","EXPERIMENTAL","Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to \\~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.",[13,14,15],"Biological: Pembrolizumab","Drug: Belzutifan","Drug: Lenvatinib",{"label":17,"type":10,"description":18,"interventionNames":19},"Pembrolizumab\u002FQuavonlimab + Lenvatinib","Participants will receive pembrolizumab\u002Fquavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab\u002Fquavonlimab will be administered IV Q6W for up to 18 administrations (up to \\~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.",[20,15],"Biological: Pembrolizumab\u002FQuavonlimab",{"label":22,"type":23,"description":24,"interventionNames":25},"Pembrolizumab + Lenvatinib","ACTIVE_COMPARATOR","Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to \\~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.",[13,15],[27,35,44,50],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","Pembrolizumab","Pembrolizumab 400 mg administered Q6W via IV infusion",[9,22],[33,34],"MK-3475","KEYTRUDA®",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Belzutifan","Belzutifan 120 mg administered QD via oral tablet",[9],[41,42,43],"MK-6482","PT2977","WELIREG™",{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Pembrolizumab\u002FQuavonlimab","Pembrolizumab\u002Fquavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion",[17],[49],"MK-1308A",{"type":36,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Lenvatinib","Lenvatinib 20 mg administered QD via oral capsule",[9,22,17],[55,56,57],"MK-7902","E7080","LENVIMA®",[59],{"name":60,"affiliation":5,"role":61},"Medical Director","STUDY_DIRECTOR",null,[64,77,87,97,103,109,119,129,139,148,158,168,178,188,198,207,216],{"facility":65,"status":62,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":62},"Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)","Beijing","Beijing Municipality","100142","China","CN",{"type":72,"coordinates":73},"Point",[74,75],116.39723,39.9075,{"lat":75,"lon":74},{"facility":78,"status":62,"city":79,"state":80,"zip":81,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":62},"Chongqing University Cancer Hospital ( Site 6009)","Chongqing","Chongqing Municipality","400030",{"type":72,"coordinates":83},[84,85],106.55771,29.56026,{"lat":85,"lon":84},{"facility":88,"status":62,"city":89,"state":90,"zip":91,"country":69,"countryCode":70,"cosmosGeoPoint":92,"geoPoint":96,"contacts":62},"SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)","Guangzhou","Guangdong","510060",{"type":72,"coordinates":93},[94,95],113.25,23.11667,{"lat":95,"lon":94},{"facility":98,"status":62,"city":89,"state":90,"zip":99,"country":69,"countryCode":70,"cosmosGeoPoint":100,"geoPoint":102,"contacts":62},"The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)","510120",{"type":72,"coordinates":101},[94,95],{"lat":95,"lon":94},{"facility":104,"status":62,"city":89,"state":90,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":108,"contacts":62},"Guangzhou First People's Hospital ( Site 6007)","510180",{"type":72,"coordinates":107},[94,95],{"lat":95,"lon":94},{"facility":110,"status":62,"city":111,"state":112,"zip":113,"country":69,"countryCode":70,"cosmosGeoPoint":114,"geoPoint":118,"contacts":62},"Henan Cancer Hospital-Urology ( Site 6006)","Zhengzhou","Henan","450008",{"type":72,"coordinates":115},[116,117],113.64861,34.75778,{"lat":117,"lon":116},{"facility":120,"status":62,"city":121,"state":122,"zip":123,"country":69,"countryCode":70,"cosmosGeoPoint":124,"geoPoint":128,"contacts":62},"Wuhan Union Hospital ( Site 6002)","Wuhan","Hubei","430022",{"type":72,"coordinates":125},[126,127],114.26667,30.58333,{"lat":127,"lon":126},{"facility":130,"status":62,"city":131,"state":132,"zip":133,"country":69,"countryCode":70,"cosmosGeoPoint":134,"geoPoint":138,"contacts":62},"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S","Nanjing","Jiangsu","210000",{"type":72,"coordinates":135},[136,137],118.77778,32.06167,{"lat":137,"lon":136},{"facility":140,"status":62,"city":141,"state":132,"zip":142,"country":69,"countryCode":70,"cosmosGeoPoint":143,"geoPoint":147,"contacts":62},"The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)","Suzhou","215004",{"type":72,"coordinates":144},[145,146],120.59538,31.30408,{"lat":146,"lon":145},{"facility":149,"status":62,"city":150,"state":151,"zip":152,"country":69,"countryCode":70,"cosmosGeoPoint":153,"geoPoint":157,"contacts":62},"The First Affiliated Hospital of Nanchang University ( Site 6019)","Nanchang","Jiangxi","330006",{"type":72,"coordinates":154},[155,156],115.85306,28.68396,{"lat":156,"lon":155},{"facility":159,"status":62,"city":160,"state":161,"zip":162,"country":69,"countryCode":70,"cosmosGeoPoint":163,"geoPoint":167,"contacts":62},"The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)","Xi'an","Shaanxi","710061",{"type":72,"coordinates":164},[165,166],108.92861,34.25833,{"lat":166,"lon":165},{"facility":169,"status":62,"city":170,"state":171,"zip":172,"country":69,"countryCode":70,"cosmosGeoPoint":173,"geoPoint":177,"contacts":62},"West China Hospital Sichuan University-Urology Surgery ( Site 6016)","Chengdu","Sichuan","610041",{"type":72,"coordinates":174},[175,176],104.06667,30.66667,{"lat":176,"lon":175},{"facility":179,"status":62,"city":180,"state":181,"zip":182,"country":69,"countryCode":70,"cosmosGeoPoint":183,"geoPoint":187,"contacts":62},"The Second Hospital of Tianjin Medical University ( Site 6032)","Tianjin","Tianjin Municipality","300211",{"type":72,"coordinates":184},[185,186],117.17667,39.14222,{"lat":186,"lon":185},{"facility":189,"status":62,"city":190,"state":191,"zip":192,"country":69,"countryCode":70,"cosmosGeoPoint":193,"geoPoint":197,"contacts":62},"The First Affiliated Hospital, Zhejiang University ( Site 6024)","Hangzhou","Zhejiang","310003",{"type":72,"coordinates":194},[195,196],120.16142,30.29365,{"lat":196,"lon":195},{"facility":199,"status":62,"city":200,"state":191,"zip":201,"country":69,"countryCode":70,"cosmosGeoPoint":202,"geoPoint":206,"contacts":62},"The First Hospital of Jiaxing ( Site 6033)","Jiaxing","314001",{"type":72,"coordinates":203},[204,205],120.75,30.7522,{"lat":205,"lon":204},{"facility":208,"status":62,"city":209,"state":191,"zip":210,"country":69,"countryCode":70,"cosmosGeoPoint":211,"geoPoint":215,"contacts":62},"Ningbo First Hospital-Urology ( Site 6028)","Ningbo","315010",{"type":72,"coordinates":212},[213,214],121.54945,29.87819,{"lat":214,"lon":213},{"facility":217,"status":62,"city":218,"state":191,"zip":219,"country":69,"countryCode":70,"cosmosGeoPoint":220,"geoPoint":224,"contacts":62},"The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)","Wenzhou","325000",{"type":72,"coordinates":221},[222,223],120.66682,27.99942,{"lat":223,"lon":222},{"type":226,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR",[228],{"name":229,"class":6},"Eisai Inc.","100508333","phase-3-a-study-of-pembrolizumab-mk-3475-in-combination-with-belzutifan-mk-6482-and-lenvatinib-mk-7902-or-pembrolizumabquavonlimab-mk-1308a-in-combination-with-lenvatinib-vs-pembrolizumab-and-lenvatinib-for-treatment-of-advanced-clear-cell-renal-cell-carcinoma-mk-6482-012-china-extension-study-100508333",false,"NCT05899049","A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab\u002FQuavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study","An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of RCC with clear cell component.\n* Has received no prior systemic therapy for advanced ccRCC\n* 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.\n* 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\u002Fquavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last\n* Has adequately controlled blood pressure with or without antihypertensive medications\n* Has adequate organ function.\n* Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization\u002Fallocation\n\nExclusion Criteria:\n\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has had major surgery, other than nephrectomy within 4 weeks prior to randomization\n* Has known central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has received prior radiotherapy within 2 weeks prior to first dose of study intervention\n* Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen\n* Has clinically significant cardiac disease within 12 months from first dose of study intervention\n* Has a history of interstitial lung disease\n* Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible\n* Has preexisting gastrointestinal or non-gastrointestinal fistula\n* 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\n* Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Has a known history of Hepatitis B\n* Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel\n* Has clinically significant history of bleeding within 3 months prior to randomization\n* Has had an allogenic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":240,"type":241},251,"ACTUAL","INTERVENTIONAL",[244],"PHASE3","The goal of this China extension study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab\u002Fquavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in Chinese participants with advanced clear cell renal cell carcinoma (ccRCC).\n\nThe 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\u002Fquavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.",[247],"Carcinoma, Renal Cell",[249,250,251,252,253],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Death-Ligand 1 (PDL1, PD-L1)","Hypoxia inducible factor (HIF)","Hypoxia inducible factor 1B (HIF-1B)","Hypoxia inducible factor 2 alpha (HIF-2 alpha)","ACTIVE_NOT_RECRUITING","2026-08-18",{"date":257,"type":241},"2026-08-20",{"date":259,"type":241},"2022-07-27",{"date":261,"type":262},"2027-04-22","ESTIMATED",{"name":5,"class":6},17]