[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609813":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":50,"centralContacts":51,"locations":58,"responsibleParty":251,"collaborators":50,"id":253,"slug":254,"hasResults":255,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":255,"sex":261,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":50,"studyType":267,"phases":268,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":61,"whyStopped":50,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},{"fullName":5,"class":6},"CatalYm GmbH","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Visugromab (IV) + Nivolumab intravenous (IV) + Lenvatinib (PO)",[13,14,15],"Biological: Visugromab RDE (recommended dose for expansion)","Biological: Nivolumab","Drug: Lenvatinib",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm B","ACTIVE_COMPARATOR","Lenvatinib (PO) + saline (double-placebo) intravenous (IV)",[15,21],"Other: Placebo Saline Infusion",[23,30,36,43],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Visugromab RDE (recommended dose for expansion)","Participants receive visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments",[9],[29],"CTL-002",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Nivolumab","Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion",[9],[35],"OPDIVO®",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Lenvatinib","Participants receive Lenvatinib per os (PO) once daily according to body weight (\\> 60kg: 12mg; \\\u003C 60kg: 8mg)",[9,17],[42],"Lenvima",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"OTHER","Placebo Saline Infusion","Saline (0.9%NaCl) intravenous (2x IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) for up to 35 treatments",[17],[49],"0.9% NaCl",null,[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Tomáš Janík, MD","CONTACT","+49892000664","31","regulatory-005@catalym.com",[59,81,100,114,131,146,160,176,190,207,222,237],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-118.24368,34.05223,{"lat":71,"lon":70},[74,78],{"name":75,"role":54,"phone":76,"phoneExt":50,"email":77},"Anthony El-Khoueiry, Dr","+1 (323) 865 3000","elkhouei@med.usc.edu",{"name":79,"role":54,"phone":76,"phoneExt":50,"email":80},"Charlean Ketchens","ketchens_c@med.usc.edu",{"facility":82,"status":61,"city":83,"state":84,"zip":85,"country":65,"countryCode":66,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Peidmont Healthcare, Inc","Atlanta","Georgia","30309",{"type":68,"coordinates":87},[88,89],-84.38798,33.749,{"lat":89,"lon":88},[92,96],{"name":93,"role":54,"phone":94,"phoneExt":50,"email":95},"Sope Olugbile, MD","404 (425) 1777","sope.olugbile@piedmont.org",{"name":97,"role":54,"phone":98,"phoneExt":50,"email":99},"Karma MCcants","404 (605) 2366","karma.mccants@piedmont.org",{"facility":101,"status":61,"city":102,"state":103,"zip":104,"country":65,"countryCode":66,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"OSF St. Francis Medical Center","Peoria","Illinois","61637",{"type":68,"coordinates":106},[107,108],-89.58899,40.69365,{"lat":108,"lon":107},[111],{"name":112,"role":54,"phone":50,"phoneExt":50,"email":113},"Robert McWilliams, Dr.","Robert.R.McWilliams@osfhealthcare.org",{"facility":115,"status":61,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Hannover Medical School","Hanover","Lower Saxony","30625","Germany","DE",{"type":68,"coordinates":122},[123,124],9.73322,52.37052,{"lat":124,"lon":123},[127],{"name":128,"role":54,"phone":129,"phoneExt":50,"email":130},"Anna Saborowski, PD Dr. med.","+495115329592","Saborowski.Anna@mh-hannover.de",{"facility":132,"status":61,"city":133,"state":134,"zip":135,"country":119,"countryCode":120,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"University Medical Center of Johannes Gutenberg University Mainz","Mainz","Rhineland-Palatinate","55131",{"type":68,"coordinates":137},[138,139],8.28008,49.98185,{"lat":139,"lon":138},[142],{"name":143,"role":54,"phone":144,"phoneExt":50,"email":145},"Peter R. Galle, Prof. Dr. med.","+49 (0) 6131 17 7276","galle@uni-mainz.de",{"facility":147,"status":61,"city":148,"state":50,"zip":149,"country":119,"countryCode":120,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität","Frankfurt","60590",{"type":68,"coordinates":151},[152,153],10.53333,49.68333,{"lat":153,"lon":152},[156],{"name":157,"role":54,"phone":158,"phoneExt":50,"email":159},"Jörg Trojan, Prof.","+4969630187769","trojan@em.uni-frankfurt.de",{"facility":161,"status":61,"city":162,"state":50,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Polyclinic S. Orsola-Malpighi","Bologna","40138","Italy","IT",{"type":68,"coordinates":167},[168,169],11.33875,44.49381,{"lat":169,"lon":168},[172],{"name":173,"role":54,"phone":174,"phoneExt":50,"email":175},"Fabio Piscaglia, MD","+39 0512142477","fabio.piscaglia@unibo.it",{"facility":177,"status":61,"city":178,"state":50,"zip":179,"country":164,"countryCode":165,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Asst Grande Ospedale Metropolitano Niguarda","Milan","20162",{"type":68,"coordinates":181},[182,183],12.59836,42.78235,{"lat":183,"lon":182},[186],{"name":187,"role":54,"phone":188,"phoneExt":50,"email":189},"Katia Bencardino, Dr.","+390264442291","oncologia@ospedaleniguarda.it",{"facility":191,"status":61,"city":192,"state":193,"zip":194,"country":195,"countryCode":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"University Hospital Miguel Servet","Zaragoza","Aragon","50009","Spain","ES",{"type":68,"coordinates":198},[199,200],-0.87734,41.65606,{"lat":200,"lon":199},[203],{"name":204,"role":54,"phone":205,"phoneExt":50,"email":206},"Roberto Pazo Cid, Dr.","+34 (976) 765 500","rpazo@salud.aragon.es",{"facility":208,"status":61,"city":209,"state":210,"zip":211,"country":195,"countryCode":196,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Hospital Clinic of Barcelona","Barcelona","Catalonia","08036",{"type":68,"coordinates":213},[214,215],2.15899,41.38879,{"lat":215,"lon":214},[218],{"name":219,"role":54,"phone":220,"phoneExt":50,"email":221},"María Reig, Dr","+34 932279235","MREIG1@clinic.cat",{"facility":223,"status":61,"city":224,"state":225,"zip":226,"country":195,"countryCode":196,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"University Clinic of Navarra - Pamplona","Pamplona","Chartered Community of Navarra","31008",{"type":68,"coordinates":228},[229,230],-1.64323,42.81687,{"lat":230,"lon":229},[233],{"name":234,"role":54,"phone":235,"phoneExt":50,"email":236},"Bruno Sangro Gomez-Acebo","+34 948 255 400","bsangro@unav.es",{"facility":238,"status":61,"city":239,"state":239,"zip":240,"country":195,"countryCode":196,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"University Hospital Ramon y Cajal","Madrid","28034",{"type":68,"coordinates":242},[243,244],-3.70256,40.4165,{"lat":244,"lon":243},[247],{"name":248,"role":54,"phone":249,"phoneExt":50,"email":250},"José Luis Lledó Navarro","+34 913368592","jllledo63@yahoo.es",{"type":252,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100609813","phase-2-visugromab-nivolumab-and-lenvatinib-compared-to-double-placebo-and-lenvatinib-in-unresectable-or-metastatic-hepatocellular-carcinoma-post-anti-pd-l1-failure-100609813",false,"NCT07219459","Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure","A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)","GDFATHERHCC01","Main Inclusion Criteria:\n\n* Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach.\n* Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment.\n* Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period.\n* Age ≥ 18 years on the day of signing the informed consent.\n* Life expectancy of at least 3 months as assessed by the Investigator.\n* ECOG performance status ≤1.\n* Child-Pugh score of A6 or better.\n\nMain Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.\n* More than 1 line of prior systemic treatment for unresectable or metastatic HCC.\n* Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP.\n* Expected to require any other form of antineoplastic therapy during the trial.\n* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and\u002For gastrointestinal obstruction.\n* Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n* Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors.\n* Have one of the following cardiovascular risk factors: myocardial infarction, peri\u002Fmyocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex.\n* An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start.\n* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.\n* Chronic systemic corticosteroid treatment for other reasons.\n* Prior liver or other organ transplantation.","ALL","18 Years","100 Years",{"count":265,"type":266},104,"ESTIMATED","INTERVENTIONAL",[269],"PHASE2","This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.",[272,273,274],"Unresectable or Metastatic Hepatocellular Carcinoma","Child-Pugh A Hepatocellular Carcinoma","Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound",[29,276,277],"Visugromab","GDF-15","2026-06-23",{"date":280,"type":281},"2026-06-24","ACTUAL",{"date":283,"type":281},"2026-03-19",{"date":285,"type":266},"2031-09",{"name":5,"class":6},12]