[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Abivax S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ABX196","EXPERIMENTAL","IM injection of 0.1, 0.2, and 0.4 µg of ABX196",[13],"Drug: ABX196",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","ABX196 will be administered as an IM injection 120 minutes (+\u002F- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day treatment cycle (i.e., every 8 weeks).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Darren SIGAL, MD","Scripps Clinic\u002FScripps MD Anderson Cancer Center","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Paul GINESTE, PhD","CONTACT","+33 153 830 961","paul.gineste@abivax.com",[32,49],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Scripps Clinic Torrey Pines","RECRUITING","La Jolla","California","92037","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.2742,32.84727,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":19,"phoneExt":19,"email":19},"Darren Sigal, Prof.",{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":41,"coordinates":55},[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60],{"name":61,"role":28,"phone":62,"phoneExt":19,"email":63},"Ahmed Kaseb, MD","713-792-2828","akaseb@mdanderson.org",{"type":65,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[67],{"name":68,"class":69},"C3 Research Associates","UNKNOWN","100354639","phase-1-abx196-in-combination-with-nivolumab-in-patients-with-hepatocellular-carcinoma-100354639",false,"NCT03897543","ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Men or women, Age ≥18 years\n* Patients with ECOG performance status 0 or 1\n* Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy\n* Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent\n* Patients with at least one prior systemic therapy for HCC\n* Patients eligible to be treated with nivolumab\n* Patients with measurable disease based on RECIST v1.1\n* Patients with Child-Pugh class A liver score within 7 days of first study dose\n* Patients with no history of hepatic encephalopathy\n* Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)\n* Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \\\u003C100 IU\u002FmL within 7 days of first study dose\n* Patients with no active co-infection with HBV and HCV or HBV and HDV\n* Patients with no active drug or alcohol abuse\n\nExclusion Criteria:\n\n* Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose\n* Patients with esophageal or gastric variceal bleeding within the past 6 months\n* Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging\n* Patients with previous solid organ or hematologic transplantation\n* Patients with active autoimmune disease requiring systemic treatment in the past 2 years\n* Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose\n* Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose\n* Patients with minor surgery to liver or another site within 1 week before first study dose","ALL","18 Years",{"count":80,"type":81},48,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma",[88],"Carcinoma, Hepatocellular",[90,91,9],"HCC","Nivolumab","2021-03-25",{"date":94,"type":95},"2021-03-26","ACTUAL",{"date":97,"type":95},"2019-08-30",{"date":99,"type":81},"2023-06-30",{"name":5,"class":6},2]