[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":63,"collaborators":65,"id":69,"slug":19,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":19,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":19,"enrollmentInfo":77,"targetDuration":19,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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",[32,48],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Scripps Clinic Torrey Pines","RECRUITING","La Jolla","California","92037","United States",{"type":40,"coordinates":41},"Point",[42,43],-117.2742,32.84727,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":19,"phoneExt":19,"email":19},"Darren Sigal, Prof.",{"facility":49,"status":34,"city":50,"state":51,"zip":52,"country":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":40,"coordinates":54},[55,56],-95.36327,29.76328,{"lat":56,"lon":55},[59],{"name":60,"role":28,"phone":61,"phoneExt":19,"email":62},"Ahmed Kaseb, MD","713-792-2828","akaseb@mdanderson.org",{"type":64,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[66],{"name":67,"class":68},"C3 Research Associates","UNKNOWN","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":78,"type":79},48,"ESTIMATED","INTERVENTIONAL",[82,83],"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",[86],"Carcinoma, Hepatocellular",[88,89,9],"HCC","Nivolumab","2021-03-25",{"date":92,"type":93},"2021-03-26","ACTUAL",{"date":95,"type":93},"2019-08-30",{"date":97,"type":79},"2023-06-30",{"name":5,"class":6},2]