[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07722741":3,"trial-entities:NCT07722741":97,"trial-summary:NCT07722741":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":49,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":86,"overall_officials":91,"references":92,"see_also_links":93},"NCT07722741","GT-31","Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC","IMPACT31: A Randomized Open-label, Multi-center, Phase II Adjuvant Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC","NOT_YET_RECRUITING","2032-06","2026-07","2026-07-28","2026-09","Geneos Therapeutics","INDUSTRY",true,"This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report, who were eligible to undergo definitive resection, have demonstrated laboratory, radiographic and\u002For pathologic high-risk criteria for recurrence (described under eligibility), have no evidence of disease (NED) as per MRI approximately 28 days post resection, and are able to provide a tissue sample for personalized neoantigen DNA vaccine development.",null,[19],"HCC",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},90,"ESTIMATED",[29,35,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation","delivered by intradermal injection and electroporation",[34],"Personalized Immunotherapy for Cancer:",{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Electroporation Device","GNOS-PV02 + INO-9012 ID followed by electroporation",[34],{"type":30,"name":41,"description":42,"armGroupLabels":43},"INO-9012","cytokine interleukin-12 (IL-12), a vaccine adjuvant",[34],[45],{"measure":46,"description":47,"timeFrame":48},"Recurrence-free survival","RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first.","Up to 5 years",[50,53,56],{"measure":51,"description":52,"timeFrame":48},"Incidence of treatment emergent adverse events (safety and tolerability)","Summary adverse events according to CTCAE 6.0",{"measure":54,"description":55,"timeFrame":48},"Time to extra-hepatic spread or macro-vascular invasion","Time to extra-hepatic spread or macro-vascular invasion (TTEHS\u002FMVI)",{"measure":57,"description":58,"timeFrame":59},"Overall survival","OS is defined as time from randomization to death of any cause","Up to 5 years on study + 3 years follow up","ALL","18 Years",false,{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\n1. Written informed consent\n2. ≥18 years of age\n3. Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)\n4. Child-Pugh Class A liver score\n5. Documented virology status of hepatitis\n6. Availability of a representative post-resection tumor tissue sample\n7. ECOG performance status of 0 or 1\n8. Adequate organ function\n9. Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception\n\nExclusion Criteria:\n\n1. Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline\n2. Evidence of residual, recurrent, or metastatic disease at randomization\n3. Active or history of autoimmune disease or immune deficiency\n4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n5. Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening.\n6. Active infection requiring systemic therapy\n7. Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration\n8. History of human immunodeficiency virus (HIV) (HIV I\u002FII antibodies).\n9. Co-infection with HBV and hepatitis D viral infection\n10. Co-infection with HBV and HCV\n11. Has received a live vaccine within 30 days of planned start of study",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Johns Hopkins University","Baltimore","Maryland","21287","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Principal Investigator, MD","CONTACT","410-955-8893","GIClinicalTrials@jh.edu",{"lat":84,"lon":85},39.29038,-76.61219,[87],{"name":88,"role":80,"phone":89,"email":90},"Joann Peters, MHA","434-825-2551","peters@geneostx.com",[],[],[94],{"label":95,"url":96},"Geneos Therapeutics Website - Platform and company information","https:\u002F\u002Fwww.geneostx.com\u002F",{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Hepatocellular Carcinoma",[],{"nct_id":4,"found":15,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a randomized, open-label (meaning you and your doctors will know which treatment you are receiving), multi-site Phase II study planning to enroll 90 participants.","completed","Personalized Vaccine for High-Risk Liver Cancer (HCC)","This study is testing a personalized vaccine called GNOS-PV02 along with INO-9012, a plasmid (a small piece of DNA) that helps the immune system, in people with high-risk hepatocellular carcinoma (HCC), a type of liver cancer. You might be able to join if you are at least 18 years old, have a confirmed diagnosis of HCC that has been removed by surgery, and have a good liver score (Child-Pugh Class A). The study aims to see if this treatment can help prevent the cancer from coming back (recurrence-free survival) over a period of up to 5 years. The current recruitment status is unclear.","Participants will be followed for recurrence-free survival for up to 5 years after treatment.",103,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]