RecruitingPhase 1Phase 2NCT03897543
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
Sponsor
Abivax S.A.
Enrollment
48 participants
Start Date
Aug 30, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- Men or women, Age ≥18 years
- Patients with ECOG performance status 0 or 1
- Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy
- 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
- Patients with at least one prior systemic therapy for HCC
- Patients eligible to be treated with nivolumab
- Patients with measurable disease based on RECIST v1.1
- Patients with Child-Pugh class A liver score within 7 days of first study dose
- Patients with no history of hepatic encephalopathy
- 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)
- Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \<100 IU/mL within 7 days of first study dose
- Patients with no active co-infection with HBV and HCV or HBV and HDV
- Patients with no active drug or alcohol abuse
Exclusion Criteria8
- Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose
- Patients with esophageal or gastric variceal bleeding within the past 6 months
- Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging
- Patients with previous solid organ or hematologic transplantation
- Patients with active autoimmune disease requiring systemic treatment in the past 2 years
- Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose
- Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose
- Patients with minor surgery to liver or another site within 1 week before first study dose
Interventions
DRUGABX196
ABX196 will be administered as an IM injection 120 minutes (+/- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day treatment cycle (i.e., every 8 weeks).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03897543
Related Trials
A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma
NCT070104971 location
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
NCT053668292 locations
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
NCT038949171 location
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
NCT037276334 locations
A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
NCT072270121 location