Investigational Drug for Hepatocellular Carcinoma(HCC)/Liver Cancer
Darren Sigal, M.D.
ABX196 is an investigational immune therapy. For this study, it will be combined with an FDA approved dose of Nivolumab. The purpose of this Phase I study is to find a safe dose range of ABX196 that can be given to patients with liver cancer.
Be 18 years of age or older
Have a confirmed diagnosis of HCC not amenable to curative surgery or local therapy
Be intolerant to or have disease progression after treatment with a checkpoint inhibitor and/or a tyrosine kinase inhibitor
Be eligible to be treated with Nivolumab, but no prior treatment with Nivolumab in combination with Ipilimumab
No active co-infection with HBV and HCV or HBV and HDV
Patients must not:
Be pregnant or planning to become pregnant
Have a diagnosis of immunodeficiency or have received systemic steroid therapy or other immunosuppressive therapy within 7 days before the first day of study treatment
Have had minor surgery to the liver or another site within 1 week before the first day of study treatment
Have had a previous solid organ or hematologic transplantation
ABX196 is an experimental drug that has not been approved by the FDA. ABX196 will be combined with the standard therapy (Nivolumab) to see if it can help your immune system fight more effectively against your liver cancer.
The first study treatment will include an overnight stay at Scripps Green Hospital.
All other study treatments and physician visits will occur at Scripps Clinic Torrey Pines.
Search for NCT# 03897543 on www.clinicaltrials.gov for additional information.