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Investigational Drug for Hepatocellular Carcinoma (HCC)/Liver Cancer
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
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 biopsy confirmed diagnosis of HCC not amenable to curative surgery or local therapy
Have disease progression after treatment with sorafenib (nexavar®) or lenvatinib (lenvima®), or intolerant to sorafenib (nexavar®) or lenvatinib (lenvima®)
Be eligible to be treated with nivolumab
Not have active co-infection with HBV and HCV or HBV and HDV
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 first study dose
Have had minor surgery to liver or another site within 1 week before first study dose
Have had previous solid organ or hematologic transplantation
ABX196 is an experimental drug that has not been approved by the FDA. It will be combined with standard therapy (nivolumab) to see if it can help your immune system fight more effectively against tumor cells.
The first study treatment will include an overnight stay in Scripps Green Hospital.
All other treatments and physician visits during this study will take place at Scripps Clinic Torrey Pines.
Up to 20 participants will be enrolled and be asked to participate in this study for up to 13 months
For more information, search for NCT#03897543 @ https://clinicaltrials.gov/