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ABX196 with Nivolumab for Liver Cancer

This study is testing ABX196 in combination with nivolumab for patients with hepatocellular carcinoma (a type of liver cancer). Researchers want to see how safe the combination is and if it has any positive effects. You may be able to join if you are at least 18 years old, have liver cancer that cannot be cured by surgery or local treatment, and your cancer has progressed after other treatments like sorafenib or lenvatinib. The main goal is to track any side effects (adverse events) throughout the study, which is expected to last about one year. The current status of this trial is unclear, and it plans to enroll 48 participants.

Study design
This is an open-label, uncontrolled Phase 1-2 study. It will enroll 48 participants to evaluate the safety and preliminary effectiveness of the treatment.
What's involved
You would receive nivolumab as an IV infusion every 28 days, and ABX196 as an injection every 8 weeks, after the nivolumab infusion.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03897543

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Abivax S.A.
~48 participants
Updated 2021-03-26 on ClinicalTrials.gov
What's tested:ABX196

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Through study completion, an average of 1 year

Conditions

Carcinoma, Hepatocellular

Explore related trials

Hepatocellular Carcinoma

NCT03897543

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Scripps Clinic Torrey Pines

    La Jolla, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Darren SIGAL, MD · PRINCIPAL_INVESTIGATOR · Scripps Clinic/Scripps MD Anderson Cancer Center

Who to contact

Paul GINESTE, PhD
[email protected]
+33 153 830 961
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of adverse events (AEs)Through study completion, an average of 1 year

    Adverse Events evaluated according to CTC-AE