NCT03897543 ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
| NCT ID | NCT03897543 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Abivax S.A. |
| Condition | Carcinoma, Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2019-08-30 |
| Primary Completion | 2021-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2019-08-30 with a primary completion date of 2021-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Darren SIGAL, MD
PRINCIPAL INVESTIGATOR
Scripps Clinic/Scripps MD Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03897543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03897543 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03897543 currently recruiting?
Yes, NCT03897543 is actively recruiting participants. Contact the research team at paul.gineste@abivax.com for enrollment information.
Where is the NCT03897543 trial being conducted?
This trial is being conducted at La Jolla, United States, Houston, United States.
Who is sponsoring the NCT03897543 clinical trial?
NCT03897543 is sponsored by Abivax S.A.. The principal investigator is Darren SIGAL, MD at Scripps Clinic/Scripps MD Anderson Cancer Center. The trial plans to enroll 48 participants.