ABX196 combined with nivolumab for treating liver cancer
A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
This study is testing if a new treatment combining ABX196 and nivolumab can help people with liver cancer who haven't had success with other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abivax S.A. Industry-sponsored |
| Drugs / interventions | nivolumab, lenvatinib |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT03897543 on ClinicalTrials.gov |
What this trial studies
This open-label, uncontrolled phase 1-2 study evaluates the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 when administered alongside nivolumab in patients with hepatocellular carcinoma (HCC). The study includes a Dose Escalation Phase and an Expansion Phase, where nivolumab is given as a 30-minute IV infusion on specific days of a 28-day cycle, while ABX196 is administered as an intramuscular injection shortly after the nivolumab infusion. The goal is to determine how well this combination works in patients who have not responded to previous treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed hepatocellular carcinoma that is not amenable to curative surgery or local therapy.
Not a fit: Patients with a history of hepatic encephalopathy or significant ascites requiring active treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced liver cancer who have limited options.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this combination.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California and 1 other locations
- Scripps Clinic Torrey Pines — La Jolla, California, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Darren SIGAL, MD — Scripps Clinic/Scripps MD Anderson Cancer Center
- Study coordinator: Paul GINESTE, PhD
- Email: paul.gineste@abivax.com
- Phone: +33 153 830 961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.