Actively Recruiting
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Led by Abivax S.A. · Updated on 2021-03-26
48
Participants Needed
2
Research Sites
200 weeks
Total Duration
On this page
Sponsors
A
Abivax S.A.
Lead Sponsor
C
C3 Research Associates
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed hepatocellular carcinoma not treatable by surgery or local therapy
- Documented disease progression during or after local therapy or after treatment with sorafenib or lenvatinib, or intolerance/refusal of these agents
- At least one prior systemic therapy for hepatocellular carcinoma
- Eligible for treatment with nivolumab
- Measurable disease based on RECIST v1.1 criteria
- Child-Pugh class A liver score within 7 days before first study dose
- No history of hepatic encephalopathy
- No clinically significant ascites requiring active paracentesis (ascites only on imaging allowed)
- If infected with HBV, antiviral therapy for at least 12 weeks and viral load under 100 IU/mL within 7 days before first study dose
- No active co-infection with HBV and HCV or HBV and HDV
- No active drug or alcohol abuse
You will not qualify if you...
- Tyrosine kinase inhibitor treatment within 2 weeks before first study dose
- Esophageal or gastric variceal bleeding within the past 6 months
- Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac involvement of hepatocellular carcinoma
- Previous solid organ or hematologic transplantation
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Diagnosis of immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before first study dose
- Locoregional therapy or major liver surgery within 6 weeks before first study dose
- Minor surgery to liver or other site within 1 week before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paul GINESTE, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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