NCT03897543 · Abivax S.A.
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
What this study is about
where both patients and doctors know the treatment given, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, how the drug affects the body effects, and preliminary effectiveness of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma
View original scientific description
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
Interventions
DRUG
ABX196
ABX196 will be administered as an IM injection 120 minutes (+/- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day treatment cycle (i.e., every 8 weeks).
Primary outcome measures
Incidence of adverse events (AEs)
Time frame: Through study completion, an average of 1 year
Adverse Events evaluated according to CTC-AE
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
- Houston, Texas
Collaborators
C3 Research Associates
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 26, 2021 · Source of record for eligibility and locations