RECRUITING

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Conditions

Carcinoma, Hepatocellular HCC Nivolumab ABX196

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Quick Facts

Study Start:2019-08-30

Study Completion:2023-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03897543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Paul GINESTE, PhD

CONTACT

+33 153 830 961

paul.gineste@abivax.com

Principal Investigator

Darren SIGAL, MD

PRINCIPAL_INVESTIGATOR

Scripps Clinic/Scripps MD Anderson Cancer Center

Study Locations (Sites)

Scripps Clinic Torrey Pines

La Jolla, California, 92037

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Abivax S.A.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-30

Study Completion Date2023-06-30

Study Record Updates

Study Start Date2019-08-30

Study Completion Date2023-06-30

Terms related to this study

Keywords Provided by Researchers

HCC
Nivolumab
ABX196

Additional Relevant MeSH Terms

Carcinoma, Hepatocellular