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NCT03897543 | RECRUITING | Carcinoma, Hepatocellular

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Sponsor:

Abivax S.A.

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

Condition or disease

Carcinoma, Hepatocellular

Intervention/treatment

ABX196

Phase

PHASE1

PHASE2

Detailed Description:

This is an 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. The study consists of 2 phases, a Dose Escalation Phase and an Expansion Phase. Nivolumab will be administered, consistent with the US prescribing information, as a 30-minute IV infusion on Days 1 and 15 of each 28-Day cycle. 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 cycle (i.e., every 8 weeks).

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Actual Study Start Date : 2019-08-30
Estimated Primary Completion Date : 2021-06-30
Estimated Study Completion Date : 2023-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Location Details

NCT03897543

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How to Participate

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Locations

RECRUITING

United States, California

Scripps Clinic Torrey Pines

THE JOLLA, California, United States, 92037

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030