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Recruiting NCT03897543

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Phase I / Phase II Interventional Carcinoma, Hepatocellular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABX196.
Who it may be relevant to
Registry conditions: Carcinoma, Hepatocellular. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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).

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]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: From date of randomization until the date of first documented progression, assessed up to 12 months]
  • Duration of Response (DOR) [Time frame: From date of randomization until the date of first documented progression, assessed up to 12 months]
  • Progression-Free Survival [Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months]
  • Alpha Fetoprotein Serum concentrations [Time frame: Every 2 weeks, assessed up to 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Scripps Clinic Torrey Pines — La Jolla
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT03897543 · ABX196-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗