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ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABX196
Sponsored by
Abivax S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, Nivolumab, ABX196

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Clinic Torrey PinesRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABX196

Arm Description

IM injection of 0.1, 0.2, and 0.4 µg of ABX196

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)
Adverse Events evaluated according to CTC-AE

Secondary Outcome Measures

Objective Response Rate (ORR)
Partial and Complete response according to RECIST V1.1
Duration of Response (DOR)
Progression-Free Survival
Alpha Fetoprotein Serum concentrations

Full Information

First Posted
March 27, 2019
Last Updated
March 25, 2021
Sponsor
Abivax S.A.
Collaborators
C3 Research Associates
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1. Study Identification

Unique Protocol Identification Number
NCT03897543
Brief Title
ABX196 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abivax S.A.
Collaborators
C3 Research Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
HCC, Nivolumab, ABX196

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABX196
Arm Type
Experimental
Arm Description
IM injection of 0.1, 0.2, and 0.4 µg of ABX196
Intervention Type
Drug
Intervention Name(s)
ABX196
Intervention Description
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 Measure Information:
Title
Incidence of adverse events (AEs)
Description
Adverse Events evaluated according to CTC-AE
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Partial and Complete response according to RECIST V1.1
Time Frame
From date of randomization until the date of first documented progression, assessed up to 12 months
Title
Duration of Response (DOR)
Time Frame
From date of randomization until the date of first documented progression, assessed up to 12 months
Title
Progression-Free Survival
Time Frame
From date of randomization until the date of first documented progression, assessed up to 24 months
Title
Alpha Fetoprotein Serum concentrations
Time Frame
Every 2 weeks, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul GINESTE, PhD
Phone
+33 153 830 961
Email
paul.gineste@abivax.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren SIGAL, MD
Organizational Affiliation
Scripps Clinic/Scripps MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Sigal, Prof.
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Kaseb, MD
Phone
713-792-2828
Email
akaseb@mdanderson.org

12. IPD Sharing Statement

Plan to Share IPD
No

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ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

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