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ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897543
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
C3 Research Associates
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: ABX196 Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 : August 30, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: ABX196
IM injection of 0.1, 0.2, and 0.4 µg of ABX196
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 :
  1. Incidence of adverse events (AEs) [ Time Frame: Through study completion, an average of 1 year ]
    Adverse Events evaluated according to CTC-AE


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 12 months ]
    Partial and Complete response according to RECIST V1.1

  2. Duration of Response (DOR) [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 12 months ]
  3. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 24 months ]
  4. Alpha Fetoprotein Serum concentrations [ Time Frame: Every 2 weeks, assessed up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897543


Contacts
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Contact: Paul GINESTE, PhD +33 153 830 961 paul.gineste@abivax.com

Locations
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United States, California
Scripps Clinic Torrey Pines Recruiting
La Jolla, California, United States, 92037
Contact: Darren Sigal, Prof.         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ahmed Kaseb, MD    713-792-2828    akaseb@mdanderson.org   
Sponsors and Collaborators
Abivax S.A.
C3 Research Associates
Investigators
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Principal Investigator: Darren SIGAL, MD Scripps Clinic/Scripps MD Anderson Cancer Center

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Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT03897543    
Other Study ID Numbers: ABX196-001
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Abivax S.A.:
HCC
Nivolumab
ABX196
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents