Clinical trial NCT03897543: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
Nivolumab
ABX196
Lead sponsor: Abivax S.A.
Sponsor class: INDUSTRY
Collaborators: name: C3 Research Associates
First posted: 2019-04-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 12 months
measure: Duration of Response (DOR)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 12 months
measure: Progression-Free Survival
timeFrame: From date of randomization until the date of first documented progression, assessed up to 24 months
measure: Alpha Fetoprotein Serum concentrations
timeFrame: Every 2 weeks, assessed up to 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Scripps Clinic/Scripps MD Anderson Cancer Center
name: Darren SIGAL, MD
role: PRINCIPAL_INVESTIGATOR
References: