Phase 2 Trial of Adaptive Dosing of Immune Checkpoint Inhibitors for Unresectable Child Pugh B Hepatocellular Carcinoma
University of Texas Southwestern Medical Center
Summary
The goal of this clinical trial is to learn if immunotherapy including nivolumab plus ipilimumab is effective and safe in treating hepatocellular carcinoma.
Description
This clinical trial will examine an adaptive dosing strategy for patients with Child-Pugh B disease and HCC in which immunotherapy doses will be interrupted for a short-interval restaging exam for patients who have achieved a favorable radiographic response. If disease response or control is sustained at this early interim imaging assessment, subsequent treatment management is up to the treating investigator discretion. Treatment may be resumed if the investigator judges that continued therapy is likely to provide additional clinical benefit. Alternatively, treatment may be further held or dis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC or combined HCC-cholangiocarcinoma will be excluded. 2. Patients may not have received any prior anti-PD-1/L1 or anti-CTLA-4 therapies for the treatment of advanced HCC. 3. Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional the…
Interventions
- DrugNivolumab
Nivolumab 1 mg/kg every 3 weeks for a maximum of 4 doses as part of combination therapy; then 240 mg every 2 weeks or 480 mg every 4 weeks as single agent.
- DrugIpilimumab (3 mg/kg)
ipilimumab 3 mg/kg for a maximum of 4 doses as part of combination therapy, for a maximum of 4 doses.
Location
- University of Texas Southwestern Medical CenterDallas, Texas