Pembrolizumab in Advanced Hepatocellular Carcinoma as Second-line Treatment After Failure of Sorafenib
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects
with advanced hepatocellular carcinoma as second-line treatment after failure of sorafenib.
Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of
pembrolizumab.
Enrollment will begin with all subjects without regard for PD-L1 expression status.
An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.
All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug
adminstration for the first 12 months and every 12 weeks (+/- 7 days) thereafter until
progression of disease is documented with radiologic imaging (computed tomography or magnetic
resonance imaging).
The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1.