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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Robin Kate Kelley

Description

Summary

This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in participants with previously systemically treated hepatocellular carcinoma (HCC). Study participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up to approximately 2 years). The primary objective of this study is to determine the Objective Response Rate (ORR) of pembrolizumab given as monotherapy in participants with previously systemically treated HCC

Official Title

A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-224)

Keywords

Hepatocellular Carcinoma PD1 PD-1 PDL1 PD-L1 Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Has histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) based on pathology report.
  • Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach.
  • Has a Child-Pugh Class A liver score within 7 days of first dose of study drug.
  • Has a predicted life expectancy>3 months.
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as confirmed by the blinded central imaging vendor.
  • Has a performance status of 0 or 1 using the Eastern Cooperative Oncology Group(ECOG) Performance Scale within 7 days of first dose of study drug.
  • Has documented objective radiographic progression after stopping treatment with sorafenib or else intolerance to sorafenib.
  • Participants with chronic infection by Hepatitis C Virus (HCV) who are untreated are allowed on study. In addition, participants with successful HCV treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug.
  • Is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential).
  • Demonstrates adequate organ function.

You CAN'T join if...

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, herbal/complementary oral or IV medicine, or used an investigational device within 4 weeks of the first dose of study drug. Participant must also have recovered from associated therapy (i.e., to Grade ≤1 or baseline) and from adverse events due to any prior therapy.
  • Has received sorafenib within 14 days of first dose of study drug.
  • Has had esophageal or gastric variceal bleeding within the last 6 months.
  • Has clinically apparent ascites on physical examination.
  • Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging.
  • Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to control their encephalopathy are not allowed.
  • Had a solid organ or hematologic transplant.
  • Had prior systemic therapy for HCC other than sorafenib, or intercurrent local therapy to the liver tumor between sorafenib and study drug.
  • Has active autoimmune disease that has required systemic treatment in past 2 years(i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has received locoregional therapy to liver (transcatheter chemoembolization [TACE],transcatheter embolization [TAE], radiation, radioembolization, or ablation) or major surgery to liver or other site within 6 weeks prior to the first dose of study drug.Minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days prior to the first dose of study drug (Cycle 1, Day 1). Participants must have recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to starting study drug.
  • Has a diagnosed additional malignancy within 5 years prior to first dose of study treatment with the exception of curatively treated basal cell carcinoma of the skin,squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
  • Has radiographically detectable central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has evidence or history of interstitial lung disease or active noninfectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Has received prior immunotherapy including anti-programmed death-1 (anti-PD-1),anti-PD-ligand-1 (anti-PD-L1), or anti-PD-L2 agents, or if the participant has previously participated in Merck pembrolizumab (MK-3475) clinical stduies.
  • Has a known history of human immunodeficiency virus (HIV)
  • Has untreated active Hepatitis B (HBV).
  • Has dual infection with HBV/HCV or other hepatitis combinations at study entry.
  • Has received a live vaccine within 30 days of planned start of study drug (Cycle 1,Day 1).

Locations

  • Call for Information (Investigational Site 0016)
    San Francisco, California, 94158, USA
  • Call for Information (Investigational Site 0003)
    Duarte, California, 91010, USA
  • Call for Information (Investigational Site 8001)
    Santa Barbara, California, 93105, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT02702414
Phase
Phase 2
Lead Scientist
Robin Kate Kelley
Study Type
Interventional
Last Updated
February 2017