Hepatocellular Carcinoma
Conditions
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has an HCC diagnosis confirmed by histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) - 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 - 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
Exclusion criteria
Exclusion criteria: - 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 less than or equal 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 (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 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 clinical studies with pembrolizumab (MK-3475) - Has a known history of human immunodeficiency virus (HIV) - Has untreated active Hepatitis B virus (HBV) - Has dual infection with HBV/Hepatitis C virus (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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) To estimate the ORR for up to approximately 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of Response (DOR) - Disease Control Rate (DCR) - Time to Progression (TTP) - Progression-Free Survival (PFS) - Overall Survival (OS) To evaluate the duration of response (DOR), disease control rate (DCR), time to progression (TTP), and progression-free survival (PFS) per RECIST 1.1 assessed by central imaging vendor, and OS for up to approximately 2 years. | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Japan, Sweden, United Kingdom, USA
Contacts
Public Contactmailbox MSDJRCT
MSD K.K.
Outcome results
None listed