A Phase III Study of Pembrolizumab (MK 3475) plus Best Supportive Care in Subjects with Advanced Hepatocellular Carcinoma

Phase 1

• Conditions: Hepatocellular Carcinoma; MedDRA version: 19.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004567-36-FR
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-08
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Subjects must: provide informed consent, be > or = 18 years of age, have confirmed diagnosis of HCC, have a life expectancy greater than 3 months, have 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, have a Child-Pugh A liver score, have measurable disease based on RECIST 1.1 as confirmed by central imaging vendor, have ECOG Performance Scale of 0 or 1, have documented objective radiographic progression after stopping treatment with sorafenib or else intolerance to sorafenib, subjects with chronic infection by HCV who are untreated are allowed on study and subjects with successful HCV treatment are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug, demonstrate adequate organ function, have negative pregnancy test for females of child bearing potential prior to starting study and male and female subjects of childbearing potential must be willing to use an adequate method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 258

Exclusion Criteria

The subject will be excluded from participating in the trial if the subject: 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 investigation device within 4 weeks of the first dose of treatment., has received sorafenib within 14 days of first dose of study medication, has had esophageal or gastric variceal bleeding within the last 6 months, has clinically apparent ascites on physical examination, (ascites detectable on imaging studies only IS allowed), has portal vein invasion of HCC based on imaging, has had encephalopathy in the last 6 months, 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 required treatment in the past two years, 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 trial treatment, has received locoregional therapy to liver or major surgery to liver or other site within 6 weeks prior to the first dose of study drug, has a diagnosed additional malignancy within 5 years prior to first dose of study treatment with some exceptions, has radiographically detectable central nervous system (CNS) metastases and/or carcinomatous meningitis, has a known history of, or evidence of, interstitial lung disease or active non-infectious pneumonitis, has known psychiatric or substance abuse disorders, is pregnant or breastfeeding, has received prior immunotherapy or previously participated in Merck pembrolizumab clinical trials, has untreated active Hepatitis B, 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 therapy, with exception for killed virus vaccines used for seasonal influenza vaccines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified