About this trial
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation (KEYNOTE-937).
Pembrolizumab is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Pembrolizumab has been designed to attach to and block an antigen called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells. This increases the ability of the immune system to kill tumour cells.
The purpose of this study is to test for safety, efficacy, recurrence-free survival and overall survival in using pembrolizumab versus placebo as adjuvant therapy.
Patients who are eligible to participate on this study will be assigned by chance (one chance in two) to one of two treatment groups via a process called randomization. The two treatment groups are the experimental arm: pembrolizumab, or the placebo arm: where there will be a placebo given in place of pembrolizumab.
|Has a diagnosis of HCC by radiological criteria and/or pathological confirmation and has had a complete radiological response ≥4 weeks after complete surgical resection or local ablation.|
Where’s this trial being run?
Tallaght University Hospital and St Vincents University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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For more detailed informationClick Here
A Phase 3 Double-Blinded, Two-Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation.
|Principal Investigator:||Prof. Ray McDermott (St Vincent's University Hospital), Dr Fergal Kelleher (Tallaght University Hospital)|
Merck Sharp & Dohme (MSD)
Global: May 2019
Ireland: October 2019
|Global Recruitment Target:||950|
|Ireland Recruitment Target:||8|