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About this trial

The purpose of this study is to compare Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

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.
In this trial, adding Pembrolizumab to chemotherapy treatment will be compared to chemotherapy alone with a placebo.
The primary endpoints are Progression Free Surivival and Overall Survival.
The secondary endpoints are to evaluate the cancer’s response to Pembrolizumab and how well the therapy controls the growth of the cancer, also to evaluate the safety and tolerability of consuming of Pembrolizumab as part of the treatment.
The patient will be randomised into one of two arms – Pembrolizumab plus Gemcitabine/Cisplatin or Placebo plus Gemcitabine/Cisplatin.

Patient Profile

An adult (18 years or older) that has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)

Where’s this trial being run?

Bon Secours Cork, 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.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: MK3475-966-00
Number: 19-23
Full Title:

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

Principal Investigator: Dr Brian Bird (Bon Secours Hospital Cork)
Type: Industry Sponsored
Sponsor:

Merck Sharp & Dohme Corp.

Recruitment Started: Global: Sep 2019
Ireland: March 2020
Global Recruitment Target:
Ireland Recruitment Target: 9