Pembrolizumab in biliary tract cancer (EORTC 1607-GITCG / ABC-09)
Research type
Research Study
Full title
Open-label first line, single-arm phase II study of CisGem combined with pembrolizumab in patients with advanced or metastatic biliary tract cancer
IRAS ID
266741
Contact name
Juan Valle
Contact email
Sponsor organisation
European Organisation for the Research and Treatment of Cancer (EORTC)
Eudract number
2017-003323-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
This study is for adults who have advanced or metastatic biliary tract cancer (BTC), which includes gallbladder cancer and cancer of the bile ducts in and outside of the liver, called cholangiocarcinoma; and ampullary cancer. The purpose of the study is to find out whether giving the immune therapy drug pembrolizumab in combination with standard treatment (cisplatin and gemcitabine chemotherapy) gives better initial results than would be expected with standard treatment alone. This is determined by looking at progression-free survival rates (the length of time without the disease worsening) at 6 months after participants start in the study.
Advanced BTC is a collection of rare cancers that have a poor prognosis and new therapies are needed to improve patient outcomes. Few data are available for the combination of immune therapy and chemotherapy in BTC patients. This is the first study addressing this combination of treatment in BTC patients and it aims to improve the choice of treatment options available. The study will make a clear contribution to the rare set of clinical trials for advanced BTC.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0727
Date of REC Opinion
20 Jan 2020
REC opinion
Further Information Favourable Opinion