EORTC-1607-GITCG

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Open-label first line, single-arm phase II study of CisGem combined with pembrolizumab in patients with advanced or metastatic biliary tract cancer

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 04-Dec-2019 Date Step1 close: 12-May-2021
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 50 - All Groups: 50
Treatment	Drug Cisplatin, Gemcitabine, Pembrolizumab
Study Staff	Markus Moehler (Study Coordinator) , Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz John Bridgewater (Study Co-Coordinator) , University College Hospital, London Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Jozefien Debruyne (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Florence Dujardin (Data Manager) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels Belma Malanda (Project Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Anja Mestnik (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Davide Passariello (Clinical Operations Manager) , EORTC Headquarters, Brussels Jerome Rapion (Statistical Analyst) , EORTC Headquarters, Brussels Konstantina Tsechilidou (Data Manager) , EORTC Headquarters, Brussels Juan Valle (Study Co-Coordinator) , Cholangiocarcinoma Foundation, Herriman
Type of cancer	Biliary Tract
Participating groups	EORTC Gastrointestinal Tract Cancer Group
Recruiting centers	Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) The Christie NHS Foundation Trust (Manchester, United Kingdom) Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) University College Hospital (London, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT03260712
NCT number	NCT03260712
EudraCT	2017-003323-30
Financial Support	Educational Grant