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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 Recruiting
Dates Date of activation: 04-Dec-2019
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) jose.casas (at), EORTC Headquarters, Brussels
Carla Figueiredo (Pharmacovigilance Manager) carla.figueiredo (at), EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at), EORTC Headquarters, Brussels
Anne Giraut (Clinical Scientist) anne.giraut (at), EORTC Headquarters, Brussels
Marsha Greene (Regulatory Affairs Administrator) marsha.greene (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Murielle Mauer (Statistician) murielle.mauer (at), EORTC Headquarters, Brussels
Sophie Schrevens (Clinical Research Associate/Monitor) sophie.schrevens (at), EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) maira.seini (at), EORTC Headquarters, Brussels
Ionela Stanciu (Clinical Operations Manager) ionela.stanciu (at), EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) bette.stofs (at), EORTC Headquarters, Brussels
Juan Valle (Study Co-Coordinator) , The Christie NHS Foundation Trust, Manchester
Tomas Verdeyen (Data Manager) tomas.verdeyen (at), EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) christine.debalincourt (at), EORTC Headquarters, Brussels
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)
Centers to be activated Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Landesklinikum Wiener Neustadt (Wiener Neustadt, Austria)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Protocol summary
NCT number NCT03260712
EudraCT 2017-003323-30