144
Participants
Start Date
September 12, 2017
Primary Completion Date
February 20, 2019
Study Completion Date
November 30, 2021
Pembrolizumab
Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
Gemcitabine
"Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide)."
Vinorelbine
Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
Hospital Teresa Herrera, A Coruña
ICO Hospitalet, Barcelona
Hospital Clínico Universitario de Valladolid, Valladolid
Kantonsspital Aarau, Aarau
Centre Hospitalier Universitaire Vaudois, Lausanne
Kantonsspital Luzern, Lucerne
Kantonsspital Winterthur, Winterthur
University Hospital Zürich, Zurich
Addenbrooke's Hospital, Cambridge
Clatterbridge Cancer Centre, Liverpool
Guy's and St Thomas' Hospital, London
Maidstone and Tunbridge Wells NHS Trust, Kent Oncology Centre, Maidstone
Royal Marsden Hospital, London
Plymouth Hospitals NHS Trust, Plymouth
Weston Park Hospital, Sheffield
Merck Sharp & Dohme LLC
INDUSTRY
Frontier Science Foundation, Hellas
OTHER
ETOP IBCSG Partners Foundation
NETWORK