PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma

PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 12, 2017

Primary Completion Date

February 20, 2019

Study Completion Date

November 30, 2021

Conditions
Pleural Mesothelioma Malignant Advanced
Interventions
DRUG

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.

DRUG

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)."

DRUG

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.

Trial Locations (15)

Unknown

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

ME16 9QQ

Maidstone and Tunbridge Wells NHS Trust, Kent Oncology Centre, Maidstone

SW3 6JJ

Royal Marsden Hospital, London

PL6 8DH

Plymouth Hospitals NHS Trust, Plymouth

UK S10 2SJ

Weston Park Hospital, Sheffield

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Frontier Science Foundation, Hellas

OTHER

lead

ETOP IBCSG Partners Foundation

NETWORK

NCT02991482 - PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma | Biotech Hunter | Biotech Hunter