Spots Global Cancer Trial Database for Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder
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Trial Identification
Brief Title: Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder
Official Title: A Phase II Study Investigating Preoperative MPDL3280A in Operable Transitional Cell Carcinoma of the Bladder (ABACUS)
Study ID: NCT02662309
Conditions
Interventions
Study Description
Brief Summary: ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data.
Detailed Description: MPDL3280A (also called atezolizumab) is an immune check point inhibitor which targets programmed death-ligand 1 (PD-L1). Overexpression of PD-L1 prevents the immune system from eradicating cancerous cells as it blocks antigen recognition. MPDL3280A inhibits this interaction, allowing immune-mediated tumour cell killing.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, , France
Hospices Civils de Lyon, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Institut Claudius Régaud, Toulouse, , France
Netherlands Cancer Institute (NKI), Amsterdam, , Netherlands
Athaia Xarxa Manresa, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Reina Sofía, Córdoba, , Spain
Hospital 12 de Octubre, Madrid, , Spain
CHU de Santiago, Santiago de Compostela, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Contact Details
Name: Thomas Powles, MBBS MD MRCP
Affiliation: Queen Mary University of London
Role: PRINCIPAL_INVESTIGATOR
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