Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy

PHASE2TerminatedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

April 7, 2017

Study Completion Date

April 7, 2017

Conditions
Urinary Bladder Neoplasms
Interventions
BIOLOGICAL

recMAGE-A3 + AS15 ASCI

5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

BIOLOGICAL

Placebo

5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

Trial Locations (50)

Unknown

Faculty teaching Hospital in Plzen, Pilsen

Hospital Motol, Prague

Thomayerova nemocnice, Prague

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem

Institut Bergonié, Bordeaux

Hôpital Huriez, Lille

Hôpital Edouard Herriot, Lyon

Institut Curie, Paris

Hôpital Rangueil, Toulouse

Universitätsklinikum Aachen, Aachen

Universitätsklinikum C.-G. Carus Dresden, Dresden

Heinrich-Heine University, Düsseldorf

Waldkrankenhaus St. Marien gGmbH, Erlangen

Universitätsklinikum Giessen, Giessen

Universitätsklinikum Jena, Jena

Universitätsmedizin, Mannheim

Universitätsklinikum Marburg, Marburg

Klinikum rechts der Isar der TU München, München

Universitätklinikum Rostock, Rostock

Universitätsklinikum Tübingen, Tübingen

Universitaria Policlinico Consorziale di Bari, Bari

Università Vita e Saluta, Milan

Ospedaliera di Perugia, Perugia

Universitaria Pisana, Pisa

Università di Roma, La Sapienza, Rome

NKI, Amsterdam

St Antoniusziekenhuis, Nieuwegein

RadboudUMC, Nijmegen

Kliniczny Dzial Urologii Swietokrzyskiego Centrum Onkologii, Kielce

Medical University of Warsaw, Warsaw

Oddzial Urologii Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

Fundeni Clinical Institute, Bucharest

Clinical County Emergency Hospital Craiova, Craiova

"Federal State Budget Institution Scientific Research Institute of Urology of the Ministry of Healthcare and Social Development of the Russian Federation", Moscow

"Federal State Institution Moscow Research Oncology Institute named after P.A. Gertsen of the Ministry of Healthcare and Social Development of the Russian Federation", Moscow

Institution of the Russian Academy of Medical Science Russian Oncology Research Center named after N.N. Blokhin of RAMS, Moscow

"Municipal Budget Institution of Health Care Clinical Diagnostic Center Zdorovie of Rostov-on-Don city", Rostov-on-Don

"Saint Petersburg State Institution of Health Care City Multi-Field Hospital #2", Saint Petersburg

Hospital Universitario A Coruña, A Coruña

Hospital Universitario Principe de Asturias, Alcalá de Henares

Hospital Universitario Fundación Alcorcón, Alcorcón

Fundación Puigvert, Barcelona

Hospital Clinic Barcelona, Barcelona

Hospital del Mar, Barcelona

Hospital Universitario Puerta del Mar, Cadiz

Hospital 12 de Octubre, Fundación de Investigación Biomédica, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Central de Asturias, Oviedo

Hospital Infanta Sofia, San Sebastián de los Reyes

Kyiv City Clinical Oncology Hospital, Kiev

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

European Association of Urology Research Foundation

OTHER

NCT01435356 - Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy | Biotech Hunter | Biotech Hunter