1,513
Participants
Start Date
January 31, 2007
Primary Completion Date
April 30, 2012
Study Completion Date
April 30, 2015
Tecemotide (L-BLP25)
After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.
Single low dose cyclophosphamide
A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.
Placebo
A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.
St. Vincents Comprehensive Cancer Center, New York
Hematology Oncology Associates of Rockland, Nyack
Univ. of Pennsylvania Abramson Cancer Center, Philadelphia
Fox Chase Cancer Center, Philadelphia
Sinai Hospital of Baltimore, Baltimore
Fairfax-Northern Virginia Hematology Oncology, PC, Fairfax
Wheeling Hospital, Wheeling
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, Chapel Hill
Carolinas Hematology-Oncology, Charlotte
Hanover Medical Specialts PA, Wilmington
Florida Hospital Memorial System, Ormond Beach
Pasco Hernando Oncology Associates P.A, Brooksville
Pasco Hernando Oncology Associates, PA, New Port Richey
The Jones Clinic, PC, Germantown
Kentucky Cancer Center, Hazard
University Hospitals of Cleveland, Cleveland
Gabrail Cancer Center, Canton
Signal Point Clinical Research Center, LLC, Middletown
Oncology Care Associates, Saint Joseph
Deaconess Billings Clinic, Billings
Big Sky Oncology, Sletten Cancer Institute, Great Falls
Joliet Oncology-Hematology Associates, Ltd., Joliet
Rush University Medical Center, Chicago
Southern Illinois Hematology/Oncology, Centralia
Southeast Nebraska Cancer Center, Lincoln
Nebraska Cancer Care, LLC, Hastings
Hematology and Oncology Specialists, LLC, Metarie
Saint Edward Mercy Medical Center, Fort Smith
Southwestern Regional Medical Center, Tulsa
Center for Oncology Research, Dallas
John Peter Smith Center for Cancer Care, Fort Worth
The Center for Cancer and Blood Disorders, Fort Worth
Cancer Therapy & Research Center, Institute for Drug Development, San Antonio
University of Colorado Cancer Center, Denver
Norris Cancer Hospital, Los Angeles
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute, Los Angeles
Clinical Trials and Research Associates, Inc., Montebello
Glendale Adventist Medical Center, Glendale
Pacific Cancer Medical Center, Anaheim
Stockton Hematology Oncology Medical Group, Inc., Stockton
Providence Portland Medical Center, Portland
Desert Hematology Oncology Medical Group, Inc, Rancho Mirage
University of Miami, Sylvester Comprehensive Cancer Center, Miami
Leonard J. Chabert Medical Center, Houma
University of Maryland, Marlene and Steward Greenbaum Cancer Center, Baltimore
Lahey Clinic, Burlington
University of Minnesota Physicians, Masonic Cancer Center, Minneapolis
Saint Louis University Cance Center, St Louis
Southwestern Regional Medical Center, Tulsa
Hospital Italiano Regional del Sur, Bahía Blanca
Paliar, Capital, Buenos Aires
Corporacion Medica General San Martin, San Martín
Centro Oncologico de Roario, Rosario
"Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)", Buenos Aires
Instituto Especializado Alexander Fleming, Buenos Aires
Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano, Buenos Aires
Clinica Universitaria Reina Fabiola, Córdoba
Research Site, Tandil
Research Site, Nedlands
Research Site, Bankstown, NSW
Research Site, Camperdown
Research Site, Heidelberg
Research Site, Kingswood
Research Site, Saint Leonards
Research Site, Woolloongabba
Research Site, Graz
Research Site, Linz
Research Site, Inssbruck
Research Site, Salzburg
Research Site, Vienna
Research Site, Wein, Venna
Research Site, Wels
Research Site, Brasschaat
Research Site, Brussels
Research Site, Haine-Saint-Paul
Research Site, Leuven
Research Site, Liège
Research Site, Mechelen
Hospital das Clinicas da Faculdade de Medinina de Univeridade, São Paulo
Nugieo de Oncologia da Bahia, Salvador
Hospital LifeCenter, Belo Horizonte
Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos, Porto Alegre
Associacao Hospital de Caridade Ijui, Ijuí
Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia, Porto Alegre
Hospital Sao Lucas-Pucrs, Porto Alegre
Research Site, Porto Algre
Centro de Oncologia de Campinas - OCC, Campinas
Fundacao Hospital Amaral Carvalho, Jaú
Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia, São Paulo
Santa Casa de Misericordia De Sao Paulo, São Paulo
Instituto de Oncologia de Sorocaba, Sorocaba
Research Site, Ondina-Salvdor
Instituto Nacional do Cancer - INCA, Rio de Janeriro
Tom Baker Cancer Center, Calgary
Cross Cancer Institue, Edmonton
Frazer Valley Cancer Center, Surrey
British Columbia Cancer Agency, Vancouver
Vancouver Island Cancer Center, Victoria
Cancer Care Manitoba, Winnipeg
Capital District Health Authority, Halifax
Cape Breton Districk Health Authority Cancer Care, Sydney
Juravinski Cancer Center, Hamilton
Niagara Health System, St. Catharines
Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center, Thunder Bay
Mount Sinai Hospital, Toronto
Princess Margaret Hospital, Toronto
Windsor Regional Cancer Center, Windsor
Hopital Notre Dame, Montreal
Jewish General Hospital, Montreal
Hopital Laval, Sainte-Foy
Research Site, Beijing
Research Site, Guangzhou
Research Site, Shanghai
Research Site, Hradec Králové
Research Site, Ostrava-Poruba
Research Site, Prague
Research Site, Ústí nad Labem
Research Site, Herlev
Research Site, Odense C
Research Site, Pierre-Bénite
Research Site, Besançon
Research Site, Beuvry
Research Site, Brest
Research Site, Caen
Research Site, Chauny
Research Site, Marseille
Research Site, Nancy
Research Site, Nantes-Saint Herblain
Research Site, Paris
Research Site, Perpignan
Research Site, Poitiers
Research Site, Strasbourg
Research Site, Essen
Research Site, Hemer
Research Site, Mainz
Research Site, Homburg
Research Site, Berlin
Research Site, Cologne
Research Site, Coswig
Research Site, Essen
Research Site, Frankfurt am Main
Research Site, Freiburg im Breisgau
Research Site, Gauting
Research Site, Großhansdorf
Research Site, Hamburg
Reseach Site, Heidelberg
Research Site, Kassel
Research Site, Kiel
Research Site, Leipzig
Research Site, Magdeburg
Research Site, Mainz
Research Site, Minden
Research Site, Mutzschen
Research Site, München
Research Site, Oldenburg
Research Site, Rostock
Research Site, Marousi
Research Site, Athens
Research Site, Thessaloniki
Research Site, Athens
Research Site, Chidari, Athens
Research Site, Heraklion
Research Site, Shatin
Research Site, Hong Kong
Research Site, Budapest
Research Site, Mátraháza
Research Site, Nyíregyháza
Research Site, Tatabayana
Research Site, Chennai
Research Site, Hyderabad
Research Site, Mumbai
Research Site, New Delhi
Research Site, Vellore
Research Site, Dublin
Research Site, Tel Litwinsky
Research Site, Beersheba
Research Site, Haifa
Research Site, Jerusalem
Research Site, Kfar Saba
Research Site, Petah Tikva
Research Site, Tel Aviv
Research Site, Ẕerifin
Research Site, Genova
Research Site, Palermo
Research Site, Candiolo
Research Site, Avelino
Research Site, Bologna
Research Site, Carpi
Research Site, Chieti
Research Site, Forlì
Research Site, Meldola
Research Site, Milan
Research Site, Napoli
Research Site, Orbassano-Torino
Research Site, Parma
Research Site, Rome
Research Site, Rozzano-Milano
Research Site, Sassari
Research Site, Trento
Centro Oncologico de Chihuahua, Chihuahua City
Consultorio del, Morelia
Instituto Nacional de Cancerologia (INCAN), Mexico City
Research Site, Amsterdam
Research Site, Amsterdam
Research Site, Eindhoven
Research Site, Hoofdrop
Research Site, Tilburg
Research Site, Zwolle
Research Site, Warsaw
Research Site, Bialystok
Research Site, Bydgoszcz
Research Site, Bytom
Research Site, Gdynia
Research Site, Krakow
Genova, Lodz
Research Site, Olsztyn
Research Site, Otwock
Research Site, Poznan
Research Site, Torun
Genova, Warsaw
Research Site, Warsaw
Research Site, Wroclaw
Research Site, Zabrze
Genova, Coimbra
Genova, Lisbon
Genova, Porto
Genova, Santa Maria de Feira
Research Site, Bucharest
Research Site, Cluj-Napoca
Research Site, Iași
Research Site, Sibiu
Research Site, Suceava
Research Site, Timișoara
Reseaerch Site, Kazan'
Research Site, Yaroslavl
Research Site, Barnaul
Genova, Chelaybinsk
Research Site, Ivanovo
Research Site, Kazan'
Research Site, Moscow
Research Site, Obninsk
Research Site, Saint Petersburg
Research Site, Tomsk
Research Site, Voronezh
Research Site, Singapore
Research Site, Bratislava
Research Site, Košice
Research Site, Nitra
Research Site, Goyang-si
Research Site, Seoul
Research Site, Seoul
Research Site, Mataró
Research Site, Barakaldo
Research Site, Donostia / San Sebastian
Research Site, Jaén
Research Site, A Coruña
Research Site, Alicante
Research Site, Barcelona
Research Site, Burgos
Research Site, Girona
Research Site, Lugo
Research Site, Madrid
Research Site, Málaga
Research Site, Gävle
Research Site, Gothenburg
Research Site, Lund
Research Site, Stockholm
Research Site, Umeå
Research Site, Uppsala
Research Site, Basel
Research Site, Geneva
Research Site, Winterthur
Research Site, Kaohsiung City
Research Site, Taichung
Research Site, Tainan City
Research Site, Taipei
Research Site, Taoyuan District
Research Site, Cornwall
Research Site, Edinburgh
Research Site, Glasgow
Research Site, Guildford
Research Site, Inverness
Research Site, Leeds
Research Site, Leicester
Research Site, London
Research Site, Manchester
Research Site, Metropolitan Borough of Wirral
Research Site, Southampton
Research Site, Surrey
Research Site, Torquay
Lead Sponsor
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono
INDUSTRY