Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
NCT ID: NCT01285609
Last Updated: 2020-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1289 participants
INTERVENTIONAL
2011-01-16
2017-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone
Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Ipilimumab
Paclitaxel
Carboplatin
Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone
Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo
Paclitaxel
Carboplatin
Interventions
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Ipilimumab
Placebo
Paclitaxel
Carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV or recurrent NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Autoimmune diseases
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Vila Nova de Gaia, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Sibiu, , Romania
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Suceava, , Romania
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Timișoara, , Romania
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Chelyabinsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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St-Peterburg, , Russia
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Tula, , Russia
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Singapore, , Singapore
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Vereeniging, Gauteng, South Africa
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Gyeonggi-do, , South Korea
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Panorama,cape Town, Western Cape, South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Goyang-si, Gyeonggi-do, South Korea
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Suwon, Gyeonggi-do, South Korea
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Seoul, Kangnam-gu, South Korea
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Cheonju-si, North Chungcheong, South Korea
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Seoul, Seodaemungu, South Korea
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Busan, , South Korea
Sharp Memorial Hospital
San Diego, California, United States
Va Connecticut Healthcare System
West Haven, Connecticut, United States
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
University Of Illinois At Chicago Medical Center
Chicago, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Presence Medical Group Hematology Oncology
Skokie, Illinois, United States
Southern Illinois University School Of Medicine
Springfield, Illinois, United States
St. Francis Hospital & Health Centers
Indianapolis, Indiana, United States
Floyd Memorial Cancer Center Of Indiana
New Albany, Indiana, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
St Joseph Mercy Hospital
Ypsilanti, Michigan, United States
University Of Kansas Cancer Center
Kansas City, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Clinical Research Alliance, Inc.
Lake Success, New York, United States
Durham Va Medical Center (111g)
Durham, North Carolina, United States
Carolina Biooncology Institute
Huntersville, North Carolina, United States
Novant Health Oncology Specialists
Lexington, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Oklahoma Oncology And Hematology, Pc Dba
Tulsa, Oklahoma, United States
Kaiser Permanente Northwest Region
Portland, Oregon, United States
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, United States
Wjb Dorn Va Medical Center
Columbia, South Carolina, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, United States
Associated in Oncology and Hematology
Chattanooga, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Thompson Oncology Group
Knoxville, Tennessee, United States
Texas Oncology, PA - South Austin Cancer Center
Austin, Texas, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Local Institution
Daegu, , South Korea
Wisconsin Institutes for Medical Research
Madison, Wisconsin, United States
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Quilmes, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Santa Fe, , Argentina
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Frankston, Victoria, Australia
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Heidelberg, Victoria, Australia
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Wodonga, Victoria, Australia
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Aalst, , Belgium
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Liège, , Belgium
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Sint-Niklaas, , Belgium
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Yvoir, , Belgium
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Fortaleza, Ceará, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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São José dos Campos, São Paulo, Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Oshawa, , Canada
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Guangzhou, Guangdong, China
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Guanzhou, Guangdong, China
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Shantou, Guangdong, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, China
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Xi'an, Shaanxi, China
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Xi'an, Shaanxi, China
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Ürümqi, Xinjiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Santiago, , China
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Shanghai, , China
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Shanghai, , China
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Montería, Departamento de Córdoba, Colombia
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Pereira, Risaralda Department, Colombia
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Ostrava, Poruba, Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Pribram V-Zdabor, , Czechia
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Ústí nad Labem, , Czechia
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Znojmo, , Czechia
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Aalborg, , Denmark
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Herlev, , Denmark
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Hillerød, , Denmark
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Næstved, , Denmark
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Odense, , Denmark
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Caen, , France
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Marseille, , France
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Paris, , France
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Poitiers, , France
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Rennes, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Bad Berka, , Germany
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Bochum, , Germany
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Darmstadt, , Germany
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Dresden, , Germany
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Frankfurt am Main, , Germany
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Gauting, , Germany
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Grosshandsdorf, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Kassel, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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München, , Germany
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Neumünster, , Germany
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Nuremberg, , Germany
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Regensburg, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Villingen-Schwenningen, , Germany
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Farkasgyepű, , Hungary
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Gyula, , Hungary
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Mátraháza, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Sopron, , Hungary
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Székesfehérvár, , Hungary
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Szolnok, , Hungary
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Benevento, , Italy
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Bologna, , Italy
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Lido di Camaiore, , Italy
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Lucca, , Italy
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Monza, , Italy
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Padua, , Italy
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Perugia, , Italy
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Siena, , Italy
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Sondrio, , Italy
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Terni, , Italy
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Treviglio, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Natori-shi, Miyagi, Japan
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Sendai, Miyagi, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Hirakata-shi, Osaka, Japan
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Osaka, Osaka, Japan
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Sunto-gun, Shizuoka, Japan
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Chuo-ku, Tokyo, Japan
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Ube-shi, Yamaguchi, Japan
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Akashi, Hyogo, , Japan
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Fukuoka, , Japan
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Matsuyama, Ehime, , Japan
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Sapporo Hokkaido, , Japan
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Sapporo, Hokkaido, , Japan
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Sayama, , Japan
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Sendai, Miyagi, , Japan
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Takatsuki, , Japan
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Tokyo, , Japan
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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's-Hertogenbosch, , Netherlands
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Breda, , Netherlands
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Harderwijk, , Netherlands
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Nieuwegein, , Netherlands
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Trujillo, La Libertad, Peru
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Arequipa, , Peru
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Cercado, , Peru
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Lima, , Peru
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Elblag, , Poland
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Gdansk, , Poland
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Gdansk- Zaspa, , Poland
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Grudziądz, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Torun, , Poland
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Warsaw, , Poland
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São Martinho do Bispo, Coimbra District, Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Barakaldo, Vizcaya, Spain
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Ávila, , Spain
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Benidorm-alicante, , Spain
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Castellon, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Manresa, , Spain
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Ourense, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Basel, , Switzerland
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Winterthur, , Switzerland
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Changhua, , Taiwan
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Chiayi City, , Taiwan
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Kaohsiung County, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, Tungpayathai, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Songkhla, , Thailand
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Dundee, Angus/forfarshire, United Kingdom
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Truro, Cornwall, United Kingdom
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Southampton, Hampshire, United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2009-017396-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-104
Identifier Type: -
Identifier Source: org_study_id
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