Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
1,289
35 countries
287
Brief Summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2011
Longer than P75 for phase_3
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2011
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2015
CompletedResults Posted
Study results publicly available
June 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2017
CompletedJune 18, 2020
June 1, 2020
4.4 years
January 24, 2011
May 16, 2016
June 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Secondary Outcomes (2)
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Study Arms (2)
Ipilimumab + Paclitaxel and Carboplatin
EXPERIMENTALIpilimumab + 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
Placebo + Paclitaxel and Carboplatin
PLACEBO COMPARATORPlacebo + 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
Interventions
Eligibility Criteria
You may qualify if:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You may not qualify if:
- Brain Metastases
- Autoimmune diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (290)
Sharp Memorial Hospital
San Diego, California, 92123, United States
Va Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, 33486, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
University Of Illinois At Chicago Medical Center
Chicago, Illinois, 60612, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Presence Medical Group Hematology Oncology
Skokie, Illinois, 60076, United States
Southern Illinois University School Of Medicine
Springfield, Illinois, 62794-9678, United States
St. Francis Hospital & Health Centers
Indianapolis, Indiana, 46237, United States
Floyd Memorial Cancer Center Of Indiana
New Albany, Indiana, 47150, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353, United States
St Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
University Of Kansas Cancer Center
Kansas City, Missouri, 64131, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Clinical Research Alliance, Inc.
Lake Success, New York, 11042, United States
Durham Va Medical Center (111g)
Durham, North Carolina, 27705, United States
Carolina Biooncology Institute
Huntersville, North Carolina, 28078, United States
Novant Health Oncology Specialists
Lexington, North Carolina, 27295, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Oklahoma Oncology And Hematology, Pc Dba
Tulsa, Oklahoma, 74146, United States
Kaiser Permanente Northwest Region
Portland, Oregon, 97227, United States
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, 18840, United States
Wjb Dorn Va Medical Center
Columbia, South Carolina, 29209, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, 29615, United States
Associated in Oncology and Hematology
Chattanooga, Tennessee, 37421, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Thompson Oncology Group
Knoxville, Tennessee, 37916, United States
Texas Oncology, PA - South Austin Cancer Center
Austin, Texas, 78745, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Wisconsin Institutes for Medical Research
Madison, Wisconsin, 53705, United States
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Quilmes, Buenos Aires, B1878DVB, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Córdoba, X5006HBF, Argentina
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Córdoba, X5006IKK, Argentina
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Mendoza, M5500AYB, Argentina
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Santa Fe, S3000FFU, Argentina
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Bedford Park, South Australia, 5042, Australia
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Box Hill, Victoria, 3128, Australia
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Frankston, Victoria, 3199, Australia
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Heidelberg, Victoria, 3084, Australia
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Wodonga, Victoria, 3690, Australia
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Graz, 8036, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Aalst, 9300, Belgium
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Liège, 4000, Belgium
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Sint-Niklaas, 9100, Belgium
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Yvoir, 5530, Belgium
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Fortaleza, Ceará, 60160-230, Brazil
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Belo Horizonte, Minas Gerais, 30150-270, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Passo Fundo, Rio Grande do Sul, 99010260, Brazil
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Barretos, São Paulo, 14784, Brazil
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São José dos Campos, São Paulo, 12245, Brazil
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Porto Alegre, 90430, Brazil
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Ribeirão Preto, 14015, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São Paulo, 01224-010, Brazil
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São Paulo, 04039-901, Brazil
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Montreal, Quebec, H2W 1S6, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Oshawa, L1G 2B9, Canada
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Viña del Mar, Región de Valparaíso, 2540364, Chile
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Santiago, Santiago Metropolitan, 7520378, Chile
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Santiago, Santiago Metropolitan, 8380455, Chile
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Guangzhou, Guangdong, 510060, China
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Guanzhou, Guangdong, 510080, China
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Shantou, Guangdong, 515041, China
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Wuhan, Hubei, 430023, China
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Nanjing, Jiangsu, 210002, China
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Nanjing, Jiangsu, 210009, China
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Suzhou, Jiangsu, 215006, China
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Changchun, Jilin, 130012, China
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Xi'an, Shaanxi, 710038, China
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Xi'an, Shaanxi, 710061, China
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Ürümqi, Xinjiang, 830011, China
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Hangzhou, Zhejiang, 310016, China
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Beijing, 100032, China
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Beijing, 100071, China
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Beijing, 100142, China
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Beijing, 100853, China
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Santiago, 7630370, China
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Shanghai, 200030, China
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Shanghai, 200433, China
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Montería, Departamento de Córdoba, Colombia
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Pereira, Risaralda Department, Colombia
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Ostrava, Poruba, 70852, Czechia
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Prague, 12808, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Pribram V-Zdabor, 26195, Czechia
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Ústí nad Labem, 401 13, Czechia
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Znojmo, 669 02, Czechia
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Aalborg, 9000, Denmark
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Herlev, 2730, Denmark
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Hillerød, 3400, Denmark
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Næstved, 4700, Denmark
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Odense, 5000, Denmark
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Caen, 14076, France
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Marseille, 13915, France
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Paris, 75014, France
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Poitiers, 86000, France
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Rennes, 35033, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Bad Berka, 99437, Germany
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Bochum, 44791, Germany
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Darmstadt, 64283, Germany
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Dresden, 01307, Germany
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Frankfurt am Main, 60590, Germany
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Gauting, 82131, Germany
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Grosshandsdorf, 22927, Germany
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Hamburg, D-21075, Germany
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Heidelberg, 69126, Germany
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Kassel, 34125, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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München, 81925, Germany
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Neumünster, 24534, Germany
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Nuremberg, 90419, Germany
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Regensburg, 93049, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Villingen-Schwenningen, 78052, Germany
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Hong Kong, 8525, Hong Kong
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Hong Kong, Hong Kong
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New Territories, 8520, Hong Kong
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Budapest, 1121, Hungary
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Budapest, 1125, Hungary
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Deszk, 6772, Hungary
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Farkasgyepű, 8582, Hungary
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Gyula, 5703, Hungary
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Mátraháza, 3233, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7602, Hungary
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Sopron, 9400, Hungary
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Székesfehérvár, 8000, Hungary
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Szolnok, 5000, Hungary
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Dublin, 24, Ireland
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Dublin, 4, Ireland
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Dublin, 8, Ireland
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Galway, Ireland
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Tel Aviv, 69710, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Benevento, 82100, Italy
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Bologna, 40138, Italy
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Lido di Camaiore, 55041, Italy
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Lucca, 55100, Italy
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Monza, 20052, Italy
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Padua, 35128, Italy
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Perugia, 06156, Italy
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Siena, 53100, Italy
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Sondrio, 23100, Italy
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Terni, 05100, Italy
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Treviglio, 24047, Italy
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Nagoya, Aichi-ken, 4600001, Japan
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Nagoya, Aichi-ken, 4648681, Japan
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Kashiwa, Chiba, 277-8577, Japan
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Kanazawa, Ishikawa-ken, 9208641, Japan
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Yokohama, Kanagawa, 2360051, Japan
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Yokohama, Kanagawa, 2408555, Japan
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Natori-shi, Miyagi, 9811293, Japan
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Sendai, Miyagi, 9808574, Japan
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Kurashiki-shi, Okayama-ken, 7010192, Japan
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Kurashiki-shi, Okayama-ken, 710-8602, Japan
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Hirakata-shi, Osaka, 5731191, Japan
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Osaka, Osaka, 5340021, Japan
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Sunto-gun, Shizuoka, 411-8777, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Ube-shi, Yamaguchi, 7550241, Japan
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Akashi, Hyogo, 6738558, Japan
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Fukuoka, 8128582, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Sapporo Hokkaido, 003-080, Japan
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Sapporo, Hokkaido, 0608648, Japan
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Sayama, 5898511, Japan
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Sendai, Miyagi, 980-0873, Japan
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Takatsuki, 569-8686, Japan
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Tokyo, 135-8550, Japan
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Zapopan, Jalisco, 45170, Mexico
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Mexico City, Mexico City, 06760, Mexico
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Monterrey, Nuevo León, 64060, Mexico
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's-Hertogenbosch, 5223 GZ, Netherlands
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Breda, 4818 CK, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Nieuwegein, 3435 CM, 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, LIMA 11, Peru
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Elblag, 82-300, Poland
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Gdansk, 80-952, Poland
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Gdansk- Zaspa, 80-462, Poland
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Grudziądz, 86-300, Poland
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Olsztyn, 10-357, Poland
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Otwock, 05-400, Poland
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Poznan, 60 569, Poland
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Szczecin, 70-891, Poland
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Torun, 87-100, Poland
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Warsaw, 02-781, Poland
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São Martinho do Bispo, Coimbra District, 3041801, Portugal
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Lisbon, 1099023, Portugal
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Lisbon, 1769-001, Portugal
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Porto, 4200-072, Portugal
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Santa Maria da Feira, 4520211, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Bucharest, 010976, Romania
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Bucharest, 030171, Romania
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Cluj-Napoca, 400058, Romania
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Sibiu, 550245, Romania
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Suceava, 720237, Romania
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Timișoara, 300239, Romania
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Chelyabinsk, 454087, Russia
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Moscow, 125009, Russia
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Pyatigorsk, 357502, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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St-Peterburg, 198255, Russia
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Tula, 300053, Russia
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Singapore, 308433, Singapore
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Vereeniging, Gauteng, 1939, South Africa
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Panorama,cape Town, Western Cape, 7500, South Africa
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Cape Town, 7925, South Africa
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Durban, 4067, South Africa
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Goyang-si, Gyeonggi-do, 410-769, South Korea
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Suwon, Gyeonggi-do, 442-723, South Korea
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Seoul, Kangnam-gu, 135-710, South Korea
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Cheonju-si, North Chungcheong, 361-771, South Korea
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Seoul, Seodaemungu, 120-752, South Korea
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Busan, 602-739, South Korea
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Daegu, 700-712, South Korea
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Gyeonggi-do, 463-802, South Korea
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Seoul, 110-744, South Korea
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Seoul, 134-791, South Korea
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Seoul, 135-720, South Korea
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Seoul, 136-705, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
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Seoul, 156-755, South Korea
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Suwon, 443-721, South Korea
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Barakaldo, Vizcaya, 48903, Spain
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Ávila, 05004, Spain
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Benidorm-alicante, 03501, Spain
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Castellon, 12002, Spain
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Madrid, 28033, Spain
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Madrid, 28041, Spain
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Manresa, 08243, Spain
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Ourense, 32005, Spain
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Valencia, 46014, Spain
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Valencia, 46015, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Stockholm, 17176, Sweden
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Umeå, SE-901 85, Sweden
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Basel, 4031, Switzerland
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Winterthur, 8401, Switzerland
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Changhua, 500, Taiwan
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Chiayi City, 61363, Taiwan
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Kaohsiung County, 83301, Taiwan
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Taichung, 404, Taiwan
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Taichung, 407.5, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taipei, Taiwan
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Bangkok, Tungpayathai, 10400, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Songkhla, 90110, Thailand
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Dundee, Angus/forfarshire, DD1 9SY, United Kingdom
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Truro, Cornwall, TR1 3LJ, United Kingdom
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Southampton, Hampshire, SO16 6YD, United Kingdom
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Nottingham, NG51PB, United Kingdom
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Sheffield, s10 2SJ, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 28, 2011
Study Start
January 16, 2011
Primary Completion
June 9, 2015
Study Completion
August 22, 2017
Last Updated
June 18, 2020
Results First Posted
June 23, 2016
Record last verified: 2020-06