Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
NCT ID: NCT01057810
Last Updated: 2016-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
837 participants
INTERVENTIONAL
2010-07-31
2015-07-31
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
Ipilimumab
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Placebo
Placebo
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Interventions
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Ipilimumab
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Placebo
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asymptomatic or minimally symptomatic
* Progression during hormonal therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Exclusion Criteria
* Prior immunotherapy or chemotherapy for metastatic prostate cancer
* Autoimmune disease
* HIV, Hepatitis B, or Hepatitis C infection
18 Years
MALE
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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Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Desert Hematology Oncology
Rancho Mirage, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States
Straub Clinic And Hospital
Honolulu, Hawaii, United States
University Of Chicago
Chicago, Illinois, United States
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States
Goshen Center For Cancer Care
Goshen, Indiana, United States
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
University Of Maryland
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States
Goshen Medical Associates
Goshen, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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La Rioja, La Rioja Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Kogarah, New South Wales, Australia
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Ashford, South Australia, Australia
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Box Hill, Victoria, Australia
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East Bentleigh, Victoria, Australia
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Frankston, Victoria, Australia
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Heidelberg, Victoria, Australia
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Subiaco, Western Australia, Australia
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Brasília, Federal District, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte - Mg, Minas Gerais, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Kingston, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Temuco, Región de la Araucanía, Chile
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, , Chile
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Montería, Departamento de Córdoba, Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Medellín, , Colombia
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Hradec Králové, , Czechia
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Liberec, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Herlev, , Denmark
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København Ø, , Denmark
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Bordeaux, , France
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Clermont-Ferrand, , France
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Marseille, , France
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Pointe à Pitre, , France
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Poitiers, , France
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Villejuif, , France
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Aachen, , Germany
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Heidelberg, , Germany
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Marktredwitz, , Germany
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Munich, , Germany
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Wesel, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Székesfehérvár, , Hungary
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Meldola (FC), , Italy
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Milan, , Italy
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Siena, , Italy
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Terni, , Italy
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Tlalpan, Mexico City, Mexico
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México, Querétaro, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Amsterdam, , Netherlands
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Sittard-geleen, , Netherlands
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Kristiansand, , Norway
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Gdansk, , Poland
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Kościerzyna, , Poland
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Krakow, , Poland
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Kutno, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Słupsk, , Poland
Va Caribbean Healthcare System
San Juan, , Puerto Rico
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Bucharest, , Romania
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Cluj-napoca, Cluj County, , Romania
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Timisoara,timis County, , Romania
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Stockholm, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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Adana, , Turkey (Türkiye)
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Bornova, Izmir, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Glasgow, Lanarkshire, United Kingdom
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Guildford, Surrey, United Kingdom
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Birmingham, West Midlands, United Kingdom
Countries
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References
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de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2009-016217-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-095
Identifier Type: -
Identifier Source: org_study_id
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