Study of Immunotherapy to Treat Advanced Prostate Cancer
NCT ID: NCT00861614
Last Updated: 2016-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
988 participants
INTERVENTIONAL
2009-05-31
2015-08-31
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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 bone metastasis
* Testosterone \< 50 ng/dl
* Prior treatment with docetaxel
Exclusion Criteria
* Autoimmune disease
* Known HIV, Hep B, or Hep C infection
* More than 2 prior systemic anticancer regimens for prostate cancer
* Prior treatment on BMS CA180227 for prostate cancer
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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Southern Cancer Center
Mobile, Alabama, United States
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States
Marsha G. Fink, Md, Inc.
Fountain Valley, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States
Comprehensive Cancer Center
Palm Springs, California, United States
Va San Diego Healthcare System
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Suburban Hematology-Oncology Associates, Pc
Lawrenceville, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States
Edward Cancer Center
Naperville, Illinois, United States
Mid-Illinois Hematology & Oncology Associates, Ltd
Normal, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Siouxland Hematology-Oncology Assoc., Llp
Sioux City, Iowa, United States
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
St Johns Medical Research Institute, Inc.
Springfield, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, United States
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Associates In Hematology & Oncology, P.C.
Upland, Pennsylvania, United States
Musc Hollings Cancer Center
Charleston, South Carolina, United States
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 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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Buenos Aires, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Córdoba, Córdoba Province, 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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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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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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Subiaco, Western Australia, Australia
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Roeselare, , Belgium
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Fortaleza, Ceará, Brazil
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Curitiba, Paraná, 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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Porto Alegre, Rio Grande do Sul, Brazil
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Curitiba, São Paulo, Brazil
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Divinopolis, São Paulo, Brazil
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Mogi das Cruzes, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Temuco, Región de la Araucanía, Chile
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Vi?a 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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Santiago - Independencia, Santiago Metropolitan, Chile
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Montería, Departamento de Córdoba, Colombia
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Bogotá, , Colombia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Liberec, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Herlev, , Denmark
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København Ø, , Denmark
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Odense C, , Denmark
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Besançon, , France
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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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Villejuif, , France
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Berlin, , Germany
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Bonn, , Germany
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Eschweiler, , Germany
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Mannheim, , Germany
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Wuppertal, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Dublin, Dublin, Ireland
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Tallaght, Dublin, Ireland
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Beer Jacob, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Meldola (fc), , Italy
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Milan, , Italy
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Napoli, , Italy
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Rimini, , Italy
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Siena, , Italy
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Sondrio, , Italy
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Aguascalientes, Aguascalientes, Mexico
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Acapulco de Juárez, Guerrero, Mexico
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Guadalajara, Jalisco, Mexico
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Df, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Puebla City, Puebla, Mexico
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Amsterdam, , Netherlands
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Mb Amsterdam, , Netherlands
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Arequipa, , Peru
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Olsztyn, , Poland
Ponce School Of Medicine
Ponce, , Puerto Rico
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Bucharest, , Romania
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Romania, , Romania
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Suceava, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Barcelona, , Spain
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Barcelona, , Spain
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Benidorm-alicante, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Chelmsford, Essex, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Scunthorpe, Lincolnshire, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Trump D. Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: [email protected]; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonie, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Medico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijui, Ijui, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Britanico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston, Urol Oncol. 2016 May;34(5):249-50. doi: 10.1016/j.urolonc.2015.03.013. Epub 2015 Apr 20.
Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. doi: 10.1016/S1470-2045(14)70189-5. Epub 2014 May 13.
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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2008-003314-97
Identifier Type: -
Identifier Source: secondary_id
CA184-043
Identifier Type: -
Identifier Source: org_study_id
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