Study of Immunotherapy to Treat Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00861614
First received: March 12, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone


Condition Intervention Phase
Prostate Cancer
Drug: Ipilimumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare progression free survival (PFS) [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated ] [ Designated as safety issue: No ]
  • Compare pain response [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the End of Treatment visit ] [ Designated as safety issue: No ]
  • Characterize safety profile [ Time Frame: Assessed at each study visit while on treatment and for 70 days following the last dose of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 796
Study Start Date: May 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ipilimumab Drug: 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
Other Name: BMS 734016
Placebo Comparator: Placebo Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Advanced prostate cancer
  • At least 1 bone metastasis
  • Testosterone < 50 ng/dl
  • Prior treatment with docetaxel

Exclusion Criteria:

  • Brain metastasis
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861614

  Hide Study Locations
Locations
United States, Alabama
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, Arkansas
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States, 72703
United States, California
Marsha G. Fink, Md, Inc.
Fountain Valley, California, United States, 92708
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Prostate Oncology Specialists, Inc.
Marina Del Rey, California, United States, 90292
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Va San Diego Healthcare System
San Diego, California, United States, 92161
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Orlando Health, Inc
Orlando, Florida, United States, 32806
United States, Georgia
Suburban Hematology-Oncology Associates, Pc
Lawrenceville, Georgia, United States, 30046
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States, 62526
Edward Cancer Center
Naperville, Illinois, United States, 60540
Mid-Illinois Hematology & Oncology Associates, Ltd
Normal, Illinois, United States, 61761
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
Siouxland Hematology-Oncology Assoc., Llp
Sioux City, Iowa, United States, 51101
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, United States, 21231
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
St Johns Medical Research Institute, Inc.
Springfield, Missouri, United States, 65807
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
University Of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, United States, 18015
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Associates In Hematology & Oncology, P.C.
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Musc Hollings Cancer Center
Charleston, South Carolina, United States, 29445
United States, Texas
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States, 75230
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States, 76104
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Northwest Cancer Center
Houston, Texas, United States, 77090
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Argentina
Local Institution
Caba, Buenos Aires, Argentina, 1417
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Capital Federal, Buenos Aires, Argentina, 1426
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Rosario, Santa Fe, Argentina, 2000
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Rosario, Santa Fe, Argentina, S2000DSK
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San Miguel De Tucuman, Tucuman, Argentina, 4000
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San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, C1426ANZ
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Buenos Aires, Argentina, 1120
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Buenos Aires, Argentina, 1019
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Cordoba, Argentina, X5002AOQ
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Cordoba, Argentina, X5006HBF
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La Rioja, Argentina, 5300
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Frankston, Victoria, Australia, 3199
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Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
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Subiaco, Western Australia, Australia, 6008
Austria
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Salzburg, Austria, 5020
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Wien, Austria, 1090
Belgium
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Brussels, Belgium, 1090
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1200
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Roeselare, Belgium, 8800
Brazil
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Fortaleza, Ceara, Brazil, 60430
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Curitiba, Parana, Brazil, 80440
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Ijui, Rio Grande Do Sul, Brazil, 98700000
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Porto Alegre, Rio Grande Do Sul, Brazil, 90430
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
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Curitiba, Sao Paulo, Brazil, 80530
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Divinopolis, Sao Paulo, Brazil, 35500
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Mogi Das Cruzes, Sao Paulo, Brazil, 08730
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Sao Paulo, Brazil, 05403
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Sao Paulo, Brazil, 09060
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H2L 4M1
Chile
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Temuco, Araucania, Chile
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Santiago, Metropolitana, Chile, 7510032
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Santiago - Independencia, Metropolitana, Chile
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Santiago De Chile, Metropolitana, Chile, 7650635
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Vi?a Del Mar, Valparaiso, Chile
Colombia
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Monteria, Cordoba, Colombia
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Bogota, Colombia
Czech Republic
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Brno, Czech Republic, 656 91
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Hradec Kralove, Czech Republic, 500 05
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Liberec, Czech Republic, 460 63
Denmark
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Aalborg, Denmark, 9000
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Aarhus, Denmark, 8000
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Herlev, Denmark, 2730
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Kobenhavn O, Denmark, 2100
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Odense C, Denmark, 5000
France
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Besancon Cedex, France, 25030
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Bordeaux, France, 33076
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Clermont-ferrand, France, 63000
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Marseille Cedex 20, France, 13915
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Pointe A Pitre, France, 97159
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Villejuif Cedex, France, 94800
Germany
Local Institution
Berlin, Germany, 14197
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Bonn, Germany, 53127
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Eschweiler, Germany, 52249
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Mannheim, Germany, 68167
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Wuppertal, Germany, 42103
Greece
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Athens, Greece, 115 28
Hungary
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Budapest, Hungary, 1122
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Gyula, Hungary, 5700
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Kaposvar, Hungary, 7400
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Kecskemet, Hungary, 6000
Ireland
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Dublin 7, Dublin, Ireland
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Tallaght, Dublin, Ireland, DUBLIN 24
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Dublin, Ireland
Israel
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Beer Jacob, Israel, 70300
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Beer-sheva, Israel, 84101
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Haifa, Israel, 31096
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52621
Italy
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Meldola (fc), Italy, 47014
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Milano, Italy, 20132
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Napoli, Italy, 80131
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Rimini, Italy, 47900
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Siena, Italy, 53100
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Sondrio, Italy, 23100
Mexico
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Df, Distrito Federal, Mexico, 06720
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Mexico, Distrito Federal, Mexico, 07760
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Acapulco, Guerrero, Mexico, 39570
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico, 62290
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Aguascalientes, Mexico, 20234
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Puebla, Mexico, 72270
Netherlands
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Amsterdam, Netherlands, 1066 CX
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Mb Amsterdam, Netherlands, 1007MB
Peru
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Arequipa, Peru, AREQUIPA54
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Lima, Peru, 18
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Lima, Peru, 34
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Lima, Peru, LIMA 11
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Lima, Peru, L-27
Poland
Local Institution
Olsztyn, Poland, 10-228
Puerto Rico
Ponce School Of Medicine
Ponce, Puerto Rico, 00716
Romania
Local Institution
Bucharest, Romania, 011172
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Romania, Romania, 400015
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Suceava, Romania, 720237
Russian Federation
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Moscow, Russian Federation, 117997
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Moscow, Russian Federation, 129128
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Moscow, Russian Federation, 115478
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Obninsk, Russian Federation, 249036
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St Petersburg, Russian Federation, 197758
Spain
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Barcelona, Spain, 08035
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Barcelona, Spain, 08208
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Benidorm-alicante, Spain, 03501
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Madrid, Spain, 28922
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Santiago De Compostela, Spain, 157706
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Valencia, Spain, 46009
United Kingdom
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Chelmsford, Essex, United Kingdom, CM1 7ET
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Cardiff, Glamorgan, United Kingdom, CF14 2TL
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Manchester, Greater Manchester, United Kingdom, M20 4BX
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Scunthorpe, Lincolnshire, United Kingdom, DN15 7BH
Local Institution
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00861614     History of Changes
Other Study ID Numbers: CA184-043, 2008-003314-97
Study First Received: March 12, 2009
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014