Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: August 4, 2016
Last verified: August 2016
  Purpose
The purpose of the study is to determine if advanced prostate cancer patients 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 (OS) [ Time Frame: Date of randomization to date of death ] [ Designated as safety issue: No ]
    OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.

  • Overall Survival Rate [ Time Frame: Date of randomization to date of death ] [ Designated as safety issue: No ]
    The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death ] [ Designated as safety issue: No ]
    All PFS events were based on investigator's assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.

  • Pain Response [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit ] [ Designated as safety issue: No ]
    The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.

  • Duration of Pain Response [ Time Frame: Day of initial pain response to day of completion of pain response or date of death ] [ Designated as safety issue: No ]
    The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.

  • Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR) [ Time Frame: Randomization to date of death ] [ Designated as safety issue: Yes ]

    AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

    SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.


  • Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE) [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

  • Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE) [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.

  • Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR) [ Time Frame: Day 1 to time of onset of the imAR of interest ] [ Designated as safety issue: Yes ]

    The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.

    Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.


  • Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0 [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]

    Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.

    Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.


  • Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.

  • Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.

  • Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.

  • Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.


Enrollment: 988
Study Start Date: May 2009
Study Completion Date: August 2015
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   (Adult, Senior)
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, 1019
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Buenos Aires, Argentina, 1120
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, C1426ANZ
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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 - Independencia, Metropolitana, Chile
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Santiago De Chile, Metropolitana, Chile, 7650635
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Santiago, Metropolitana, Chile, 7510032
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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
Local Institution
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
Local Institution
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, L-27
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Lima, Peru, LIMA 11
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
Local Institution
Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 117997
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Moscow, Russian Federation, 129128
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Obninsk, Russian Federation, 249036
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St Petersburg, Russian Federation, 197758
Spain
Local Institution
Barcelona, Spain, 08035
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Barcelona, Spain, 08208
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Benidorm-alicante, Spain, 03501
Local Institution
Madrid, Spain, 28922
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Santiago De Compostela, Spain, 157706
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Valencia, Spain, 46009
United Kingdom
Local Institution
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
Local Institution
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:
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
Results First Received: March 15, 2016
Last Updated: August 4, 2016
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016