Trial record 1 of 1 for:    NCT01057810
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Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: January 26, 2010
Last updated: September 2, 2015
Last verified: September 2015
The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare overall survival (OS) of subjects, defined as the time from the date of randomization until the date of death. For those subjects who have not died OS will be censored at the last date the subject was known to be alive [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up [ Time Frame: Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit [ Time Frame: Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible ] [ Designated as safety issue: Yes ]

Enrollment: 602
Study Start Date: May 2010
Study Completion Date: July 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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 Names:
  • BMS-734016
  • MDX010
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 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


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

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • Metastatic prostate cancer
  • Asymptomatic or minimally symptomatic
  • Progression during hormonal therapy
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection
  Contacts and Locations
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Please refer to this study by its identifier: NCT01057810

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United States, Alaska
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
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Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center
Tucson, Arizona, United States, 85724
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Desert Hematology Oncology
Rancho Mirage, California, United States, 92270
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San Diego, California, United States, 92108
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San Francisco, California, United States, 94115
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Washington, District of Columbia, United States, 20037
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Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States, 33486
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Jacksonville, Florida, United States, 32207
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
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Orlando, Florida, United States, 32806
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Port Saint Lucie, Florida, United States, 34952
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Atlanta, Georgia, United States, 30341
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Augusta, Georgia, United States, 30912
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Lawrenceville, Georgia, United States, 30046
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Honolulu, Hawaii, United States, 96813
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Decatur, Illinois, United States, 62526
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Goshen, Indiana, United States, 46526
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Hutchinson, Kansas, United States, 67502
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East Setauket, New York, United States, 11733
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Goshen, New York, United States, 10924
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Stony Brook, New York, United States, 11794
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Syracuse, New York, United States, 13210
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Winston Salem, North Carolina, United States, 27103
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Tulsa, Oklahoma, United States, 74136
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Greenville, South Carolina, United States, 29615
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Myrtle Beach, South Carolina, United States, 29572
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Temple, Texas, United States, 76508
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Salt Lake City, Utah, United States, 84106
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Everett, Washington, United States, 98201
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Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01057810     History of Changes
Other Study ID Numbers: CA184-095  2009-016217-23 
Study First Received: January 26, 2010
Last Updated: September 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on May 30, 2016