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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01057810
First received: January 26, 2010
Last updated: September 26, 2014
Last verified: September 2014

January 26, 2010
September 26, 2014
July 2010
November 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01057810 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
  • Experimental: Ipilimumab
    Intervention: Drug: Ipilimumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
February 2016
November 2015   (final data collection date for primary outcome measure)

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

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Puerto Rico,   Romania,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT01057810
CA184-095, 2009-016217-23
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP