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Phase 3 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:
NCT01057810
First received: January 26, 2010
Last updated: July 11, 2016
Last verified: July 2016
Results First Received: March 7, 2016  
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
Condition: Prostate Cancer
Interventions: Drug: Ipilimumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
837 participants enrolled; 602 randomized; 598 treated. Of the 235 not randomized, 189 no longer met criteria, 28 withdrew consent, 2 suffered Adverse Events, 2 were non-compliant, 1 was lost to follow-up, and 13 were removed for other/unspecified reasons. Post-randomization, 4 no longer met criteria and were not treated (3 placebo, 1 ipilimumab)

Reporting Groups
  Description
Placebo Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.

Participant Flow:   Overall Study
    Placebo   Ipilimumab
STARTED   199   399 
COMPLETED   1   1 
NOT COMPLETED   198   398 
Disease progression                156                197 
Study drug toxicity                5                114 
Adverse event unrelated to study drug                13                29 
Withdrawal by Subject                10                25 
Death                2                12 
Maximum clinical benefit                5                5 
Poor/non-compliance                0                1 
No longer met study criteria                0                1 
Unspecified                7                14 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups
  Description
Placebo Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ipilimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 202   400   602 
Age 
[Units: Years]
Mean (Full Range)
 68.6 
 (42 to 92) 
 69.3 
 (44 to 91) 
 69.0 
 (42 to 92) 
Age, Customized 
[Units: Participants]
     
< 65 years   65   104   169 
>= 65 years   137   296   433 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   202   400   602 
Region of Enrollment 
[Units: Participants]
     
North America   79   154   233 
South America   25   52   77 
Europe   74   161   235 
Australia   24   33   57 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS) Time   [ Time Frame: Randomization until death from any cause, up to April 2015, approximately 57 months ]

2.  Secondary:   Progression-Free Survival (PFS) Time   [ Time Frame: Randomization until disease progression, up to April 2015, approximately 57 months ]

3.  Secondary:   Time to Subsequent Non-hormonal Cytotoxic Therapy   [ Time Frame: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months ]

4.  Secondary:   Time to Pain Progression   [ Time Frame: Randomization until pain progression, up to April 2015, approximately 57 months ]

5.  Secondary:   Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)   [ Time Frame: Day 1 of study therapy to last dose plus 70 days ]

6.  Secondary:   Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities   [ Time Frame: Randomization up to April 2015, approximately 57 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01057810     History of Changes
Other Study ID Numbers: CA184-095
2009-016217-23 ( EudraCT Number )
Study First Received: January 26, 2010
Results First Received: March 7, 2016
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration