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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
Results First Received: March 15, 2016  
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
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
988 enrolled, 799 randomized (399 ipilimumab, 400 placebo); 149 no longer met study criteria, 17 withdrew, 6 adverse events, 4 died, 1 lost to follow-up,12 unspecified. 789 treated with radiotherapy (393 ipilimumab, 396 placebo); 2 no longer met study criteria, 3 withdrew consent, 1 died, 2 adverse events, 2 lost to follow-up.

Reporting Groups
  Description
Ipilimumab + Radiotherapy Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
Placebo + Radiotherapy Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.

Participant Flow:   Overall Study
    Ipilimumab + Radiotherapy     Placebo + Radiotherapy  
STARTED     393     396  
COMPLETED     22     28  
NOT COMPLETED     371     368  
Disease Progression                 182                 263  
Study Drug Toxicity                 79                 6  
Death                 32                 19  
Adverse Event                 27                 23  
Withdrawal by Subject                 34                 35  
Unspecified                 17                 22  



  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.
No text entered.

Reporting Groups
  Description
Ipilimumab + Radiotherapy Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
Placebo + Radiotherapy Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab + Radiotherapy     Placebo + Radiotherapy     Total  
Number of Participants  
[units: participants]
  399     400     799  
Age  
[units: years]
Mean (Standard Deviation)
  68.2  (7.53)     67.1  (7.56)     67.6  (7.56)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     399     400     799  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Date of randomization to date of death ]

2.  Primary:   Overall Survival Rate   [ Time Frame: Date of randomization to date of death ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death ]

4.  Secondary:   Pain Response   [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit ]

5.  Secondary:   Duration of Pain Response   [ Time Frame: Day of initial pain response to day of completion of pain response or date of death ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: 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