Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01611558
First received: May 25, 2012
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: March 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Intervention: Biological: Ipilimumab

  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
A total of 49 participants were enrolled, and 40 received study drug. Of those 9 who did not receive treatment, 7 no longer met study criteria, 1 withdrew consent, and 1 was excluded due to poor compliance with study procedures.

Reporting Groups
  Description
Ipilimumab, 10 mg/kg Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.

Participant Flow for 2 periods

Period 1:   Induction Phase
    Ipilimumab, 10 mg/kg  
STARTED     40  
COMPLETED     2  
NOT COMPLETED     38  
Study drug toxicity                 17  
Disease progression                 14  
Not reported                 5  
Adverse event unrelated to study drug                 1  
Death                 1  

Period 2:   Maintenance Phase
    Ipilimumab, 10 mg/kg  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Study drug toxicity                 1  



  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 participants who received at least 1 dose of study drug

Reporting Groups
  Description
Ipilimumab,10 mg/kg Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.

Baseline Measures
    Ipilimumab,10 mg/kg  
Number of Participants  
[units: participants]
  40  
Age  
[units: Years]
Median (Full Range)
  61.5   (42.0 to 74.0)  
Age, Customized  
[units: Participants]
 
Younger than 65 years     28  
65 years and older     12  
Gender  
[units: Participants]
 
Female     40  
Male     0  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     36  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: Participants]
 
White     35  
Black or African American     2  
Asian     2  
Other     1  



  Outcome Measures
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1.  Primary:   Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher   [ Time Frame: Day 1, first dose, to within 90 days of last dose in Induction Phase ]

2.  Secondary:   Best Overall Response Rate (BORR)   [ Time Frame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years) ]

3.  Secondary:   Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation   [ Time Frame: From first dose to within 90 days of last study dose ]


  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
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  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



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01611558     History of Changes
Other Study ID Numbers: CA184-201
Study First Received: May 25, 2012
Results First Received: March 7, 2016
Last Updated: March 21, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board