Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00623766
First received: February 19, 2008
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Ipilimumab
Drug: Corticosteroid: Betamethasone
Drug: Corticosteroid: Dexamethasone
Drug: Corticosteroid: Fludrocortisone
Drug: Corticosteroid: Hydrocortisone
Drug: Corticosteroid: Meprednisone
Drug: Corticosteroid: Methylprednisolone
Drug: Corticosteroid: Prednisolone
Drug: Corticosteroid: Prednisone
Drug: Corticosteroid: Triamcinolone

  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 99 participants were enrolled, and 27 did not receive treatment because they did not meet screening criteria.

Reporting Groups
  Description
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.

Participant Flow for 2 periods

Period 1:   Induction Phase (Day 1 to Week 24)
    Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients     Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients  
STARTED     51 [1]   21 [1]
COMPLETED     15 [2]   5 [3]
NOT COMPLETED     36     16  
Off treatment                 36                 16  
[1] Participants who received treatment
[2] 4 patients completed Induction but did not enter Maintenance; they were only followed up with scans.
[3] 3 patients completed Induction but did not enter Maintenance; they were only followed up with scans.

Period 2:   Maintenance Phase (Week 24 to Year 2)
    Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients     Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients  
STARTED     11     2  
COMPLETED     1 [1]   0  
NOT COMPLETED     10     2  
Disease progression                 4                 0  
Administrative reason by sponsor                 4                 0  
Withdrawal by Subject                 1                 2  
Patient required surgery                 1                 0  
[1] Inadvertently not noted as discontinued (disease progression); data collection error at site closure



  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, 10 mg/kg IV, in Corticosteroid-free Patients Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients     Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients     Total  
Number of Participants  
[units: participants]
  51     21     72  
Age, Customized  
[units: Participants]
     
Younger than 65 years     39     17     56  
65 years and older     12     4     16  
Gender  
[units: participants]
     
Female     18     10     28  
Male     33     11     44  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     51     21     72  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Eastern Cooperative Oncology Group (ECOG) score [1]
[units: Units on a scale]
     
0     25     14     39  
1     26     7     33  
[1] ECOG performance status assesses a participant's physical ability on a 6-point scale: 0=fully active, able to carry on all predisease activities without restriction; 1=restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Score of 0=best status and 5=worst status.



  Outcome Measures
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1.  Primary:   Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria   [ Time Frame: From Day 1, first dose to end of Week 12 ]

2.  Secondary:   Disease Control Rate by Immune-related Response Criteria (irRC)   [ Time Frame: From Day 1, first dose to end of Week 12 ]

3.  Secondary:   Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)   [ Time Frame: From Day 1, first dose until the last tumor assessment, Week 12 ]

4.  Secondary:   Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)   [ Time Frame: From Day 1, first dose to last tumor assessment up to 18.2 months ]

5.  Secondary:   Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)   [ Time Frame: From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months ]

6.  Secondary:   Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)   [ Time Frame: From first dose to Months 6, 12, 18, 24, and 36 months ]

7.  Secondary:   Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation   [ Time Frame: Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab ]

8.  Secondary:   Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)   [ Time Frame: From Day 1, first dose to a maximum of 4.2 months ]

9.  Secondary:   Overall Survival (OS)   [ Time Frame: From first dose to 24 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
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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


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00623766     History of Changes
Other Study ID Numbers: CA184-042
Study First Received: February 19, 2008
Results First Received: December 17, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration