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Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (CheckMate 069)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01927419
First received: August 20, 2013
Last updated: June 20, 2016
Last verified: November 2015
Results First Received: November 3, 2015  
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
Conditions: Unresectable Melanoma
Metastatic Melanoma
Interventions: Drug: Nivolumab
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
Of 179 participants enrolled, 142 (95 in the nivolumab + ipilimumab group and 47 in the ipilimumab group) were randomized, and 140 (94 in the nivolumab + ipilimumab group and 46 in the ipilimumab group) received treatment.

Reporting Groups
  Description
Nivolumab + Ipilimumab Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Placebo + Ipilimumab Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.

Participant Flow:   Overall Study
    Nivolumab + Ipilimumab   Placebo + Ipilimumab
STARTED   95   47 
Received Treatment   94   46 
COMPLETED   25 [1]   19 [1] 
NOT COMPLETED   70   28 
Disease progression                15                17 
Study drug toxicity                43                7 
Death                0                1 
Adverse event unrelated to study drug                6                1 
Withdrawal by Subject                3                1 
Not specified                2                1 
Not reported                1                0 
[1] All participants who did not discontinue study drug during treatment period (Parts 1 and 2)



  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
Nivolumab + Ipilimumab Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Placebo + Ipilimumab Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Total Total of all reporting groups

Baseline Measures
   Nivolumab + Ipilimumab   Placebo + Ipilimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   47   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.3  (11.02)   64.5  (10.24)   63.7  (10.74) 
Age, Customized 
[Units: Participants]
     
Younger than 65 years   48   20   68 
65 years and older to younger than 75 years   35   22   57 
75 years and older   12   5   17 
Gender 
[Units: Participants]
     
Female   32   15   47 
Male   63   32   95 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   92   47   139 
Asian   1   0   1 
Other   2   0   2 
Black or African American   0   0   0 
American Indian or Alaska Native   0   0   0 
Native Hawaiian or other Pacific Islander   0   0   0 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 86.26  (23.368)   83.29  (20.248)   85.28  (22.355) 
Time from initial diagnosis 
[Units: Years]
Median (Full Range)
 2.34 
 (0.1 to 47.4) 
 1.71 
 (0.1 to 20.4) 
 2.01 
 (0.1 to 47.4) 
Time from initial diagnosis 
[Units: Participants]
     
Less than 1 year   28   18   46 
1 to less than 2 years   16   9   25 
2 to less than 3 years   17   3   20 
3 to less than 4 years   4   1   5 
4 to less than 5 years   4   5   9 
5 years or more   26   11   37 
Baseline lactate dehydrogenase level 
[Units: Participants]
     
Upper limit of normal (ULN) or lower   70   36   106 
Higher than ULN   24   11   35 
2*ULN or lower   88   46   134 
Higher than 2*ULN   6   1   7 
Not reported   1   0   1 
History of brain metastases 
[Units: Participants]
     
Yes   4   0   4 
No   90   47   137 
Not reported   1   0   1 
Smoking status 
[Units: Participants]
     
Yes   39   24   63 
No   55   22   77 
Unknown   1   1   2 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
 79   37   116 
 14   10   24 
 2   0   2 
[1] ECOG is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.


  Outcome Measures
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1.  Primary:   Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population   [ Time Frame: Randomization to a minimum of 6 months ]

2.  Secondary:   Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population   [ Time Frame: Randomization to a minimum of 6 months ]

3.  Secondary:   Investigator-assessed Progression-free Survival (PFS) in All Populations   [ Time Frame: Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months ]

4.  Secondary:   Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response   [ Time Frame: Randomization to a minimum of 6 months ]

5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score   [ Time Frame: From Baseline to Week 25 ]

6.  Other Pre-specified:   Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs   [ Time Frame: Day 1 of treatment to within 30 days past last 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


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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01927419     History of Changes
Other Study ID Numbers: CA209-069
2013-002018-11 ( EudraCT Number )
Study First Received: August 20, 2013
Results First Received: November 3, 2015
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration
France: Ministry of Health