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Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844505
First Posted: May 1, 2013
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
Results First Submitted: July 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Unresectable or Metastatic Melanoma
Interventions: Biological: Nivolumab
Biological: Ipilimumab
Biological: Placebo for Nivolumab
Biological: Placebo for 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
1296 participants were enrolled; 945 were randomized to a treatment group; 937 received at least one dose of study drug.

Reporting Groups
  Description
Nivolumab Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
Nivolumab + Ipilimumab Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
Ipilimumab Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses

Participant Flow:   Overall Study
    Nivolumab   Nivolumab + Ipilimumab   Ipilimumab
STARTED   313   313   311 
COMPLETED   64 [1]   44 [1]   16 [1] 
NOT COMPLETED   249   269   295 
Disease progression                170                88                224 
Study drug toxicity                40                131                50 
Death                1                3                1 
Adverse event unrelated to study drug                7                15                6 
Subject request discontinue treatment                17                14                8 
Withdrawal by Subject                0                3                0 
Lost to Follow-up                1                0                0 
Maximum clinical benefit                8                11                2 
Poor/non-compliance                1                1                1 
Subject no longer meets criteria                0                1                0 
Other Reasons                4                2                2 
Not Reported                0                0                1 
[1] Completed = Number of subjects continuing in the treatment period



  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 Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
Nivolumab + Ipilimumab Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
Ipilimumab Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Total Total of all reporting groups

Baseline Measures
   Nivolumab   Nivolumab + Ipilimumab   Ipilimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 316   314   315   945 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (13.92)   59.3  (13.86)   60.8  (13.23)   59.6  (13.69) 
Age, Customized 
[Units: Participants]
Count of Participants
       
< 65 years   198   185   182   565 
>= 65 and < 75 years   79   94   89   262 
>=75 years   39   35   44   118 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      114  36.1%      108  34.4%      113  35.9%      335  35.4% 
Male      202  63.9%      206  65.6%      202  64.1%      610  64.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
WHITE   308   310   303   921 
BLACK OR AFRICAN AMERICAN   0   0   0   0 
ASIAN   2   2   6   10 
AMERICAN INDIAN OR ALASKA NATIVE   1   0   0   1 
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER   1   0   0   1 
OTHER   4   2   5   11 
NOT REPORTED   0   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months) ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: From randomization to date of death (Assessed up to September 2016, approximately 39 months) ]

3.  Primary:   Rate of Overall Survival   [ Time Frame: 6, 12, and 24 months ]

4.  Primary:   Rate of Progression-Free Survival   [ Time Frame: 6, 12, and 24 months ]

5.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization to date of death (Assessed up to September 2016, approximately 39 months) ]

7.  Secondary:   Objective Response Rate (ORR) Per Investigator Assessment   [ Time Frame: From randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (Assessed up to February 2015, approximately 20 months) ]

8.  Secondary:   Progression-Free Survival Based on PD-L1 Expression Level   [ Time Frame: From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months) ]

9.  Secondary:   Overall Survival Based on PD-L1 Expression Level   [ Time Frame: From randomization until date of death (Assessed up to September 2016, approximately 39 months) ]

10.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]

11.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]

12.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]

13.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]

14.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]

15.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning   [ Time Frame: Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation ]


  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: NCT01844505     History of Changes
Other Study ID Numbers: CA209-067
2012-005371-13 ( EudraCT Number )
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Submitted: July 14, 2017
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017