Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (CheckMate 069)
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| ClinicalTrials.gov Identifier: NCT01927419 |
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Recruitment Status :
Completed
First Posted : August 22, 2013
Results First Posted : February 8, 2016
Last Update Posted : March 18, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Unresectable Melanoma Metastatic Melanoma |
| Interventions |
Drug: Nivolumab Drug: Ipilimumab Drug: Placebo |
| Enrollment | 142 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 142 participants were randomized, and 140 participants received treatment. |
| Arm/Group Title | Nivolumab + Ipilimumab | Ipilimumab |
|---|---|---|
 Arm/Group Description |
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. | Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. |
| Period Title: Pre-Treatment Period | ||
| Started | 95 | 47 |
| Completed | 94 | 46 |
| Not Completed | 1 | 1 |
| Reason Not Completed | ||
| Adverse event unrelated to study drug | 0 | 1 |
| Participants no longer meeting study criteria | 1 | 0 |
| Period Title: Treatment Period | ||
| Started | 94 | 46 |
| Completed | 0 | 0 |
| Not Completed | 94 | 46 |
| Reason Not Completed | ||
| Disease progression | 17 | 20 |
| Study drug toxicity | 48 | 10 |
| Death | 0 | 1 |
| Adverse event unrelated to study drug | 6 | 3 |
| Participant request to discontinue | 12 | 4 |
| Withdrawal by Subject | 1 | 1 |
| Maximum Clinical Benefit | 6 | 2 |
| Other reasons | 3 | 4 |
| Not Reported | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Nivolumab + Ipilimumab | Ipilimumab | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. | Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 95 | 47 | 142 | |
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Baseline Analysis Population Description |
All randomized participants
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 95 participants | 47 participants | 142 participants | |
| 63.3 (11.0) | 64.5 (10.2) | 63.7 (10.7) | ||
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 95 participants | 47 participants | 142 participants | |
| Younger than 65 years |
48 50.5%
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20 42.6%
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68 47.9%
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| 65 years and older to younger than 75 years |
35 36.8%
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22 46.8%
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57 40.1%
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| 75 years and older |
12 12.6%
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5 10.6%
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17 12.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 95 participants | 47 participants | 142 participants | |
| Female |
32 33.7%
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15 31.9%
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47 33.1%
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| Male |
63 66.3%
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32 68.1%
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95 66.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 95 participants | 47 participants | 142 participants | |
| Hispanic or Latino |
1 1.1%
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0 0.0%
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1 0.7%
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| Not Hispanic or Latino |
82 86.3%
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43 91.5%
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125 88.0%
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| Unknown or Not Reported |
12 12.6%
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4 8.5%
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16 11.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 95 participants | 47 participants | 142 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 1.1%
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0 0.0%
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1 0.7%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
92 96.8%
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47 100.0%
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139 97.9%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
2 2.1%
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0 0.0%
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2 1.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title: | Bristol-Myers Squibb Study Director |
| Organization: | Bristol-Myers Squibb |
| Phone: | Please email |
| EMail: | 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 |
| Other Study ID Numbers: |
CA209-069 2013-002018-11 ( EudraCT Number ) |
| First Submitted: | August 20, 2013 |
| First Posted: | August 22, 2013 |
| Results First Submitted: | November 3, 2015 |
| Results First Posted: | February 8, 2016 |
| Last Update Posted: | March 18, 2022 |