A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
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| ClinicalTrials.gov Identifier: NCT01721746 |
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Recruitment Status :
Completed
First Posted : November 6, 2012
Results First Posted : March 22, 2017
Last Update Posted : April 19, 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: None (Open Label); Primary Purpose: Treatment |
| Condition |
Unresectable or Metastatic Melanoma |
| Interventions |
Biological: BMS-936558 Drug: Dacarbazine Drug: Carboplatin Drug: Paclitaxel |
| Enrollment | 405 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 405 participants randomized and 370 treated. |
| Arm/Group Title | Nivolumab | Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) |
|---|---|---|
 Arm/Group Description |
Nivolumab 3 mg/kg IV over 60 minutes Q2W | Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W |
| Period Title: Pre-Treatment | ||
| Started [1] | 272 | 133 |
| Completed [2] | 268 | 102 |
| Not Completed | 4 | 31 |
| Reason Not Completed | ||
| Participant request to discontinue Study treatment | 0 | 13 |
| Withdrawal by Subject | 1 | 16 |
| Poor/Non-compliance | 1 | 0 |
| Participant no longer met study criteria | 2 | 2 |
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[1]
Started = Randomized
[2]
Completed = Received Treatment
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| Period Title: Treatment | ||
| Started [1] | 268 | 102 |
| Completed [2] | 0 | 0 |
| Not Completed | 268 | 102 |
| Reason Not Completed | ||
| Disease Progression | 192 | 74 |
| Study Drug Toxicity | 19 | 11 |
| Adverse Event unrelated to Study Drug | 6 | 3 |
| Participant request to discontinue Study treatment | 26 | 7 |
| Participant withdrew consent | 4 | 2 |
| Maximum Clinical Benefit | 9 | 3 |
| Poor/Non-compliance | 2 | 0 |
| Participant no longer met Study criteria | 4 | 0 |
| Other reasons | 6 | 2 |
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[1]
Started = Received treatment
[2]
Completed = Completed treatment
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Baseline Characteristics
| Arm/Group Title | Nivolumab | Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Nivolumab 3 mg/kg IV over 60 minutes Q2W | Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W | Total of all reporting groups | |
| Overall Number of Baseline Participants | 272 | 133 | 405 | |
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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 | 272 participants | 133 participants | 405 participants | |
| 58.7 (14.1) | 60.3 (12.4) | 59.2 (13.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 272 participants | 133 participants | 405 participants | |
| Female |
96 35.3%
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48 36.1%
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144 35.6%
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| Male |
176 64.7%
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85 63.9%
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261 64.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 272 participants | 133 participants | 405 participants | |
| Hispanic or Latino |
4 1.5%
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1 0.8%
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5 1.2%
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| Not Hispanic or Latino |
116 42.6%
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61 45.9%
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177 43.7%
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| Unknown or Not Reported |
152 55.9%
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71 53.4%
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223 55.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 272 participants | 133 participants | 405 participants |
| White | 269 | 129 | 398 | |
| Black or African American | 1 | 2 | 3 | |
| Asian | 2 | 0 | 2 | |
| American Indian or Alaska Native | 0 | 0 | 0 | |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | |
| Other | 0 | 2 | 2 | |
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: | NCT01721746 |
| Other Study ID Numbers: |
CA209-037 2012-001828-35 ( EudraCT Number ) |
| First Submitted: | November 2, 2012 |
| First Posted: | November 6, 2012 |
| Results First Submitted: | February 1, 2017 |
| Results First Posted: | March 22, 2017 |
| Last Update Posted: | April 19, 2022 |