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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721746
First received: November 2, 2012
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: February 1, 2017  
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

  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
631 enrolled. 405 randomized. Reasons not randomized: 1 adverse event, 17 withdrew consent, 3 deaths, 1 lost to follow-up, 1 poor/non compliance, 200 no longer met study criteria, 3 unspecified. 370 treated. Reasons not treated: 13 request to discontinue study treatment, 17 withdrew consent, 1 poor/non compliance, 4 no longer met study criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nivolumab 3 mg/kg (IV) Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Investigator's Choice (Dacarbazine) Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Investigator's Choice (Carboplatin+Paclitaxel)

Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends


Participant Flow for 2 periods

Period 1:   Treatment Period
    Nivolumab 3 mg/kg (IV)   Investigator's Choice (Dacarbazine)   Investigator's Choice (Carboplatin+Paclitaxel)
STARTED   268   45   57 
COMPLETED   35 [1]   0   0 
NOT COMPLETED   233   45   57 
Disease Progression                182                40                34 
Study Drug Toxicity                15                2                9 
Adverse Event Unrelated to Study Drug                6                1                2 
Subject Request to Discontinue Treatment                19                1                6 
Subject Withdrew Consent                3                0                2 
Maximum Clinical Benefit                1                0                3 
Poor/Non-compliance                1                0                0 
Subject No Longer Met Study Criteria                4                0                0 
Unspecified                2                1                1 
[1] Completed=Continuing in Treatment Period

Period 2:   Follow-Up Period
    Nivolumab 3 mg/kg (IV)   Investigator's Choice (Dacarbazine)   Investigator's Choice (Carboplatin+Paclitaxel)
STARTED   92 [1]   11 [1]   19 [1] 
COMPLETED   92 [2]   11 [2]   19 [2] 
NOT COMPLETED   0   0   0 
[1] Participants could enter follow-up after discontinuing treatment for safety assessments
[2] Completed=Continuing in Follow-up Period; Study on-going



  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 3 mg/kg (IV) Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Total Total of all reporting groups

Baseline Measures
   Nivolumab 3 mg/kg (IV)   Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)   Total 
Overall Participants Analyzed 
[Units: Participants]
 272   133   405 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (14.12)   60.3  (12.43)   59.2  (13.59) 
Age, Customized 
[Units: Participants]
Count of Participants
     
< 65 years   177   80   257 
>=65 years and < 75 years   55   37   92 
>=75 years and < 85 years   36   15   51 
>=85 years   4   1   5 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      96  35.3%      48  36.1%      144  35.6% 
Male      176  64.7%      85  63.9%      261  64.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of 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 
Quantifiable Programmed Death-ligand 1 (PD-L1) Expression 
[Units: Participants]
Count of Participants
 248   99   347 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy; approx. 16 months ]

2.  Primary:   Median Overall Survival (OS) at Primary Endpoint   [ Time Frame: From the date of randomization to the date of death; up to 37 months ]

3.  Secondary:   Median Months of Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRC/IRRC)   [ Time Frame: From the date of randomization to the date of the first documented progression or death; up to 37 months ]

4.  Secondary:   Objective Response Rate (ORR) by Baseline PD-L1 Expression   [ Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent therapy; approx. 16 months ]

5.  Secondary:   Median Overall Survival (OS) Time in Months by Baseline PD-L1 Expression   [ Time Frame: From the date of randomization to the date of death; up to 37 months ]

6.  Secondary:   Mean Change From Baseline in Health-related Quality of Life (HRQoL) Global Health Status Scores   [ Time Frame: From Baseline (Day1) to second Follow-Up; up to 37 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


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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01721746     History of Changes
Other Study ID Numbers: CA209-037
2012-001828-35 ( EudraCT Number )
Study First Received: November 2, 2012
Results First Received: February 1, 2017
Last Updated: April 4, 2017