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Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01642004
First received: July 9, 2012
Last updated: March 16, 2016
Last verified: March 2016
Results First Received: February 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Non-small Cell Lung Cancer
Interventions: Biological: Nivolumab
Drug: Docetaxel

  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
A total of 352 participants enrolled in the study; 272 were randomized to a treatment group. Of the 80 participants not randomized, 67 no longer met study criteria, 6 experienced an Adverse Event (AE), 3 withdrew consent, 3 died, and 1 failed screening. Study is ongoing.

Reporting Groups
  Description
Nivolumab Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Docetaxel Docetaxel 75 mg/m^2 solution intravenously 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:   Randomization
    Nivolumab   Docetaxel
STARTED   135   137 
COMPLETED   131   129 
NOT COMPLETED   4   8 
Adverse Event unrelated to study drug                1                0 
Withdrawal by Subject                1                6 
No longer meets study criteria                2                2 

Period 2:   Treatment
    Nivolumab   Docetaxel
STARTED   131   129 
COMPLETED   21   2 
NOT COMPLETED   110   127 
Disease progression                88                80 
Study drug toxicity                5                13 
Death                1                0 
Adverse event unrelated to study drug                6                13 
Withdrawal by Subject                5                9 
Maximum clinical benefit                2                7 
Poor/non-compliance                1                0 
No longer meets study criteria                1                2 
Unspecified                1                2 
Missing from data                0                1 



  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 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Docetaxel Docetaxel 75 mg/m^2 solution intravenously 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   Docetaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 135   137   272 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (8.33)   64.4  (8.28)   63.3  (8.36) 
Age, Customized 
[Units: Participants]
     
<= 18 years   0   0   0 
< 65 years   79   73   152 
>= 65 AND < 75 years   45   46   91 
>= 75 AND < 85 years   10   18   28 
>= 85 years   1   0   1 
Gender 
[Units: Participants]
     
Female   24   40   64 
Male   111   97   208 
PD-L1 Expression Level 
[Units: Participants]
     
PD-L1 expression >= 5%   42   39   81 
PD-L1 expression < 5%   75   69   144 
PD-L1 not quantifiable at baseline   18   29   47 


  Outcome Measures
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1.  Primary:   Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

2.  Primary:   Overall Survival (OS) Rate in All Randomized Participants   [ Time Frame: Randomization to 18 months post-randomization, up to June 2015 ]

3.  Primary:   Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

4.  Secondary:   Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

5.  Secondary:   Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint   [ Time Frame: Randomization until confirmed response, up to November 2014, approximately 25 months ]

6.  Secondary:   Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint   [ Time Frame: Date of confirmed response to date of documented tumor progression, up to November 2014, approximately 25 months ]

7.  Secondary:   Progression-Free Survival (PFS) at Primary Endpoint   [ Time Frame: Randomization to 12 months post-randomization, up to November 2014 ]

8.  Secondary:   Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

9.  Secondary:   Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12   [ Time Frame: Randomization to Week 12 ]

10.  Secondary:   Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

11.  Secondary:   Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

12.  Secondary:   Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

13.  Other Pre-specified:   Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up   [ Time Frame: Randomization until July 2015, approximately 33 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: NCT01642004     History of Changes
Other Study ID Numbers: CA209-017
2011-004792-36 ( EudraCT Number )
Study First Received: July 9, 2012
Results First Received: February 19, 2016
Last Updated: March 16, 2016
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