Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate057)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01673867
First received: August 24, 2012
Last updated: July 18, 2016
Last verified: January 2016
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-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 792 participants enrolled in the study; 582 were randomized. Of the 210 participants not randomized, 4 experienced an adverse event (AE), 24 withdrew consent, 5 died, 1 was lost to follow-up, 163 no longer met study criteria, 1 was removed by sponsor for administrative reasons, and 12 were removed for other reasons. Study is ongoing.

Reporting Groups
  Description
Nivolumab Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Docetaxel Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion 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     292     290  
COMPLETED     287     268  
NOT COMPLETED     5     22  
AE unrelated to study drug                 1                 0  
Requested treatment discontinuation                 0                 4  
Withdrawal by Subject                 0                 12  
Lost to Follow-up                 0                 1  
No longer meets criteria                 4                 5  

Period 2:   Treatment
    Nivolumab     Docetaxel  
STARTED     287     268  
COMPLETED     43     0  
NOT COMPLETED     244     268  
Disease Progression                 194                 179  
Study Drug Toxicity                 17                 42  
Death                 1                 1  
AE unrelated to study drug                 19                 11  
Requested treatment discontinuation                 5                 16  
Withdrawal by Subject                 4                 6  
Maximum clinical benefit                 0                 10  
No longer meets criteria                 2                 0  
Required steroid therapy                 1                 0  
Health status not improved                 1                 0  
Required prolonged hospitalization                 0                 1  
Symptomatic deterioration                 0                 1  
Physician Decision                 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 (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Docetaxel Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion 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  
Number of Participants  
[units: participants]
  292     290     582  
Age  
[units: years]
Mean (Standard Deviation)
  60.9  (9.27)     62.3  (9.75)     61.6  (9.53)  
Age, Customized  
[units: participants]
     
< 65     184     155     339  
>= 65 AND < 75     88     112     200  
>= 75 AND < 85     20     21     41  
>= 85     0     2     2  
Gender  
[units: participants]
     
Female     141     122     263  
Male     151     168     319  
PD-L1 Expression  
[units: participants]
     
PD-L1 not quantifiable at baseline     61     66     127  
PD-L1 expression <1%     108     101     209  
PD-L1 expression >=1%     123     123     246  



  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 413 deaths, up to March 2015 (approximately 29 months) ]

2.  Primary:   One-year Overall Survival (OS) Rate in All Randomized Participants   [ Time Frame: 12 months ]

3.  Primary:   Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 413 deaths, up to March 2015 (approximately 29 months) ]

4.  Secondary:   Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 413 deaths, up to March 2015 (approximately 29 months) ]

5.  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 or death, up to March 2015 (approximately 29 months) ]

6.  Secondary:   Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint   [ Time Frame: Randomization until confirmed response, up to March 2015 (approximately 29 months) ]

7.  Secondary:   Progression-Free Survival (PFS) Rate at 12 Months   [ Time Frame: Randomization to 12 months ]

8.  Secondary:   Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 413 deaths, up to March 2015 (approximately 29 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 413 deaths, up to March 2015 (approximately 29 months) ]

11.  Secondary:   Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint   [ Time Frame: Randomization until 413 deaths, up to March 2015 (approximately 29 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: NCT01673867     History of Changes
Other Study ID Numbers: CA209-057
2012-002472-14 ( EudraCT Number )
Study First Received: August 24, 2012
Results First Received: January 29, 2016
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Norway: Data Protection Authority
Norway: Directorate of Health
Peru: Instituto Nacional de Salud
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Federal Office of Public Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency