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Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721759
First received: November 2, 2012
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: September 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Non-small Cell Lung Cancer
Intervention: Drug: Nivolumab

  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 140 patients were enrolled, and 117 received treatment. Of those 23 patients who were enrolled but did not receive study drug, 20 were eliminated because they no longer met study criteria, 2 died, and 1 was lost to follow-up.

Reporting Groups
  Description
Nivolumab, 3 mg/kg Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.

Participant Flow:   Overall Study
    Nivolumab, 3 mg/kg
STARTED   117 
COMPLETED   15 [1] 
NOT COMPLETED   102 
Disease progression                78 
Study drug toxicity                14 
Adverse event unrelated to study drug                9 
Withdrawal by Subject                1 
[1] Completed=continuing to receive treatment



  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.
Participants who received at least 1 dose of study drug

Reporting Groups
  Description
Nivolumab, 3 mg/kg Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.

Baseline Measures
   Nivolumab, 3 mg/kg 
Overall Participants Analyzed 
[Units: Participants]
 117 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (9.11) 
Age, Customized 
[Units: Participants]
 
Younger than 65 years   58 
At least 65 years and younger than 75 years   43 
75 years and older   16 
Gender 
[Units: Participants]
 
Female   32 
Male   85 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   69 
Unknown or Not Reported   48 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   99 
Black or African American   11 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or other Pacific Islander   0 
Other   5 
Disease stage [1] 
[Units: Participants]
 
Stage IIIB   20 
Stage IV   97 
[1] Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body
Cell type 
[Units: Participants]
 
Squamous cell carcinoma   117 
Other   0 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
 
 26 
 91 
 0 
 0 
 0 
[1] ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
Central nervous system metastasis 
[Units: Participants]
 
Yes   2 
No   115 


  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)   [ Time Frame: Day 1 of treatment to approximately 19 months ]

2.  Primary:   Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)   [ Time Frame: Day 1 of treatment to approximately 16 months ]

3.  Secondary:   Objective Response Rate (ORR) as Assessed by Investigator   [ Time Frame: Day 1 of treatment to approximately 16 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
No text entered.


  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: NCT01721759     History of Changes
Other Study ID Numbers: CA209-063
2012-003965-16 ( EudraCT Number )
Study First Received: November 2, 2012
Results First Received: September 14, 2015
Last Updated: May 16, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
United States: Food and Drug Administration
United States: Institutional Review Board