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BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01354431
First received: May 10, 2011
Last updated: December 9, 2015
Last verified: December 2015
History of Changes
Results First Received: September 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Intervention: Biological: 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
Study is still on-going.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
198 participants enrolled and 168 were randomized to study drug: 27 were not randomized to a study arm because they no longer met criteria and 3 were not randomized because the participants withdrew consent.

Reporting Groups
  Description
0.3 mg/kg Nivolumab Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
2.0 mg/kg Nivolumab Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
10.0 mg/kg Nivolumab Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Participant Flow for 2 periods

 Period 1:   Randomized to Enter Treatment Period
    0.3 mg/kg Nivolumab     2.0 mg/kg Nivolumab     10.0 mg/kg Nivolumab  
STARTED     60     54     54  
COMPLETED     59     54     54  
NOT COMPLETED     1     0     0  
No longer met criteria                 1                 0                 0  

Period 2:   Participants Treated
    0.3 mg/kg Nivolumab     2.0 mg/kg Nivolumab     10.0 mg/kg Nivolumab  
STARTED     59     54     54  
COMPLETED     0     0     0  
NOT COMPLETED     59     54     54  
Continuing Treatment                 6                 2                 4  
Disease Progression                 49                 40                 41  
Study Drug Toxicity                 2                 7                 4  
Death                 0                 1                 0  
Adverse Event                 1                 2                 4  
Withdrawal by Subject                 1                 2                 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 were included.

Reporting Groups
  Description
0.3 mg/kg Nivolumab Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
2.0 mg/kg Nivolumab Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
10.0 mg/kg Nivolumab Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
Total Total of all reporting groups

Baseline Measures
    0.3 mg/kg Nivolumab     2.0 mg/kg Nivolumab     10.0 mg/kg Nivolumab     Total  
Number of Participants  
[units: participants]
 		  60     54     54     168  
Age  
[units: years]
Mean (Standard Deviation) 		  61.0  (8.82)     60.8  (8.23)     60.6  (9.61)     60.8  (8.85)  
Age, Customized  
[units: participants]
 		       
Less than (<) 65 years     37     41     35     113  
65 to < 75 years     20     9     15     44  
Greater than, equal to (>=)75 years     3     4     4     11  
Gender  
[units: participants]
 		       
Female     19     14     14     47  
Male     41     40     40     121  



  Outcome Measures
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1.  Primary:   Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population   [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]
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2.  Secondary:   Objective Response Rate (ORR) at Primary Endpoint- Randomized Population   [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]
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3.  Secondary:   Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population   [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]
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4.  Secondary:   Median Overall Survival in Months at Interim Data Cut-off - Randomized Population   [ Time Frame: From Randomization to approximately 4 years post randomization ]
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5.  Secondary:   Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population   [ Time Frame: From Randomization to approximately 4 years post randomization ]
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  Serious Adverse Events
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  Other Adverse Events
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  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: NCT01354431     History of Changes
Other Study ID Numbers: CA209-010
Study First Received: May 10, 2011
Results First Received: September 8, 2015
Last Updated: December 9, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board