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Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01905657
First received: July 18, 2013
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: September 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer (NSCLC)
Interventions: Biological: Pembrolizumab
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
Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The data cut-off date for this results disclosure was 30 Sep 2015, at which time 159 participants were continuing on study treatment.

Reporting Groups
  Description
Pembrolizumab 2 mg/kg Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years.
Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
Docetaxel 75 mg/m^2 Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.

Participant Flow:   Overall Study
    Pembrolizumab 2 mg/kg   Pembrolizumab 10 mg/kg   Docetaxel 75 mg/m^2
STARTED   345   346   343 
Treated   339   343   309 
COMPLETED   0   0   15 
NOT COMPLETED   345   346   328 
Not Treated                0                1                0 
Adverse Event                33                32                47 
Death                21                21                21 
Unspecified                3                7                1 
Physician Decision                82                74                113 
Progressive Disease                124                126                89 
Protocol Violation                2                1                1 
Withdrawal by Subject                5                10                45 
Continuing in Study                74                74                11 
Excluded from Efficacy Analysis                1                0                0 



  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.
The Intent-To-Treat population consisted of all participants who were randomized. Participants were included in the treatment group to which they were randomized. Data from one participant in the Pembrolizumab 2 mg/kg group were excluded from efficacy analyses due to Good Clinical Practice (GCP) non-compliance.

Reporting Groups
  Description
Pembrolizumab 2 mg/kg Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
Docetaxel 75 mg/m^2 Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
Total Total of all reporting groups

Baseline Measures
   Pembrolizumab 2 mg/kg   Pembrolizumab 10 mg/kg   Docetaxel 75 mg/m^2   Total 
Overall Participants Analyzed 
[Units: Participants]
 344   346   343   1033 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.1  (9.6)   62.3  (9.7)   61.6  (9.8)   62.0  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      132  38.4%      133  38.4%      134  39.1%      399  38.6% 
Male      212  61.6%      213  61.6%      209  60.9%      634  61.4% 
PD-L1 Tumor Expression Status [1] 
[Units: Participants]
       
Weakly PD-L1 Positive   205   195   191   591 
Strongly PD-L1 Positive   139   151   152   442 
[1] PD-L1 expression was evaluated by immunohistochemistry (IHC) assay with a newly obtained tumor tissue with biopsy. If PD-L1 expression was observed in >1%, but ≤49% of tumor cells, a participant was categorized as weakly PD-L1 positive. If PD-L1 expression was observed in ≥50% of tumor cells, a participant was categorized as strongly PD-L1 positive.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Through database cutoff date of 30 Sep 2015 (Approximately 23 months) ]

2.  Primary:   Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)   [ Time Frame: Through database cutoff date of 30 Sep 2015 (Approximately 23 months) ]

3.  Primary:   Percentage of Participants Experiencing Adverse Events (AEs)   [ Time Frame: AEs: Up to 30 days after last dose of study drug (Up to approximately 24 months). Serious AEs: Up to 90 days after last dose of study drug (Up to approximately 27 months). ]

4.  Primary:   Percentage of Participants Discontinuing Study Drug Due to AEs   [ Time Frame: Up to approximately 23 months ]

5.  Secondary:   Overall Response Rate (ORR) by RECIST 1.1   [ Time Frame: Through database cutoff date of 30 Sep 2015 (Approximately 23 months) ]

6.  Secondary:   Duration of Response (DOR) by RECIST 1.1   [ Time Frame: Through database cutoff date of 30 Sep 2015 (Approximately 23 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01905657     History of Changes
Other Study ID Numbers: 3475-010
2012-004391-19 ( EudraCT Number )
132355 ( Registry Identifier: Japic-CTI )
Study First Received: July 18, 2013
Results First Received: September 15, 2016
Last Updated: May 8, 2017