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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (P08719/KEYNOTE-002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01704287
First received: October 8, 2012
Last updated: February 8, 2017
Last verified: February 2017
Results First Received: October 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Dacarbazine
Drug: Temozolomide

  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
These results are based on a database cutoff date of 16 Nov 2015 at which time, 48 participants were continuing in the study.

Reporting Groups
  Description
Pembrolizumab 2 mg/kg Participants received pembrolizumab 2 mg/kg intravenously (IV) every 3 weeks (Q3W).
Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV Q3W.
Investigator-Choice Chemotherapy (ICC) Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
ICC→Pembrolizumab 2 mg/kg Participants who were assigned to ICC, experienced confirmed progressive disease (PD) and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
ICC→Pembrolizumab 10 mg/kg Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.

Participant Flow for 2 periods

Period 1:   Initial Treatment Period
    Pembrolizumab 2 mg/kg   Pembrolizumab 10 mg/kg   Investigator-Choice Chemotherapy (ICC)   ICC→Pembrolizumab 2 mg/kg   ICC→Pembrolizumab 10 mg/kg
STARTED   180   181   179   0   0 
Treated   178   179   171   0   0 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   180   181   179   0   0 
Death                123                117                30                0                0 
Withdrawal by Subject                1                1                4                0                0 
Unspecified                1                0                0                0                0 
Ongoing in Study                52                62                44                0                0 
Lost to Follow-up                3                1                3                0                0 
Switched to Pembrolizumab                0                0                98                0                0 

Period 2:   Switch to Pembrolizumab Treatment Period
    Pembrolizumab 2 mg/kg   Pembrolizumab 10 mg/kg   Investigator-Choice Chemotherapy (ICC)   ICC→Pembrolizumab 2 mg/kg   ICC→Pembrolizumab 10 mg/kg
STARTED   0   0   0   53   45 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   0   0   0   53   45 
Lost to Follow-up                0                0                0                2                1 
Death                0                0                0                29                28 
Withdrawal by Subject                0                0                0                1                0 
Ongoing in Study                0                0                0                21                16 



  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 (ITT) population consisted of all randomized participants. Participants were included in the group to which they were randomized for Baseline Characteristics.

Reporting Groups
  Description
Pembrolizumab 2 mg/kg Participants received pembrolizumab 2 mg/kg IV Q3W.
Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV Q3W.
Investigator-Choice Chemotherapy (ICC) Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
Total Total of all reporting groups

Baseline Measures
   Pembrolizumab 2 mg/kg   Pembrolizumab 10 mg/kg   Investigator-Choice Chemotherapy (ICC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   181   179   540 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.5  (14.9)   60.1  (13.3)   60.5  (12.7)   60.1  (13.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      76  42.2%      72  39.8%      65  36.3%      213  39.4% 
Male      104  57.8%      109  60.2%      114  63.7%      327  60.6% 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Up to approximately 33 months ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: Up to approximately 33 months ]

3.  Secondary:   Best Overall Response - Initial Treatment Period   [ Time Frame: Up to approximately 33 months ]

4.  Secondary:   Best Overall Response Among Participants Receiving ICC Who Switched to Receiving Pembrolizumab   [ Time Frame: Up to approximately 29 months ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: Up to approximately 33 months ]

6.  Secondary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to approximately 36 months ]

7.  Secondary:   Number of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01704287     History of Changes
Other Study ID Numbers: P08719
MK-3475-002 ( Other Identifier: Merck Protocol Number )
2012-003030-17 ( EudraCT Number )
Study First Received: October 8, 2012
Results First Received: October 17, 2016
Last Updated: February 8, 2017