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A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02256436
Recruitment Status : Active, not recruiting
First Posted : October 3, 2014
Results First Posted : August 31, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Urothelial Cancer
Interventions: Biological: pembrolizumab
Drug: paclitaxel
Drug: vinflunine
Drug: docetaxel

  Participant Flow

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
This interim analysis of the results disclosure is based on data collected prior to the database cutoff date of 07-Sep-2016 (up to approximately 20 months of follow up from study start), at which time, 175 participants were ongoing in the study.

Reporting Groups
  Description
Pembrolizumab Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W).
Active Comparator Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.

Participant Flow:   Overall Study
    Pembrolizumab   Active Comparator
STARTED   270   272 
Treated   266   255 
COMPLETED   0   0 
NOT COMPLETED   270   272 
Adverse Event                15                13 
Death                137                158 
Lost to Follow-up                1                1 
Physician Decision                1                3 
Protocol Violation                1                0 
Withdrawal by Subject                7                30 
Ongoing in Study                108                67 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Pembrolizumab Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
Active Comparator Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
Total Total of all reporting groups

Baseline Measures
   Pembrolizumab   Active Comparator   Total 
Overall Participants Analyzed 
[Units: Participants]
 270   272   542 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.0  (10.2)   65.1  (9.2)   65.5  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      70  25.9%      70  25.7%      140  25.8% 
Male      200  74.1%      202  74.3%      402  74.2% 


  Outcome Measures

1.  Primary:   Overall Survival (OS) - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

2.  Primary:   Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

3.  Primary:   OS - Participants With Strongly PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

4.  Primary:   PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

5.  Primary:   OS - Participants With PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

6.  Primary:   PFS Per RECIST 1.1 - Participants With PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

7.  Secondary:   Objective Response Rate (ORR) Per RECIST 1.1 - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

8.  Secondary:   ORR Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

9.  Secondary:   ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

10.  Secondary:   PFS Per Modified RECIST - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

11.  Secondary:   ORR Per Modified RECIST - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

12.  Secondary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to approximately 23 months ]

13.  Secondary:   Number of Participants Who Discontinued Study Treatment Due to an AE   [ Time Frame: Up to approximately 20 months ]

14.  Secondary:   Response Duration Per RECIST 1.1 - All Participants   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

15.  Secondary:   Response Duration Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]

16.  Secondary:   Response Duration Per RECIST 1.1 - Participants With PD-L1 Positive Tumors   [ Time Frame: Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02256436     History of Changes
Other Study ID Numbers: 3475-045
2014-002009-40 ( EudraCT Number )
152903 ( Registry Identifier: JAPIC-CTI )
MK-3475-045 ( Other Identifier: Merck Protocol Number )
First Submitted: September 29, 2014
First Posted: October 3, 2014
Results First Submitted: June 12, 2017
Results First Posted: August 31, 2017
Last Update Posted: December 20, 2017