This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01848834
First received: May 3, 2013
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer
Solid Tumor
Intervention: Biological: Pembrolizumab

  Participant Flow
  Hide 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 results disclosure is based on a data cutoff date of 26 April 2016 for Cohorts A and D, and a data cutoff date of 01 Sep 2015 for Cohorts B, B2 and C. As of the data cutoff dates, 33 participants were on treatment in the study. One additional participant was enrolled in Cohort B, but did not receive any study treatment.

Reporting Groups
  Description
Cohort A: Triple Negative Breast Cancer Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort B: Head & Neck Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort C: Urothelial Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort D: Gastric Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort B2: Head & Neck Cancer Expansion Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.

Participant Flow:   Overall Study
    Cohort A: Triple Negative Breast Cancer   Cohort B: Head & Neck Cancer   Cohort C: Urothelial Cancer   Cohort D: Gastric Cancer   Cohort B2: Head & Neck Cancer Expansion
STARTED   32   61   33   39   132 
Treated   32   60   33   39   132 
COMPLETED   2 [1]   1 [1]   1 [1]   2 [1]   0 [1] 
NOT COMPLETED   30   60   32   37   132 
Ongoing in Study                0                6                1                0                26 
Physician Decision                0                0                0                0                1 
Adverse Event                3                8                6                1                15 
Complete Response                0                1                0                0                0 
Death                0                1                0                0                3 
Progressive Disease                27                41                21                36                78 
Protocol Violation                0                0                1                0                2 
Withdrawal by Subject                0                2                3                0                7 
Not Treated                0                1                0                0                0 
[1] Completed means two-year treatment completed



  Baseline Characteristics
  Hide 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.
The baseline analysis population consisted of all participants who received at least one dose of study treatment. One additional participant was enrolled in Cohort B, but did not receive any study treatment.

Reporting Groups
  Description
Cohort A: Triple Negative Breast Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort B: Head & Neck Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort C: Urothelial Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort D: Gastric Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort B2: Head & Neck Cancer Expansion Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Total Total of all reporting groups

Baseline Measures
   Cohort A: Triple Negative Breast Cancer   Cohort B: Head & Neck Cancer   Cohort C: Urothelial Cancer   Cohort D: Gastric Cancer   Cohort B2: Head & Neck Cancer Expansion   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   60   33   39   132   296 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.9  (12.1)   61.2  (11.3)   68.5  (10.3)   58.3  (13.2)   58.9  (9.7)   59.6  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      32 100.0%      11  18.3%      10  30.3%      11  28.2%      22  16.7%      86  29.1% 
Male      0   0.0%      49  81.7%      23  69.7%      28  71.8%      110  83.3%      210  70.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Adverse Events (AEs)   [ Time Frame: Serious AEs: Up to 90 days after last dose of study treatment (Up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (Up to 32 months) ]

2.  Primary:   Number of Participants Discontinuing From Study Treatment Due to an AE   [ Time Frame: Up to last dose of study treatment (Up to approximately 31 months) ]

3.  Primary:   Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B & B2, C, and D)   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 34 months) ]

4.  Primary:   Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 14 months) ]

5.  Secondary:   Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 HPV-positive Participants   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 27 months) ]

6.  Secondary:   Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 30 months) ]

7.  Secondary:   Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 27 months) ]

8.  Secondary:   Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 34 months) ]

9.  Secondary:   Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2   [ Time Frame: Every 8 weeks until disease progression (Up to approximately 14 months) ]

10.  Other Pre-specified:   Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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 of Results:
Nanda R, Chow LQ, Dees EC, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Aktan G, Cheng J, Karantza V, Buisseret L. Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study. J Clin Oncol. 2016;[e-pub 2May2016]. doi: 10.1200/JCO.2015.64.8931

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01848834     History of Changes
Other Study ID Numbers: 3475-012
2012-005771-14 ( EudraCT Number )
142453 ( Registry Identifier: JAPIC_CTI )
P21477 ( Other Identifier: Merck Protocol Number )
Study First Received: May 3, 2013
Results First Received: April 7, 2017
Last Updated: April 7, 2017