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Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

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ClinicalTrials.gov Identifier: NCT02555657
Recruitment Status : Completed
First Posted : September 21, 2015
Results First Posted : May 4, 2020
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Triple Negative Breast Cancer
Interventions Biological: pembrolizumab
Drug: capecitabine
Drug: eribulin
Drug: gemcitabine
Drug: vinorelbine
Enrollment 622
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
Period Title: Overall Study
Started 312 310
Treated 309 292
Completed 0 0
Not Completed 312 310
Reason Not Completed
Death             257             247
Withdrawal by Subject             11             32
Status Not Recorded             44             31
Arm/Group Title Pembrolizumab Chemotherapy Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations. Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines. Total of all reporting groups
Overall Number of Baseline Participants 312 310 622
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 312 participants 310 participants 622 participants
51.4  (11.4) 52.6  (11.2) 52.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 312 participants 310 participants 622 participants
Female
312
 100.0%
308
  99.4%
620
  99.7%
Male
0
   0.0%
2
   0.6%
2
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 312 participants 310 participants 622 participants
American Indian or Alaska Native
4
   1.3%
4
   1.3%
8
   1.3%
Asian
87
  27.9%
101
  32.6%
188
  30.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
   4.2%
4
   1.3%
17
   2.7%
White
183
  58.7%
180
  58.1%
363
  58.4%
More than one race
12
   3.8%
12
   3.9%
24
   3.9%
Unknown or Not Reported
13
   4.2%
9
   2.9%
22
   3.5%
1.Primary Outcome
Title Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
Hide Description Overall survival (OS) was defined as the time from randomization to death due to any cause.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥10 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 96 98
Median (95% Confidence Interval)
Unit of Measure: Months
12.7
(9.9 to 16.3)
11.6
(8.3 to 13.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0574
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.57 to 1.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival in Participants With PD-L1 CPS ≥1
Hide Description Overall survival (OS) was defined as the time from randomization to death due to any cause.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 203 202
Median (95% Confidence Interval)
Unit of Measure: Months
10.7
(9.3 to 12.5)
10.2
(7.9 to 12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0728
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.69 to 1.06
Estimation Comments [Not Specified]
3.Primary Outcome
Title Overall Survival in All Participants
Hide Description Overall survival (OS) was defined as the time from randomization to death due to any cause.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 312 310
Median (95% Confidence Interval)
Unit of Measure: Months
9.9
(8.3 to 11.4)
10.8
(9.1 to 12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3802
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.82 to 1.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
Hide Description Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RESIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥10 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.7
(10.7 to 26.8)
9.2
(4.3 to 16.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0457
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 8.3
Confidence Interval (2-Sided) 95%
-1.4 to 18.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Hide Description Overall Response Rate (ORR), based on BICR assessment per RESIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 203 202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.3
(8.1 to 17.6)
9.4
(5.8 to 14.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1752
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-3.3 to 9.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Response Rate Per RECIST 1.1 in All Participants
Hide Description Overall Response Rate (ORR), based on BICR assessment per RESIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 312 310
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.6
(6.6 to 13.4)
10.6
(7.4 to 14.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6629
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-5.9 to 3.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
Hide Description Progression-Free Survival (PFS), based on BICR assessment per RESIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥10 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 96 98
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.0 to 2.5)
3.4
(2.3 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7936
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.82 to 1.59
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Hide Description Progression-Free Survival (PFS), based on BICR assessment per RESIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 203 202
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.0 to 2.1)
3.1
(2.3 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9964
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.08 to 1.68
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Progression-Free Survival Per RECIST 1.1 in All Participants
Hide Description Progression-Free Survival (PFS), based on BICR assessment per RESIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 312 310
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.0 to 2.1)
3.3
(2.7 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.33 to 1.92
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response
Hide Description For participants with PD-L1 CPS ≥10 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
Time Frame Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with PD-L1 CPS ≥10, whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 17 9
Median (Full Range)
Unit of Measure: Months
NA [1] 
(2.2 to NA)
7.1 [2] 
(3.8 to NA)
[1]

NA=Median DOR not reached

NA=DOR upper limit not reached (no progressive disease by time of last assessment)

[2]
NA=DOR upper limit not reached (no progressive disease by time of last assessment)
11.Secondary Outcome
Title Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response
Hide Description For participants with PD-L1 CPS ≥1 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
Time Frame Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with PD-L1 CPS ≥1, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 25 19
Median (Full Range)
Unit of Measure: Months
12.2 [1] 
(2.2 to NA)
6.5 [2] 
(NA to NA)
[1]
NA=DOR upper limit not reached (no progressive disease by time of last assessment)
[2]

NA=DOR lower limit not reached (no progressive disease by time of last assessment)

NA=DOR upper limit not reached (no progressive disease by time of last assessment)

12.Secondary Outcome
Title Duration of Response Per RESIST 1.1 in All Participants Who Had a Confirmed Response
Hide Description For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
Time Frame Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 30 33
Median (Full Range)
Unit of Measure: Months
12.2 [1] 
(2.2 to NA)
8.3 [2] 
(NA to NA)
[1]
NA=DOR upper limit not reached (no progressive disease by time of last assessment)
[2]

NA=DOR lower limit not reached (no progressive disease by time of last assessment)

NA=DOR upper limit not reached (no progressive disease by time of last assessment)

13.Secondary Outcome
Title Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
Hide Description Disease Control Rate (DCR), based on BICR assessment per RESIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.])
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥10 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 96 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
19.8
(12.4 to 29.2)
17.3
(10.4 to 26.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3388
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-8.7 to 13.5
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Hide Description Disease Control Rate (DCR), based on BICR assessment per RESIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.])
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 203 202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.3
(9.8 to 19.9)
15.8
(11.1 to 21.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6701
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-8.6 to 5.5
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Disease Control Rate Per RECIST 1.1 in All Participants
Hide Description Disease Control Rate (DCR), based on BICR assessment per RESIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.])
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were included in a treatment group at randomization, regardless of treatment duration
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 312 310
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.2
(8.8 to 16.3)
18.7
(14.5 to 23.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9877
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -6.5
Confidence Interval (2-Sided) 95%
-12.2 to -0.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants Who Experienced One or More Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
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Hide Analysis Population Description
All randomized participants who received at least 1 dose of study treatment
Arm/Group Title Pembrolizumab Chemotherapy
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Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 309 292
Measure Type: Count of Participants
Unit of Measure: Participants
283
  91.6%
279
  95.5%
17.Secondary Outcome
Title Number of Participants Who Discontinued Study Due to an Adverse Event
Hide Description An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
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Hide Analysis Population Description
All randomized participants who received at least 1 dose of study treatment
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations.
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Overall Number of Participants Analyzed 309 292
Measure Type: Count of Participants
Unit of Measure: Participants
14
   4.5%
16
   5.5%
Time Frame Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Adverse Event Reporting Description

Serious AEs and Other AEs: All randomized participants who received at least 1 dose of study treatment.

All-Cause Mortality: All participants who were included in a treatment group at randomization, regardless of treatment duration.

Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

 
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations. Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines
All-Cause Mortality
Pembrolizumab Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   266/312 (85.26%)      273/310 (88.06%)    
Hide Serious Adverse Events
Pembrolizumab Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/309 (19.74%)      58/292 (19.86%)    
Blood and lymphatic system disorders     
Anaemia  1  2/309 (0.65%)  2 2/292 (0.68%)  2
Febrile neutropenia  1  1/309 (0.32%)  1 5/292 (1.71%)  6
Neutropenia  1  1/309 (0.32%)  1 4/292 (1.37%)  6
Pancytopenia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Thrombocytopenia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Cardiac disorders     
Cardiac arrest  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Cardio-respiratory arrest  1  2/309 (0.65%)  2 0/292 (0.00%)  0
Cardiogenic shock  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Sinus tachycardia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Endocrine disorders     
Secondary adrenocortical insufficiency  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Colitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Constipation  1  0/309 (0.00%)  0 3/292 (1.03%)  3
Diarrhoea  1  1/309 (0.32%)  1 2/292 (0.68%)  2
Large intestine polyp  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Oesophageal achalasia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Small intestinal perforation  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Vomiting  1  0/309 (0.00%)  0 1/292 (0.34%)  1
General disorders     
Chest pain  1  0/309 (0.00%)  0 2/292 (0.68%)  2
Death  1  0/309 (0.00%)  0 4/292 (1.37%)  4
Fatigue  1  3/309 (0.97%)  3 0/292 (0.00%)  0
Hyperthermia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Influenza like illness  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Malaise  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Mucosal inflammation  1  0/309 (0.00%)  0 2/292 (0.68%)  2
Oedema peripheral  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Pyrexia  1  3/309 (0.97%)  3 2/292 (0.68%)  2
Hepatobiliary disorders     
Cholangitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Cholecystitis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Cholelithiasis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Liver disorder  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Infections and infestations     
Cellulitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Device related infection  1  2/309 (0.65%)  2 1/292 (0.34%)  1
Device related sepsis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Enterococcal sepsis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Erysipelas  1  1/309 (0.32%)  2 0/292 (0.00%)  0
Gastroenteritis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Herpes zoster  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Infectious pleural effusion  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Klebsiella infection  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Liver abscess  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Lower respiratory tract infection  1  1/309 (0.32%)  1 1/292 (0.34%)  1
Lung infection  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Mastitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Pharyngotonsillitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Pneumonia  1  5/309 (1.62%)  5 7/292 (2.40%)  7
Pyelonephritis  1  1/309 (0.32%)  2 0/292 (0.00%)  0
Respiratory tract infection  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Sepsis  1  2/309 (0.65%)  2 1/292 (0.34%)  1
Staphylococcal bacteraemia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Systemic candida  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Tonsillitis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Upper respiratory tract infection  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Urinary tract infection  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Wound infection  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Post procedural complication  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Radiation associated pain  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Toxicity to various agents  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Investigations     
Alanine aminotransferase increased  1  2/309 (0.65%)  2 0/292 (0.00%)  0
Aspartate aminotransferase increased  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Blood corticotrophin abnormal  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Decreased appetite  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Dehydration  1  0/309 (0.00%)  0 2/292 (0.68%)  2
Diabetic ketoacidosis  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Hypercalcaemia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Hyperglycaemia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Hypocalcaemia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Type 1 diabetes mellitus  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Back pain  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Flank pain  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Muscular weakness  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Myositis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Rhabdomyolysis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  3/309 (0.97%)  4 1/292 (0.34%)  1
Infected neoplasm  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Inflammatory carcinoma of the breast  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Myelodysplastic syndrome  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Pelvic neoplasm  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Tumour associated fever  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Nervous system disorders     
Brain oedema  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Headache  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Horner's syndrome  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Lethargy  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Neuralgia  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Neuropathy peripheral  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Post herpetic neuralgia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Spinal cord compression  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Syncope  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Transient ischaemic attack  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Psychiatric disorders     
Completed suicide  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Depression  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/309 (0.00%)  0 2/292 (0.68%)  2
Tubulointerstitial nephritis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Dyspnoea  1  3/309 (0.97%)  3 0/292 (0.00%)  0
Haemothorax  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Interstitial lung disease  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Oropharyngeal pain  1  0/309 (0.00%)  0 1/292 (0.34%)  1
Pleural effusion  1  7/309 (2.27%)  7 3/292 (1.03%)  3
Pneumonitis  1  2/309 (0.65%)  2 0/292 (0.00%)  0
Pulmonary embolism  1  2/309 (0.65%)  2 2/292 (0.68%)  2
Respiratory failure  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Rash maculo-papular  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Urticaria  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Vascular disorders     
Circulatory collapse  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Deep vein thrombosis  1  1/309 (0.32%)  1 1/292 (0.34%)  1
Jugular vein thrombosis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Peripheral ischaemia  1  1/309 (0.32%)  1 0/292 (0.00%)  0
Thrombosis  1  1/309 (0.32%)  1 0/292 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   250/309 (80.91%)      262/292 (89.73%)    
Blood and lymphatic system disorders     
Anaemia  1  27/309 (8.74%)  30 43/292 (14.73%)  61
Neutropenia  1  1/309 (0.32%)  1 60/292 (20.55%)  145
Endocrine disorders     
Hypothyroidism  1  24/309 (7.77%)  25 4/292 (1.37%)  4
Gastrointestinal disorders     
Abdominal pain  1  16/309 (5.18%)  16 15/292 (5.14%)  18
Constipation  1  50/309 (16.18%)  56 51/292 (17.47%)  59
Diarrhoea  1  28/309 (9.06%)  33 60/292 (20.55%)  82
Nausea  1  47/309 (15.21%)  60 87/292 (29.79%)  115
Stomatitis  1  6/309 (1.94%)  7 23/292 (7.88%)  24
Vomiting  1  22/309 (7.12%)  29 32/292 (10.96%)  43
General disorders     
Asthenia  1  34/309 (11.00%)  38 38/292 (13.01%)  41
Fatigue  1  54/309 (17.48%)  66 53/292 (18.15%)  60
Malaise  1  9/309 (2.91%)  9 16/292 (5.48%)  18
Mucosal inflammation  1  1/309 (0.32%)  1 22/292 (7.53%)  22
Oedema peripheral  1  16/309 (5.18%)  17 13/292 (4.45%)  16
Pyrexia  1  33/309 (10.68%)  43 32/292 (10.96%)  47
Infections and infestations     
Nasopharyngitis  1  18/309 (5.83%)  22 13/292 (4.45%)  19
Urinary tract infection  1  15/309 (4.85%)  17 18/292 (6.16%)  21
Investigations     
Alanine aminotransferase increased  1  21/309 (6.80%)  24 23/292 (7.88%)  42
Aspartate aminotransferase increased  1  32/309 (10.36%)  38 27/292 (9.25%)  49
Neutrophil count decreased  1  3/309 (0.97%)  8 44/292 (15.07%)  121
Weight decreased  1  10/309 (3.24%)  10 16/292 (5.48%)  16
White blood cell count decreased  1  5/309 (1.62%)  11 30/292 (10.27%)  74
Metabolism and nutrition disorders     
Decreased appetite  1  30/309 (9.71%)  31 37/292 (12.67%)  41
Hyperglycaemia  1  12/309 (3.88%)  14 15/292 (5.14%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia  1  29/309 (9.39%)  38 16/292 (5.48%)  17
Back pain  1  20/309 (6.47%)  22 29/292 (9.93%)  32
Pain in extremity  1  14/309 (4.53%)  15 21/292 (7.19%)  25
Nervous system disorders     
Dizziness  1  13/309 (4.21%)  14 20/292 (6.85%)  21
Dysgeusia  1  6/309 (1.94%)  6 20/292 (6.85%)  20
Headache  1  43/309 (13.92%)  60 33/292 (11.30%)  42
Neuropathy peripheral  1  4/309 (1.29%)  4 26/292 (8.90%)  28
Peripheral sensory neuropathy  1  6/309 (1.94%)  6 19/292 (6.51%)  20
Psychiatric disorders     
Insomnia  1  9/309 (2.91%)  9 15/292 (5.14%)  16
Respiratory, thoracic and mediastinal disorders     
Cough  1  51/309 (16.50%)  58 28/292 (9.59%)  30
Dyspnoea  1  36/309 (11.65%)  40 30/292 (10.27%)  37
Skin and subcutaneous tissue disorders     
Alopecia  1  2/309 (0.65%)  2 42/292 (14.38%)  43
Palmar-plantar erythrodysaesthesia syndrome  1  2/309 (0.65%)  2 36/292 (12.33%)  47
Pruritus  1  34/309 (11.00%)  43 12/292 (4.11%)  12
Rash  1  22/309 (7.12%)  24 11/292 (3.77%)  12
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02555657    
Other Study ID Numbers: 3475-119
2015-001020-27 ( EudraCT Number )
153082 ( Registry Identifier: JAPIC-CTI )
MK-3475-119 ( Other Identifier: Merck Protocol Number )
KEYNOTE-119 ( Other Identifier: Merck )
First Submitted: September 18, 2015
First Posted: September 21, 2015
Results First Submitted: March 27, 2020
Results First Posted: May 4, 2020
Last Update Posted: January 8, 2021