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Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)

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: NCT02564263
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Results First Posted : November 20, 2019
Last Update Posted : March 4, 2020
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
Conditions Esophageal Carcinoma
Esophagogastric Junction Carcinoma
Interventions Biological: pembrolizumab
Drug: paclitaxel
Drug: docetaxel
Drug: irinotecan
Enrollment 628
Recruitment Details  
Pre-assignment Details This results disclosure is based on a data cutoff date of 15-Oct-2018, at which time 67 participants were ongoing in the study.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months). Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Period Title: Overall Study
Started 314 314
Treated 314 296
Completed 0 0
Not Completed 314 314
Reason Not Completed
Adverse Event             31             29
Death             236             242
Withdrawal by Subject             5             18
Ongoing in Study             42             25
Arm/Group Title Pembrolizumab Chemotherapy Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months). Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months). Total of all reporting groups
Overall Number of Baseline Participants 314 314 628
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 314 participants 628 participants
62.6  (9.4) 62.0  (9.6) 62.3  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
Female
41
  13.1%
43
  13.7%
84
  13.4%
Male
273
  86.9%
271
  86.3%
544
  86.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
Hispanic or Latino
19
   6.1%
26
   8.3%
45
   7.2%
Not Hispanic or Latino
288
  91.7%
274
  87.3%
562
  89.5%
Unknown or Not Reported
7
   2.2%
14
   4.5%
21
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.2%
Asian
126
  40.1%
122
  38.9%
248
  39.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.2%
Black or African American
3
   1.0%
3
   1.0%
6
   1.0%
White
179
  57.0%
173
  55.1%
352
  56.1%
More than one race
2
   0.6%
4
   1.3%
6
   1.0%
Unknown or Not Reported
4
   1.3%
10
   3.2%
14
   2.2%
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
PD-L1 CPS ≥10
107
  34.1%
115
  36.6%
222
  35.4%
PD-L1 CPS <10
201
  64.0%
196
  62.4%
397
  63.2%
Not Evaluable
6
   1.9%
3
   1.0%
9
   1.4%
[1]
Measure Description: Participants were assessed for their PD-L1 tumor expression levels by immunohistochemistry assay on tumor tissue from a newly obtained biopsy. PD-L1 CPS was calculated as the number of PD-L1 positive cells (tumor cells, macrophages, lymphocytes) divided by the total tumor cells and is expressed as a percentage. Participants were classified based on their PD-L1 tumor status as being either PD-L1 CPS ≥10 or PD-L1 CPS <10.
Geographic Region   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
Asia
121
  38.5%
122
  38.9%
243
  38.7%
RoW
193
  61.5%
192
  61.1%
385
  61.3%
[1]
Measure Description: Participants were classified based on their geographic region of enrollment as either being from Asia or from outside of Asia (Rest of World [RoW]).
Tumor Histology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 314 participants 628 participants
Squamous cell carcinoma
198
  63.1%
203
  64.6%
401
  63.9%
Adenocarcinoma of esophagus & EGJ Siewert type I
116
  36.9%
111
  35.4%
227
  36.1%
[1]
Measure Description: Participants were classified based on their tumor histology (cell type) as either having squamous cell carcinoma or having adenocarcinoma of esophagus and esophagogastric junction (EGJ) Siewert type I.
1.Primary Outcome
Title Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Hide Description OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 198 203
Median (95% Confidence Interval)
Unit of Measure: Months
8.2
(6.7 to 10.3)
7.1
(6.1 to 8.2)
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 0.00894
Comments One-sided p-value based on stratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.63 to 0.96
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)
2.Primary Outcome
Title Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Hide Description OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 107 115
Median (95% Confidence Interval)
Unit of Measure: Months
9.3
(6.6 to 12.5)
6.7
(5.1 to 8.2)
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 0.00855
Comments One-sided p-value based on stratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.52 to 0.94
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction [EGJ])
3.Primary Outcome
Title Overall Survival (OS) in All Participants
Hide Description OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 314 314
Median (95% Confidence Interval)
Unit of Measure: Months
7.1
(6.2 to 8.1)
7.1
(6.3 to 8.0)
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 0.0531
Comments One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic & a weighted log-rank Fleming-Harrington (0,1) test statistic
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.75 to 1.05
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction [EGJ])
4.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description PFS 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 have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 314 314
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.1 to 2.2)
3.4
(2.8 to 3.9)
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 0.287
Comments One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic & a weighted log-rank Fleming-Harrington (0,1) test statistic
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.94 to 1.31
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)
5.Secondary Outcome
Title Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 314 314
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
13.1
(9.5 to 17.3)
6.7
(4.2 to 10.0)
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 0.0037
Comments One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %>0.
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
1.7 to 11.2
Estimation Comments Miettinen & Nurminen method stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)
6.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Hide Description PFS 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 have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 198 203
Median (95% Confidence Interval)
Unit of Measure: Months
2.2
(2.1 to 3.2)
3.1
(2.2 to 3.9)
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 0.216
Comments One-sided p-value based on stratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.75 to 1.13
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)
7.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Hide Description PFS 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 have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 107 115
Median (95% Confidence Interval)
Unit of Measure: Months
2.6
(2.1 to 4.1)
3.0
(2.1 to 3.7)
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 0.015
Comments One-sided p-value based on stratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.54 to 0.97
Estimation Comments Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)
8.Secondary Outcome
Title Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Hide Description ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 198 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
16.7
(11.8 to 22.6)
7.4
(4.2 to 11.9)
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 0.0022
Comments One-sided p-value for testing. H0: difference in %=0; H1: difference in %>0.
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
3.0 to 15.8
Estimation Comments Miettinen & Nurminen method stratified by geographic region (Asia vs RoW)
9.Secondary Outcome
Title Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Hide Description ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR is presented.
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Number of Participants Analyzed 107 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
21.5
(14.1 to 30.5)
6.1
(2.5 to 12.1)
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 0.0006
Comments One-sided p-value for testing. H0: difference in %=0; H1: difference in %>0.
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 15.1
Confidence Interval (2-Sided) 95%
6.2 to 24.7
Estimation Comments Miettinen & Nurminen method stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)
10.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.
Time Frame Through End-of-Trial Analysis data cutoff date of 31-Dec-2020 (up to approximately 5 years)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE will be presented.
Time Frame Through End-of-Trial Analysis data cutoff date of 31-Dec-2020 (up to approximately 5 years)
Outcome Measure Data Not Reported
Time Frame Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
Adverse Event Reporting Description Safety Population: All participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an Adverse events (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
 
Arm/Group Title Pembrolizumab Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months). Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
All-Cause Mortality
Pembrolizumab Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   271/314 (86.31%)      284/314 (90.45%)    
Hide Serious Adverse Events
Pembrolizumab Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/314 (39.49%)      121/296 (40.88%)    
Blood and lymphatic system disorders     
Anaemia  1  2/314 (0.64%)  2 5/296 (1.69%)  5
Febrile neutropenia  1  1/314 (0.32%)  1 22/296 (7.43%)  24
Immune thrombocytopenic purpura  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Leukopenia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Neutropenia  1  0/314 (0.00%)  0 4/296 (1.35%)  5
Cardiac disorders     
Acute left ventricular failure  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Acute myocardial infarction  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Atrial fibrillation  1  2/314 (0.64%)  3 2/296 (0.68%)  2
Cardio-respiratory arrest  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Myocarditis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Sinus tachycardia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Tachycardia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Endocrine disorders     
Hypercalcaemia of malignancy  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hypophysitis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Inappropriate antidiuretic hormone secretion  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Eye disorders     
Cataract  1  1/314 (0.32%)  2 0/296 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Abdominal pain  1  3/314 (0.96%)  3 2/296 (0.68%)  2
Colitis  1  3/314 (0.96%)  3 0/296 (0.00%)  0
Constipation  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Diarrhoea  1  1/314 (0.32%)  1 5/296 (1.69%)  5
Diverticulum oesophageal  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Dysphagia  1  11/314 (3.50%)  12 1/296 (0.34%)  1
Enterocolitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Gastrointestinal haemorrhage  1  2/314 (0.64%)  2 4/296 (1.35%)  4
Gastrointestinal hypomotility  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Haematemesis  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Impaired gastric emptying  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Intestinal perforation  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Nausea  1  1/314 (0.32%)  1 3/296 (1.01%)  3
Oesophageal fistula  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Oesophageal haemorrhage  1  4/314 (1.27%)  4 0/296 (0.00%)  0
Oesophageal obstruction  1  3/314 (0.96%)  3 1/296 (0.34%)  1
Oesophageal perforation  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Oesophageal stenosis  1  2/314 (0.64%)  2 1/296 (0.34%)  1
Oesophageal ulcer  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Oesophagitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Peritoneal adhesions  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Upper gastrointestinal haemorrhage  1  0/314 (0.00%)  0 3/296 (1.01%)  3
Vomiting  1  2/314 (0.64%)  2 5/296 (1.69%)  5
General disorders     
Asthenia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Chest pain  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Death  1  5/314 (1.59%)  5 10/296 (3.38%)  10
Fatigue  1  2/314 (0.64%)  2 2/296 (0.68%)  2
General physical health deterioration  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Pyrexia  1  4/314 (1.27%)  4 5/296 (1.69%)  5
Strangulated hernia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Hepatobiliary disorders     
Autoimmune hepatitis  1  4/314 (1.27%)  4 0/296 (0.00%)  0
Cholecystitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Cholecystitis acute  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Hepatic failure  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Hepatic function abnormal  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Liver injury  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/314 (0.00%)  0 2/296 (0.68%)  2
Bacteraemia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Bronchitis  1  1/314 (0.32%)  1 2/296 (0.68%)  2
Candida infection  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Cellulitis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Clostridium difficile colitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Device related infection  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Device related sepsis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Empyema  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hepatic infection  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Herpes zoster  1  1/314 (0.32%)  1 2/296 (0.68%)  2
Infection  1  0/314 (0.00%)  0 2/296 (0.68%)  2
Liver abscess  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Lower respiratory tract infection viral  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Lung infection  1  0/314 (0.00%)  0 2/296 (0.68%)  2
Mediastinitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Peritonitis  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Pneumonia  1  14/314 (4.46%)  15 20/296 (6.76%)  24
Pneumonia bacterial  1  0/314 (0.00%)  0 2/296 (0.68%)  2
Pneumonia necrotising  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Pulmonary sepsis  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Respiratory tract infection  1  3/314 (0.96%)  3 2/296 (0.68%)  2
Sepsis  1  3/314 (0.96%)  3 3/296 (1.01%)  4
Septic shock  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Stoma site infection  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Subcutaneous abscess  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Tracheitis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Tracheostomy infection  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Upper respiratory tract infection  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Urinary tract infection  1  2/314 (0.64%)  2 1/296 (0.34%)  1
Varicella zoster virus infection  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Injury, poisoning and procedural complications     
Anastomotic fistula  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Anastomotic leak  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Fall  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Femoral neck fracture  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Foreign body in gastrointestinal tract  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Gastrostomy failure  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Infusion related reaction  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Radiation pneumonitis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Spinal compression fracture  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Subdural haematoma  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Tracheal injury  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Tracheal obstruction  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Upper limb fracture  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Investigations     
Hepatic enzyme increased  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Liver function test increased  1  1/314 (0.32%)  2 0/296 (0.00%)  0
Neutrophil count decreased  1  1/314 (0.32%)  1 3/296 (1.01%)  3
Weight decreased  1  1/314 (0.32%)  1 0/296 (0.00%)  0
White blood cell count decreased  1  1/314 (0.32%)  1 2/296 (0.68%)  2
White blood cell count increased  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  2/314 (0.64%)  2 2/296 (0.68%)  2
Dehydration  1  2/314 (0.64%)  2 4/296 (1.35%)  4
Electrolyte imbalance  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hypercalcaemia  1  3/314 (0.96%)  3 0/296 (0.00%)  0
Hyperglycaemia  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Hypoglycaemia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hypokalaemia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hyponatraemia  1  0/314 (0.00%)  0 2/296 (0.68%)  2
Hypophosphataemia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Type 1 diabetes mellitus  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Back pain  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Fistula inflammation  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Neck pain  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Polymyositis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Cancer pain  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Head and neck cancer  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Metastases to bone  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Nervous system disorders     
Cerebellar stroke  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Cerebral infarction  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Cerebrovascular accident  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Demyelination  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Dyskinesia  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Dystonia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Facial paralysis  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Guillain-Barre syndrome  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Haemorrhage intracranial  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Haemorrhagic stroke  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Headache  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Hemiparesis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Neuralgia  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Neuropathy peripheral  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Radiculopathy  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Spinal cord compression  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Vocal cord paralysis  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Product Issues     
Device dislocation  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Device occlusion  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Confusional state  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Delirium  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  2/314 (0.64%)  2 1/296 (0.34%)  1
Chronic kidney disease  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Acute respiratory failure  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Aspiration  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Chronic obstructive pulmonary disease  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Dyspnoea  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Haemoptysis  1  2/314 (0.64%)  2 0/296 (0.00%)  0
Hiccups  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Interstitial lung disease  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Lung disorder  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Pleural effusion  1  1/314 (0.32%)  2 2/296 (0.68%)  2
Pneumonia aspiration  1  11/314 (3.50%)  12 5/296 (1.69%)  5
Pneumonitis  1  7/314 (2.23%)  7 0/296 (0.00%)  0
Pneumothorax  1  1/314 (0.32%)  1 1/296 (0.34%)  1
Pulmonary embolism  1  3/314 (0.96%)  3 0/296 (0.00%)  0
Pulmonary necrosis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Respiratory failure  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Stridor  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Tracheal fistula  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Upper airway obstruction  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Skin and subcutaneous tissue disorders     
Dermal cyst  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/314 (0.32%)  1 0/296 (0.00%)  0
Haemorrhage  1  0/314 (0.00%)  0 1/296 (0.34%)  1
Shock haemorrhagic  1  0/314 (0.00%)  0 1/296 (0.34%)  1
1
Term from vocabulary, MedDRA 21.0
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   280/314 (89.17%)      281/296 (94.93%)    
Blood and lymphatic system disorders     
Anaemia  1  52/314 (16.56%)  60 83/296 (28.04%)  110
Neutropenia  1  0/314 (0.00%)  0 36/296 (12.16%)  65
Endocrine disorders     
Hypothyroidism  1  36/314 (11.46%)  38 7/296 (2.36%)  7
Gastrointestinal disorders     
Abdominal pain  1  34/314 (10.83%)  35 27/296 (9.12%)  32
Abdominal pain upper  1  14/314 (4.46%)  16 17/296 (5.74%)  19
Constipation  1  56/314 (17.83%)  63 55/296 (18.58%)  62
Diarrhoea  1  38/314 (12.10%)  65 79/296 (26.69%)  120
Dysphagia  1  40/314 (12.74%)  44 27/296 (9.12%)  28
Nausea  1  59/314 (18.79%)  66 82/296 (27.70%)  109
Stomatitis  1  9/314 (2.87%)  9 28/296 (9.46%)  30
Vomiting  1  37/314 (11.78%)  45 53/296 (17.91%)  74
General disorders     
Asthenia  1  45/314 (14.33%)  48 43/296 (14.53%)  58
Fatigue  1  69/314 (21.97%)  72 87/296 (29.39%)  121
Malaise  1  15/314 (4.78%)  18 19/296 (6.42%)  26
Oedema peripheral  1  19/314 (6.05%)  20 19/296 (6.42%)  19
Pyrexia  1  31/314 (9.87%)  41 45/296 (15.20%)  58
Investigations     
Alanine aminotransferase increased  1  22/314 (7.01%)  26 9/296 (3.04%)  15
Aspartate aminotransferase increased  1  26/314 (8.28%)  33 14/296 (4.73%)  16
Neutrophil count decreased  1  2/314 (0.64%)  2 50/296 (16.89%)  113
Weight decreased  1  39/314 (12.42%)  39 34/296 (11.49%)  43
White blood cell count decreased  1  1/314 (0.32%)  1 52/296 (17.57%)  114
Metabolism and nutrition disorders     
Decreased appetite  1  76/314 (24.20%)  82 75/296 (25.34%)  96
Hyperglycaemia  1  17/314 (5.41%)  22 14/296 (4.73%)  14
Hypoalbuminaemia  1  17/314 (5.41%)  23 15/296 (5.07%)  16
Hypokalaemia  1  15/314 (4.78%)  15 28/296 (9.46%)  39
Hyponatraemia  1  19/314 (6.05%)  27 17/296 (5.74%)  24
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/314 (6.05%)  21 16/296 (5.41%)  18
Back pain  1  37/314 (11.78%)  39 24/296 (8.11%)  27
Myalgia  1  8/314 (2.55%)  10 25/296 (8.45%)  31
Nervous system disorders     
Dysgeusia  1  6/314 (1.91%)  6 17/296 (5.74%)  17
Neuropathy peripheral  1  6/314 (1.91%)  7 25/296 (8.45%)  28
Peripheral sensory neuropathy  1  3/314 (0.96%)  3 52/296 (17.57%)  53
Psychiatric disorders     
Insomnia  1  25/314 (7.96%)  25 16/296 (5.41%)  42
Respiratory, thoracic and mediastinal disorders     
Cough  1  40/314 (12.74%)  46 30/296 (10.14%)  33
Dyspnoea  1  31/314 (9.87%)  36 16/296 (5.41%)  20
Skin and subcutaneous tissue disorders     
Alopecia  1  4/314 (1.27%)  4 88/296 (29.73%)  88
Pruritus  1  23/314 (7.32%)  27 8/296 (2.70%)  8
Rash  1  20/314 (6.37%)  23 25/296 (8.45%)  27
1
Term from vocabulary, MedDRA 21.0
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 study 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: NCT02564263    
Other Study ID Numbers: 3475-181
2015-002782-32 ( EudraCT Number )
163145 ( Registry Identifier: JAPAN-CTI )
MK-3475-181 ( Other Identifier: Merck )
KEYNOTE-181 ( Other Identifier: Merck )
First Submitted: September 29, 2015
First Posted: September 30, 2015
Results First Submitted: September 26, 2019
Results First Posted: November 20, 2019
Last Update Posted: March 4, 2020