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A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)

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ClinicalTrials.gov Identifier: NCT02370498
Recruitment Status : Active, not recruiting
First Posted : February 25, 2015
Results First Posted : November 20, 2018
Last Update Posted : March 5, 2019
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 Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions Biological: pembroliziumab
Drug: paclitaxel
Enrollment 592
Recruitment Details After 20 March 2016, enrollment was limited to programmed cell death ligand 1 (PD-L1) positive participants.
Pre-assignment Details Of 592 participants that were randomized to trial, 570 received treatment. At the time of the primary analysis data cut-off, 89 participants are ongoing in the study.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 296 296
Treated 294 276
PD-L1 Positive Participants 196 199
Completed 0 0
Not Completed 296 296
Reason Not Completed
Adverse Event             10             8
Death             222             242
Lost to Follow-up             1             0
Protocol Violation             1             2
Withdrawal by Subject             6             11
Ongoing In Trial             56             33
Arm/Group Title Pembrolizumab Paclitaxel Total
Hide Arm/Group Description Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 296 296 592
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 296 participants 592 participants
60.7  (12.0) 59.6  (11.7) 60.2  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
Female
94
  31.8%
88
  29.7%
182
  30.7%
Male
202
  68.2%
208
  70.3%
410
  69.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
Hispanic or Latino
27
   9.1%
24
   8.1%
51
   8.6%
Not Hispanic or Latino
269
  90.9%
272
  91.9%
541
  91.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
American Indian or Alaska Native
4
   1.4%
3
   1.0%
7
   1.2%
Asian
93
  31.4%
91
  30.7%
184
  31.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   1.4%
2
   0.7%
6
   1.0%
White
193
  65.2%
198
  66.9%
391
  66.0%
More than one race
2
   0.7%
2
   0.7%
4
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
Europe/Israel/North America/Australia 190 187 377
Asia 88 89 177
Rest of World 18 20 38
PD-L1 Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
Positive
196
  66.2%
199
  67.2%
395
  66.7%
Negative
99
  33.4%
96
  32.4%
195
  32.9%
Unknown
1
   0.3%
1
   0.3%
2
   0.3%
Time To Progression (TTP) on first-line therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 296 participants 592 participants
<6 months
186
  62.8%
182
  61.5%
368
  62.2%
≥6 months
110
  37.2%
114
  38.5%
224
  37.8%
1.Primary Outcome
Title Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
Hide Description PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
1.5
(1.4 to 2.0)
4.1
(3.1 to 4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98358
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (< 6 months vs. >= 6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
1.03 to 1.57
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS) in PD-L1 Positive Participants
Hide Description OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(6.2 to 10.7)
8.3
(7.6 to 9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04205
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (< 6 months vs. >= 6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.66 to 1.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PFS According to RECIST 1.1 Based on BICR in All Participants
Hide Description PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
1.5
(1.4 to 1.6)
4.1
(3.2 to 4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99999
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
1.25 to 1.77
Estimation Comments [Not Specified]
4.Secondary Outcome
Title OS in All Participants
Hide Description OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
6.7
(5.4 to 8.9)
8.3
(7.7 to 8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24463
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.79 to 1.12
Estimation Comments [Not Specified]
5.Secondary Outcome
Title PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
Hide Description PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.5 to 2.7)
3.1
(2.8 to 4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41331
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.79 to 1.21
Estimation Comments [Not Specified]
6.Secondary Outcome
Title PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants
Hide Description PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.5 to 1.9)
3.2
(2.9 to 4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97481
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.00 to 1.42
Estimation Comments [Not Specified]
7.Secondary Outcome
Title PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants
Hide Description PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated stable disease (SD; neither sufficient shrinkage or increase of target lesion), partial response (PR; ≥30% decrease in the SOD of target lesions), or complete response (CR; disappearance of all non-nodal target lesions), participant could continue treatment at investigator’s discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.4 to 3.0)
4.2
(3.5 to 4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80696
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.89 to 1.38
Estimation Comments [Not Specified]
8.Secondary Outcome
Title PFS According to irRECIST Based on BICR in All Participants
Hide Description PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated SD (neither sufficient shrinkage or increase of target lesion), PR (≥30% decrease in the SOD of target lesions), or CR (disappearance of all non-nodal target lesions), participant could continue treatment at investigator’s discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.5 to 2.5)
4.2
(4.0 to 4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99932
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
1.12 to 1.60
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
Hide Description TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.4 to 2.7)
4.0
(3.1 to 4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99661
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.11 to 1.89
Estimation Comments [Not Specified]
10.Secondary Outcome
Title TTP According to RECIST 1.1 Based on BICR in All Participants
Hide Description TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
1.5
(1.4 to 1.8)
4.1
(3.2 to 4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00000
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
1.42 to 2.20
Estimation Comments [Not Specified]
11.Secondary Outcome
Title TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
Hide Description TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(1.5 to 3.0)
3.3
(2.9 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39280
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.77 to 1.23
Estimation Comments [Not Specified]
12.Secondary Outcome
Title TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants
Hide Description TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.5 to 2.7)
3.8
(3.0 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97033
Comments One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).
Method Regression, Cox
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
1.00 to 1.47
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
Hide Description ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
15.8
(11.0 to 21.7)
13.6
(9.1 to 19.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Stratified Miettinen and Nurminen’s (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28967
Comments Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months) weighting by sample size.
Method Miettinen and Nurminen method
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-5.0 to 9.1
Estimation Comments [Not Specified]
14.Secondary Outcome
Title ORR According to RECIST 1.1 Based on BICR in All Participants
Hide Description ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
11.1
(7.8 to 15.3)
12.5
(9.0 to 16.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69010
Comments Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size
Method Miettinen and Nurminen method
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.5 to 4.0
Estimation Comments [Not Specified]
15.Secondary Outcome
Title ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
Hide Description ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 196 199
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.3
(12.3 to 23.4)
15.6
(10.8 to 21.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33220
Comments Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months), weighting by sample size.
Method Miettinen and Nurminen method
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-5.8 to 9.1
Estimation Comments [Not Specified]
16.Secondary Outcome
Title ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants
Hide Description ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 296 296
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.2
(8.7 to 16.4)
15.2
(11.3 to 19.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Stratified Miettinen and Nurminen’s method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85922
Comments Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.
Method Miettinen and Nurminen method
Comments P-value rounded to 5 decimal places.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-8.5 to 2.6
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
Hide Description For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 31 27
Median (Full Range)
Unit of Measure: months
18.0
(1.4 to 26.0)
5.2
(1.3 to 16.8)
18.Secondary Outcome
Title DOR According to RECIST 1.1 Based on BICR in All Participants
Hide Description For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 33 37
Median (Full Range)
Unit of Measure: months
18.0
(1.4 to 26.0)
5.5
(1.3 to 17.7)
19.Secondary Outcome
Title DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
Hide Description For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 34 31
Median (Full Range)
Unit of Measure: months
15.7
(2.7 to 23.7)
4.3
(1.8 to 19.1)
20.Secondary Outcome
Title DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants
Hide Description For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 36 45
Median (Full Range)
Unit of Measure: months
15.7
(2.7 to 23.7)
4.3
(1.3 to 19.1)
21.Secondary Outcome
Title Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The percentage of participants with at least one AE was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants who received at least 1 dose of study treatment.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 194 188
Measure Type: Number
Unit of Measure: Percentage of participants
93.3 97.3
22.Secondary Outcome
Title Percentage of All Participants Who Experienced an AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The percentage of participants with at least one AE was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study treatment.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 294 276
Measure Type: Number
Unit of Measure: Percentage of participants
93.9 97.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.9 to 0.2
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for PD-L1 positive participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized PD-L1 positive participants who received at least 1 dose of study treatment.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 194 188
Measure Type: Number
Unit of Measure: Percentage of participants
4.6 8.0
24.Secondary Outcome
Title Percentage of All Participants That Discontinued Study Treatment Due to AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for all participants by treatment group.
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study treatment.
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description:
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 294 276
Measure Type: Number
Unit of Measure: Percentage of participants
5.1 9.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, Paclitaxel
Comments Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-8.4 to 0.3
Estimation Comments [Not Specified]
Time Frame Up to 30 months (through database cut-off date of 26 Oct 2017)
Adverse Event Reporting Description

All-Cause Mortality was reported for all randomized participants.

Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

 
Arm/Group Title Pembrolizumab Paclitaxel
Hide Arm/Group Description Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
All-Cause Mortality
Pembrolizumab Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   239/296 (80.74%)      262/296 (88.51%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pembrolizumab Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/294 (37.07%)      68/276 (24.64%)    
Blood and lymphatic system disorders     
Anaemia  1  11/294 (3.74%)  14 5/276 (1.81%)  6
Disseminated intravascular coagulation  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Febrile neutropenia  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Microcytic anaemia  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Neutropenia  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Cardiac disorders     
Atrial fibrillation  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Myocardial infarction  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Endocrine disorders     
Addison's disease  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Hypophysitis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Hypopituitarism  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Hypothyroidism  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Eye disorders     
Cataract  1  0/294 (0.00%)  0 1/276 (0.36%)  2
Retinal detachment  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Gastrointestinal disorders     
Abdominal adhesions  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Abdominal pain  1  8/294 (2.72%)  9 4/276 (1.45%)  4
Abdominal pain lower  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Abdominal pain upper  1  4/294 (1.36%)  4 0/276 (0.00%)  0
Ascites  1  4/294 (1.36%)  4 2/276 (0.72%)  2
Colitis  1  1/294 (0.34%)  1 3/276 (1.09%)  3
Constipation  1  5/294 (1.70%)  5 4/276 (1.45%)  4
Duodenal stenosis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Dyspepsia  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Dysphagia  1  2/294 (0.68%)  2 2/276 (0.72%)  2
Gastric haemorrhage  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Gastric hypomotility  1  0/294 (0.00%)  0 1/276 (0.36%)  2
Gastric stenosis  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Gastrointestinal haemorrhage  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Gastrointestinal perforation  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Haematemesis  1  0/294 (0.00%)  0 2/276 (0.72%)  2
Ileal perforation  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Ileus  1  4/294 (1.36%)  4 2/276 (0.72%)  2
Impaired gastric emptying  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Intestinal obstruction  1  1/294 (0.34%)  1 4/276 (1.45%)  7
Large intestinal obstruction  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Large intestine perforation  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Melaena  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Nausea  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Obstruction gastric  1  0/294 (0.00%)  0 2/276 (0.72%)  2
Oesophageal obstruction  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Oesophageal stenosis  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Pancreatic failure  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Pancreatitis  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Rectal haemorrhage  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Small intestinal obstruction  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Subileus  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Upper gastrointestinal haemorrhage  1  3/294 (1.02%)  3 1/276 (0.36%)  1
Vomiting  1  6/294 (2.04%)  6 2/276 (0.72%)  2
General disorders     
Asthenia  1  2/294 (0.68%)  2 1/276 (0.36%)  1
Complication associated with device  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Death  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Fatigue  1  2/294 (0.68%)  2 0/276 (0.00%)  0
General physical health deterioration  1  4/294 (1.36%)  4 0/276 (0.00%)  0
Influenza like illness  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Oedema peripheral  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Pyrexia  1  5/294 (1.70%)  7 4/276 (1.45%)  4
Hepatobiliary disorders     
Autoimmune hepatitis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Bile duct obstruction  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Bile duct stenosis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Cholangitis  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Cholecystitis acute  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Cholelithiasis  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Hepatitis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Hyperbilirubinaemia  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Jaundice cholestatic  1  2/294 (0.68%)  2 1/276 (0.36%)  1
Immune system disorders     
Hypersensitivity  1  0/294 (0.00%)  0 1/276 (0.36%)  3
Infections and infestations     
Aspergillus infection  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Bacteraemia  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Bacterial sepsis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Biliary sepsis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Enterobacter infection  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Escherichia infection  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Escherichia urinary tract infection  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Gastroenteritis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Infection  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Infective exacerbation of chronic obstructive airways disease  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Influenza  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Lower respiratory tract infection  1  1/294 (0.34%)  1 3/276 (1.09%)  3
Medical device site infection  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Otitis media  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Pneumonia  1  9/294 (3.06%)  9 7/276 (2.54%)  8
Pneumonia bacterial  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Pyelonephritis  1  1/294 (0.34%)  2 0/276 (0.00%)  0
Respiratory tract infection  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Sepsis  1  2/294 (0.68%)  2 3/276 (1.09%)  3
Septic shock  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Urinary tract infection  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Injury, poisoning and procedural complications     
Contusion  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Femoral neck fracture  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Hip fracture  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Humerus fracture  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Muscle strain  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Skin wound  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Toxicity to various agents  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Urinary tract stoma complication  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Wrist fracture  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Investigations     
Alanine aminotransferase increased  1  2/294 (0.68%)  2 1/276 (0.36%)  1
Aspartate aminotransferase increased  1  2/294 (0.68%)  2 1/276 (0.36%)  1
Aspiration bronchial  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Blood bilirubin increased  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Weight decreased  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Dehydration  1  4/294 (1.36%)  4 1/276 (0.36%)  1
Hypercalcaemia  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Hyperglycaemia  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Hypoglycaemia  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Hyponatraemia  1  2/294 (0.68%)  2 0/276 (0.00%)  0
Type 2 diabetes mellitus  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Muscle disorder  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to meninges  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Tumour pain  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Nervous system disorders     
Cerebral infarction  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Cerebral ischaemia  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Depressed level of consciousness  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Epilepsy  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Intracranial mass  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Product Issues     
Device dislocation  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Device occlusion  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Confusional state  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Panic disorder  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Renal and urinary disorders     
Acute kidney injury  1  3/294 (1.02%)  3 0/276 (0.00%)  0
Chronic kidney disease  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Dysuria  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Haematuria  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Hydronephrosis  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Nephrolithiasis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Renal failure  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Renal injury  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Urinary retention  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Urinary tract obstruction  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Dyspnoea  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Dyspnoea paroxysmal nocturnal  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Interstitial lung disease  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Pleural effusion  1  3/294 (1.02%)  3 1/276 (0.36%)  1
Pneumonia aspiration  1  3/294 (1.02%)  3 2/276 (0.72%)  3
Pneumonitis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Pneumothorax  1  0/294 (0.00%)  0 1/276 (0.36%)  1
Pulmonary embolism  1  1/294 (0.34%)  1 4/276 (1.45%)  4
Respiratory failure  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/294 (0.34%)  1 1/276 (0.36%)  1
Shock haemorrhagic  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Subclavian vein thrombosis  1  1/294 (0.34%)  1 0/276 (0.00%)  0
Vascular compression  1  0/294 (0.00%)  0 1/276 (0.36%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   255/294 (86.73%)      260/276 (94.20%)    
Blood and lymphatic system disorders     
Anaemia  1  43/294 (14.63%)  55 66/276 (23.91%)  84
Neutropenia  1  5/294 (1.70%)  5 31/276 (11.23%)  62
Endocrine disorders     
Hypothyroidism  1  21/294 (7.14%)  23 1/276 (0.36%)  1
Gastrointestinal disorders     
Abdominal distension  1  17/294 (5.78%)  17 12/276 (4.35%)  12
Abdominal pain  1  40/294 (13.61%)  42 49/276 (17.75%)  57
Abdominal pain upper  1  16/294 (5.44%)  20 16/276 (5.80%)  17
Ascites  1  19/294 (6.46%)  19 12/276 (4.35%)  14
Constipation  1  57/294 (19.39%)  63 53/276 (19.20%)  71
Diarrhoea  1  40/294 (13.61%)  42 72/276 (26.09%)  104
Dyspepsia  1  17/294 (5.78%)  17 11/276 (3.99%)  13
Dysphagia  1  19/294 (6.46%)  20 17/276 (6.16%)  22
Nausea  1  65/294 (22.11%)  76 77/276 (27.90%)  119
Stomatitis  1  7/294 (2.38%)  7 19/276 (6.88%)  22
Vomiting  1  49/294 (16.67%)  59 47/276 (17.03%)  65
General disorders     
Asthenia  1  30/294 (10.20%)  41 38/276 (13.77%)  63
Fatigue  1  77/294 (26.19%)  94 89/276 (32.25%)  132
Mucosal inflammation  1  2/294 (0.68%)  4 16/276 (5.80%)  19
Oedema peripheral  1  24/294 (8.16%)  25 29/276 (10.51%)  37
Pyrexia  1  32/294 (10.88%)  40 30/276 (10.87%)  38
Infections and infestations     
Nasopharyngitis  1  7/294 (2.38%)  9 17/276 (6.16%)  21
Investigations     
Alanine aminotransferase increased  1  18/294 (6.12%)  19 18/276 (6.52%)  26
Aspartate aminotransferase increased  1  24/294 (8.16%)  26 16/276 (5.80%)  22
Blood alkaline phosphatase increased  1  21/294 (7.14%)  21 9/276 (3.26%)  12
Neutrophil count decreased  1  2/294 (0.68%)  5 36/276 (13.04%)  71
Weight decreased  1  22/294 (7.48%)  23 17/276 (6.16%)  21
White blood cell count decreased  1  2/294 (0.68%)  5 19/276 (6.88%)  45
Metabolism and nutrition disorders     
Decreased appetite  1  75/294 (25.51%)  82 79/276 (28.62%)  99
Hypoalbuminaemia  1  19/294 (6.46%)  20 6/276 (2.17%)  7
Hypokalaemia  1  15/294 (5.10%)  17 10/276 (3.62%)  11
Musculoskeletal and connective tissue disorders     
Arthralgia  1  15/294 (5.10%)  18 21/276 (7.61%)  41
Back pain  1  33/294 (11.22%)  36 23/276 (8.33%)  29
Myalgia  1  9/294 (3.06%)  10 25/276 (9.06%)  31
Nervous system disorders     
Dizziness  1  14/294 (4.76%)  15 15/276 (5.43%)  18
Headache  1  10/294 (3.40%)  12 15/276 (5.43%)  20
Neuropathy peripheral  1  8/294 (2.72%)  8 42/276 (15.22%)  45
Peripheral sensory neuropathy  1  5/294 (1.70%)  5 37/276 (13.41%)  43
Psychiatric disorders     
Insomnia  1  16/294 (5.44%)  16 24/276 (8.70%)  27
Respiratory, thoracic and mediastinal disorders     
Cough  1  18/294 (6.12%)  18 28/276 (10.14%)  34
Dyspnoea  1  25/294 (8.50%)  28 19/276 (6.88%)  22
Skin and subcutaneous tissue disorders     
Alopecia  1  1/294 (0.34%)  1 116/276 (42.03%)  120
Pruritus  1  29/294 (9.86%)  29 18/276 (6.52%)  24
Rash  1  28/294 (9.52%)  32 22/276 (7.97%)  29
1
Term from vocabulary, MedDRA 20.1
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
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02370498     History of Changes
Other Study ID Numbers: 3475-061
2014-005241-45 ( EudraCT Number )
152988 ( Registry Identifier: JAPIC )
MK-3475-061 ( Other Identifier: Merck Protocol Number )
First Submitted: February 23, 2015
First Posted: February 25, 2015
Results First Submitted: October 22, 2018
Results First Posted: November 20, 2018
Last Update Posted: March 5, 2019