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Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)

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ClinicalTrials.gov Identifier: NCT02335424
Recruitment Status : Completed
First Posted : January 9, 2015
Results First Posted : July 5, 2019
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urothelial Cancer
Intervention Biological: pembrolizumab
Enrollment 374
Recruitment Details Participants were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, only data generated during the initial course of treatment contributed to efficacy and safety outcome measures.
Pre-assignment Details Results are based on a database cutoff date of 18-February-2022.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Period Title: Overall Study
Started 374
Treated 370
Received Second Course Treatment 13
Completed 0
Not Completed 374
Reason Not Completed
Withdrawal by Subject             19
Adverse Event             25
Death             273
Lost to Follow-up             3
Physician Decision             13
Participation in study terminated by Sponsor             39
Protocol Violation             1
Screen failure             1
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Baseline Participants 374
Hide Baseline Analysis Population Description
The baseline analysis population consisted of all allocated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 374 participants
73.0  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants
Female
86
  23.0%
Male
288
  77.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants
Hispanic or Latino
22
   5.9%
Not Hispanic or Latino
326
  87.2%
Unknown or Not Reported
26
   7.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants
American Indian or Alaska Native
2
   0.5%
Asian
26
   7.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   2.1%
White
332
  88.8%
More than one race
2
   0.5%
Unknown or Not Reported
4
   1.1%
1.Primary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
28.9
(24.3 to 33.8)
2.Primary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
32.6
(27.2 to 38.4)
3.Primary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.3
(37.7 to 57.0)
4.Secondary Outcome
Title Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and who had a confirmed CR or confirmed PR.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 107
Median (95% Confidence Interval)
Unit of Measure: Months
33.4
(18.2 to 48.7)
5.Secondary Outcome
Title Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment, had a PD-L1 positive expression of ≥1% CPS, and who had a confirmed CR or PR.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 92
Median (95% Confidence Interval)
Unit of Measure: Months
35.8 [1] 
(20.4 to NA)
[1]
NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
6.Secondary Outcome
Title Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death and was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment, had a PD-L1 strong positive expression of ≥10% CPS, and who had a confirmed CR or PR.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(18.1 to NA)
[1]
NA = median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
7.Secondary Outcome
Title Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description PFS was determined in all participants. 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 as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Median (95% Confidence Interval)
Unit of Measure: Months
2.5
(2.1 to 3.4)
8.Secondary Outcome
Title Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. 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 as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Median (95% Confidence Interval)
Unit of Measure: Months
3.4
(2.3 to 4.0)
9.Secondary Outcome
Title Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description PFS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. 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 as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Median (95% Confidence Interval)
Unit of Measure: Months
4.9
(3.8 to 10.8)
10.Secondary Outcome
Title Overall Survival (OS) in All Participants
Hide Description OS was determined for all participants and was defined as the time from randomization to death due to any cause. OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Median (95% Confidence Interval)
Unit of Measure: Months
11.3
(9.7 to 13.1)
11.Secondary Outcome
Title Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description OS was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Median (95% Confidence Interval)
Unit of Measure: Months
12.4
(10.8 to 15.0)
12.Secondary Outcome
Title Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description OS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Median (95% Confidence Interval)
Unit of Measure: Months
18.5
(12.2 to 28.5)
13.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 6 in All Participants
Hide Description The PFS rate was determined in all participants at Month 6. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.0
(29.2 to 38.8)
14.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
37.9
(32.2 to 43.5)
15.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
49.0
(39.4 to 57.9)
16.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants
Hide Description The PFS rate was determined in all participants at Month 12. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
22.9
(18.7 to 27.3)
17.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
25.8
(20.8 to 31.1)
18.Secondary Outcome
Title Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Per RECIST 1.1, PD was a ≥20% increase in the sum of diameters of target lesions plus an absolute increase of ≥5 mm in the sum, or the appearance of ≥1 new lesions. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. PFS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
38.6
(29.5 to 47.7)
19.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 6 in All Participants
Hide Description The OS rate was determined for all participants at Month 6 and was defined as the time from randomization to death due to any cause. OS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
67.0
(62.0 to 71.5)
20.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. OS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
71.3
(65.6 to 76.2)
21.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. OS at Month 6 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
76.3
(67.2 to 83.2)
22.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 12 in All Participants
Hide Description The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. OS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
46.9
(41.8 to 51.9)
23.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. OS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.9
(45.0 to 56.6)
24.Secondary Outcome
Title Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. OS at Month 12 was calculated using product-limit (Kaplan-Meier) method for censored data. Participants were censored at the date of their last assessment. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 strong positive expression of ≥10% CPS.
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.7
(50.9 to 69.1)
25.Secondary Outcome
Title Programmed Cell Death Ligand 1 (PD-L1) Expression Status
Hide Description PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of <1% = negative; ≥1% = positive; and ≥10% = strongly positive. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Count of Participants
Unit of Measure: Participants
PD-L1 CPS <1%
79
  21.4%
PD-L1 CPS ≥1% to <10%
172
  46.5%
PD-L1 CPS ≥10%
110
  29.7%
Unknown
9
   2.4%
26.Secondary Outcome
Title Number of Participants Who Experienced At Least One Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Count of Participants
Unit of Measure: Participants
361
  97.6%
27.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Count of Participants
Unit of Measure: Participants
62
  16.8%
28.Other Pre-specified Outcome
Title Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in All Participants
Hide Description ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment during the initial course of treatment
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.5
(25.9 to 35.5)
29.Other Pre-specified Outcome
Title Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%
Hide Description ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥1% CPS
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.4
(28.9 to 40.3)
30.Other Pre-specified Outcome
Title Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%
Hide Description ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
Time Frame Up to approximately 80.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment, during the initial course of treatment, and had a PD-L1 positive expression of ≥10% CPS
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
49.1
(39.4 to 58.8)
Time Frame Up to approximately 80.5 months
Adverse Event Reporting Description Adverse events=all participants who received ≥1 dose of study treatment; all-cause mortality=all allocated participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" & "Disease progression" not related to study drug are excluded as AEs.
 
Arm/Group Title Pembrolizumab Second Course Pembrolizumab
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year. Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment.
All-Cause Mortality
Pembrolizumab Second Course Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   305/374 (81.55%)      8/13 (61.54%)    
Hide Serious Adverse Events
Pembrolizumab Second Course Pembrolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   190/370 (51.35%)      6/13 (46.15%)    
Blood and lymphatic system disorders     
Anaemia † 1  6/370 (1.62%)  6 0/13 (0.00%)  0
Febrile neutropenia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Immune thrombocytopenia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Cardiac disorders     
Acute left ventricular failure † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Acute myocardial infarction † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Angina pectoris † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Atrial fibrillation † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Atrioventricular block † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Ischaemic cardiomyopathy † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Myocardial infarction † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Myocarditis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Pericarditis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Supraventricular tachycardia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Endocrine disorders     
Addison's disease † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Adrenal insufficiency † 1  5/370 (1.35%)  5 0/13 (0.00%)  0
Hypophysitis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypopituitarism † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Thyroiditis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
Ascites † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Colitis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Constipation † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Diarrhoea † 1  5/370 (1.35%)  5 1/13 (7.69%)  1
Duodenal obstruction † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Gastrointestinal haemorrhage † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Gastrointestinal motility disorder † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Ileus † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Intestinal ischaemia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Intestinal obstruction † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Large intestinal obstruction † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Large intestine perforation † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Nausea † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Pancreatitis acute † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Proctitis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Rectal haemorrhage † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Small intestinal obstruction † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Vomiting † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
General disorders     
Asthenia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Cardiac complication associated with device † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Death † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Fatigue † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
General physical health deterioration † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Multiple organ dysfunction syndrome † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Oedema peripheral † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Pyrexia † 1  5/370 (1.35%)  5 0/13 (0.00%)  0
Hepatobiliary disorders     
Autoimmune hepatitis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Cholecystitis † 1  1/370 (0.27%)  2 0/13 (0.00%)  0
Drug-induced liver injury † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hepatitis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Liver injury † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Infections and infestations     
Abscess neck † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Acute sinusitis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Atypical pneumonia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Bronchitis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Candida infection † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Cellulitis † 1  3/370 (0.81%)  3 1/13 (7.69%)  1
Clostridium difficile infection † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Diverticulitis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Escherichia sepsis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Gastroenteritis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Infected skin ulcer † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Influenza † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Kidney infection † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Lower respiratory tract infection † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Pneumonia † 1  15/370 (4.05%)  15 1/13 (7.69%)  1
Pyelonephritis † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Pyelonephritis acute † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Renal abscess † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Respiratory tract infection † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Sepsis † 1  9/370 (2.43%)  9 0/13 (0.00%)  0
Septic shock † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Upper respiratory tract infection † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Urinary tract infection † 1  26/370 (7.03%)  31 0/13 (0.00%)  0
Urosepsis † 1  14/370 (3.78%)  14 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Fall † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Femur fracture † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Incisional hernia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Injury † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Intentional overdose † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Overdose † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Stoma obstruction † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Urinary tract stoma complication † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Urostomy complication † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Aspartate aminotransferase increased † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Blood creatinine increased † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Diabetic ketoacidosis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Gout † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypercalcaemia † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Hyperkalaemia † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Hyperuricaemia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypocalcaemia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypoglycaemia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hyponatraemia † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Ketoacidosis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Type 1 diabetes mellitus † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Type 2 diabetes mellitus † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Autoimmune arthritis † 1  1/370 (0.27%)  2 0/13 (0.00%)  0
Back pain † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Bone pain † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Crystal arthropathy † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Muscular weakness † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Musculoskeletal pain † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Myositis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain † 1  4/370 (1.08%)  4 0/13 (0.00%)  0
Lymphoma † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Malignant melanoma in situ † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Malignant neoplasm progression † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Metastases to central nervous system † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Plasma cell myeloma † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Squamous cell carcinoma † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Tumour associated fever † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Tumour pain † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Nervous system disorders     
Central nervous system haemorrhage † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Cerebrovascular accident † 1  3/370 (0.81%)  3 2/13 (15.38%)  2
Encephalopathy † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Facial paralysis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Spinal cord compression † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Syncope † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Transient ischaemic attack † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Product Issues     
Device occlusion † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Psychiatric disorders     
Delirium † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Panic attack † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury † 1  13/370 (3.51%)  14 1/13 (7.69%)  1
Chronic kidney disease † 1  3/370 (0.81%)  3 0/13 (0.00%)  0
Haematuria † 1  12/370 (3.24%)  13 0/13 (0.00%)  0
Hydronephrosis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Renal failure † 1  5/370 (1.35%)  5 0/13 (0.00%)  0
Tubulointerstitial nephritis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Urinary incontinence † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Urinary retention † 1  5/370 (1.35%)  5 0/13 (0.00%)  0
Urinary tract obstruction † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Dyspnoea † 1  5/370 (1.35%)  5 0/13 (0.00%)  0
Emphysema † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Hypoxia † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Pleural effusion † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Pneumonitis † 1  6/370 (1.62%)  6 0/13 (0.00%)  0
Pneumothorax † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Pulmonary embolism † 1  3/370 (0.81%)  4 0/13 (0.00%)  0
Respiratory failure † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash pruritic † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Vascular disorders     
Angiopathy † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Deep vein thrombosis † 1  2/370 (0.54%)  2 0/13 (0.00%)  0
Embolism † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypertensive crisis † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
Hypovolaemic shock † 1  1/370 (0.27%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab Second Course Pembrolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   342/370 (92.43%)      12/13 (92.31%)    
Blood and lymphatic system disorders     
Anaemia † 1  73/370 (19.73%)  84 3/13 (23.08%)  3
Ear and labyrinth disorders     
Ear swelling † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Endocrine disorders     
Hypothyroidism † 1  42/370 (11.35%)  42 1/13 (7.69%)  1
Eye disorders     
Diplopia † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Abdominal pain † 1  47/370 (12.70%)  57 1/13 (7.69%)  1
Abdominal pain lower † 1  6/370 (1.62%)  6 1/13 (7.69%)  1
Ascites † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Constipation † 1  87/370 (23.51%)  100 3/13 (23.08%)  3
Diarrhoea † 1  82/370 (22.16%)  121 0/13 (0.00%)  0
Dry mouth † 1  23/370 (6.22%)  23 0/13 (0.00%)  0
Nausea † 1  77/370 (20.81%)  89 1/13 (7.69%)  1
Vomiting † 1  56/370 (15.14%)  79 0/13 (0.00%)  0
General disorders     
Asthenia † 1  44/370 (11.89%)  49 0/13 (0.00%)  0
Chest pain † 1  20/370 (5.41%)  22 0/13 (0.00%)  0
Chills † 1  27/370 (7.30%)  31 0/13 (0.00%)  0
Fatigue † 1  129/370 (34.86%)  156 0/13 (0.00%)  0
Influenza like illness † 1  19/370 (5.14%)  21 0/13 (0.00%)  0
Oedema † 1  6/370 (1.62%)  6 1/13 (7.69%)  1
Oedema peripheral † 1  63/370 (17.03%)  74 1/13 (7.69%)  1
Peripheral swelling † 1  7/370 (1.89%)  7 1/13 (7.69%)  1
Pyrexia † 1  51/370 (13.78%)  64 0/13 (0.00%)  0
Hepatobiliary disorders     
Hepatitis acute † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations     
Nasopharyngitis † 1  16/370 (4.32%)  17 1/13 (7.69%)  1
Tooth infection † 1  2/370 (0.54%)  3 1/13 (7.69%)  1
Upper respiratory tract infection † 1  19/370 (5.14%)  23 0/13 (0.00%)  0
Urinary tract infection † 1  76/370 (20.54%)  98 1/13 (7.69%)  1
Injury, poisoning and procedural complications     
Fall † 1  22/370 (5.95%)  26 0/13 (0.00%)  0
Stoma site haemorrhage † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Investigations     
Alanine aminotransferase increased † 1  27/370 (7.30%)  31 0/13 (0.00%)  0
Aspartate aminotransferase increased † 1  27/370 (7.30%)  31 0/13 (0.00%)  0
Blood alkaline phosphatase increased † 1  27/370 (7.30%)  30 0/13 (0.00%)  0
Blood creatinine increased † 1  53/370 (14.32%)  67 0/13 (0.00%)  0
Inspiratory capacity decreased † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Weight decreased † 1  44/370 (11.89%)  47 2/13 (15.38%)  2
White blood cell count decreased † 1  2/370 (0.54%)  2 1/13 (7.69%)  1
Metabolism and nutrition disorders     
Decreased appetite † 1  102/370 (27.57%)  116 1/13 (7.69%)  1
Dehydration † 1  19/370 (5.14%)  19 0/13 (0.00%)  0
Hyperglycaemia † 1  37/370 (10.00%)  51 1/13 (7.69%)  1
Hyperkalaemia † 1  24/370 (6.49%)  29 1/13 (7.69%)  1
Hypoalbuminaemia † 1  19/370 (5.14%)  26 0/13 (0.00%)  0
Hypokalaemia † 1  14/370 (3.78%)  20 1/13 (7.69%)  1
Hyponatraemia † 1  41/370 (11.08%)  53 0/13 (0.00%)  0
Type 2 diabetes mellitus † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  54/370 (14.59%)  74 0/13 (0.00%)  0
Back pain † 1  47/370 (12.70%)  55 1/13 (7.69%)  1
Joint stiffness † 1  3/370 (0.81%)  3 1/13 (7.69%)  1
Muscular weakness † 1  26/370 (7.03%)  29 0/13 (0.00%)  0
Myalgia † 1  20/370 (5.41%)  22 0/13 (0.00%)  0
Neck pain † 1  5/370 (1.35%)  5 1/13 (7.69%)  1
Pain in extremity † 1  30/370 (8.11%)  31 0/13 (0.00%)  0
Vertebral lesion † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Nervous system disorders     
Cognitive disorder † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Dizziness † 1  35/370 (9.46%)  41 2/13 (15.38%)  2
Headache † 1  20/370 (5.41%)  23 1/13 (7.69%)  1
Psychiatric disorders     
Insomnia † 1  29/370 (7.84%)  29 0/13 (0.00%)  0
Renal and urinary disorders     
Haematuria † 1  53/370 (14.32%)  63 0/13 (0.00%)  0
Pollakiuria † 1  16/370 (4.32%)  16 1/13 (7.69%)  1
Proteinuria † 1  21/370 (5.68%)  23 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis † 1  3/370 (0.81%)  3 1/13 (7.69%)  1
Cough † 1  76/370 (20.54%)  92 1/13 (7.69%)  1
Dyspnoea † 1  48/370 (12.97%)  57 1/13 (7.69%)  1
Emphysema † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Nasal congestion † 1  12/370 (3.24%)  14 1/13 (7.69%)  1
Pleural effusion † 1  12/370 (3.24%)  15 1/13 (7.69%)  1
Productive cough † 1  17/370 (4.59%)  19 1/13 (7.69%)  2
Skin and subcutaneous tissue disorders     
Pruritus † 1  87/370 (23.51%)  114 1/13 (7.69%)  1
Rash † 1  59/370 (15.95%)  83 0/13 (0.00%)  0
Stasis dermatitis † 1  0/370 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders     
Hypertension † 1  20/370 (5.41%)  21 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, Plimack ER, Hahn NM, de Wit R, Pang L, Savage MJ, Perini RF, Keefe SM, Bajorin D, Bellmunt J. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Nov;18(11):1483-1492. doi: 10.1016/S1470-2045(17)30616-2. Epub 2017 Sep 26.
Vuky J, Balar AV, Castellano D, O'Donnell PH, Grivas P, Bellmunt J, Powles T, Bajorin D, Hahn NM, Savage MJ, Fang X, Godwin JL, Frenkl TL, Homet Moreno B, de Wit R, Plimack ER. Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2020 Aug 10;38(23):2658-2666. doi: 10.1200/JCO.19.01213. Epub 2020 Jun 17.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT02335424    
Other Study ID Numbers: 3475-052
MK-3475-052 ( Other Identifier: Merck Protocol Number )
KEYNOTE-052 ( Other Identifier: Merck )
2014-002206-20 ( EudraCT Number )
First Submitted: January 7, 2015
First Posted: January 9, 2015
Results First Submitted: May 29, 2019
Results First Posted: July 5, 2019
Last Update Posted: March 2, 2023