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Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255097
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : July 6, 2017
Last Update Posted : June 28, 2022
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 Head and Neck Squamous Cell Carcinoma
Intervention Biological: pembrolizumab
Enrollment 172
Recruitment Details Participants were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, response or progression during the second course of pembrolizumab was not counted towards efficacy outcome measures and adverse events during the second course of pembrolizumab were not counted towards safety outcome measures.
Pre-assignment Details

Final analyses for all primary outcome measures were done at the protocol-specified primary outcome measure met date. The analyses for all secondary outcome measures and the collection of adverse events were updated at the end of study date.

One participant allocated to receive pembrolizumab did not receive treatment. This participant was not eligible for safety or efficacy analysis.

Arm/Group Title Pembrolizumab
Hide Arm/Group Description Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Period Title: Overall Study
Started 172
Treated 171
Received Second Course of Pembrolizumab 3
Completed 0
Not Completed 172
Reason Not Completed
Death             151
Lost to Follow-up             5
Participation in Study Discontinued by Sponsor             8
Withdrawal by Subject             7
Allocated but not treated             1
Arm/Group Title Pembrolizumab
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Baseline Participants 172
Hide Baseline Analysis Population Description
The baseline population included all participants allocated to receive ≥1 dose of pembrolizumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants
61.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Female
34
  19.8%
Male
138
  80.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Hispanic or Latino
9
   5.2%
Not Hispanic or Latino
153
  89.0%
Unknown or Not Reported
10
   5.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
American Indian or Alaska Native
1
   0.6%
Asian
7
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
   6.4%
White
153
  89.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
≥50%
44
  25.6%
≥1 - <50%
77
  44.8%
<1%
46
  26.7%
Unknown
5
   2.9%
[1]
Measure Description: Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and <1% = PD-L1 negative.
1.Primary Outcome
Title Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description ORR was assessed by RECIST 1.1 by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
16.4
(11.2 to 22.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p > 0.05
2.Primary Outcome
Title Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a strong PD-L1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD-L1 was determined by immunohistochemistry (IHC) and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
27.3
(15.0 to 42.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
3.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product, whether or not considered related to the product. Worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, or was another important medical event. Per protocol, analysis for this outcome measure was planned to be performed during the initial (first) course of therapy only.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: Participants
166
4.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product, whether or not considered related to the product. Worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, or was another important medical event. Per protocol, analysis for this outcome measure was planned to be performed during the initial (first) course of therapy only.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: Participants
24
5.Secondary Outcome
Title Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a positive PD-L1 expression status were evaluated for ORR by RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥1%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
18.2
(11.8 to 26.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
6.Secondary Outcome
Title Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Human Papillomavirus (HPV) Positive Tumors
Hide Description Participants with a HPV-positive tumor biopsy were evaluated for ORR by RECIST 1.1. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a HPV-positive tumor
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.1
(7.0 to 24.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
7.Secondary Outcome
Title Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description ORR was assessed by modified RECIST 1.1 by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
16.4
(11.2 to 22.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
8.Secondary Outcome
Title Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a positive PD-L1 expression status were evaluated for ORR by modified RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a tumor proportion score ≥1%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥1%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
18.2
(11.8 to 26.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
9.Secondary Outcome
Title Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a strong positive PD-L1 expression status were evaluated for ORR by modified RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a tumor proportion score ≥50%. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
27.3
(15.0 to 42.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab
Comments Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method exact binomial distribution
Comments H0: p ≤ 0.05 versus H1: p > 0.05
10.Secondary Outcome
Title Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description DOR was based on RECIST 1.1 and measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a best overall response as confirmed complete response or partial response
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 28
Median (Full Range)
Unit of Measure: Months
15.7 [1] 
(2.8 to NA)
[1]
NA=Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
11.Secondary Outcome
Title Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a positive PD-L1 expression status were evaluated for DOR based on RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a combined positive score ≥1% and a best overall response as confirmed complete response or partial response
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 25
Median (Full Range)
Unit of Measure: Months
15.7 [1] 
(2.8 to NA)
[1]
NA=Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
12.Secondary Outcome
Title Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a strong PD-L1 expression status were evaluated for DOR based n RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥50% and a best overall response as confirmed complete response or partial response
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Months
22.8 [1] 
(4.2 to NA)
[1]
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
13.Secondary Outcome
Title Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Hide Description PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.1 to 2.1)
14.Secondary Outcome
Title Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a positive PD-L1 expression status were evaluated for PFS. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a combined positive score ≥1%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 141
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(2.0 to 2.1)
15.Secondary Outcome
Title Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a strong PD-L1 expression status were evaluated for PFS by modified RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(1.8 to 3.6)
16.Secondary Outcome
Title Overall Survival (OS) in All Participants
Hide Description OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
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Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 171
Median (95% Confidence Interval)
Unit of Measure: Months
8.5
(6.6 to 11.1)
17.Secondary Outcome
Title Overall Survival (OS) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a positive PD-L1 expression status were evaluated for OS. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
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Hide Analysis Population Description
All participants who received at least one dose of study treatment with a combined positive score ≥1%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 141
Median (95% Confidence Interval)
Unit of Measure: Months
9.0
(6.2 to 11.8)
18.Secondary Outcome
Title Overall Survival (OS) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
Hide Description Participants with a strong PD-L1 expression status were evaluated for OS. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Time Frame Up to 76.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Arm/Group Title Pembrolizumab
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: Months
6.9
(4.0 to 11.8)
Time Frame First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
Adverse Event Reporting Description All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
 
Arm/Group Title Pembrolizumab Pembrolizumab Second Course
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment. Participants who met the criteria for re-treatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 1 year of treatment.
All-Cause Mortality
Pembrolizumab Pembrolizumab Second Course
Affected / at Risk (%) Affected / at Risk (%)
Total   153/172 (88.95%)      2/3 (66.67%)    
Hide Serious Adverse Events
Pembrolizumab Pembrolizumab Second Course
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/171 (50.88%)      1/3 (33.33%)    
Blood and lymphatic system disorders     
Anaemia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Febrile neutropenia  1  0/171 (0.00%)  0 1/3 (33.33%)  1
Neutropenia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Atrial fibrillation  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Cardiac arrest  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Myocardial infarction  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Pericardial effusion  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hyperthyroidism  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Constipation  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Diarrhoea  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Dysphagia  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Impaired gastric emptying  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Mouth haemorrhage  1  1/171 (0.58%)  2 0/3 (0.00%)  0
Nausea  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Pancreatitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Salivary duct inflammation  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Vomiting  1  1/171 (0.58%)  1 0/3 (0.00%)  0
General disorders     
Chills  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Death  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Facial pain  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Malaise  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Oedema peripheral  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Pyrexia  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Swelling face  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Systemic inflammatory response syndrome  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hepatitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Infections and infestations     
Cellulitis  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Clostridium difficile colitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Empyema  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Endocarditis bacterial  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Osteomyelitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Pneumonia  1  15/171 (8.77%)  18 0/3 (0.00%)  0
Pneumonia escherichia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Pneumonia staphylococcal  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Pseudomonas infection  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Sepsis  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Septic shock  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Soft tissue infection  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Staphylococcal bacteraemia  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Staphylococcal sepsis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Tracheitis  1  1/171 (0.58%)  2 0/3 (0.00%)  0
Tracheobronchitis  1  1/171 (0.58%)  1 1/3 (33.33%)  1
Urinary tract infection  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Vascular device infection  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Wound infection  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Gastrointestinal stoma complication  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Post procedural haemorrhage  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Radiation oesophagitis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Subdural haematoma  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Tracheal obstruction  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Traumatic fracture  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Investigations     
Clostridium test positive  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Decreased appetite  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Dehydration  1  5/171 (2.92%)  6 0/3 (0.00%)  0
Diabetes mellitus  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Diabetic ketoacidosis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hypercalcaemia  1  5/171 (2.92%)  5 0/3 (0.00%)  0
Hyperkalaemia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hypernatraemia  1  1/171 (0.58%)  2 0/3 (0.00%)  0
Hypoglycaemia  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Hypokalaemia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hyponatraemia  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Type 1 diabetes mellitus  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Muscular weakness  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Neck pain  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Appendix cancer  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Basal cell carcinoma  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Cancer pain  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Infected neoplasm  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Keratoacanthoma  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Malignant melanoma  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Squamous cell carcinoma of skin  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Tumour associated fever  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Nervous system disorders     
Altered state of consciousness  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Amyotrophic lateral sclerosis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Cerebral haemorrhage  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Cerebrovascular accident  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Cranial nerve paralysis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Depressed level of consciousness  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Dizziness  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Headache  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Seizure  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Spinal cord compression  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Syncope  1  4/171 (2.34%)  4 0/3 (0.00%)  0
Product Issues     
Device dislocation  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Mental status changes  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Aspiration  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Dyspnoea  1  2/171 (1.17%)  3 0/3 (0.00%)  0
Haemoptysis  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Hypoxia  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Increased upper airway secretion  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Laryngeal haemorrhage  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Pleural effusion  1  4/171 (2.34%)  4 0/3 (0.00%)  0
Pneumonia aspiration  1  8/171 (4.68%)  8 0/3 (0.00%)  0
Pneumonitis  1  3/171 (1.75%)  3 0/3 (0.00%)  0
Pneumothorax  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Pulmonary embolism  1  4/171 (2.34%)  4 0/3 (0.00%)  0
Respiratory failure  1  2/171 (1.17%)  2 0/3 (0.00%)  0
Stridor  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/171 (0.58%)  1 0/3 (0.00%)  0
Hypotension  1  1/171 (0.58%)  1 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab Pembrolizumab Second Course
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/171 (92.40%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  32/171 (18.71%)  35 0/3 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  32/171 (18.71%)  34 0/3 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  9/171 (5.26%)  13 0/3 (0.00%)  0
Constipation  1  42/171 (24.56%)  46 1/3 (33.33%)  1
Diarrhoea  1  24/171 (14.04%)  38 0/3 (0.00%)  0
Dry mouth  1  12/171 (7.02%)  12 0/3 (0.00%)  0
Dysphagia  1  23/171 (13.45%)  24 0/3 (0.00%)  0
Lip dry  1  0/171 (0.00%)  0 1/3 (33.33%)  1
Mouth haemorrhage  1  1/171 (0.58%)  1 1/3 (33.33%)  1
Nausea  1  34/171 (19.88%)  37 0/3 (0.00%)  0
Vomiting  1  15/171 (8.77%)  15 0/3 (0.00%)  0
General disorders     
Fatigue  1  67/171 (39.18%)  71 0/3 (0.00%)  0
Oedema peripheral  1  11/171 (6.43%)  13 0/3 (0.00%)  0
Pyrexia  1  10/171 (5.85%)  11 0/3 (0.00%)  0
Infections and infestations     
Herpes zoster  1  2/171 (1.17%)  2 1/3 (33.33%)  1
Pneumonia  1  12/171 (7.02%)  15 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  9/171 (5.26%)  10 0/3 (0.00%)  0
Stoma site erythema  1  0/171 (0.00%)  0 1/3 (33.33%)  1
Investigations     
Alanine aminotransferase increased  1  11/171 (6.43%)  13 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  19/171 (11.11%)  20 0/3 (0.00%)  0
Blood alkaline phosphatase increased  1  9/171 (5.26%)  9 1/3 (33.33%)  1
Lymphocyte count decreased  1  10/171 (5.85%)  10 0/3 (0.00%)  0
Weight decreased  1  33/171 (19.30%)  33 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  30/171 (17.54%)  36 0/3 (0.00%)  0
Dehydration  1  16/171 (9.36%)  20 0/3 (0.00%)  0
Hypercalcaemia  1  13/171 (7.60%)  15 0/3 (0.00%)  0
Hyperglycaemia  1  14/171 (8.19%)  23 0/3 (0.00%)  0
Hypoalbuminaemia  1  11/171 (6.43%)  16 1/3 (33.33%)  1
Hypocalcaemia  1  11/171 (6.43%)  13 0/3 (0.00%)  0
Hypoglycaemia  1  1/171 (0.58%)  2 1/3 (33.33%)  1
Hypokalaemia  1  11/171 (6.43%)  16 0/3 (0.00%)  0
Hypomagnesaemia  1  14/171 (8.19%)  17 0/3 (0.00%)  0
Hyponatraemia  1  29/171 (16.96%)  41 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  27/171 (15.79%)  33 0/3 (0.00%)  0
Back pain  1  9/171 (5.26%)  9 0/3 (0.00%)  0
Myalgia  1  13/171 (7.60%)  13 0/3 (0.00%)  0
Neck pain  1  13/171 (7.60%)  14 0/3 (0.00%)  0
Nervous system disorders     
Dizziness  1  18/171 (10.53%)  21 0/3 (0.00%)  0
Headache  1  20/171 (11.70%)  20 0/3 (0.00%)  0
Neuropathy peripheral  1  9/171 (5.26%)  9 0/3 (0.00%)  0
Psychiatric disorders     
Depression  1  7/171 (4.09%)  7 1/3 (33.33%)  1
Insomnia  1  18/171 (10.53%)  19 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/171 (22.22%)  39 0/3 (0.00%)  0
Dyspnoea  1  23/171 (13.45%)  26 1/3 (33.33%)  1
Rhinitis allergic  1  2/171 (1.17%)  2 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  2/171 (1.17%)  2 1/3 (33.33%)  1
Dermatitis acneiform  1  4/171 (2.34%)  4 1/3 (33.33%)  1
Pruritus  1  14/171 (8.19%)  14 0/3 (0.00%)  0
Psoriasis  1  0/171 (0.00%)  0 1/3 (33.33%)  1
Rash  1  17/171 (9.94%)  20 0/3 (0.00%)  0
Rash maculo-papular  1  6/171 (3.51%)  7 1/3 (33.33%)  1
Vascular disorders     
Hypertension  1  11/171 (6.43%)  17 0/3 (0.00%)  0
Hypotension  1  16/171 (9.36%)  17 0/3 (0.00%)  0
Lymphoedema  1  2/171 (1.17%)  2 1/3 (33.33%)  1
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this 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
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT02255097    
Other Study ID Numbers: 3475-055
2014-002447-18 ( EudraCT Number )
First Submitted: September 30, 2014
First Posted: October 2, 2014
Results First Submitted: April 20, 2017
Results First Posted: July 6, 2017
Last Update Posted: June 28, 2022