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Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)

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ClinicalTrials.gov Identifier: NCT02460198
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : August 21, 2020
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Carcinoma
Intervention Biological: Pembrolizumab
Enrollment 124
Recruitment Details This study was conducted at 34 clinical sites in 10 countries.
Pre-assignment Details Participant flow as per the database cutoff date of 19FEB2021.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment. Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
Period Title: Overall Study
Started 61 63
Completed 0 0
Not Completed 61 63
Reason Not Completed
Adverse Event             1             3
Death             36             28
Lost to Follow-up             1             1
Transferred to Extension Study             15             15
Withdrawal by Subject             2             4
Site Terminated By Sponsor             0             1
Did Not Continue on Extension Study             6             11
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg Total
Hide Arm/Group Description Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment. Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment. Total of all reporting groups
Overall Number of Baseline Participants 61 63 124
Hide Baseline Analysis Population Description
The analysis population included all randomized and treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 63 participants 124 participants
54.3  (14.5) 57.8  (15.2) 56.1  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Female
25
  41.0%
30
  47.6%
55
  44.4%
Male
36
  59.0%
33
  52.4%
69
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Hispanic or Latino
1
   1.6%
3
   4.8%
4
   3.2%
Not Hispanic or Latino
59
  96.7%
60
  95.2%
119
  96.0%
Unknown or Not Reported
1
   1.6%
0
   0.0%
1
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
19
  31.1%
14
  22.2%
33
  26.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
7
  11.1%
7
   5.6%
White
42
  68.9%
42
  66.7%
84
  67.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor
Hide Description Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019.
Time Frame Up to approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
32.8
(21.3 to 46.0)
34.9
(23.3 to 48.0)
2.Secondary Outcome
Title Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor.
Hide Description Disease Control Rate was defined as the percentage of participants who achieved confirmed CR or PR or had demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. or the appearance of new lesion(s). Participants in the analysis population with missing DCR were considered as disease not under control. The data cutoff date was 19-Feb-2021.
Time Frame Up to approximately 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.8
(37.7 to 63.9)
55.6
(42.5 to 68.1)
3.Secondary Outcome
Title Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor.
Hide Description PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). PFS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
Time Frame Up to approximately 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Median (95% Confidence Interval)
Unit of Measure: Months
2.3
(2.1 to 8.1)
4.1
(2.1 to 18.9)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
Time Frame Up to approximately 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Median (95% Confidence Interval)
Unit of Measure: Months
31.4
(21.4 to 58)
47 [1] 
(19.2 to NA)
[1]
NA = OS upper limit was not reached (insufficient number of deaths by time of last disease assessment).
5.Secondary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE).
Hide Description An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time Frame Up to approximately 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Measure Type: Count of Participants
Unit of Measure: Participants
60
  98.4%
63
 100.0%
6.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an AE.
Hide Description An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time Frame Up to approximately 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 61 63
Measure Type: Count of Participants
Unit of Measure: Participants
5
   8.2%
5
   7.9%
7.Secondary Outcome
Title Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor
Hide Description For participants who demonstrated a CR or PR, duration of response was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. Duration of Response was based on Independent radiologist review (IRC) using RECIST 1.1 and was summarized by Kaplan-Meier (KM) methods for censored data. Nonresponders were excluded from the analysis of DOR.
Time Frame Up to approximately 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study treatment and demonstrated a CR or PR.
Arm/Group Title Cohort A - Pembrolizumab 200 mg Cohort B - Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
Overall Number of Participants Analyzed 20 22
Median (Full Range)
Unit of Measure: Months
NA [1] 
(6.2 to NA)
NA [1] 
(4.4 to NA)
[1]
NA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
Time Frame Up to approximately 66 months
Adverse Event Reporting Description Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
 
Arm/Group Title Cohort A First Course Cohort B First Course Cohort A Second Course Cohort B Second Course
Hide Arm/Group Description Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years). Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years). Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment. Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
All-Cause Mortality
Cohort A First Course Cohort B First Course Cohort A Second Course Cohort B Second Course
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/61 (62.30%)      31/63 (49.21%)      0/6 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Cohort A First Course Cohort B First Course Cohort A Second Course Cohort B Second Course
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/61 (50.82%)      25/63 (39.68%)      1/6 (16.67%)      1/3 (33.33%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Thrombocytopenia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Cardiac disorders         
Acute myocardial infarction † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Sinus bradycardia † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Eye disorders         
Cataract † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Corneal decompensation † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Rhegmatogenous retinal detachment † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain † 1  3/61 (4.92%)  3 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain upper † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Colitis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Diarrhoea † 1  0/61 (0.00%)  0 2/63 (3.17%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Duodenal ulcer † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Enteritis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Enterocolitis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Enterocutaneous fistula † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastric fistula † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal fistula † 1  0/61 (0.00%)  0 1/63 (1.59%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Ileus † 1  3/61 (4.92%)  7 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Incarcerated umbilical hernia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Intestinal obstruction † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Lower gastrointestinal haemorrhage † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Nausea † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pancreatitis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Pneumatosis intestinalis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Small intestinal obstruction † 1  1/61 (1.64%)  1 3/63 (4.76%)  5 0/6 (0.00%)  0 0/3 (0.00%)  0
Subileus † 1  1/61 (1.64%)  3 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Upper gastrointestinal haemorrhage † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vomiting † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
General disorders         
Euthanasia † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
General physical health deterioration † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Generalised oedema † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pyrexia † 1  2/61 (3.28%)  2 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hepatobiliary disorders         
Biloma † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Cholecystitis acute † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Cholelithiasis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hyperbilirubinaemia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Abdominal infection † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal wall abscess † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Bacteraemia † 1  0/61 (0.00%)  0 1/63 (1.59%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Bacterial pyelonephritis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Bronchitis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Device related infection † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Influenza † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Klebsiella sepsis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pneumonia † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Sepsis † 1  1/61 (1.64%)  1 4/63 (6.35%)  4 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary tract infection † 1  2/61 (3.28%)  3 2/63 (3.17%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary tract infection bacterial † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Urosepsis † 1  0/61 (0.00%)  0 2/63 (3.17%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Incisional hernia † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Wrist fracture † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Investigations         
Blood bilirubin increased † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Alkalosis hypochloraemic † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Dehydration † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Hyponatraemia † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Malnutrition † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Autoimmune arthritis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Flank pain † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Muscle swelling † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Basal cell carcinoma † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Metastases to skin † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Squamous cell carcinoma † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Tumour associated fever † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Tumour pain † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Headache † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Paralysis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Syncope † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Product Issues         
Device breakage † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders         
Suicide attempt † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Renal failure † 1  0/61 (0.00%)  0 1/63 (1.59%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary tract obstruction † 1  1/61 (1.64%)  2 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Reproductive system and breast disorders         
Female genital tract fistula † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vaginal haemorrhage † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Aspiration † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea † 1  1/61 (1.64%)  1 4/63 (6.35%)  4 0/6 (0.00%)  0 0/3 (0.00%)  0
Pleural effusion † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pneumonitis † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pulmonary embolism † 1  2/61 (3.28%)  2 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythema multiforme † 1  1/61 (1.64%)  2 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders         
Embolism † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Iliac artery occlusion † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A First Course Cohort B First Course Cohort A Second Course Cohort B Second Course
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/61 (91.80%)      58/63 (92.06%)      5/6 (83.33%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Anaemia † 1  12/61 (19.67%)  21 11/63 (17.46%)  13 2/6 (33.33%)  4 1/3 (33.33%)  1
Ear and labyrinth disorders         
Tinnitus † 1  1/61 (1.64%)  1 2/63 (3.17%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1
Endocrine disorders         
Hyperthyroidism † 1  4/61 (6.56%)  5 7/63 (11.11%)  7 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypothyroidism † 1  6/61 (9.84%)  6 13/63 (20.63%)  15 0/6 (0.00%)  0 0/3 (0.00%)  0
Eye disorders         
Dry eye † 1  4/61 (6.56%)  4 2/63 (3.17%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Ocular discomfort † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders         
Abdominal discomfort † 1  4/61 (6.56%)  5 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal distension † 1  4/61 (6.56%)  4 3/63 (4.76%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain † 1  18/61 (29.51%)  26 14/63 (22.22%)  18 1/6 (16.67%)  1 0/3 (0.00%)  0
Angular cheilitis † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Colitis † 1  2/61 (3.28%)  2 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Constipation † 1  13/61 (21.31%)  15 13/63 (20.63%)  14 1/6 (16.67%)  1 0/3 (0.00%)  0
Diarrhoea † 1  23/61 (37.70%)  46 16/63 (25.40%)  28 1/6 (16.67%)  2 0/3 (0.00%)  0
Dyspepsia † 1  5/61 (8.20%)  7 9/63 (14.29%)  9 1/6 (16.67%)  1 0/3 (0.00%)  0
Nausea † 1  22/61 (36.07%)  32 17/63 (26.98%)  26 0/6 (0.00%)  0 0/3 (0.00%)  0
Proctalgia † 1  2/61 (3.28%)  3 2/63 (3.17%)  3 0/6 (0.00%)  0 1/3 (33.33%)  1
Stomatitis † 1  3/61 (4.92%)  3 3/63 (4.76%)  5 0/6 (0.00%)  0 1/3 (33.33%)  2
Toothache † 1  2/61 (3.28%)  2 2/63 (3.17%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Vomiting † 1  18/61 (29.51%)  37 14/63 (22.22%)  18 1/6 (16.67%)  2 0/3 (0.00%)  0
General disorders         
Asthenia † 1  14/61 (22.95%)  20 5/63 (7.94%)  6 0/6 (0.00%)  0 0/3 (0.00%)  0
Chills † 1  3/61 (4.92%)  4 4/63 (6.35%)  4 0/6 (0.00%)  0 0/3 (0.00%)  0
Fatigue † 1  19/61 (31.15%)  24 24/63 (38.10%)  29 1/6 (16.67%)  1 0/3 (0.00%)  0
Influenza like illness † 1  4/61 (6.56%)  5 7/63 (11.11%)  11 0/6 (0.00%)  0 0/3 (0.00%)  0
Malaise † 1  2/61 (3.28%)  2 3/63 (4.76%)  3 1/6 (16.67%)  1 0/3 (0.00%)  0
Oedema peripheral † 1  11/61 (18.03%)  12 10/63 (15.87%)  10 0/6 (0.00%)  0 1/3 (33.33%)  1
Pyrexia † 1  13/61 (21.31%)  22 11/63 (17.46%)  19 2/6 (33.33%)  5 0/3 (0.00%)  0
Infections and infestations         
Conjunctivitis † 1  4/61 (6.56%)  6 0/63 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Enterocolitis infectious † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Folliculitis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Gingivitis † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Groin abscess † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Nasopharyngitis † 1  7/61 (11.48%)  9 2/63 (3.17%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1
Sinusitis † 1  4/61 (6.56%)  8 2/63 (3.17%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Upper respiratory tract infection † 1  8/61 (13.11%)  13 8/63 (12.70%)  10 1/6 (16.67%)  1 0/3 (0.00%)  0
Urinary tract infection † 1  4/61 (6.56%)  7 5/63 (7.94%)  7 1/6 (16.67%)  1 0/3 (0.00%)  0
Wound infection † 1  2/61 (3.28%)  2 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Fall † 1  2/61 (3.28%)  2 3/63 (4.76%)  3 0/6 (0.00%)  0 1/3 (33.33%)  1
Limb injury † 1  1/61 (1.64%)  1 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Stoma site pruritus † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Investigations         
Alanine aminotransferase increased † 1  8/61 (13.11%)  11 7/63 (11.11%)  10 0/6 (0.00%)  0 0/3 (0.00%)  0
Aspartate aminotransferase increased † 1  6/61 (9.84%)  9 5/63 (7.94%)  7 0/6 (0.00%)  0 0/3 (0.00%)  0
Blood alkaline phosphatase increased † 1  5/61 (8.20%)  5 3/63 (4.76%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Blood bilirubin increased † 1  2/61 (3.28%)  2 4/63 (6.35%)  4 0/6 (0.00%)  0 0/3 (0.00%)  0
Blood creatinine increased † 1  5/61 (8.20%)  7 3/63 (4.76%)  5 0/6 (0.00%)  0 1/3 (33.33%)  1
Weight decreased † 1  7/61 (11.48%)  7 1/63 (1.59%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite † 1  14/61 (22.95%)  16 11/63 (17.46%)  13 2/6 (33.33%)  3 0/3 (0.00%)  0
Hypoalbuminaemia † 1  5/61 (8.20%)  5 1/63 (1.59%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypocalcaemia † 1  1/61 (1.64%)  1 6/63 (9.52%)  7 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypokalaemia † 1  3/61 (4.92%)  5 4/63 (6.35%)  14 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypomagnesaemia † 1  2/61 (3.28%)  12 3/63 (4.76%)  3 1/6 (16.67%)  1 0/3 (0.00%)  0
Polydipsia † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  15/61 (24.59%)  26 16/63 (25.40%)  19 0/6 (0.00%)  0 1/3 (33.33%)  1
Back pain † 1  8/61 (13.11%)  8 14/63 (22.22%)  18 0/6 (0.00%)  0 0/3 (0.00%)  0
Flank pain † 1  3/61 (4.92%)  9 3/63 (4.76%)  3 1/6 (16.67%)  2 1/3 (33.33%)  1
Muscle spasms † 1  4/61 (6.56%)  4 3/63 (4.76%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Myalgia † 1  6/61 (9.84%)  7 7/63 (11.11%)  7 1/6 (16.67%)  1 0/3 (0.00%)  0
Pain in extremity † 1  5/61 (8.20%)  6 5/63 (7.94%)  8 0/6 (0.00%)  0 1/3 (33.33%)  2
Nervous system disorders         
Amnesia † 1  1/61 (1.64%)  1 2/63 (3.17%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1
Dizziness † 1  4/61 (6.56%)  5 3/63 (4.76%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Dysgeusia † 1  1/61 (1.64%)  1 1/63 (1.59%)  4 0/6 (0.00%)  0 1/3 (33.33%)  1
Headache † 1  9/61 (14.75%)  11 8/63 (12.70%)  16 1/6 (16.67%)  1 0/3 (0.00%)  0
Neuropathy peripheral † 1  4/61 (6.56%)  6 2/63 (3.17%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Paraesthesia † 1  2/61 (3.28%)  4 1/63 (1.59%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Psychiatric disorders         
Depression † 1  2/61 (3.28%)  3 5/63 (7.94%)  5 1/6 (16.67%)  1 0/3 (0.00%)  0
Drug dependence † 1  1/61 (1.64%)  1 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Insomnia † 1  8/61 (13.11%)  8 5/63 (7.94%)  6 1/6 (16.67%)  1 0/3 (0.00%)  0
Renal and urinary disorders         
Dysuria † 1  4/61 (6.56%)  4 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Haematuria † 1  2/61 (3.28%)  5 2/63 (3.17%)  2 1/6 (16.67%)  2 0/3 (0.00%)  0
Urinary tract discomfort † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Reproductive system and breast disorders         
Pelvic pain † 1  2/61 (3.28%)  2 0/63 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough † 1  15/61 (24.59%)  20 9/63 (14.29%)  9 1/6 (16.67%)  1 1/3 (33.33%)  1
Dysphonia † 1  1/61 (1.64%)  1 2/63 (3.17%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1
Dyspnoea † 1  9/61 (14.75%)  10 8/63 (12.70%)  9 0/6 (0.00%)  0 0/3 (0.00%)  0
Epistaxis † 1  1/61 (1.64%)  1 5/63 (7.94%)  5 0/6 (0.00%)  0 0/3 (0.00%)  0
Oropharyngeal pain † 1  3/61 (4.92%)  3 4/63 (6.35%)  4 0/6 (0.00%)  0 1/3 (33.33%)  1
Productive cough † 1  4/61 (6.56%)  4 1/63 (1.59%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermal cyst † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Dry skin † 1  4/61 (6.56%)  4 5/63 (7.94%)  8 0/6 (0.00%)  0 0/3 (0.00%)  0
Night sweats † 1  2/61 (3.28%)  2 5/63 (7.94%)  5 0/6 (0.00%)  0 0/3 (0.00%)  0
Pruritus † 1  11/61 (18.03%)  15 8/63 (12.70%)  9 1/6 (16.67%)  1 0/3 (0.00%)  0
Rash † 1  8/61 (13.11%)  13 9/63 (14.29%)  18 0/6 (0.00%)  0 0/3 (0.00%)  0
Rash maculo-papular † 1  2/61 (3.28%)  2 4/63 (6.35%)  5 0/6 (0.00%)  0 0/3 (0.00%)  0
Solar lentigo † 1  0/61 (0.00%)  0 1/63 (1.59%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Urticaria † 1  2/61 (3.28%)  2 2/63 (3.17%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Vascular disorders         
Hypertension † 1  4/61 (6.56%)  4 5/63 (7.94%)  9 0/6 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
†
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:
Le DT, Kim TW, Van Cutsem E, Geva R, Jager D, Hara H, Burge M, O'Neil B, Kavan P, Yoshino T, Guimbaud R, Taniguchi H, Elez E, Al-Batran SE, Boland PM, Crocenzi T, Atreya CE, Cui Y, Dai T, Marinello P, Diaz LA Jr, Andre T. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164. J Clin Oncol. 2020 Jan 1;38(1):11-19. doi: 10.1200/JCO.19.02107. Epub 2019 Nov 14.
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: NCT02460198    
Other Study ID Numbers: 3475-164
153046 ( Registry Identifier: JAPIC-CTI )
MK-3475-164 ( Other Identifier: Merck Protocol Number )
KEYNOTE-164 ( Other Identifier: Merck )
2015-001852-32 ( EudraCT Number )
First Submitted: May 29, 2015
First Posted: June 2, 2015
Results First Submitted: July 31, 2020
Results First Posted: August 21, 2020
Last Update Posted: September 13, 2022