NCT02362594 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) · Source last updated 2026-03-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants

groups

description
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
id
BG000
title
Pembrolizumab
description
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.6
value
53.9
group Id
BG001
spread
14.2
value
53.7
group Id
BG002
spread
13.9
value
53.8
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
190
group Id
BG001
value
201
group Id
BG002
value
391
title
Female
measurements
group Id
BG000
value
324
group Id
BG001
value
304
group Id
BG002
value
628
title
Male
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
428
group Id
BG001
value
425
group Id
BG002
value
853
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
PD-L1 Positive
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
57
group Id
BG002
value
116
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
PD-L1 Negative
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
23
group Id
BG002
value
50
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Undetermined
description
Tumor PD-L1 status was assessed by immunohistochemistry (IHC) and recorded as positive (≥1% PD-L1 IHC), negative (\<1% PD-L1 IHC), or undetermined level of expression (indeterminate PD-L1 IHC).
param Type
COUNT_OF_PARTICIPANTS
title
Programmed Death-Ligand 1 (PD-L1) Tumor Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
80
group Id
BG002
value
160
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIA (> 1 mm)
categories
measurements
group Id
BG000
value
237
group Id
BG001
value
230
group Id
BG002
value
467
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIB
categories
measurements
group Id
BG000
value
95
group Id
BG001
value
93
group Id
BG002
value
188
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIC (1-3 LN+)
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
102
group Id
BG002
value
204
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIC (≥4 LN+)
description
Participants were stratified by melanoma stage using the American Joint Committee on Cancer (AJCC) 7th edition stage as follows: Stage IIIA (with \>1 mm metastasis), Stage IIIB, Stage IIIC with 1-3 positive lymph nodes (LN+), and Stage IIIC with ≥4 LN+.
param Type
COUNT_OF_PARTICIPANTS
title
Melanoma Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
37
group Id
BG002
value
75
title
North America
measurements
group Id
BG000
value
341
group Id
BG001
value
336
group Id
BG002
value
677
title
Europe
measurements
group Id
BG000
value
111
group Id
BG001
value
112
group Id
BG002
value
223
title
Australia/New Zealand
measurements
group Id
BG000
value
24
group Id
BG001
value
20
group Id
BG002
value
44
title
Other
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants

groups

description
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
id
BG000
title
Pembrolizumab
description
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.6
value
53.9
group Id
BG001
spread
14.2
value
53.7
group Id
BG002
spread
13.9
value
53.8
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
190
group Id
BG001
value
201
group Id
BG002
value
391
title
Female
measurements
group Id
BG000
value
324
group Id
BG001
value
304
group Id
BG002
value
628
title
Male
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
428
group Id
BG001
value
425
group Id
BG002
value
853
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
PD-L1 Positive
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
57
group Id
BG002
value
116
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
PD-L1 Negative
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
23
group Id
BG002
value
50
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Undetermined
description
Tumor PD-L1 status was assessed by immunohistochemistry (IHC) and recorded as positive (≥1% PD-L1 IHC), negative (\<1% PD-L1 IHC), or undetermined level of expression (indeterminate PD-L1 IHC).
param Type
COUNT_OF_PARTICIPANTS
title
Programmed Death-Ligand 1 (PD-L1) Tumor Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
80
group Id
BG002
value
160
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIA (> 1 mm)
categories
measurements
group Id
BG000
value
237
group Id
BG001
value
230
group Id
BG002
value
467
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIB
categories
measurements
group Id
BG000
value
95
group Id
BG001
value
93
group Id
BG002
value
188
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIC (1-3 LN+)
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
102
group Id
BG002
value
204
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
title
Stage IIIC (≥4 LN+)
description
Participants were stratified by melanoma stage using the American Joint Committee on Cancer (AJCC) 7th edition stage as follows: Stage IIIA (with \>1 mm metastasis), Stage IIIB, Stage IIIC with 1-3 positive lymph nodes (LN+), and Stage IIIC with ≥4 LN+.
param Type
COUNT_OF_PARTICIPANTS
title
Melanoma Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
37
group Id
BG002
value
75
title
North America
measurements
group Id
BG000
value
341
group Id
BG001
value
336
group Id
BG002
value
677
title
Europe
measurements
group Id
BG000
value
111
group Id
BG001
value
112
group Id
BG002
value
223
title
Australia/New Zealand
measurements
group Id
BG000
value
24
group Id
BG001
value
20
group Id
BG002
value
44
title
Other
denoms
counts
group Id
BG000
value
514
group Id
BG001
value
505
group Id
BG002
value
1019
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice