NCT02991482 · BASELINE

Baseline characteristics

PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma · Source last updated 2026-08-24

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

denoms

counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants

groups

description
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment. Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
id
BG000
title
Pembrolizumab Arm
description
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated. Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination. Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide"). Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
id
BG001
title
Standard Chemotherapy Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
52.0
upper Limit
83.0
value
69.0
group Id
BG001
lower Limit
53.0
upper Limit
83.0
value
71.0
group Id
BG002
lower Limit
52.0
upper Limit
83.0
value
70.0
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
29
group Id
BG002
value
71
title
<70 years
measurements
group Id
BG000
value
31
group Id
BG001
value
42
group Id
BG002
value
73
title
≥70 years
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Age category
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
11
group Id
BG002
value
26
title
Female
measurements
group Id
BG000
value
58
group Id
BG001
value
60
group Id
BG002
value
118
title
Male
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
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
54
group Id
BG001
value
53
group Id
BG002
value
107
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
14
group Id
BG002
value
27
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Switzerland
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Spain
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
66
group Id
BG001
value
62
group Id
BG002
value
128
title
Epithelioid
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
title
Non-epithelioid
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Histologic subtype
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Current
measurements
group Id
BG000
value
34
group Id
BG001
value
28
group Id
BG002
value
62
title
Former (≥100 cigarettes in the past during the whole life)
measurements
group Id
BG000
value
33
group Id
BG001
value
39
group Id
BG002
value
72
title
Never (0-99 cigarettes during the whole life)
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown/Missing
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
14
group Id
BG002
value
35
title
0
measurements
group Id
BG000
value
51
group Id
BG001
value
57
group Id
BG002
value
108
title
1
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
2
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours. Of note, although an ECOG performance status (PS) of 0 or 1 was mandatory to be included in the study, one patient was allowed to enter the study with ECOG PS of 2 due to leg braces.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
54
group Id
BG002
value
99
title
Good prognosis
measurements
group Id
BG000
value
28
group Id
BG001
value
17
group Id
BG002
value
45
title
Poor prognosis
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
EORTC prognostic score (EPS) was calculated based on Fennell et al.(2005) prognostic model. This model takes into account WBC count, ECOG PS, histologic subtype and gender. A value of smaller or equal to 1.27 signifies a "good prognosis" while a value of more than 1.27 a "poor prognosis".
param Type
COUNT_OF_PARTICIPANTS
title
EORTC score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
27
group Id
BG002
value
54
title
Carboplatin/Pemetrexed
measurements
group Id
BG000
value
24
group Id
BG001
value
22
group Id
BG002
value
46
title
Cisplatin/Pemetrexed
measurements
group Id
BG000
value
13
group Id
BG001
value
17
group Id
BG002
value
30
title
Platinum+/-Pemetrexed+/-Other
measurements
group Id
BG000
value
7
group Id
BG001
value
1
group Id
BG002
value
8
title
Cisplatin/Pemetrexed and Carboplatin/Pemetrexed
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Missing
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Prior treatment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
30
group Id
BG002
value
66
title
<1%
measurements
group Id
BG000
value
20
group Id
BG001
value
18
group Id
BG002
value
38
title
1-20%
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
≥20%
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Not evaluable
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Not scored
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
PD-L1 expression (PD-L1 tumor proportion score) was evaluated by immunohistochemistry (IHC) assay using clone SP263. PD-L1 was quantified as number of positive cells and scored as percentage of PD-L1 positive cells within tumor region. The following classification of PD-L1 scoring was used: 0 to \<1% positive tumor cells; 1 to \<20% positive tumor cells; \>=20% positive tumor cells; Not Evaluable; Not scored.
param Type
COUNT_OF_PARTICIPANTS
title
PD-L1 Tumour proportion score
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants

groups

description
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment. Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
id
BG000
title
Pembrolizumab Arm
description
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated. Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination. Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide"). Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
id
BG001
title
Standard Chemotherapy Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
52.0
upper Limit
83.0
value
69.0
group Id
BG001
lower Limit
53.0
upper Limit
83.0
value
71.0
group Id
BG002
lower Limit
52.0
upper Limit
83.0
value
70.0
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
29
group Id
BG002
value
71
title
<70 years
measurements
group Id
BG000
value
31
group Id
BG001
value
42
group Id
BG002
value
73
title
≥70 years
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Age category
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
11
group Id
BG002
value
26
title
Female
measurements
group Id
BG000
value
58
group Id
BG001
value
60
group Id
BG002
value
118
title
Male
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
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
54
group Id
BG001
value
53
group Id
BG002
value
107
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
14
group Id
BG002
value
27
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Switzerland
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
title
Spain
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
66
group Id
BG001
value
62
group Id
BG002
value
128
title
Epithelioid
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
title
Non-epithelioid
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Histologic subtype
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Current
measurements
group Id
BG000
value
34
group Id
BG001
value
28
group Id
BG002
value
62
title
Former (≥100 cigarettes in the past during the whole life)
measurements
group Id
BG000
value
33
group Id
BG001
value
39
group Id
BG002
value
72
title
Never (0-99 cigarettes during the whole life)
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown/Missing
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
14
group Id
BG002
value
35
title
0
measurements
group Id
BG000
value
51
group Id
BG001
value
57
group Id
BG002
value
108
title
1
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
2
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours. Of note, although an ECOG performance status (PS) of 0 or 1 was mandatory to be included in the study, one patient was allowed to enter the study with ECOG PS of 2 due to leg braces.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
54
group Id
BG002
value
99
title
Good prognosis
measurements
group Id
BG000
value
28
group Id
BG001
value
17
group Id
BG002
value
45
title
Poor prognosis
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
EORTC prognostic score (EPS) was calculated based on Fennell et al.(2005) prognostic model. This model takes into account WBC count, ECOG PS, histologic subtype and gender. A value of smaller or equal to 1.27 signifies a "good prognosis" while a value of more than 1.27 a "poor prognosis".
param Type
COUNT_OF_PARTICIPANTS
title
EORTC score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
27
group Id
BG002
value
54
title
Carboplatin/Pemetrexed
measurements
group Id
BG000
value
24
group Id
BG001
value
22
group Id
BG002
value
46
title
Cisplatin/Pemetrexed
measurements
group Id
BG000
value
13
group Id
BG001
value
17
group Id
BG002
value
30
title
Platinum+/-Pemetrexed+/-Other
measurements
group Id
BG000
value
7
group Id
BG001
value
1
group Id
BG002
value
8
title
Cisplatin/Pemetrexed and Carboplatin/Pemetrexed
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Missing
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Prior treatment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
30
group Id
BG002
value
66
title
<1%
measurements
group Id
BG000
value
20
group Id
BG001
value
18
group Id
BG002
value
38
title
1-20%
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
≥20%
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Not evaluable
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Not scored
denoms
counts
group Id
BG000
value
73
group Id
BG001
value
71
group Id
BG002
value
144
units
Participants
description
PD-L1 expression (PD-L1 tumor proportion score) was evaluated by immunohistochemistry (IHC) assay using clone SP263. PD-L1 was quantified as number of positive cells and scored as percentage of PD-L1 positive cells within tumor region. The following classification of PD-L1 scoring was used: 0 to \<1% positive tumor cells; 1 to \<20% positive tumor cells; \>=20% positive tumor cells; Not Evaluable; Not scored.
param Type
COUNT_OF_PARTICIPANTS
title
PD-L1 Tumour proportion score
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice