NCT03126630 · BASELINE

Baseline characteristics

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma · Source last updated 2026-04-01

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

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
13
group Id
BG003
value
48
units
Participants

groups

description
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
id
BG000
title
Phase 2 Group I (Pembrolizumab)
description
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
id
BG001
title
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
description
Anetumab ravtansine: Day 1 of each cycle for up to 12 months\> MK-3475 (pembrolizumab): Day 1 of each cycle for up to 24 months
id
BG002
title
Phase 1 Cohort DLT 1: Anetumab Ravtansine & MK-3475
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
46.0
upper Limit
85.0
value
70.0
group Id
BG001
lower Limit
23.0
upper Limit
88.0
value
67.5
group Id
BG002
lower Limit
48
upper Limit
81
value
72
group Id
BG003
lower Limit
23.0
upper Limit
88.0
value
68.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
4
group Id
BG003
value
16
title
Female
measurements
group Id
BG000
value
11
group Id
BG001
value
12
group Id
BG002
value
9
group Id
BG003
value
32
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
16
group Id
BG001
value
17
group Id
BG002
value
5
group Id
BG003
value
38
title
Not Hispanic or Latino
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
7
group Id
BG003
value
8
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
4
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Black or African American
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
11
group Id
BG003
value
41
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
2
group Id
BG003
value
3
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Borderline malignancy
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
7
group Id
BG003
value
25
title
Grade cannot be assessed
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
Poorly Differentiated
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Well Differentiated
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
5
group Id
BG003
value
18
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Histologic Grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
2
title
Stage IA
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
3
title
Stage IB
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Stage II
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
3
title
Stage III
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
1
group Id
BG003
value
6
title
Stage IIIB
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
6
group Id
BG003
value
22
title
Stage IV
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
group Id
BG003
value
10
title
Missing
description
IA: Stage grouping (T1, N0, M0) or (T2, N0, M0)\> IB: Stage grouping (T3, N0, M0)\> II: Stage grouping (T1 or T2, N1, M0)\> IIIA: Stage grouping (T3, N1, M0)\> IIIB: Stage grouping (T1-T3, N2, M0) or (T4, Any N, M0)\> IV: Stage grouping (Any T, Any N, M1)
param Type
COUNT_OF_PARTICIPANTS
title
Disease Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
48.8
upper Limit
100.2
value
77.2
group Id
BG001
lower Limit
53.2
upper Limit
108.0
value
80.1
group Id
BG002
lower Limit
51.8
upper Limit
173
value
85.0
group Id
BG003
lower Limit
48.8
upper Limit
173
value
80.4
dispersion Type
FULL_RANGE
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
lower Limit
152.8
upper Limit
188.0
value
168.4
group Id
BG001
lower Limit
152.0
upper Limit
188.0
value
173.1
group Id
BG002
lower Limit
90.9
upper Limit
196
value
167.3
group Id
BG003
lower Limit
90.9
upper Limit
196
value
169.2
dispersion Type
FULL_RANGE
param Type
MEAN
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
lower Limit
1.4
upper Limit
2.3
value
1.9
group Id
BG001
lower Limit
1.6
upper Limit
2.3
value
1.9
group Id
BG002
lower Limit
1.5
upper Limit
2.6
value
1.9
group Id
BG003
lower Limit
1.4
upper Limit
2.6
value
1.9
description
Body Surface Area
dispersion Type
FULL_RANGE
param Type
MEAN
title
BSA
unit Of Measure
m^2
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
2
group Id
BG003
value
10
title
0
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
11
group Id
BG003
value
38
title
1
description
Eastern Cooperative Oncology Group (ECOG) performance status.\> ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. \> ECOG = 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. \> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. \> ECOG = 0 is better. ECOG = 2 is worse.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG Performance Score
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
13
group Id
BG003
value
48
units
Participants

groups

description
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
id
BG000
title
Phase 2 Group I (Pembrolizumab)
description
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
id
BG001
title
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
description
Anetumab ravtansine: Day 1 of each cycle for up to 12 months\> MK-3475 (pembrolizumab): Day 1 of each cycle for up to 24 months
id
BG002
title
Phase 1 Cohort DLT 1: Anetumab Ravtansine & MK-3475
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
46.0
upper Limit
85.0
value
70.0
group Id
BG001
lower Limit
23.0
upper Limit
88.0
value
67.5
group Id
BG002
lower Limit
48
upper Limit
81
value
72
group Id
BG003
lower Limit
23.0
upper Limit
88.0
value
68.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
4
group Id
BG003
value
16
title
Female
measurements
group Id
BG000
value
11
group Id
BG001
value
12
group Id
BG002
value
9
group Id
BG003
value
32
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
16
group Id
BG001
value
17
group Id
BG002
value
5
group Id
BG003
value
38
title
Not Hispanic or Latino
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
7
group Id
BG003
value
8
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
4
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Black or African American
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
11
group Id
BG003
value
41
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
2
group Id
BG003
value
3
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Borderline malignancy
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
7
group Id
BG003
value
25
title
Grade cannot be assessed
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
Poorly Differentiated
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Well Differentiated
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
5
group Id
BG003
value
18
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Histologic Grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
2
title
Stage IA
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
3
title
Stage IB
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Stage II
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
3
title
Stage III
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
1
group Id
BG003
value
6
title
Stage IIIB
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
6
group Id
BG003
value
22
title
Stage IV
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
group Id
BG003
value
10
title
Missing
description
IA: Stage grouping (T1, N0, M0) or (T2, N0, M0)\> IB: Stage grouping (T3, N0, M0)\> II: Stage grouping (T1 or T2, N1, M0)\> IIIA: Stage grouping (T3, N1, M0)\> IIIB: Stage grouping (T1-T3, N2, M0) or (T4, Any N, M0)\> IV: Stage grouping (Any T, Any N, M1)
param Type
COUNT_OF_PARTICIPANTS
title
Disease Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
48.8
upper Limit
100.2
value
77.2
group Id
BG001
lower Limit
53.2
upper Limit
108.0
value
80.1
group Id
BG002
lower Limit
51.8
upper Limit
173
value
85.0
group Id
BG003
lower Limit
48.8
upper Limit
173
value
80.4
dispersion Type
FULL_RANGE
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
lower Limit
152.8
upper Limit
188.0
value
168.4
group Id
BG001
lower Limit
152.0
upper Limit
188.0
value
173.1
group Id
BG002
lower Limit
90.9
upper Limit
196
value
167.3
group Id
BG003
lower Limit
90.9
upper Limit
196
value
169.2
dispersion Type
FULL_RANGE
param Type
MEAN
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
lower Limit
1.4
upper Limit
2.3
value
1.9
group Id
BG001
lower Limit
1.6
upper Limit
2.3
value
1.9
group Id
BG002
lower Limit
1.5
upper Limit
2.6
value
1.9
group Id
BG003
lower Limit
1.4
upper Limit
2.6
value
1.9
description
Body Surface Area
dispersion Type
FULL_RANGE
param Type
MEAN
title
BSA
unit Of Measure
m^2
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
2
group Id
BG003
value
10
title
0
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
11
group Id
BG003
value
38
title
1
description
Eastern Cooperative Oncology Group (ECOG) performance status.\> ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. \> ECOG = 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. \> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. \> ECOG = 0 is better. ECOG = 2 is worse.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG Performance Score
unit Of Measure
Participants

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Preserved source evidence · Not medical advice