NCT01675765 · OUTCOME

Objective Tumor Response

Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma · Source last updated 2020-09-30

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline to measured disease progression or death (up to 12 months or longer)

What was measured

Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions.

Analysis population: Safety analysis set: all enrolled subjects who received at least one dose of study treatment and had measurable disease.

Groups in this outcome

Immunotherapy Plus Chemotherapy

Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Immunotherapy With Cyclophosphamide Plus Chemotherapy

Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Immunotherapy Plus Chemotherapy	36
Immunotherapy With Cyclophosphamide Plus Chemotherapy	21

Reported measurements

Complete Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Immunotherapy Plus Chemotherapy	1	Not reported	Not reported	Not reported	Not reported
Immunotherapy With Cyclophosphamide Plus Chemotherapy	0	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Immunotherapy Plus Chemotherapy	19	Not reported	Not reported	Not reported	Not reported
Immunotherapy With Cyclophosphamide Plus Chemotherapy	11	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Immunotherapy Plus Chemotherapy	14	Not reported	Not reported	Not reported	Not reported
Immunotherapy With Cyclophosphamide Plus Chemotherapy	8	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Immunotherapy Plus Chemotherapy	1	Not reported	Not reported	Not reported	Not reported
Immunotherapy With Cyclophosphamide Plus Chemotherapy	2	Not reported	Not reported	Not reported	Not reported

Not Assessable

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Immunotherapy Plus Chemotherapy	1	Not reported	Not reported	Not reported	Not reported
Immunotherapy With Cyclophosphamide Plus Chemotherapy	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Complete Response
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
11
title
Partial Response
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
8
title
Stable Disease
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
title
Progressive Disease
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Not Assessable

denoms

counts
group Id
OG000
value
36
group Id
OG001
value
21
units
Participants

description

groups

description
Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
id
OG000
title
Immunotherapy Plus Chemotherapy
description
Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
id
OG001
title
Immunotherapy With Cyclophosphamide Plus Chemotherapy

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set: all enrolled subjects who received at least one dose of study treatment and had measurable disease.

reporting Status

POSTED

time Frame

Baseline to measured disease progression or death (up to 12 months or longer)

title

Objective Tumor Response

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice