Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma · Source last updated 2024-02-02
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
Median follow-up: 3.4 months (1.9 months and 5.0 months)
What was measured
Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Groups in this outcome
Dose Level 1: 400 mcg LMB-100
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
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
Dose Level 1: 400 mcg LMB-100
2
Reported measurements
Grade 1 Non-Serious Abdominal pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 1 Non-Serious Edema limbs
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 1 Non-Serious Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 1 Non-Serious Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
2
Not reported
Not reported
Not reported
Not reported
Grade 1 Non-Serious Non-cardiac chest pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
2
Not reported
Not reported
Not reported
Not reported
Grade 1 Non-Serious Weight gain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Capillary leak syndrome
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Edema limbs
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
2
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Pneumonitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Non-Serious Sinus tachycardia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 3 Serious and/or Non-Serious Events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
0
Not reported
Not reported
Not reported
Not reported
Grade 4 Serious Pericardial tamponade
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
1
Not reported
Not reported
Not reported
Not reported
Grade 5 Serious and/or Non-Serious Events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Dose Level 1: 400 mcg LMB-100
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
title
Grade 1 Non-Serious Abdominal pain
categories
measurements
group Id
OG000
value
1
title
Grade 1 Non-Serious Edema limbs
categories
measurements
group Id
OG000
value
1
title
Grade 1 Non-Serious Fatigue
categories
measurements
group Id
OG000
value
2
title
Grade 1 Non-Serious Hypoalbuminemia
categories
measurements
group Id
OG000
value
2
title
Grade 1 Non-Serious Non-cardiac chest pain
categories
measurements
group Id
OG000
value
1
title
Grade 1 Non-Serious Weight gain
categories
measurements
group Id
OG000
value
1
title
Grade 2 Non-Serious Anemia
categories
measurements
group Id
OG000
value
1
title
Grade 2 Non-Serious Capillary leak syndrome
categories
measurements
group Id
OG000
value
1
title
Grade 2 Non-Serious Edema limbs
categories
measurements
group Id
OG000
value
2
title
Grade 2 Non-Serious Hypoalbuminemia
categories
measurements
group Id
OG000
value
1
title
Grade 2 Non-Serious Pneumonitis
categories
measurements
group Id
OG000
value
1
title
Grade 2 Non-Serious Sinus tachycardia
denoms
counts
group Id
OG000
value
2
units
Participants
description
Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
groups
description
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
id
OG000
title
Dose Level 1: 400 mcg LMB-100
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Median follow-up: 3.4 months (1.9 months and 5.0 months)
title
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100