NCT04840615 · OUTCOME
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
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 Hypoalbuminemia
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 Non-Serious Hypoxia
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 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 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 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 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
- title
- Grade 1 Non-Serious Abdominal pain
- title
- Grade 1 Non-Serious Hypoalbuminemia
- title
- Grade 2 Non-Serious Hypoalbuminemia
- title
- Grade 2 Non-Serious Hypoxia
- title
- Grade 2 Non-Serious Pneumonitis
- title
- Grade 3 Serious and/or Non-Serious Events
- title
- Grade 4 Serious and/or Non-Serious Events
- title
- Grade 5 Serious and/or Non-Serious Events
- 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 Ipilimumab
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice