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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

GroupSource count
Dose Level 1: 400 mcg LMB-1002

Reported measurements

Grade 1 Non-Serious Abdominal pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1001Not reportedNot reportedNot reportedNot reported
Grade 1 Non-Serious Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1001Not reportedNot reportedNot reportedNot reported
Grade 2 Non-Serious Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1001Not reportedNot reportedNot reportedNot reported
Grade 2 Non-Serious Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1001Not reportedNot reportedNot reportedNot reported
Grade 2 Non-Serious Pneumonitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1001Not reportedNot reportedNot reportedNot reported
Grade 3 Serious and/or Non-Serious Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Grade 4 Serious and/or Non-Serious Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Grade 5 Serious and/or Non-Serious Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: 400 mcg LMB-1000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 Non-Serious Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 Non-Serious Hypoalbuminemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 Non-Serious Hypoalbuminemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 Non-Serious Hypoxia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 Non-Serious Pneumonitis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 3 Serious and/or Non-Serious Events
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 4 Serious and/or Non-Serious Events
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 Serious and/or Non-Serious Events
denoms
  1. counts
    1. 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
  1. 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

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Preserved source evidence · Not medical advice