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NCT03436732 · OUTCOME

Number of Participants With Partial Response or Complete Response (PR + CR)

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma · Source last updated 2019-11-22

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
42 days

What was measured

Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Groups in this outcome

140 mcg/kg

Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles

100 mcg/kg

Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles

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

Analysis denominator · Participants

GroupSource count
140 mcg/kg4
100 mcg/kg1

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
140 mcg/kg0Not reportedNot reportedNot reportedNot reported
100 mcg/kg0Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
140 mcg/kg0Not reportedNot reportedNot reportedNot reported
100 mcg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
groups
  1. description
    Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
    id
    OG000
    title
    140 mcg/kg
  2. description
    Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
    id
    OG001
    title
    100 mcg/kg
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
42 days
title
Number of Participants With Partial Response or Complete Response (PR + CR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice