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NCT02592551 · OUTCOME

Change in Percentage of Inducible T-cell Co-stimulator (ICOS) + CD4 T Cells.

MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma · Source last updated 2022-09-29

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

Measure
MEDIAN
Unit
percentage of inducible T-cell co-stimul
Interval / dispersion
Inter-Quartile Range
Time frame
at day 1 after screening and at a surgery within one to six weeks after treatment

What was measured

Tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The percentages of ICOS+CD4 T cells are calculated by dividing by total cells.

Analysis population: The objective was the comparison of percentage of inducible T-cell co-stimulator (ICOS) + CD4 T cells before and after treatment with combination MEDI-4736 and Tremelimumab group. Therefore, the analysis population was from one arm (MEDI4736+Tremelimumab).

Groups in this outcome

MEDI4736 + Tremelimumab

8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.

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

Analysis denominator · Participants

GroupSource count
MEDI4736 + Tremelimumab8

Reported measurements

Source class 1
Values in percentage of inducible T-cell co-stimul · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
MEDI4736 + Tremelimumab-2.1Not reported-5.21Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab
    non Inferiority Type
    OTHER
    p Value
    1
    statistical Method
    Wilcoxon signed rank test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab
    non Inferiority Type
    OTHER
    p Value
    1
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.2
        upper Limit
        1
        value
        -2.1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The percentages of ICOS+CD4 T cells are calculated by dividing by total cells.
dispersion Type
Inter-Quartile Range
groups
  1. description
    8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
    id
    OG000
    title
    MEDI4736 + Tremelimumab
param Type
MEDIAN
population Description
The objective was the comparison of percentage of inducible T-cell co-stimulator (ICOS) + CD4 T cells before and after treatment with combination MEDI-4736 and Tremelimumab group. Therefore, the analysis population was from one arm (MEDI4736+Tremelimumab).
reporting Status
POSTED
time Frame
at day 1 after screening and at a surgery within one to six weeks after treatment
title
Change in Percentage of Inducible T-cell Co-stimulator (ICOS) + CD4 T Cells.
type
SECONDARY
unit Of Measure
percentage of inducible T-cell co-stimul

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

Preserved source evidence · Not medical advice