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NCT02592551 · OUTCOME

Change in Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg)

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
no unit of ratios with same units(%)
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 immune response of CD8 and Treg to before and after MEDI-4736 and Tremelimumab will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The ratios of CD8/Treg are calculated by diving CD8 by Treg.

Analysis population: The primary objective was the comparison of CD8/Treg 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 no unit of ratios with same units(%) · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
MEDI4736 + Tremelimumab8.6Not reported-1.429.9Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.109
    param Type
    Median Difference (Final Values)
    param Value
    8.6
    statistical Method
    Wilcoxon signed rank test
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.109
    param Type
    Median Difference (Final Values)
    param Value
    8.6
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.4
        upper Limit
        29.9
        value
        8.6
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Tissue biomarker immune response of CD8 and Treg to before and after MEDI-4736 and Tremelimumab will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The ratios of CD8/Treg are calculated by diving CD8 by Treg.
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 primary objective was the comparison of CD8/Treg 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 Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg)
type
PRIMARY
unit Of Measure
no unit of ratios with same units(%)

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

Preserved source evidence · Not medical advice