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NCT02516241 · OUTCOME

Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).

What was measured

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.

Analysis population: The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

Monotherapy

MEDI4736 (Durvalumab)

Standard of Care

Standard of Care Chemotherapy Treatment

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

Analysis denominator · Participants

GroupSource count
Combination Therapy137
Monotherapy137
Standard of Care137

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy32.1Not reported24.540.0Not reported
Monotherapy24.5Not reported17.632.0Not reported
Standard of Care28.6Not reported21.236.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.5
        upper Limit
        40.0
        value
        32.1
      2. group Id
        OG001
        lower Limit
        17.6
        upper Limit
        32.0
        value
        24.5
      3. group Id
        OG002
        lower Limit
        21.2
        upper Limit
        36.4
        value
        28.6
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      137
    units
    Participants
description
Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
dispersion Type
95% Confidence Interval
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    OG001
    title
    Monotherapy
  3. description
    Standard of Care Chemotherapy Treatment
    id
    OG002
    title
    Standard of Care
param Type
NUMBER
population Description
The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
reporting Status
POSTED
time Frame
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
title
Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice