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NCT02516241 · OUTCOME

OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy11.8Not reported8.915.8Not reported
Monotherapy10.9Not reported8.014.8Not reported
Standard of Care12.2Not reported10.414Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.799
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.359
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7599
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    1.04
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.692
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.175
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4424
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.799
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.359
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7599
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    1.04
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.692
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.175
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4424
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.9
        upper Limit
        15.8
        value
        11.8
      2. group Id
        OG001
        lower Limit
        8.0
        upper Limit
        14.8
        value
        10.9
      3. group Id
        OG002
        lower Limit
        10.4
        upper Limit
        14
        value
        12.2
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      137
    units
    Participants
description
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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
MEDIAN
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 the data cut-off date (27JAN2020, a maximum of 5 years).
title
OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice