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NCT02516241 · OUTCOME

Objective Response Rate (ORR), 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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.

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: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy20.4Not reportedNot reportedNot reportedNot reported
Monotherapy22.6Not reportedNot reportedNot reportedNot reported
Standard of Care50.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.135
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.406
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    0.24
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.469
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.566
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6195
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    0.86
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.135
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.406
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    0.24
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.469
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.566
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6195
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    0.86
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20.4
      2. group Id
        OG001
        value
        22.6
      3. group Id
        OG002
        value
        50.4
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      137
    units
    Participants
description
Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.
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
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
Objective Response Rate (ORR), 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
percentage of participants

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Preserved source evidence · Not medical advice