NCT02516241 · OUTCOME

Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

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-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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

Group	Source count
Combination Therapy	205
Monotherapy	209
Standard of Care	207

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	46.8	Not reported	Not reported	Not reported	Not reported
Monotherapy	27.8	Not reported	Not reported	Not reported	Not reported
Standard of Care	48.3	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.639
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.394
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7708
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
0.94
statistical Method
Regression, Logistic
ci Lower Limit
0.268
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.610
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
group Ids
OG001
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
0.41
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.639
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.394
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7708
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
0.94
statistical Method
Regression, Logistic
ci Lower Limit
0.268
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.610
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.
group Ids
OG001
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
0.41
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
46.8
group Id
OG001
value
27.8
group Id
OG002
value
48.3

denoms

counts
group Id
OG000
value
205
group Id
OG001
value
209
group Id
OG002
value
207
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

description
MEDI4736 (Durvalumab) + Tremelimumab
id
OG000
title
Combination Therapy
description
MEDI4736 (Durvalumab)
id
OG001
title
Monotherapy
description
Standard of Care Chemotherapy Treatment
id
OG002
title
Standard of Care

param Type

NUMBER

population Description

The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice