NCT02516241 · OUTCOME

Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.

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

Patients with improvement in fatigue

Analysis denominator · Participants

Group	Source count
Combination Therapy	86
Monotherapy	83
Standard of Care	74

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	23	Not reported	Not reported	Not reported	Not reported
Monotherapy	24	Not reported	Not reported	Not reported	Not reported
Standard of Care	14	Not reported	Not reported	Not reported	Not reported

Patient with deterioration in pain

Analysis denominator · Participants

Group	Source count
Combination Therapy	156
Monotherapy	164
Standard of Care	145

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	78	Not reported	Not reported	Not reported	Not reported
Monotherapy	71	Not reported	Not reported	Not reported	Not reported
Standard of Care	51	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
0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.4
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patients with improvement in fatigue
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2473
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
1.6
statistical Method
Regression, Logistic
ci Lower Limit
0.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.8
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patients with improvement in fatigue
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0148
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
1.7
statistical Method
Regression, Logistic
ci Lower Limit
1.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.0
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood
group Description
Patient with deterioration in pain
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0090
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
1.9
statistical Method
Regression, Logistic
ci Lower Limit
0.9
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.3
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patient with deterioration in pain
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1510
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
1.4
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.4
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patients with improvement in fatigue
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2473
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
1.6
statistical Method
Regression, Logistic
ci Lower Limit
0.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.8
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patients with improvement in fatigue
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0148
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
1.7
statistical Method
Regression, Logistic
ci Lower Limit
1.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.0
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood
group Description
Patient with deterioration in pain
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0090
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
1.9
statistical Method
Regression, Logistic
ci Lower Limit
0.9
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.3
estimate Comment
The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
group Description
Patient with deterioration in pain
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1510
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
1.4
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
23
group Id
OG001
value
24
group Id
OG002
value
14
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
83
group Id
OG002
value
74
units
Participants
title
Patients with improvement in fatigue
categories
measurements
group Id
OG000
value
78
group Id
OG001
value
71
group Id
OG002
value
51
denoms
counts
group Id
OG000
value
156
group Id
OG001
value
164
group Id
OG002
value
145
units
Participants
title
Patient with deterioration in pain

denoms

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

description

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

COUNT_OF_PARTICIPANTS

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

At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

title

Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice