NCT02516241 · OUTCOME

PFS2, Full 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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique.

Analysis population: Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

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	342
Monotherapy	346
Standard of Care	344

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	14.6	Not reported	11.3	17.8	Not reported
Monotherapy	11.9	Not reported	8.9	14.6	Not reported
Standard of Care	11.5	Not reported	10.3	12.8	Not reported

Source statistical analyses

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

ci Lower Limit
0.683
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.998
estimate Comment
The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0477
p Value Comment
The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Log Rank
ci Lower Limit
0.809
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 PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7885
p Value Comment
The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.683
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.998
estimate Comment
The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0477
p Value Comment
The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Log Rank
ci Lower Limit
0.809
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 PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7885
p Value Comment
The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
11.3
upper Limit
17.8
value
14.6
group Id
OG001
lower Limit
8.9
upper Limit
14.6
value
11.9
group Id
OG002
lower Limit
10.3
upper Limit
12.8
value
11.5

denoms

counts
group Id
OG000
value
342
group Id
OG001
value
346
group Id
OG002
value
344
units
Participants

description

dispersion Type

95% Confidence Interval

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

MEDIAN

population Description

Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

reporting Status

POSTED

time Frame

Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

title

PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice