NCT03732677 · OUTCOME

Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: Inter-Quartile Range
Time frame: Up to 48 months

What was measured

MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first

Analysis population: The full analysis set (FAS) Intention to treat included all randomized patients.

Groups in this outcome

Durvalumab + Gemcitabine + Cisplatin

Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Gemcitabine + Cisplatin

Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

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
Durvalumab + Gemcitabine + Cisplatin	533
Gemcitabine + Cisplatin	530

Reported measurements

Source class 1

Values in Months · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Durvalumab + Gemcitabine + Cisplatin	NA	Not reported	24.2	NA	Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.
Gemcitabine + Cisplatin	NA	Not reported	15	NA	Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.

Source statistical analyses

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

ci Lower Limit
0.541
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.826
estimate Comment
The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0002
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Comment
Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.541
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.826
estimate Comment
The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0002
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Comment
Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)
statistical Method
Log Rank

classes

categories
measurements
comment
Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.
group Id
OG000
lower Limit
24.2
upper Limit
NA
value
NA
comment
Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.
group Id
OG001
lower Limit
15
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
533
group Id
OG001
value
530
units
Participants

description

MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first

dispersion Type

Inter-Quartile Range

groups

description
Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
id
OG000
title
Durvalumab + Gemcitabine + Cisplatin
description
Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
id
OG001
title
Gemcitabine + Cisplatin

param Type

MEDIAN

population Description

The full analysis set (FAS) Intention to treat included all randomized patients.

reporting Status

POSTED

time Frame

Up to 48 months

title

Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.

type

SECONDARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice