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NCT03732677 · OUTCOME

Overall Survival

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 65 months

What was measured

OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)

Groups in this outcome

Durvalumab+Gemcitabine+Cisplatin

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

GroupSource count
Durvalumab+Gemcitabine+Cisplatin533
Gemcitabine+Cisplatin530

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Durvalumab+Gemcitabine+CisplatinNANot reported41.9NAMedian OS was not reached due to insufficient number of participants with events 75th percentile OS was not reached due to insufficient number of participants with events.
Gemcitabine+CisplatinNANot reported24.1NAMedian OS was not reached due to insufficient number of participants with events 75th percentile OS 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.

  1. ci Lower Limit
    0.563
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.457
    ci Upper Limit
    0.985
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% CI: 0.594 to 0.934
    p Value
    0.0106
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.563
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.457
    ci Upper Limit
    0.985
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% CI: 0.594 to 0.934
    p Value
    0.0106
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median OS was not reached due to insufficient number of participants with events 75th percentile OS was not reached due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        41.9
        upper Limit
        NA
        value
        NA
      2. comment
        Median OS was not reached due to insufficient number of participants with events 75th percentile OS was not reached due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        24.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      533
    2. group Id
      OG001
      value
      530
    units
    Participants
description
OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)
dispersion Type
Inter-Quartile Range
groups
  1. description
    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
    id
    OG000
    title
    Durvalumab+Gemcitabine+Cisplatin
  2. 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
reporting Status
POSTED
time Frame
Up to 65 months
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice