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NCT03036098 · OUTCOME

Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

What was measured

This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.

Analysis population: All Cisplatin-eligible Randomized Participants - Sub-study

Groups in this outcome

Treatment 3

Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study

Treatment 4

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment 3304
Treatment 4304

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment 321.72Not reported18.6326.38Not reported
Treatment 418.86Not reported14.7222.44Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0171
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Comment
    Stratified weighted log-rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0171
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Comment
    Stratified weighted log-rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.63
        upper Limit
        26.38
        value
        21.72
      2. group Id
        OG001
        lower Limit
        14.72
        upper Limit
        22.44
        value
        18.86
denoms
  1. counts
    1. group Id
      OG000
      value
      304
    2. group Id
      OG001
      value
      304
    units
    Participants
description
This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    OG000
    title
    Treatment 3
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    OG001
    title
    Treatment 4
param Type
MEDIAN
population Description
All Cisplatin-eligible Randomized Participants - Sub-study
reporting Status
POSTED
time Frame
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
title
Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice