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NCT03036098 · OUTCOME

Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary 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 participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary 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 unable to receive cisplatin chemotherapy live longer.

Analysis population: All Cisplatin-ineligible Randomized Participants - Primary Study

Groups in this outcome

Treatment 1

Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study

Treatment 2

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary 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 1221
Treatment 2224

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment 119.06Not reported13.4722.60Not reported
Treatment 213.21Not reported11.6315.24Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0032
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    statistical Comment
    Stratified weighted log-rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0032
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    statistical Comment
    Stratified weighted log-rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.47
        upper Limit
        22.60
        value
        19.06
      2. group Id
        OG001
        lower Limit
        11.63
        upper Limit
        15.24
        value
        13.21
denoms
  1. counts
    1. group Id
      OG000
      value
      221
    2. group Id
      OG001
      value
      224
    units
    Participants
description
This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary 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 unable to receive cisplatin chemotherapy live longer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    OG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    OG001
    title
    Treatment 2
param Type
MEDIAN
population Description
All Cisplatin-ineligible Randomized Participants - Primary 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-ineligible Randomized Participants for Primary Study
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice