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NCT03036098 · OUTCOME

Overall Survival (OS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) 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 participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) 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 whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.

Analysis population: All PD-L1 \>= 1% 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 3111
Treatment 4110

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment 325.10Not reported17.2835.55Not reported
Treatment 415.34Not reported11.7024.87Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.28
        upper Limit
        35.55
        value
        25.10
      2. group Id
        OG001
        lower Limit
        11.70
        upper Limit
        24.87
        value
        15.34
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    2. group Id
      OG001
      value
      110
    units
    Participants
description
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) 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 whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.
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 PD-L1 \>= 1% 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) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice