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NCT02387996 · OUTCOME

Objective Response Rate (ORR) Per Investigator

A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer · Source last updated 2022-11-01

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

Measure
NUMBER
Unit
Percent of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months)

What was measured

Investigator-assessed ORR was defined as the percent of participants with a best overall response of confirmed complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.

Analysis population: All treated participants

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W

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

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg270

Reported measurements

All treated participants

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg270
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg24.8Not reported19.830.4Not reported
PD-L1 <1%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg146
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg19.9Not reported13.727.3Not reported
PD-L1 >= 1%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg124
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg30.6Not reported22.739.6Not reported
PD-L1 <5%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg187
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg20.9Not reported15.327.4Not reported
PD-L1 >=5%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg83
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg33.7Not reported23.744.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.8
        upper Limit
        30.4
        value
        24.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      units
      Participants
    title
    All treated participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.7
        upper Limit
        27.3
        value
        19.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    PD-L1 <1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.7
        upper Limit
        39.6
        value
        30.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      units
      Participants
    title
    PD-L1 >= 1%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.3
        upper Limit
        27.4
        value
        20.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      units
      Participants
    title
    PD-L1 <5%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.7
        upper Limit
        44.9
        value
        33.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      units
      Participants
    title
    PD-L1 >=5%
denoms
  1. counts
    1. group Id
      OG000
      value
      270
    units
    Participants
description
Investigator-assessed ORR was defined as the percent of participants with a best overall response of confirmed complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
    id
    OG000
    title
    Nivolumab 3 mg/kg
param Type
NUMBER
population Description
All treated participants
reporting Status
POSTED
time Frame
From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months)
title
Objective Response Rate (ORR) Per Investigator
type
SECONDARY
unit Of Measure
Percent of Participants

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

Preserved source evidence · Not medical advice