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NCT02387996 · OUTCOME

Objective Response Rate (ORR) Per BIRC Assessment - Extended Collection

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 approximately to 43 months)

What was measured

Objective Response Rate (ORR) was defined as the percent of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria). RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date."

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/kg20.7Not reported16.126.1Not 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/kg16.4Not reported10.823.5Not 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/kg25.8Not reported18.434.4Not 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/kg16.0Not reported11.122.1Not 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/kg31.3Not reported21.642.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.1
        upper Limit
        26.1
        value
        20.7
    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
        10.8
        upper Limit
        23.5
        value
        16.4
    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
        18.4
        upper Limit
        34.4
        value
        25.8
    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
        11.1
        upper Limit
        22.1
        value
        16.0
    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
        21.6
        upper Limit
        42.4
        value
        31.3
    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
Objective Response Rate (ORR) was defined as the percent of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria). RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date."
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 approximately to 43 months)
title
Objective Response Rate (ORR) Per BIRC Assessment - Extended Collection
type
POST_HOC
unit Of Measure
Percent of Participants

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Preserved source evidence · Not medical advice