NCT02387996 · OUTCOME

ORR Per BIRC Assessment by PD-L1 Expression Level

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 (assessed up to 14 months)

What was measured

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. 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. n = Number of participants in each category

Analysis population: All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.

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

Group	Source count
Nivolumab 3 mg/kg	265

Reported measurements

PD-L1 <1%

Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	16.1	Not reported	10.5	23.1	Not reported

PD-L1 >= 1%

Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	23.8	Not reported	16.5	32.3	Not reported

PD-L1 <5%

Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	15.8	Not reported	10.8	21.8	Not reported

PD-L1 >=5%

Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	28.4	Not reported	18.9	39.5	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
10.5
upper Limit
23.1
value
16.1
title
PD-L1 <1%
categories
measurements
group Id
OG000
lower Limit
16.5
upper Limit
32.3
value
23.8
title
PD-L1 >= 1%
categories
measurements
group Id
OG000
lower Limit
10.8
upper Limit
21.8
value
15.8
title
PD-L1 <5%
categories
measurements
group Id
OG000
lower Limit
18.9
upper Limit
39.5
value
28.4
title
PD-L1 >=5%

denoms

counts
group Id
OG000
value
265
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.

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 (assessed up to 14 months)

title

ORR Per BIRC Assessment by PD-L1 Expression Level

type

PRIMARY

unit Of Measure

Percent of Participants

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Preserved source evidence · Not medical advice