NCT04602078 · OUTCOME

ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression

Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma · Source last updated 2025-04-24

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: PD-L1 expression measured at the end of the trial. ORR assessed Through study completion, average 2 years

What was measured

Correlation between the expression of PD-L1 with ORR during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. ORR will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.

Analysis population: 26 patients had no PD-L1 determined

Groups in this outcome

AUREA Single-arm

Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.

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
AUREA Single-arm	40

Reported measurements

PD-L1 positive

Analysis denominator · Participants

Group	Source count
AUREA Single-arm	14

Tumor objective response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AUREA Single-arm	8	Not reported	Not reported	Not reported	Not reported

No response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AUREA Single-arm	6	Not reported	Not reported	Not reported	Not reported

PD-L1 negative

Analysis denominator · Participants

Group	Source count
AUREA Single-arm	26

Tumor objective response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AUREA Single-arm	10	Not reported	Not reported	Not reported	Not reported

No response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AUREA Single-arm	16	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

group Description
Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.414
statistical Method
Chi-squared

Complete source fields

analyses

group Description
Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.414
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
value
8
title
Tumor objective response
measurements
group Id
OG000
value
6
title
No response
denoms
counts
group Id
OG000
value
14
units
Participants
title
PD-L1 positive
categories
measurements
group Id
OG000
value
10
title
Tumor objective response
measurements
group Id
OG000
value
16
title
No response
denoms
counts
group Id
OG000
value
26
units
Participants
title
PD-L1 negative

denoms

counts
group Id
OG000
value
40
units
Participants

description

groups

description
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
id
OG000
title
AUREA Single-arm

param Type

COUNT_OF_PARTICIPANTS

population Description

26 patients had no PD-L1 determined

reporting Status

POSTED

time Frame

PD-L1 expression measured at the end of the trial. ORR assessed Through study completion, average 2 years

title

ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression

type

OTHER_PRE_SPECIFIED

unit Of Measure

Participants

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Preserved source evidence · Not medical advice