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NCT02807636 · OUTCOME

IRF-PFS

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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

Measure
NUMBER
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to first documented disease progression or death from any cause (up to 35 months)

What was measured

Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first.

Analysis population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.

Groups in this outcome

Placebo+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

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

Analysis denominator · Participants

GroupSource count
Placebo+Gemcitabine+Carboplatin/Cisplatin400
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin451

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo+Gemcitabine+Carboplatin/Cisplatin6.34Not reported6.248.05Not reported
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin7.10Not reported6.318.25Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.01
    group Description
    Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0373
    p Value Comment
    inverse normal combination
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.01
    group Description
    Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0373
    p Value Comment
    inverse normal combination
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.24
        upper Limit
        8.05
        value
        6.34
      2. group Id
        OG001
        lower Limit
        6.31
        upper Limit
        8.25
        value
        7.10
denoms
  1. counts
    1. group Id
      OG000
      value
      400
    2. group Id
      OG001
      value
      451
    units
    Participants
description
Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG000
    title
    Placebo+Gemcitabine+Carboplatin/Cisplatin
  2. description
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG001
    title
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
param Type
NUMBER
population Description
The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
reporting Status
POSTED
time Frame
Randomization to first documented disease progression or death from any cause (up to 35 months)
title
IRF-PFS
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice