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NCT02302807 · OUTCOME

Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)

What was measured

Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was \>/= 0.60 titer units at any time after initial drug initiation.

Analysis population: ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.

Groups in this outcome

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

IC1/2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC2/3

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

Analysis denominator · Participants

GroupSource count
Atezolizumab427
IC1/2/3 Atezolizumab289
IC2/3 Atezolizumab106

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab33.3Not reportedNot reportedNot reportedNot reported
IC1/2/3 Atezolizumab35.0Not reportedNot reportedNot reportedNot reported
IC2/3 Atezolizumab33.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        35.0
      3. group Id
        OG002
        value
        33.0
denoms
  1. counts
    1. group Id
      OG000
      value
      427
    2. group Id
      OG001
      value
      289
    3. group Id
      OG002
      value
      106
    units
    Participants
description
Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was \>/= 0.60 titer units at any time after initial drug initiation.
groups
  1. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    OG000
    title
    Atezolizumab
  2. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG001
    title
    IC1/2/3 Atezolizumab
  3. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG002
    title
    IC2/3 Atezolizumab
param Type
NUMBER
population Description
ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.
reporting Status
POSTED
time Frame
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
title
Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice