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NCT03038100 · OUTCOME

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17

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
Baseline to approximately 55 months

Analysis population: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.

Groups in this outcome

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab569

Reported measurements

Baseline evaluable participants

Analysis denominator · Participants

GroupSource count
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab563
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab0.7Not reportedNot reportedNot reportedNot reported
Post-baseline evaluable participants

Analysis denominator · Participants

GroupSource count
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab569
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab22.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        563
      units
      Participants
    title
    Baseline evaluable participants
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        569
      units
      Participants
    title
    Post-baseline evaluable participants
denoms
  1. counts
    1. group Id
      OG000
      value
      569
    units
    Participants
groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    id
    OG000
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
param Type
NUMBER
population Description
PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Baseline to approximately 55 months
title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice