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NCT03038100 · FLOW

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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.

groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo 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 placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo 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 placebo for additional 16 cycles.
    id
    FG000
    title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
  2. 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
    FG001
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        289
      2. group Id
        FG001
        num Subjects
        272
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        10
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        51
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        305
      2. group Id
        FG001
        num Subjects
        311
      type
      Study Terminated By Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        650
      2. group Id
        FG001
        num Subjects
        651
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        650
      2. group Id
        FG001
        num Subjects
        651
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study is considered "Completed" because all pre-planned study activities and analyses have been performed.
Complete source fields
groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo 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 placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo 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 placebo for additional 16 cycles.
    id
    FG000
    title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
  2. 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
    FG001
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        289
      2. group Id
        FG001
        num Subjects
        272
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        10
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        51
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        305
      2. group Id
        FG001
        num Subjects
        311
      type
      Study Terminated By Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        650
      2. group Id
        FG001
        num Subjects
        651
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        650
      2. group Id
        FG001
        num Subjects
        651
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study is considered "Completed" because all pre-planned study activities and analyses have been performed.

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Preserved source evidence · Not medical advice