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NCT03146650 · FLOW

Participant flow

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer · Source last updated 2024-01-18

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

groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    FG000
    title
    Nivolumab + Ipilimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not continue to meet protocol eligibility criteria after registration.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      Received First Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Registered for Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Completed Cycle 1 of Treatment(Nivo+Ipi)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Still on treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        23
      comment
      Nivolumab and ipilimumab administered intravenously until disease progression/intolerable toxicity.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Reached First Response Assessment
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      Received Cycle 2 Dose of Study Drugs
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      comment
      2 patients discontinued after completing Cycle 1 due to disease progression.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Continued to Cycle 2 and Beyond
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Still in follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        22
      comment
      Patients who received one dose of study drug and have discontinued treatment go into follow-up.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      NOT COMPLETED
    title
    2 Year Follow-up
recruitment Details
Opened for accrual on May 19, 2017 with goal of 63 patients. The first patient started treatment June 12, 2017. The study closed Aug. 9, 2019 without meeting the total accrual goal due to the pharma company deciding to close the study.
Complete source fields
groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    FG000
    title
    Nivolumab + Ipilimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not continue to meet protocol eligibility criteria after registration.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      Received First Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Registered for Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Completed Cycle 1 of Treatment(Nivo+Ipi)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Still on treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        23
      comment
      Nivolumab and ipilimumab administered intravenously until disease progression/intolerable toxicity.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Reached First Response Assessment
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      Received Cycle 2 Dose of Study Drugs
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      comment
      2 patients discontinued after completing Cycle 1 due to disease progression.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Continued to Cycle 2 and Beyond
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Still in follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        22
      comment
      Patients who received one dose of study drug and have discontinued treatment go into follow-up.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      NOT COMPLETED
    title
    2 Year Follow-up
recruitment Details
Opened for accrual on May 19, 2017 with goal of 63 patients. The first patient started treatment June 12, 2017. The study closed Aug. 9, 2019 without meeting the total accrual goal due to the pharma company deciding to close the study.

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Preserved source evidence · Not medical advice