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NCT04434560 · FLOW

Participant flow

Neoadjuvant Immunotherapy in Brain Metastases · Source last updated 2022-07-26

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

groups
  1. description
    Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
    id
    FG000
    title
    Standard of Care (no Neoadjuvant Immunotherapy)
  2. description
    Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection. Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg. Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
    id
    FG001
    title
    Neoadjuvant Immunotherapy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In a Memo to File dated March 4, 2021, the removal of randomization in favor of a single-arm study in which all patients will receive neoadjuvant immunotherapy prior to their resection and SRS was proposed. One patient had already been randomized to receive standard of care surgery and SRS without neoadjuvant immunotherapy. This patient is not part of the analyses for the primary or secondary outcomes, as after the protocol amendment all patients were to receive neoadjuvant immunotherapy.
Complete source fields
groups
  1. description
    Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
    id
    FG000
    title
    Standard of Care (no Neoadjuvant Immunotherapy)
  2. description
    Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection. Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg. Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
    id
    FG001
    title
    Neoadjuvant Immunotherapy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In a Memo to File dated March 4, 2021, the removal of randomization in favor of a single-arm study in which all patients will receive neoadjuvant immunotherapy prior to their resection and SRS was proposed. One patient had already been randomized to receive standard of care surgery and SRS without neoadjuvant immunotherapy. This patient is not part of the analyses for the primary or secondary outcomes, as after the protocol amendment all patients were to receive neoadjuvant immunotherapy.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice