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NCT04434560 · OUTCOME

Proportion of Patients Who Have Their Surgery Delayed by More Than 4 Days or Surgery Never Occurs as a Direct or Indirect Result of Ipilimumab and Nivolumab Treatment.

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.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
10 days

Analysis population: Outcome measure only applies to Neoadjuvant Immunotherapy; no participants were enrolled in the Neoadjuvant Immunotherapy group.

Groups in this outcome

Standard of Care (no Neoadjuvant Immunotherapy)

Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.

Neoadjuvant Immunotherapy

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.

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

Analysis denominator · Participants

GroupSource count
Standard of Care (no Neoadjuvant Immunotherapy)0
Neoadjuvant Immunotherapy0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
groups
  1. description
    Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
    id
    OG000
    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
    OG001
    title
    Neoadjuvant Immunotherapy
population Description
Outcome measure only applies to Neoadjuvant Immunotherapy; no participants were enrolled in the Neoadjuvant Immunotherapy group.
reporting Status
POSTED
time Frame
10 days
title
Proportion of Patients Who Have Their Surgery Delayed by More Than 4 Days or Surgery Never Occurs as a Direct or Indirect Result of Ipilimumab and Nivolumab Treatment.
type
PRIMARY

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

Preserved source evidence · Not medical advice