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NCT05041062 · OUTCOME

Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma · Source last updated 2024-01-03

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)

What was measured

The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.

Groups in this outcome

All Participants in Study Who Have Mesothelioma

Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.

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

Analysis denominator · Participants

GroupSource count
All Participants in Study Who Have Mesothelioma2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants in Study Who Have Mesothelioma2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.
groups
  1. description
    Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
    id
    OG000
    title
    All Participants in Study Who Have Mesothelioma
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)
title
Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice