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NCT02500797 · OUTCOME

6-Month Clinical Benefit Rate [Initial Cohort]

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
At 6 months

What was measured

The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).

Analysis population: Randomized Initial Cohort participants who received treatment (i.e. exclude cancel patients) Only.

Groups in this outcome

Initial Single

Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

Initial Dual

Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Initial Single42
Initial Dual42

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Initial Single10Not reported322Not reported
Initial Dual12Not reported628Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        22
        value
        10
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        28
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      42
    units
    Participants
description
The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Initial Single
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Initial Dual
param Type
NUMBER
population Description
Randomized Initial Cohort participants who received treatment (i.e. exclude cancel patients) Only.
reporting Status
POSTED
time Frame
At 6 months
title
6-Month Clinical Benefit Rate [Initial Cohort]
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice