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NCT02320058 · OUTCOME

Intracranial Objective Response Rate (ORR)

An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself · Source last updated 2021-10-05

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
95% Confidence Interval
Time frame
Up to 66 months

What was measured

Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.

Analysis population: All treated participants

Groups in this outcome

Cohort A

Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.

Cohort B

Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until 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
Cohort A101
Cohort B18

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A53.5Not reported43.363.5Not reported
Cohort B16.7Not reported3.641.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.3
        upper Limit
        63.5
        value
        53.5
      2. group Id
        OG001
        lower Limit
        3.6
        upper Limit
        41.4
        value
        16.7
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
dispersion Type
95% Confidence Interval
groups
  1. description
    Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
    id
    OG000
    title
    Cohort A
  2. description
    Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
    id
    OG001
    title
    Cohort B
param Type
NUMBER
population Description
All treated participants
reporting Status
POSTED
time Frame
Up to 66 months
title
Intracranial Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice