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NCT02320058 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 66 months

What was measured

Overall Survival (OS) is defined as the time from the date of the start of treatment until the date of death. For participants who have not died, OS will be censored at the recorded last date of participant contact, and participants with a missing recorded last date of contact will be censored at the last date the participant was known to be alive.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A45.80Not reported45.80NAupper limit of the confidence interval is not yet reached
Cohort B8.77Not reported1.77NAupper limit of the confidence interval is not yet reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        upper limit of the confidence interval is not yet reached
        group Id
        OG000
        lower Limit
        45.80
        upper Limit
        NA
        value
        45.80
      2. comment
        upper limit of the confidence interval is not yet reached
        group Id
        OG001
        lower Limit
        1.77
        upper Limit
        NA
        value
        8.77
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Overall Survival (OS) is defined as the time from the date of the start of treatment until the date of death. For participants who have not died, OS will be censored at the recorded last date of participant contact, and participants with a missing recorded last date of contact will be censored at the last date the participant was known to be alive.
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
MEDIAN
population Description
All treated participants
reporting Status
POSTED
time Frame
Up to 66 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice