Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02388906 · OUTCOME

Recurrence-free Survival (RFS)

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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 114 months

What was measured

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

Ipilimumab 10 mg/kg

Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

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

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg453
Ipilimumab 10 mg/kg453

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg61.14Not reported42.8789.23Not reported
Ipilimumab 10 mg/kg24.15Not reported16.5635.12Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    Stratified log rank
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    Stratified log rank
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.87
        upper Limit
        89.23
        value
        61.14
      2. group Id
        OG001
        lower Limit
        16.56
        upper Limit
        35.12
        value
        24.15
denoms
  1. counts
    1. group Id
      OG000
      value
      453
    2. group Id
      OG001
      value
      453
    units
    Participants
description
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
    id
    OG000
    title
    Nivolumab 3 mg/kg
  2. description
    Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
    id
    OG001
    title
    Ipilimumab 10 mg/kg
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
up to 114 months
title
Recurrence-free Survival (RFS)
type
POST_HOC
unit Of Measure
Months

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

Preserved source evidence · Not medical advice