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NCT02388906 · OUTCOME

Recurrence-free Survival by PD-L1 Expression

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 106.6 months

What was measured

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

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

Participants with >= 5% PD-L1 Expression,

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg153
Ipilimumab 10 mg/kg154
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg70.41Not reported67.6584.80Not reported
Ipilimumab 10 mg/kg54.67Not reported24.1584.40Not reported
Participants with < 5% PD-L1 Expression,

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg300
Ipilimumab 10 mg/kg299
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg38.677Not reported22.0561.04Not reported
Ipilimumab 10 mg/kg16.56Not reported11.1426.51Not reported
Participants with Non-quantifiable PD-L1 Expression

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg0
Ipilimumab 10 mg/kg0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67.65
        upper Limit
        84.80
        value
        70.41
      2. group Id
        OG001
        lower Limit
        24.15
        upper Limit
        84.40
        value
        54.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        153
      2. group Id
        OG001
        value
        154
      units
      Participants
    title
    Participants with >= 5% PD-L1 Expression,
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.05
        upper Limit
        61.04
        value
        38.677
      2. group Id
        OG001
        lower Limit
        11.14
        upper Limit
        26.51
        value
        16.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        300
      2. group Id
        OG001
        value
        299
      units
      Participants
    title
    Participants with < 5% PD-L1 Expression,
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Participants with Non-quantifiable PD-L1 Expression
denoms
  1. counts
    1. group Id
      OG000
      value
      453
    2. group Id
      OG001
      value
      453
    units
    Participants
description
Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
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 106.6 months
title
Recurrence-free Survival by PD-L1 Expression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice