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NCT01721772 · OUTCOME

Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12

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
From date of randomization to date of disease progression or death, up to approximately 94 months

What was measured

Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression \<5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine

Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

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/kg + Placebo-matching Dacarbazine210
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab208

Reported measurements

PD-L1 positive participants (cutoff=5%)

Analysis denominator · Participants

GroupSource count
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine74
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab74
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine53.36Not reported31.47NAUpper limit not reached due to insufficient number of events
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab12.39Not reported9.3318.99Not reported
PD-L1 negative/indeterminate participants (cutoff=5%)

Analysis denominator · Participants

GroupSource count
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine136
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab134
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine26.97Not reported16.3639.79Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab10.84Not reported8.3812.25Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.56
    estimate Comment
    PD-L1 positive group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Unstratified Hazard Ratio
    param Value
    0.37
  2. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    PD-L1 negative group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Unstratified Hazard Ratio
    param Value
    0.60
Complete source fields
analyses
  1. ci Lower Limit
    0.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.56
    estimate Comment
    PD-L1 positive group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Unstratified Hazard Ratio
    param Value
    0.37
  2. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    PD-L1 negative group
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Unstratified Hazard Ratio
    param Value
    0.60
classes
  1. categories
    1. measurements
      1. comment
        Upper limit not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        31.47
        upper Limit
        NA
        value
        53.36
      2. group Id
        OG001
        lower Limit
        9.33
        upper Limit
        18.99
        value
        12.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    PD-L1 positive participants (cutoff=5%)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.36
        upper Limit
        39.79
        value
        26.97
      2. group Id
        OG001
        lower Limit
        8.38
        upper Limit
        12.25
        value
        10.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        134
      units
      Participants
    title
    PD-L1 negative/indeterminate participants (cutoff=5%)
denoms
  1. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      208
    units
    Participants
description
Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression \<5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
    id
    OG000
    title
    Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
  2. description
    Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
    id
    OG001
    title
    Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From date of randomization to date of disease progression or death, up to approximately 94 months
title
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice