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NCT02823574 · OUTCOME

Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

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 randomization to death. Approximately 63 Months

What was measured

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Analysis population: Platinum Eligible Subgroup

Groups in this outcome

Treatment A - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Treatment B - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

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

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup123
Treatment B - Platinum Eligible Subgroup61

Reported measurements

<1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup51
Treatment B - Platinum Eligible Subgroup23
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup12.52Not reported8.2117.68Not reported
Treatment B - Platinum Eligible Subgroup11.17Not reported3.4221.52Not reported
PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup65
Treatment B - Platinum Eligible Subgroup33
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup7.56Not reported5.0611.24Not reported
Treatment B - Platinum Eligible Subgroup14.00Not reported7.6223.66Not reported
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup87
Treatment B - Platinum Eligible Subgroup37
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup8.72Not reported5.9112.25Not reported
Treatment B - Platinum Eligible Subgroup11.17Not reported5.3221.52Not reported
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup29
Treatment B - Platinum Eligible Subgroup19
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup12.39Not reported5.0636.30Not reported
Treatment B - Platinum Eligible Subgroup14.00Not reported6.3438.74Not reported
PD-L1: <50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup96
Treatment B - Platinum Eligible Subgroup41
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup9.10Not reported6.5712.62Not reported
Treatment B - Platinum Eligible Subgroup9.92Not reported4.0418.79Not reported
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup20
Treatment B - Platinum Eligible Subgroup15
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup9.40Not reported4.1136.30Not reported
Treatment B - Platinum Eligible Subgroup15.01Not reported7.62NAInsufficient number of events to calculate upper limit number.
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup36
Treatment B - Platinum Eligible Subgroup14
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup6.16Not reported4.578.11Not reported
Treatment B - Platinum Eligible Subgroup8.48Not reported2.8322.41Not reported
Without quantifiable PD-L1 expression at baseline

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup7
Treatment B - Platinum Eligible Subgroup5
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup26.12Not reported1.64NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup33.74Not reported5.72NAInsufficient number of events to calculate upper limit number.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.21
        upper Limit
        17.68
        value
        12.52
      2. group Id
        OG001
        lower Limit
        3.42
        upper Limit
        21.52
        value
        11.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    <1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.06
        upper Limit
        11.24
        value
        7.56
      2. group Id
        OG001
        lower Limit
        7.62
        upper Limit
        23.66
        value
        14.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    PD-L1: ≥ 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.91
        upper Limit
        12.25
        value
        8.72
      2. group Id
        OG001
        lower Limit
        5.32
        upper Limit
        21.52
        value
        11.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    PD-L1: < 25%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.06
        upper Limit
        36.30
        value
        12.39
      2. group Id
        OG001
        lower Limit
        6.34
        upper Limit
        38.74
        value
        14.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    PD-L1: ≥ 25%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.57
        upper Limit
        12.62
        value
        9.10
      2. group Id
        OG001
        lower Limit
        4.04
        upper Limit
        18.79
        value
        9.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    PD-L1: <50%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.11
        upper Limit
        36.30
        value
        9.40
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        7.62
        upper Limit
        NA
        value
        15.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        15
      units
      Participants
    title
    PD-L1: > 50%
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.57
        upper Limit
        8.11
        value
        6.16
      2. group Id
        OG001
        lower Limit
        2.83
        upper Limit
        22.41
        value
        8.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    PD-L1: 1 - < 25%
  8. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        1.64
        upper Limit
        NA
        value
        26.12
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        5.72
        upper Limit
        NA
        value
        33.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Without quantifiable PD-L1 expression at baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      61
    units
    Participants
description
Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    OG000
    title
    Treatment A - Platinum Eligible Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    OG001
    title
    Treatment B - Platinum Eligible Subgroup
param Type
MEDIAN
population Description
Platinum Eligible Subgroup
reporting Status
POSTED
time Frame
From randomization to death. Approximately 63 Months
title
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice