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NCT02823574 · OUTCOME

Progression Free Survival (PFS) - 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 disease progression or death. Approximately 63 Months

What was measured

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. 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 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

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 Subgroup2.61Not reported1.385.78Not reported
Treatment B - Platinum Eligible Subgroup2.73Not reported1.419.82Not 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 Subgroup2.89Not reported1.514.21Not reported
Treatment B - Platinum Eligible Subgroup2.99Not reported1.385.65Not 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 Subgroup2.37Not reported1.412.76Not reported
Treatment B - Platinum Eligible Subgroup2.76Not reported1.415.65Not 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 Subgroup5.75Not reported3.7116.59Not reported
Treatment B - Platinum Eligible Subgroup2.99Not reported1.38NAInsufficient number of events to calculate upper limit number.
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 Subgroup2.55Not reported1.452.89Not reported
Treatment B - Platinum Eligible Subgroup2.76Not reported1.415.65Not 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 Subgroup4.21Not reported2.79NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup2.99Not reported1.38NAInsufficient 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 Subgroup1.51Not reported1.412.86Not reported
Treatment B - Platinum Eligible Subgroup3.10Not reported1.288.28Not 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 Subgroup6.47Not reported1.51NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup13.73Not reported1.2849.84Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.38
        upper Limit
        5.78
        value
        2.61
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        9.82
        value
        2.73
    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
        1.51
        upper Limit
        4.21
        value
        2.89
      2. group Id
        OG001
        lower Limit
        1.38
        upper Limit
        5.65
        value
        2.99
    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
        1.41
        upper Limit
        2.76
        value
        2.37
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        5.65
        value
        2.76
    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
        3.71
        upper Limit
        16.59
        value
        5.75
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        1.38
        upper Limit
        NA
        value
        2.99
    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
        1.45
        upper Limit
        2.89
        value
        2.55
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        5.65
        value
        2.76
    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. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        2.79
        upper Limit
        NA
        value
        4.21
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        1.38
        upper Limit
        NA
        value
        2.99
    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
        1.41
        upper Limit
        2.86
        value
        1.51
      2. group Id
        OG001
        lower Limit
        1.28
        upper Limit
        8.28
        value
        3.10
    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
        1.51
        upper Limit
        NA
        value
        6.47
      2. group Id
        OG001
        lower Limit
        1.28
        upper Limit
        49.84
        value
        13.73
    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
The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. 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 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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 disease progression or death. Approximately 63 Months
title
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice