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NCT02823574 · OUTCOME

Duration of Response (DOR) - 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 between the date of first confirmed response to the date of the first documented tumor 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 Responders

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 Subgroup25
Treatment B - Platinum Eligible Subgroup18

Reported measurements

PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup14
Treatment B - Platinum Eligible Subgroup10
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup33.84Not reported8.28NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup24.61Not reported4.11NAInsufficient number of events to calculate upper limit number.
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup13
Treatment B - Platinum Eligible Subgroup9
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup13.17Not reported4.1735.55Not reported
Treatment B - Platinum Eligible Subgroup12.42Not reported4.11NAInsufficient number of events to calculate upper limit number.
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup9
Treatment B - Platinum Eligible Subgroup6
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible SubgroupNANot reported8.28NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Eligible SubgroupNANot reported24.61NAInsufficient number of events to calculate upper limit number and median
PD-L1: <50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup16
Treatment B - Platinum Eligible Subgroup10
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup13.67Not reported5.7835.55Not reported
Treatment B - Platinum Eligible Subgroup15.87Not reported4.11NAInsufficient number of events to calculate upper limit number.
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup6
Treatment B - Platinum Eligible Subgroup5
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible SubgroupNANot reported33.84NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Eligible SubgroupNANot reported24.61NAInsufficient number of events to calculate upper limit number and median
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup5
Treatment B - Platinum Eligible Subgroup4
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup13.13Not reported4.14NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup6.21Not reported4.1112.42Not reported
PD-L1: Unquantifiable

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup3
Treatment B - Platinum Eligible Subgroup3
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible SubgroupNANot reported27.04NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Eligible Subgroup28.99Not reported9.4948.49Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        8.28
        upper Limit
        NA
        value
        33.84
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        4.11
        upper Limit
        NA
        value
        24.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    PD-L1: ≥ 1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.17
        upper Limit
        35.55
        value
        13.17
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        4.11
        upper Limit
        NA
        value
        12.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    PD-L1: < 25%
  3. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG000
        lower Limit
        8.28
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG001
        lower Limit
        24.61
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    PD-L1: ≥ 25%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.78
        upper Limit
        35.55
        value
        13.67
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        4.11
        upper Limit
        NA
        value
        15.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    PD-L1: <50%
  5. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG000
        lower Limit
        33.84
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG001
        lower Limit
        24.61
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      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
        4.14
        upper Limit
        NA
        value
        13.13
      2. group Id
        OG001
        lower Limit
        4.11
        upper Limit
        12.42
        value
        6.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    PD-L1: 1 - < 25%
  7. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG000
        lower Limit
        27.04
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        9.49
        upper Limit
        48.49
        value
        28.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    PD-L1: Unquantifiable
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      18
    units
    Participants
description
The time between the date of first confirmed response to the date of the first documented tumor 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 Responders
reporting Status
POSTED
time Frame
From randomization to disease progression or death. Approximately 63 Months
title
Duration of Response (DOR) - 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