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NCT02823574 · OUTCOME

Duration of Response (DOR) - Platinum Refractory 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: All treated participants in the Platinum refractory subgroup with a response

Groups in this outcome

Treatment A - Platinum Refractory Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Treatment B - Platinum Refractory Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months 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 Refractory Subgroup21
Treatment B - Platinum Refractory Subgroup15

Reported measurements

PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup18
Treatment B - Platinum Refractory Subgroup9
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup39.43Not reported11.01NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Refractory Subgroup8.34Not reported2.79NAInsufficient number of events to calculate upper limit number.
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup13
Treatment B - Platinum Refractory Subgroup12
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup39.43Not reported6.87NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Refractory Subgroup11.10Not reported4.1738.51Not reported
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup9
Treatment B - Platinum Refractory Subgroup5
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory SubgroupNANot reported6.93NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Refractory Subgroup8.34Not reported2.79NAInsufficient number of events to calculate upper limit number.
PD-L1: <50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup17
Treatment B - Platinum Refractory Subgroup15
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory SubgroupNANot reported26.71NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Refractory Subgroup11.14Not reported4.1738.51Not reported
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup5
Treatment B - Platinum Refractory Subgroup2
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory SubgroupNANot reported6.93NAInsufficient number of events to calculate upper limit number and median
Treatment B - Platinum Refractory Subgroup6.24Not reported4.148.34Not reported
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup9
Treatment B - Platinum Refractory Subgroup4
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup39.43Not reported3.0639.43Not reported
Treatment B - Platinum Refractory SubgroupNANot reported4.17NAInsufficient number of events to calculate upper limit number and median
PD-L1: Unquantifiable

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup1
Treatment B - Platinum Refractory Subgroup0
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup38.67Not reportedNANAInsufficient number of events to calculate upper limit number and lower limit number
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        11.01
        upper Limit
        NA
        value
        39.43
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        2.79
        upper Limit
        NA
        value
        8.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    PD-L1: ≥ 1%
  2. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        6.87
        upper Limit
        NA
        value
        39.43
      2. group Id
        OG001
        lower Limit
        4.17
        upper Limit
        38.51
        value
        11.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        12
      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
        6.93
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        2.79
        upper Limit
        NA
        value
        8.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    PD-L1: ≥ 25%
  4. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG000
        lower Limit
        26.71
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        4.17
        upper Limit
        38.51
        value
        11.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        15
      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
        6.93
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        4.14
        upper Limit
        8.34
        value
        6.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    PD-L1: > 50%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.06
        upper Limit
        39.43
        value
        39.43
      2. comment
        Insufficient number of events to calculate upper limit number and median
        group Id
        OG001
        lower Limit
        4.17
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      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 lower limit number
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        38.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    PD-L1: Unquantifiable
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      15
    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) that has recurred during or less than 6 months 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 Refractory Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    OG001
    title
    Treatment B - Platinum Refractory Subgroup
param Type
MEDIAN
population Description
All treated participants in the Platinum refractory subgroup with a response
reporting Status
POSTED
time Frame
From randomization to disease progression or death. Approximately 63 Months
title
Duration of Response (DOR) - Platinum Refractory 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