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NCT02823574 · OUTCOME

ORR - Platinum Refractory Subgroup Based on PD-L1 Expression

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to end of study. Approximately 63 Months

What was measured

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. 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 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: Platinum Refractory subgroup

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 Subgroup159
Treatment B - Platinum Refractory Subgroup82

Reported measurements

<1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup52
Treatment B - Platinum Refractory Subgroup31
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup7.7Not reported2.118.5Not reported
Treatment B - Platinum Refractory Subgroup25.8Not reported11.944.6Not reported
PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup92
Treatment B - Platinum Refractory Subgroup46
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup19.6Not reported12.029.1Not reported
Treatment B - Platinum Refractory Subgroup19.6Not reported9.433.9Not reported
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup117
Treatment B - Platinum Refractory Subgroup57
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup11.1Not reported6.118.3Not reported
Treatment B - Platinum Refractory Subgroup21.1Not reported11.433.9Not reported
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup27
Treatment B - Platinum Refractory Subgroup20
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup33.3Not reported16.554.0Not reported
Treatment B - Platinum Refractory Subgroup25.0Not reported8.749.1Not reported
PD-L1: <50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup129
Treatment B - Platinum Refractory Subgroup66
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup13.2Not reported7.920.3Not reported
Treatment B - Platinum Refractory Subgroup22.7Not reported13.334.7Not reported
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup15
Treatment B - Platinum Refractory Subgroup11
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup33.3Not reported11.861.6Not reported
Treatment B - Platinum Refractory Subgroup18.2Not reported2.351.8Not reported
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup65
Treatment B - Platinum Refractory Subgroup26
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup13.8Not reported6.524.7Not reported
Treatment B - Platinum Refractory Subgroup15.4Not reported4.434.9Not reported
without quantifiable PD-L1 expression at baseline

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup15
Treatment B - Platinum Refractory Subgroup5
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory SubgroupNANot reportedNANANot reported when sample size is less than 10 subjects for the subgroup category
Treatment B - Platinum Refractory SubgroupNANot reportedNANANot reported when sample size is less than 10 subjects for the subgroup category
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        18.5
        value
        7.7
      2. group Id
        OG001
        lower Limit
        11.9
        upper Limit
        44.6
        value
        25.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    <1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.0
        upper Limit
        29.1
        value
        19.6
      2. group Id
        OG001
        lower Limit
        9.4
        upper Limit
        33.9
        value
        19.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        46
      units
      Participants
    title
    PD-L1: ≥ 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        18.3
        value
        11.1
      2. group Id
        OG001
        lower Limit
        11.4
        upper Limit
        33.9
        value
        21.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    PD-L1: < 25%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.5
        upper Limit
        54.0
        value
        33.3
      2. group Id
        OG001
        lower Limit
        8.7
        upper Limit
        49.1
        value
        25.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    PD-L1: ≥ 25%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.9
        upper Limit
        20.3
        value
        13.2
      2. group Id
        OG001
        lower Limit
        13.3
        upper Limit
        34.7
        value
        22.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    PD-L1: <50%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.8
        upper Limit
        61.6
        value
        33.3
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        51.8
        value
        18.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    PD-L1: > 50%
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.5
        upper Limit
        24.7
        value
        13.8
      2. group Id
        OG001
        lower Limit
        4.4
        upper Limit
        34.9
        value
        15.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    PD-L1: 1 - < 25%
  8. categories
    1. measurements
      1. comment
        Not reported when sample size is less than 10 subjects for the subgroup category
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Not reported when sample size is less than 10 subjects for the subgroup category
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    without quantifiable PD-L1 expression at baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      82
    units
    Participants
description
ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. 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 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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
NUMBER
population Description
Platinum Refractory subgroup
reporting Status
POSTED
time Frame
From randomization to end of study. Approximately 63 Months
title
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice