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NCT02823574 · OUTCOME

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) 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 Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb 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 Refractory subgroup all randomized

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

TMB: < 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup67
Treatment B - Platinum Refractory Subgroup39
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup1.45Not reported1.382.60Not reported
Treatment B - Platinum Refractory Subgroup2.50Not reported1.415.26Not reported
TMB: ≥ 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup43
Treatment B - Platinum Refractory Subgroup21
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup2.76Not reported1.454.11Not reported
Treatment B - Platinum Refractory Subgroup1.54Not reported1.254.07Not reported
TMB: < 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup91
Treatment B - Platinum Refractory Subgroup49
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup1.68Not reported1.412.60Not reported
Treatment B - Platinum Refractory Subgroup2.50Not reported1.414.24Not reported
TMB: ≥ 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup19
Treatment B - Platinum Refractory Subgroup11
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup2.81Not reported1.389.69Not reported
Treatment B - Platinum Refractory Subgroup1.41Not reported1.254.07Not reported
TMB: Not Reported

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup49
Treatment B - Platinum Refractory Subgroup22
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup2.66Not reported1.452.92Not reported
Treatment B - Platinum Refractory Subgroup2.92Not reported1.287.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.38
        upper Limit
        2.60
        value
        1.45
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        5.26
        value
        2.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    TMB: < 7
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        4.11
        value
        2.76
      2. group Id
        OG001
        lower Limit
        1.25
        upper Limit
        4.07
        value
        1.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    TMB: ≥ 7
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        2.60
        value
        1.68
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        4.24
        value
        2.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        49
      units
      Participants
    title
    TMB: < 10
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.38
        upper Limit
        9.69
        value
        2.81
      2. group Id
        OG001
        lower Limit
        1.25
        upper Limit
        4.07
        value
        1.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    TMB: ≥ 10
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.92
        value
        2.66
      2. group Id
        OG001
        lower Limit
        1.28
        upper Limit
        7.00
        value
        2.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    TMB: Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      82
    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 Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb 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
Platinum Refractory subgroup all randomized
reporting Status
POSTED
time Frame
From randomization to disease progression or death. Approximately 63 Months
title
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice