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NCT02823574 · OUTCOME

Progression Free Survival (PFS) - Platinum Eligible 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 eligible subgroup all randomized

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

TMB: < 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup59
Treatment B - Platinum Eligible Subgroup26
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup2.63Not reported1.453.06Not reported
Treatment B - Platinum Eligible Subgroup2.92Not reported1.389.59Not reported
TMB: ≥ 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup38
Treatment B - Platinum Eligible Subgroup21
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup5.82Not reported1.4512.42Not reported
Treatment B - Platinum Eligible Subgroup2.83Not reported1.4113.01Not reported
TMB: < 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup81
Treatment B - Platinum Eligible Subgroup35
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup2.63Not reported1.453.06Not reported
Treatment B - Platinum Eligible Subgroup2.99Not reported1.4113.01Not reported
TMB: ≥ 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup16
Treatment B - Platinum Eligible Subgroup12
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup6.97Not reported1.41NAInsufficient number of events to calculate upper limit number.
Treatment B - Platinum Eligible Subgroup2.76Not reported0.7227.60Not reported
TMB: Not Reported

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup26
Treatment B - Platinum Eligible Subgroup14
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup2.71Not reported1.458.48Not reported
Treatment B - Platinum Eligible Subgroup3.10Not reported1.389.82Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        3.06
        value
        2.63
      2. group Id
        OG001
        lower Limit
        1.38
        upper Limit
        9.59
        value
        2.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    TMB: < 7
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        12.42
        value
        5.82
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        13.01
        value
        2.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    TMB: ≥ 7
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        3.06
        value
        2.63
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        13.01
        value
        2.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    TMB: < 10
  4. categories
    1. measurements
      1. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG000
        lower Limit
        1.41
        upper Limit
        NA
        value
        6.97
      2. group Id
        OG001
        lower Limit
        0.72
        upper Limit
        27.60
        value
        2.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    TMB: ≥ 10
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        8.48
        value
        2.71
      2. group Id
        OG001
        lower Limit
        1.38
        upper Limit
        9.82
        value
        3.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    TMB: Not Reported
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 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) 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 all randomized
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 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