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NCT02823574 · OUTCOME

Overall Survival (OS) - 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 death. Approximately 63 Months

What was measured

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. 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

Analysis population: All Randomized Participants - Platinum Eligible Subgroup

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 Subgroup7.56Not reported4.8312.25Not reported
Treatment B - Platinum Eligible Subgroup18.27Not reported4.0433.74Not 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 Subgroup16.30Not reported9.4336.30Not reported
Treatment B - Platinum Eligible Subgroup13.08Not reported8.2838.11Not 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 Subgroup9.99Not reported6.4112.62Not reported
Treatment B - Platinum Eligible Subgroup15.01Not reported7.6227.47Not 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 Subgroup16.72Not reported4.47NAupper limit not calculable
Treatment B - Platinum Eligible Subgroup14.77Not reported2.83NAupper limit not calculable
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 Subgroup8.00Not reported3.8426.12Not reported
Treatment B - Platinum Eligible Subgroup9.71Not reported2.5618.79Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.83
        upper Limit
        12.25
        value
        7.56
      2. group Id
        OG001
        lower Limit
        4.04
        upper Limit
        33.74
        value
        18.27
    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
        9.43
        upper Limit
        36.30
        value
        16.30
      2. group Id
        OG001
        lower Limit
        8.28
        upper Limit
        38.11
        value
        13.08
    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
        6.41
        upper Limit
        12.62
        value
        9.99
      2. group Id
        OG001
        lower Limit
        7.62
        upper Limit
        27.47
        value
        15.01
    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
        upper limit not calculable
        group Id
        OG000
        lower Limit
        4.47
        upper Limit
        NA
        value
        16.72
      2. comment
        upper limit not calculable
        group Id
        OG001
        lower Limit
        2.83
        upper Limit
        NA
        value
        14.77
    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
        3.84
        upper Limit
        26.12
        value
        8.00
      2. group Id
        OG001
        lower Limit
        2.56
        upper Limit
        18.79
        value
        9.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      61
    units
    Participants
description
Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. 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
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
All Randomized Participants - Platinum Eligible Subgroup
reporting Status
POSTED
time Frame
From randomization to death. Approximately 63 Months
title
Overall Survival (OS) - 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