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NCT02823574 · OUTCOME

Overall Survival (OS) - 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 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 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

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 Subgroup5.78Not reported3.459.76Not reported
Treatment B - Platinum Refractory Subgroup8.77Not reported4.1416.66Not 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 Subgroup11.37Not reported6.4116.95Not reported
Treatment B - Platinum Refractory Subgroup7.16Not reported6.2812.29Not 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 Subgroup7.52Not reported4.9611.27Not reported
Treatment B - Platinum Refractory Subgroup8.31Not reported4.9013.04Not 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 Subgroup6.51Not reported2.5041.33Not reported
Treatment B - Platinum Refractory Subgroup9.26Not reported1.3517.51Not reported
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 Subgroup13.86Not reported9.5317318Not reported
Treatment B - Platinum Refractory Subgroup20.01Not reported7.5623.46Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.45
        upper Limit
        9.76
        value
        5.78
      2. group Id
        OG001
        lower Limit
        4.14
        upper Limit
        16.66
        value
        8.77
    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
        6.41
        upper Limit
        16.95
        value
        11.37
      2. group Id
        OG001
        lower Limit
        6.28
        upper Limit
        12.29
        value
        7.16
    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
        4.96
        upper Limit
        11.27
        value
        7.52
      2. group Id
        OG001
        lower Limit
        4.90
        upper Limit
        13.04
        value
        8.31
    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
        2.50
        upper Limit
        41.33
        value
        6.51
      2. group Id
        OG001
        lower Limit
        1.35
        upper Limit
        17.51
        value
        9.26
    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
        9.53
        upper Limit
        17318
        value
        13.86
      2. group Id
        OG001
        lower Limit
        7.56
        upper Limit
        23.46
        value
        20.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      82
    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) 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 Randomized Participants - Platinum Refractory Subgroup
reporting Status
POSTED
time Frame
From randomization to death. Approximately 63 Months
title
Overall Survival (OS) - 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