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NCT02823574 · OUTCOME

ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

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 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 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: 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup9.0Not reported3.418.5Not reported
Treatment B - Platinum Refractory Subgroup20.5Not reported9.336.5Not reported
TMB ≥ 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup43
Treatment B - Platinum Refractory Subgroup21
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup23.3Not reported11.838.6Not reported
Treatment B - Platinum Refractory Subgroup19.0Not reported5.441.9Not reported
TMB < 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup91
Treatment B - Platinum Refractory Subgroup49
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup11.0Not reported5.419.3Not reported
Treatment B - Platinum Refractory Subgroup22.4Not reported11.836.6Not reported
TMB ≥ 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup19
Treatment B - Platinum Refractory Subgroup11
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup31.6Not reported12.656.6Not reported
Treatment B - Platinum Refractory Subgroup18.2Not reported2.351.8Not reported
TMB Not Reported

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup49
Treatment B - Platinum Refractory Subgroup22
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup14.3Not reported5.927.2Not reported
Treatment B - Platinum Refractory Subgroup18.2Not reported5.240.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.4
        upper Limit
        18.5
        value
        9.0
      2. group Id
        OG001
        lower Limit
        9.3
        upper Limit
        36.5
        value
        20.5
    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
        11.8
        upper Limit
        38.6
        value
        23.3
      2. group Id
        OG001
        lower Limit
        5.4
        upper Limit
        41.9
        value
        19.0
    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
        5.4
        upper Limit
        19.3
        value
        11.0
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        36.6
        value
        22.4
    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
        12.6
        upper Limit
        56.6
        value
        31.6
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        51.8
        value
        18.2
    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
        5.9
        upper Limit
        27.2
        value
        14.3
      2. group Id
        OG001
        lower Limit
        5.2
        upper Limit
        40.3
        value
        18.2
    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
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 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 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
All Randomized Participants - Platinum Refractory Subgroup
reporting Status
POSTED
time Frame
From randomization to end of study. Approximately 63 Months
title
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice