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NCT02823574 · OUTCOME

ORR - Platinum Eligible 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 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup10.2Not reported3.820.8Not reported
Treatment B - Platinum Eligible Subgroup30.8Not reported14.351.8Not reported
TMB ≥ 7

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup38
Treatment B - Platinum Eligible Subgroup21
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup34.2Not reported19.651.4Not reported
Treatment B - Platinum Eligible Subgroup28.6Not reported11.352.2Not reported
TMB < 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup81
Treatment B - Platinum Eligible Subgroup35
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup17.3Not reported9.827.3Not reported
Treatment B - Platinum Eligible Subgroup28.6Not reported14.646.3Not reported
TMB ≥ 10

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup16
Treatment B - Platinum Eligible Subgroup12
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup31.3Not reported11.058.7Not reported
Treatment B - Platinum Eligible Subgroup33.3Not reported9.965.1Not reported
TMB Not Reported

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup26
Treatment B - Platinum Eligible Subgroup14
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup23.1Not reported9.043.6Not reported
Treatment B - Platinum Eligible Subgroup28.6Not reported8.458.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.8
        upper Limit
        20.8
        value
        10.2
      2. group Id
        OG001
        lower Limit
        14.3
        upper Limit
        51.8
        value
        30.8
    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
        19.6
        upper Limit
        51.4
        value
        34.2
      2. group Id
        OG001
        lower Limit
        11.3
        upper Limit
        52.2
        value
        28.6
    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
        9.8
        upper Limit
        27.3
        value
        17.3
      2. group Id
        OG001
        lower Limit
        14.6
        upper Limit
        46.3
        value
        28.6
    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. group Id
        OG000
        lower Limit
        11.0
        upper Limit
        58.7
        value
        31.3
      2. group Id
        OG001
        lower Limit
        9.9
        upper Limit
        65.1
        value
        33.3
    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
        9.0
        upper Limit
        43.6
        value
        23.1
      2. group Id
        OG001
        lower Limit
        8.4
        upper Limit
        58.1
        value
        28.6
    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
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) 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
NUMBER
population Description
All Randomized Participants - Platinum Eligible Subgroup
reporting Status
POSTED
time Frame
From randomization to end of study. Approximately 63 Months
title
ORR - Platinum Eligible 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