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NCT02823574 · OUTCOME

ORR - Platinum Eligible Subgroup Based on HPV p-16 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
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. 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

Positive

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup35
Treatment B - Platinum Eligible Subgroup17
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup20.0Not reported8.436.9Not reported
Treatment B - Platinum Eligible Subgroup41.2Not reported18.467.1Not reported
Negative

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup88
Treatment B - Platinum Eligible Subgroup44
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup20.5Not reported12.630.4Not reported
Treatment B - Platinum Eligible Subgroup25.0Not reported13.240.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.4
        upper Limit
        36.9
        value
        20.0
      2. group Id
        OG001
        lower Limit
        18.4
        upper Limit
        67.1
        value
        41.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.6
        upper Limit
        30.4
        value
        20.5
      2. group Id
        OG001
        lower Limit
        13.2
        upper Limit
        40.3
        value
        25.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        44
      units
      Participants
    title
    Negative
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. 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 HPV p-16 Status
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice