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NCT02823574 · OUTCOME

ORR - Platinum Refractory 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 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

OROPHARYNGEAL HPV P-16 POSITIVE

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup30
Treatment B - Platinum Refractory Subgroup16
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup23.3Not reported9.942.3Not reported
Treatment B - Platinum Refractory Subgroup37.5Not reported15.264.6Not reported
OROPHARYNGEAL HPV P-16 NEGATIVE/ NON-OROPHARYNGEAL

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup129
Treatment B - Platinum Refractory Subgroup66
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup12.4Not reported7.319.4Not reported
Treatment B - Platinum Refractory Subgroup16.7Not reported8.627.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.9
        upper Limit
        42.3
        value
        23.3
      2. group Id
        OG001
        lower Limit
        15.2
        upper Limit
        64.6
        value
        37.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    OROPHARYNGEAL HPV P-16 POSITIVE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        19.4
        value
        12.4
      2. group Id
        OG001
        lower Limit
        8.6
        upper Limit
        27.9
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    OROPHARYNGEAL HPV P-16 NEGATIVE/ NON-OROPHARYNGEAL
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. 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 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