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NCT02823574 · OUTCOME

Overall Survival (OS) - 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
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.

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

Positive

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup30
Treatment B - Platinum Refractory Subgroup16
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup13.93Not reported5.9833.81Not reported
Treatment B - Platinum Refractory Subgroup14.32Not reported6.2844.88Not reported
Negative

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup129
Treatment B - Platinum Refractory Subgroup66
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup9.36Not reported5.9810.87Not reported
Treatment B - Platinum Refractory Subgroup9.59Not reported6.9313.40Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.98
        upper Limit
        33.81
        value
        13.93
      2. group Id
        OG001
        lower Limit
        6.28
        upper Limit
        44.88
        value
        14.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.98
        upper Limit
        10.87
        value
        9.36
      2. group Id
        OG001
        lower Limit
        6.93
        upper Limit
        13.40
        value
        9.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    Negative
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.
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 HPV p-16 Status
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice