Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02823574 · OUTCOME

Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 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. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Analysis population: 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

<1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup52
Treatment B - Platinum Refractory Subgroup31
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup9.53Not reported6.3112.62Not reported
Treatment B - Platinum Refractory Subgroup12.29Not reported6.0820.27Not reported
PD-L1: ≥ 1%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup92
Treatment B - Platinum Refractory Subgroup46
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup10.22Not reported5.9514.52Not reported
Treatment B - Platinum Refractory Subgroup9.02Not reported6.7413.34Not reported
PD-L1: < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup117
Treatment B - Platinum Refractory Subgroup57
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup9.95Not reported7.2611.37Not reported
Treatment B - Platinum Refractory Subgroup8.77Not reported6.2814.78Not reported
PD-L1: ≥ 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup27
Treatment B - Platinum Refractory Subgroup20
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup5.78Not reported2.4348.69Not reported
Treatment B - Platinum Refractory Subgroup10.23Not reported7.0316.66Not reported
PD-L1: <50%

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 Subgroup9.76Not reported6.5111.37Not reported
Treatment B - Platinum Refractory Subgroup10.61Not reported6.7414.26Not reported
PD-L1: > 50%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup15
Treatment B - Platinum Refractory Subgroup11
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup26.02Not reported2.4348.69Not reported
Treatment B - Platinum Refractory Subgroup7.33Not reported1.5116.66Not reported
PD-L1: 1 - < 25%

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup65
Treatment B - Platinum Refractory Subgroup26
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup10.32Not reported5.9814.32Not reported
Treatment B - Platinum Refractory Subgroup7.56Not reported4.8617.51Not reported
Without quantifiable PD-L1 expression at baseline

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Refractory Subgroup15
Treatment B - Platinum Refractory Subgroup5
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup6.93Not reported1.7114.16Not reported
Treatment B - Platinum Refractory Subgroup28.09Not reported7.5644.88Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.31
        upper Limit
        12.62
        value
        9.53
      2. group Id
        OG001
        lower Limit
        6.08
        upper Limit
        20.27
        value
        12.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    <1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.95
        upper Limit
        14.52
        value
        10.22
      2. group Id
        OG001
        lower Limit
        6.74
        upper Limit
        13.34
        value
        9.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        46
      units
      Participants
    title
    PD-L1: ≥ 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.26
        upper Limit
        11.37
        value
        9.95
      2. group Id
        OG001
        lower Limit
        6.28
        upper Limit
        14.78
        value
        8.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    PD-L1: < 25%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.43
        upper Limit
        48.69
        value
        5.78
      2. group Id
        OG001
        lower Limit
        7.03
        upper Limit
        16.66
        value
        10.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    PD-L1: ≥ 25%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.51
        upper Limit
        11.37
        value
        9.76
      2. group Id
        OG001
        lower Limit
        6.74
        upper Limit
        14.26
        value
        10.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    PD-L1: <50%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.43
        upper Limit
        48.69
        value
        26.02
      2. group Id
        OG001
        lower Limit
        1.51
        upper Limit
        16.66
        value
        7.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    PD-L1: > 50%
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.98
        upper Limit
        14.32
        value
        10.32
      2. group Id
        OG001
        lower Limit
        4.86
        upper Limit
        17.51
        value
        7.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    PD-L1: 1 - < 25%
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.71
        upper Limit
        14.16
        value
        6.93
      2. group Id
        OG001
        lower Limit
        7.56
        upper Limit
        44.88
        value
        28.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Without quantifiable PD-L1 expression at baseline
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. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay
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
Platinum refractory subgroup
reporting Status
POSTED
time Frame
From randomization to death. Approximately 63 Months
title
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice