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NCT02823574 · OUTCOME

Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

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 disease progression or death. Approximately 63 Months

What was measured

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Analysis population: Platinum Refractory subgroup all randomized

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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Refractory Subgroup2.50Not reported1.452.76Not reported
Treatment B - Platinum Refractory Subgroup2.60Not reported1.543.38Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.41
    estimate Comment
    computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.05
Complete source fields
analyses
  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.41
    estimate Comment
    computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.05
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.76
        value
        2.50
      2. group Id
        OG001
        lower Limit
        1.54
        upper Limit
        3.38
        value
        2.60
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      82
    units
    Participants
description
The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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 all randomized
reporting Status
POSTED
time Frame
From randomization to disease progression or death. Approximately 63 Months
title
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice