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NCT02105636 · OUTCOME

Overall Survival (OS) - Extended Collection

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) · Source last updated 2022-10-05

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 date of randomization to date of death (Up to approximately 87 months)

What was measured

OS 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. Median OS time was calculated using Kaplan-Meier (KM) method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 10-Sep-2021)

Analysis population: All randomized participants

Groups in this outcome

Nivolumab 3mg/kg

Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.

Investigators Choice

Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab 3mg/kg240
Investigators Choice121

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3mg/kg7.72Not reported5.688.74Not reported
Investigators Choice5.06Not reported4.046.24Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    estimate Comment
    Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    estimate Comment
    Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.68
        upper Limit
        8.74
        value
        7.72
      2. group Id
        OG001
        lower Limit
        4.04
        upper Limit
        6.24
        value
        5.06
denoms
  1. counts
    1. group Id
      OG000
      value
      240
    2. group Id
      OG001
      value
      121
    units
    Participants
description
OS 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. Median OS time was calculated using Kaplan-Meier (KM) method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 10-Sep-2021)
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
    id
    OG000
    title
    Nivolumab 3mg/kg
  2. description
    Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
    id
    OG001
    title
    Investigators Choice
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From date of randomization to date of death (Up to approximately 87 months)
title
Overall Survival (OS) - Extended Collection
type
POST_HOC
unit Of Measure
Months

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

Preserved source evidence · Not medical advice