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NCT01866319 · OUTCOME

Percentage of Participants With Overall Survival (OS) at 12 Months

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006) · Source last updated 2020-06-02

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
Month 12

What was measured

OS was defined as the time from randomization to death due to any cause. The percentage of participants with OS (OS rate) at 12 months was reported for each arm. The reported percentage was estimated using a product-limit (Kaplan-Meier) method for censored data; data were censored at the date of cut-off. The primary analysis of OS was performed at the time of the second protocol pre-specified statistical analysis, with data cut-off of 03-Mar-2015.

Analysis population: The ITT population, comprising all participants as randomized to a study arm.

Groups in this outcome

Ipilimumab

Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).

Pembrolizumab Q2W

Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.

Pembrolizumab Q3W

Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.

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

Analysis denominator · Participants

GroupSource count
Ipilimumab278
Pembrolizumab Q2W279
Pembrolizumab Q3W277

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab58.2Not reported51.864.0Not reported
Pembrolizumab Q2W74.1Not reported68.578.9Not reported
Pembrolizumab Q3W68.4Not reported62.573.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00052
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00358
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.67
    ci Pct Value
    95
    ci Upper Limit
    1.22
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.51319
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00052
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00358
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.67
    ci Pct Value
    95
    ci Upper Limit
    1.22
    group Description
    Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.51319
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.8
        upper Limit
        64.0
        value
        58.2
      2. group Id
        OG001
        lower Limit
        68.5
        upper Limit
        78.9
        value
        74.1
      3. group Id
        OG002
        lower Limit
        62.5
        upper Limit
        73.6
        value
        68.4
denoms
  1. counts
    1. group Id
      OG000
      value
      278
    2. group Id
      OG001
      value
      279
    3. group Id
      OG002
      value
      277
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. The percentage of participants with OS (OS rate) at 12 months was reported for each arm. The reported percentage was estimated using a product-limit (Kaplan-Meier) method for censored data; data were censored at the date of cut-off. The primary analysis of OS was performed at the time of the second protocol pre-specified statistical analysis, with data cut-off of 03-Mar-2015.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
    id
    OG000
    title
    Ipilimumab
  2. description
    Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
    id
    OG001
    title
    Pembrolizumab Q2W
  3. description
    Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
    id
    OG002
    title
    Pembrolizumab Q3W
param Type
NUMBER
population Description
The ITT population, comprising all participants as randomized to a study arm.
reporting Status
POSTED
time Frame
Month 12
title
Percentage of Participants With Overall Survival (OS) at 12 Months
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice