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NCT01866319 · OUTCOME

Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by IRO

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
Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)

What was measured

ORR was defined as the percentage of the participants with a best tumor response of complete response (CR: disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to \<10 mm) or partial response (PR: ≥30% decrease in the sum of diameters of target lesions), based on IRO using RECIST 1.1. The primary analysis of ORR was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.

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
Ipilimumab11.9Not reported8.316.3Not reported
Pembrolizumab Q2W33.7Not reported28.239.6Not reported
Pembrolizumab Q3W32.9Not reported27.438.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    7.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    24.5
    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
    0.00013
    param Type
    Percent difference
    param Value
    16.1
    statistical Method
    Miettinen & Nurmimen
  2. ci Lower Limit
    9.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.6
    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
    0.00002
    param Type
    Percent difference
    param Value
    17.2
    statistical Method
    Miettinen & Nurmimen
  3. ci Lower Limit
    -10.6
    ci Pct Value
    95
    ci Upper Limit
    8.6
    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
    0.82636
    param Type
    Percent difference
    param Value
    -1.1
    statistical Method
    Miettinen & Nurmimen
Complete source fields
analyses
  1. ci Lower Limit
    7.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    24.5
    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
    0.00013
    param Type
    Percent difference
    param Value
    16.1
    statistical Method
    Miettinen & Nurmimen
  2. ci Lower Limit
    9.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.6
    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
    0.00002
    param Type
    Percent difference
    param Value
    17.2
    statistical Method
    Miettinen & Nurmimen
  3. ci Lower Limit
    -10.6
    ci Pct Value
    95
    ci Upper Limit
    8.6
    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
    0.82636
    param Type
    Percent difference
    param Value
    -1.1
    statistical Method
    Miettinen & Nurmimen
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        16.3
        value
        11.9
      2. group Id
        OG001
        lower Limit
        28.2
        upper Limit
        39.6
        value
        33.7
      3. group Id
        OG002
        lower Limit
        27.4
        upper Limit
        38.7
        value
        32.9
denoms
  1. counts
    1. group Id
      OG000
      value
      278
    2. group Id
      OG001
      value
      279
    3. group Id
      OG002
      value
      277
    units
    Participants
description
ORR was defined as the percentage of the participants with a best tumor response of complete response (CR: disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to \<10 mm) or partial response (PR: ≥30% decrease in the sum of diameters of target lesions), based on IRO using RECIST 1.1. The primary analysis of ORR was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.
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
Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)
title
Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by IRO
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice