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NCT01844505 · OUTCOME

Objective Response Rate (ORR) Per Investigator Assessment

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) · Source last updated 2025-05-21

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
From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

What was measured

The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \>=50% of previously involved sites from nadir.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity

Nivolumab + Ipilimumab

Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity

Ipilimumab

Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses

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

Analysis denominator · Participants

GroupSource count
Nivolumab316
Nivolumab + Ipilimumab314
Ipilimumab315

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab44.9Not reported39.450.6Not reported
Nivolumab + Ipilimumab58.3Not reported52.663.8Not reported
Ipilimumab19.0Not reported14.923.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.16
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    3.59
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Lower Limit
    4.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.22
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    6.35
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Lower Limit
    19.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    32.8
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    26.0
  4. ci Lower Limit
    32.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    45.9
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    39.0
  5. ci Lower Limit
    1.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.42
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Odds Ratio (OR)
    param Value
    1.75
  6. ci Lower Limit
    5.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    20.7
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    13.2
Complete source fields
analyses
  1. ci Lower Limit
    2.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.16
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    3.59
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Lower Limit
    4.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.22
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    6.35
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Lower Limit
    19.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    32.8
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    26.0
  4. ci Lower Limit
    32.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    45.9
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    39.0
  5. ci Lower Limit
    1.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.42
    estimate Comment
    Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Odds Ratio (OR)
    param Value
    1.75
  6. ci Lower Limit
    5.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    20.7
    estimate Comment
    Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Difference of Objective Response Rates
    param Value
    13.2
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.4
        upper Limit
        50.6
        value
        44.9
      2. group Id
        OG001
        lower Limit
        52.6
        upper Limit
        63.8
        value
        58.3
      3. group Id
        OG002
        lower Limit
        14.9
        upper Limit
        23.8
        value
        19.0
denoms
  1. counts
    1. group Id
      OG000
      value
      316
    2. group Id
      OG001
      value
      314
    3. group Id
      OG002
      value
      315
    units
    Participants
description
The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \>=50% of previously involved sites from nadir.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
    id
    OG000
    title
    Nivolumab
  2. description
    Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
    id
    OG001
    title
    Nivolumab + Ipilimumab
  3. description
    Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
    id
    OG002
    title
    Ipilimumab
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)
title
Objective Response Rate (ORR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice