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NCT02760498 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma · Source last updated 2025-05-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Up to Cycle 12 Day 1 (Week 89)

What was measured

EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.

Analysis population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number Analyzed" is the number evaluable at each time point. Only Groups 1, 2, 3, and 4 were planned for this outcome measure.

Groups in this outcome

Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W

Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W

Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W

Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W

Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).

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

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W44
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W68
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W38
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W54

Reported measurements

Cycle 2 Day 1 (C2D1)

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W42
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W60
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W34
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W52
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W0.0021.464Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W5.5618.895Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W6.8619.621Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W0.9617.670Not reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W37
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W55
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W30
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W43
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W11.2619.267Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W5.3021.717Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W15.2820.655Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W3.8815.680Not reportedNot reportedNot reported
C4D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W36
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W39
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W29
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W38
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W6.2525.069Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W8.7619.585Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W13.5122.539Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W4.3915.099Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W36
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W41
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W27
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W36
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W4.1722.316Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W8.3321.246Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W13.2721.466Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W5.7918.774Not reportedNot reportedNot reported
C6D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W31
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W44
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W26
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W33
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W5.1117.437Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W5.6828.118Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W12.1824.521Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W0.2521.599Not reportedNot reportedNot reported
C7D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W32
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W40
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W12
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W15
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W6.5117.676Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W9.1722.393Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W22.2223.659Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W4.4418.598Not reportedNot reportedNot reported
C8D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W29
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W33
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W11
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W15
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W4.6021.080Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W10.1021.425Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W30.3019.816Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W5.0025.158Not reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W26
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W29
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W10
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W13
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W6.0918.938Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W6.6126.199Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W26.6724.470Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W7.6920.543Not reportedNot reportedNot reported
C10D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W27
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W23
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W9
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W10
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W12.0420.844Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W13.7726.064Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W28.7013.889Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W5.8322.923Not reportedNot reportedNot reported
C11D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W25
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W19
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W10
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W9
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W10.3328.186Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W11.4022.603Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W32.5014.407Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W14.8119.444Not reportedNot reportedNot reported
C12D1

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W24
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W17
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W9
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W9
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W8.3322.388Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W12.7524.494Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W27.7816.667Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W2.7826.021Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.464
        value
        0.00
      2. group Id
        OG001
        spread
        18.895
        value
        5.56
      3. group Id
        OG002
        spread
        19.621
        value
        6.86
      4. group Id
        OG003
        spread
        17.670
        value
        0.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        60
      3. group Id
        OG002
        value
        34
      4. group Id
        OG003
        value
        52
      units
      Participants
    title
    Cycle 2 Day 1 (C2D1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.267
        value
        11.26
      2. group Id
        OG001
        spread
        21.717
        value
        5.30
      3. group Id
        OG002
        spread
        20.655
        value
        15.28
      4. group Id
        OG003
        spread
        15.680
        value
        3.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        55
      3. group Id
        OG002
        value
        30
      4. group Id
        OG003
        value
        43
      units
      Participants
    title
    C3D1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.069
        value
        6.25
      2. group Id
        OG001
        spread
        19.585
        value
        8.76
      3. group Id
        OG002
        spread
        22.539
        value
        13.51
      4. group Id
        OG003
        spread
        15.099
        value
        4.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        38
      units
      Participants
    title
    C4D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.316
        value
        4.17
      2. group Id
        OG001
        spread
        21.246
        value
        8.33
      3. group Id
        OG002
        spread
        21.466
        value
        13.27
      4. group Id
        OG003
        spread
        18.774
        value
        5.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        27
      4. group Id
        OG003
        value
        36
      units
      Participants
    title
    C5D1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.437
        value
        5.11
      2. group Id
        OG001
        spread
        28.118
        value
        5.68
      3. group Id
        OG002
        spread
        24.521
        value
        12.18
      4. group Id
        OG003
        spread
        21.599
        value
        0.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        44
      3. group Id
        OG002
        value
        26
      4. group Id
        OG003
        value
        33
      units
      Participants
    title
    C6D1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.676
        value
        6.51
      2. group Id
        OG001
        spread
        22.393
        value
        9.17
      3. group Id
        OG002
        spread
        23.659
        value
        22.22
      4. group Id
        OG003
        spread
        18.598
        value
        4.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        15
      units
      Participants
    title
    C7D1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.080
        value
        4.60
      2. group Id
        OG001
        spread
        21.425
        value
        10.10
      3. group Id
        OG002
        spread
        19.816
        value
        30.30
      4. group Id
        OG003
        spread
        25.158
        value
        5.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        15
      units
      Participants
    title
    C8D1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.938
        value
        6.09
      2. group Id
        OG001
        spread
        26.199
        value
        6.61
      3. group Id
        OG002
        spread
        24.470
        value
        26.67
      4. group Id
        OG003
        spread
        20.543
        value
        7.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        13
      units
      Participants
    title
    C9D1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.844
        value
        12.04
      2. group Id
        OG001
        spread
        26.064
        value
        13.77
      3. group Id
        OG002
        spread
        13.889
        value
        28.70
      4. group Id
        OG003
        spread
        22.923
        value
        5.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    C10D1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.186
        value
        10.33
      2. group Id
        OG001
        spread
        22.603
        value
        11.40
      3. group Id
        OG002
        spread
        14.407
        value
        32.50
      4. group Id
        OG003
        spread
        19.444
        value
        14.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        9
      units
      Participants
    title
    C11D1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.388
        value
        8.33
      2. group Id
        OG001
        spread
        24.494
        value
        12.75
      3. group Id
        OG002
        spread
        16.667
        value
        27.78
      4. group Id
        OG003
        spread
        26.021
        value
        2.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        9
      units
      Participants
    title
    C12D1
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      68
    3. group Id
      OG002
      value
      38
    4. group Id
      OG003
      value
      54
    units
    Participants
description
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
    id
    OG000
    title
    Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
  2. description
    Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
    id
    OG001
    title
    Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
  3. description
    Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
    id
    OG002
    title
    Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
  4. description
    Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
    id
    OG003
    title
    Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
param Type
MEAN
population Description
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number Analyzed" is the number evaluable at each time point. Only Groups 1, 2, 3, and 4 were planned for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, Up to Cycle 12 Day 1 (Week 89)
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice