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NCT02760498 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      59
    2. group Id
      BG001
      value
      78
    3. group Id
      BG002
      value
      56
    4. group Id
      BG003
      value
      63
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      167
    7. group Id
      BG006
      value
      432
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
  5. description
    Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
    id
    BG004
    title
    Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
  6. description
    Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
    id
    BG005
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          98
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          43
        7. group Id
          BG006
          value
          130
      title
      >= 65 to < 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          94
        7. group Id
          BG006
          value
          204
      title
      >= 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          37
        7. group Id
          BG006
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          53
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          130
        7. group Id
          BG006
          value
          349
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          62
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          147
        7. group Id
          BG006
          value
          405
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          164
        7. group Id
          BG006
          value
          420
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) included all enrolled participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      59
    2. group Id
      BG001
      value
      78
    3. group Id
      BG002
      value
      56
    4. group Id
      BG003
      value
      63
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      167
    7. group Id
      BG006
      value
      432
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
  5. description
    Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
    id
    BG004
    title
    Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
  6. description
    Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
    id
    BG005
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          98
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          43
        7. group Id
          BG006
          value
          130
      title
      >= 65 to < 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          94
        7. group Id
          BG006
          value
          204
      title
      >= 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          37
        7. group Id
          BG006
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          53
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          130
        7. group Id
          BG006
          value
          349
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          62
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          147
        7. group Id
          BG006
          value
          405
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          164
        7. group Id
          BG006
          value
          420
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) included all enrolled participants.

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Preserved source evidence · Not medical advice