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NCT02760498 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        23
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Non-compliance with study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        6
      type
      Participant decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Sponsor decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        18
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        55
      type
      Disease progression
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      type
      Withdrawal by Subject
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Other than specified
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        167
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        165
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        50
      type
      Completed Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        64
      comment
      Completed Study
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        34
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 432 participants with advanced cutaneous squamous cell carcinoma (CSCC) (metastatic CSCC \[mCSCC\] or locally advanced CSCC \[laCSCC\]) were enrolled.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        23
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Non-compliance with study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        6
      type
      Participant decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Sponsor decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        18
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        55
      type
      Disease progression
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        6
      type
      Withdrawal by Subject
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Other than specified
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        167
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        165
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        50
      type
      Completed Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        64
      comment
      Completed Study
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        34
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 432 participants with advanced cutaneous squamous cell carcinoma (CSCC) (metastatic CSCC \[mCSCC\] or locally advanced CSCC \[laCSCC\]) were enrolled.

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Preserved source evidence · Not medical advice