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NCT02760498 · OUTCOME

Peak Concentration (Cmax) of Cemiplimab

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
milligram per liter (mg/L)
Interval / dispersion
Standard Deviation
Time frame
Up to approximately 43 months

Analysis population: The Pharmacokinetic (PK) analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.

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 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W

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).

Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W

Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 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 Q2W58
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W75
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W52
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W62
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W9
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W162

Reported measurements

After the First Dose

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W58
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W75
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W52
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W62
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W9
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W162
Values in milligram per liter (mg/L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W108147Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W84.1105Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W132203Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W17450.1Not reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W52.918.4Not reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W96.356.2Not reportedNot reportedNot reported
At Steady State

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W38
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W58
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W33
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W41
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W7
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W104
Values in milligram per liter (mg/L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W15183.7Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W14876.6Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W15146.2Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W281235Not reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W17462.2Not reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W14278.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        147
        value
        108
      2. group Id
        OG001
        spread
        105
        value
        84.1
      3. group Id
        OG002
        spread
        203
        value
        132
      4. group Id
        OG003
        spread
        50.1
        value
        174
      5. group Id
        OG004
        spread
        18.4
        value
        52.9
      6. group Id
        OG005
        spread
        56.2
        value
        96.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        75
      3. group Id
        OG002
        value
        52
      4. group Id
        OG003
        value
        62
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        162
      units
      Participants
    title
    After the First Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.7
        value
        151
      2. group Id
        OG001
        spread
        76.6
        value
        148
      3. group Id
        OG002
        spread
        46.2
        value
        151
      4. group Id
        OG003
        spread
        235
        value
        281
      5. group Id
        OG004
        spread
        62.2
        value
        174
      6. group Id
        OG005
        spread
        78.3
        value
        142
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        58
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        41
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        104
      units
      Participants
    title
    At Steady State
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      75
    3. group Id
      OG002
      value
      52
    4. group Id
      OG003
      value
      62
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      162
    units
    Participants
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
  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
    OG004
    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
    OG005
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
param Type
MEAN
population Description
The Pharmacokinetic (PK) analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.
reporting Status
POSTED
time Frame
Up to approximately 43 months
title
Peak Concentration (Cmax) of Cemiplimab
type
SECONDARY
unit Of Measure
milligram per liter (mg/L)

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

Preserved source evidence · Not medical advice