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NCT02760498 · OUTCOME

Trough Concentration (Ctrough) 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
mg/L
Interval / dispersion
Standard Deviation
Time frame
Up to approximately 43 months

Analysis population: The 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 Q2W53
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W71
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W46
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W58
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 Q3W143

Reported measurements

After the First Dose

Analysis denominator · Participants

GroupSource count
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W53
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W71
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W46
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W58
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 Q3W142
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W21.57.12Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W26.314.3Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W33.632.1Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W32.110.4Not reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W34.114.1Not reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W23.010.9Not 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 Q3W34
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W44
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 Q3W106
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W69.919.3Not reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W67.529.8Not reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W62.728.3Not reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W62.524.1Not reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W65.922.9Not reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W53.320.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.12
        value
        21.5
      2. group Id
        OG001
        spread
        14.3
        value
        26.3
      3. group Id
        OG002
        spread
        32.1
        value
        33.6
      4. group Id
        OG003
        spread
        10.4
        value
        32.1
      5. group Id
        OG004
        spread
        14.1
        value
        34.1
      6. group Id
        OG005
        spread
        10.9
        value
        23.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        71
      3. group Id
        OG002
        value
        46
      4. group Id
        OG003
        value
        58
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        142
      units
      Participants
    title
    After the First Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.3
        value
        69.9
      2. group Id
        OG001
        spread
        29.8
        value
        67.5
      3. group Id
        OG002
        spread
        28.3
        value
        62.7
      4. group Id
        OG003
        spread
        24.1
        value
        62.5
      5. group Id
        OG004
        spread
        22.9
        value
        65.9
      6. group Id
        OG005
        spread
        20.1
        value
        53.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        58
      3. group Id
        OG002
        value
        34
      4. group Id
        OG003
        value
        44
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        106
      units
      Participants
    title
    At Steady State
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      71
    3. group Id
      OG002
      value
      46
    4. group Id
      OG003
      value
      58
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      143
    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 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
Trough Concentration (Ctrough) of Cemiplimab
type
SECONDARY
unit Of Measure
mg/L

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

Preserved source evidence · Not medical advice