Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02760498 · OUTCOME

Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 43 months

Analysis population: The Anti-drug Antibody (ADA) population for cemiplimab included all treated participants who had at least 1 postdose ADA result for cemiplimab.

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 Q2W50
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W66
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W41
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W50
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W8
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W133

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W1Not reportedNot reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W0Not reportedNot reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W0Not reportedNot reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W0Not reportedNot reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W0Not reportedNot reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      66
    3. group Id
      OG002
      value
      41
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      133
    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
    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
COUNT_OF_PARTICIPANTS
population Description
The Anti-drug Antibody (ADA) population for cemiplimab included all treated participants who had at least 1 postdose ADA result for cemiplimab.
reporting Status
POSTED
time Frame
Up to approximately 43 months
title
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice