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NCT02760498 · OUTCOME

Number of Participants With Any Treatment Emergent Adverse Event (TEAE)

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 108 weeks plus 105 days (5 half-lives)

What was measured

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Analysis population: The Safety Analysis Set (SAF) included all enrolled participants who received at least one dose of study drug.

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 Q2W59
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W78
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W56
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W63
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 Q3W165

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W59Not reportedNot reportedNot reportedNot reported
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W78Not reportedNot reportedNot reportedNot reported
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W55Not reportedNot reportedNot reportedNot reported
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W63Not reportedNot reportedNot reportedNot reported
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W9Not reportedNot reportedNot reportedNot reported
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W163Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        78
      3. group Id
        OG002
        value
        55
      4. group Id
        OG003
        value
        63
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        163
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    2. group Id
      OG001
      value
      78
    3. group Id
      OG002
      value
      56
    4. group Id
      OG003
      value
      63
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      165
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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 Safety Analysis Set (SAF) included all enrolled participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Up to 108 weeks plus 105 days (5 half-lives)
title
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice