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NCT02760498 · OUTCOME

DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)

What was measured

DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.

Analysis population: The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.

Groups in this outcome

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 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W44

Reported measurements

PD-L1 < 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W15
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W31.6Not reported12.6NANot reached due to insufficient number of events
PD-L1 >= 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W29
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3WNANot reportedNANANot reached due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        12.6
        upper Limit
        NA
        value
        31.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    PD-L1 < 1%
  2. categories
    1. measurements
      1. comment
        Not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    PD-L1 >= 1%
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
    id
    OG000
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
param Type
MEDIAN
population Description
The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
reporting Status
POSTED
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
title
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice