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NCT02760498 · OUTCOME

ORR 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 108 weeks

What was measured

ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no 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' is the number of participants who 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 Q3W96

Reported measurements

PD-L1 < 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W37
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W40.5Not reported24.857.9Not reported
PD-L1 >= 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W59
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W49.2Not reported35.962.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.8
        upper Limit
        57.9
        value
        40.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    PD-L1 < 1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.9
        upper Limit
        62.5
        value
        49.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    PD-L1 >= 1%
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    units
    Participants
description
ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no 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
NUMBER
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' is the number of participants who 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 108 weeks
title
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice