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NCT03284424 · OUTCOME

Progression-free Survival (PFS)

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) · Source last updated 2024-08-23

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 56 months

What was measured

PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented.

Analysis population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

Groups in this outcome

Recurrent or Metastatic Cutaneous cSCC Cohort

Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).

Locally Advanced Unresectable cSCC Cohort

Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Recurrent or Metastatic Cutaneous cSCC Cohort105
Locally Advanced Unresectable cSCC Cohort54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Cutaneous cSCC Cohort5.7Not reported3.18.5Not reported
Locally Advanced Unresectable cSCC Cohort14.4Not reported5.543.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        8.5
        value
        5.7
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        43.6
        value
        14.4
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      54
    units
    Participants
description
PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
    id
    OG000
    title
    Recurrent or Metastatic Cutaneous cSCC Cohort
  2. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
    id
    OG001
    title
    Locally Advanced Unresectable cSCC Cohort
param Type
MEDIAN
population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 56 months
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice