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NCT03284424 · OUTCOME

Disease Control Rate (DCR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 56 months

What was measured

DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR 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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Cutaneous cSCC Cohort52.4Not reported42.462.2Not reported
Locally Advanced Unresectable cSCC Cohort64.8Not reported50.677.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.4
        upper Limit
        62.2
        value
        52.4
      2. group Id
        OG001
        lower Limit
        50.6
        upper Limit
        77.3
        value
        64.8
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      54
    units
    Participants
description
DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR 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
NUMBER
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
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice