Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03284424 · OUTCOME

Objective Response Rate (ORR)

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 32 months

What was measured

ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (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 Cohort35.2Not reported26.245.2Not reported
Locally Advanced Unresectable cSCC Cohort51.9Not reported37.865.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.2
        upper Limit
        45.2
        value
        35.2
      2. group Id
        OG001
        lower Limit
        37.8
        upper Limit
        65.7
        value
        51.9
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      54
    units
    Participants
description
ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (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 32 months
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice