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NCT02559687 · OUTCOME

Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180) · Source last updated 2022-09-14

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 67 months

What was measured

PFS was defined as the time from first day of study treatment to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported per protocol for the first course of treatment.

Analysis population: All allocated participants who received at least 1 dose of study treatment.

Groups in this outcome

Pembrolizumab 200 mg

Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab 200 mg121

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg2.0Not reported1.92.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        2.1
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    units
    Participants
description
PFS was defined as the time from first day of study treatment to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported per protocol for the first course of treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
    id
    OG000
    title
    Pembrolizumab 200 mg
param Type
MEDIAN
population Description
All allocated participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 67 months
title
Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice