Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03189719 · OUTCOME

OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590) · Source last updated 2024-10-15

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 34 months

What was measured

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.

Analysis population: All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.

Groups in this outcome

Pembrolizumab + SOC

Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

Placebo + SOC

Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

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 + SOC186
Placebo + SOC197

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + SOC13.5Not reported11.115.6Not reported
Placebo + SOC9.4Not reported8.010.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Method
    Stratified Log-Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Method
    Stratified Log-Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        15.6
        value
        13.5
      2. group Id
        OG001
        lower Limit
        8.0
        upper Limit
        10.7
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      186
    2. group Id
      OG001
      value
      197
    units
    Participants
description
Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    OG000
    title
    Pembrolizumab + SOC
  2. description
    Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    OG001
    title
    Placebo + SOC
param Type
MEDIAN
population Description
All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.
reporting Status
POSTED
time Frame
Up to approximately 34 months
title
OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice