Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03221426 · OUTCOME

Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) · Source last updated 2026-03-09

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 75 months

What was measured

EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.

Analysis population: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified per protocol.

Groups in this outcome

Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined

Neoadjuvant and adjuvant pembrolizumab + XP/FP and neoadjuvant and adjuvant pembrolizumab + FLOT Cohort treatment arms combined

Placebo + XP/FP and Placebo + FLOT Cohort Combined

Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined

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 + XP/FP and Pembrolizumab + FLOT Cohort Combined502
Placebo + XP/FP and Placebo + FLOT Cohort Combined505

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined47.0Not reported36.2NANA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
Placebo + XP/FP and Placebo + FLOT Cohort Combined26.9Not reported22.134.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00589
    p Value Comment
    One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00589
    p Value Comment
    One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
        group Id
        OG000
        lower Limit
        36.2
        upper Limit
        NA
        value
        47.0
      2. group Id
        OG001
        lower Limit
        22.1
        upper Limit
        34.7
        value
        26.9
denoms
  1. counts
    1. group Id
      OG000
      value
      502
    2. group Id
      OG001
      value
      505
    units
    Participants
description
EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.
dispersion Type
95% Confidence Interval
groups
  1. description
    Neoadjuvant and adjuvant pembrolizumab + XP/FP and neoadjuvant and adjuvant pembrolizumab + FLOT Cohort treatment arms combined
    id
    OG000
    title
    Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
  2. description
    Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
    id
    OG001
    title
    Placebo + XP/FP and Placebo + FLOT Cohort Combined
param Type
MEDIAN
population Description
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified per protocol.
reporting Status
POSTED
time Frame
Up to approximately 75 months
title
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice