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NCT04221945 · OUTCOME

OS in PD-L1 Positive Participants

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) · Source last updated 2026-02-20

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 55 months

What was measured

OS is the time from randomization to death due to any cause. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS.

Analysis population: All randomized participants analyzed in the treatment group to which they were randomized. PD-L1 positive participants were analyzed.

Groups in this outcome

Chemoradiotherapy + Pembrolizumab

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).

Chemoradiotherapy + Placebo for Pembrolizumab

Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).

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

Analysis denominator · Participants

GroupSource count
Chemoradiotherapy + Pembrolizumab502
Chemoradiotherapy + Placebo for Pembrolizumab498

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiotherapy + PembrolizumabNANot reportedNANANA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
Chemoradiotherapy + Placebo for PembrolizumabNANot reportedNANANA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.

Source statistical analyses

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

  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0083
    p Value Comment
    One-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0083
    p Value Comment
    One-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      502
    2. group Id
      OG001
      value
      498
    units
    Participants
description
OS is the time from randomization to death due to any cause. PD-L1 positive participants have a CPS equal or greater than 1. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    OG000
    title
    Chemoradiotherapy + Pembrolizumab
  2. description
    Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    OG001
    title
    Chemoradiotherapy + Placebo for Pembrolizumab
param Type
MEDIAN
population Description
All randomized participants analyzed in the treatment group to which they were randomized. PD-L1 positive participants were analyzed.
reporting Status
POSTED
time Frame
Up to approximately 55 months
title
OS in PD-L1 Positive Participants
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice