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NCT04221945 · OUTCOME

PFS Per RECIST 1.1 at Month 24 as Assessed by BICR

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
24 months

What was measured

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by BICR is presented.

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

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 + Pembrolizumab529
Chemoradiotherapy + Placebo for Pembrolizumab531

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiotherapy + Pembrolizumab76.0Not reported72.079.5Not reported
Chemoradiotherapy + Placebo for Pembrolizumab68.1Not reported63.872.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.5
    estimate Comment
    Pembrolizumab minus Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Difference in Survival Rate
    param Value
    7.9
Complete source fields
analyses
  1. ci Lower Limit
    2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.5
    estimate Comment
    Pembrolizumab minus Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Difference in Survival Rate
    param Value
    7.9
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.0
        upper Limit
        79.5
        value
        76.0
      2. group Id
        OG001
        lower Limit
        63.8
        upper Limit
        72.0
        value
        68.1
denoms
  1. counts
    1. group Id
      OG000
      value
      529
    2. group Id
      OG001
      value
      531
    units
    Participants
description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by BICR is presented.
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
NUMBER
population Description
All randomized participants analyzed in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
24 months
title
PFS Per RECIST 1.1 at Month 24 as Assessed by BICR
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice