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NCT04221945 · OUTCOME

ORR Per RECIST 1.1 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
Up to approximately 55 months

What was measured

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.

Analysis population: All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers 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 + Pembrolizumab527
Chemoradiotherapy + Placebo for Pembrolizumab531

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiotherapy + Pembrolizumab90.5Not reported87.792.9Not reported
Chemoradiotherapy + Placebo for Pembrolizumab88.3Not reported85.390.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -1.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.9
    estimate Comment
    Pembrolizumab minus Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.
    p Value
    0.1244
    param Type
    Difference in Percentage
    param Value
    2.2
    statistical Method
    One-sided p-value for testing.
Complete source fields
analyses
  1. ci Lower Limit
    -1.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.9
    estimate Comment
    Pembrolizumab minus Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.
    p Value
    0.1244
    param Type
    Difference in Percentage
    param Value
    2.2
    statistical Method
    One-sided p-value for testing.
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.7
        upper Limit
        92.9
        value
        90.5
      2. group Id
        OG001
        lower Limit
        85.3
        upper Limit
        90.9
        value
        88.3
denoms
  1. counts
    1. group Id
      OG000
      value
      527
    2. group Id
      OG001
      value
      531
    units
    Participants
description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.
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. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed.
reporting Status
POSTED
time Frame
Up to approximately 55 months
title
ORR Per RECIST 1.1 as Assessed by BICR
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice