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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.

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
    FG000
    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
    FG001
    title
    Chemoradiotherapy + Placebo for Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        140
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        400
      2. group Id
        FG001
        num Subjects
        372
      type
      Participants Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        529
      2. group Id
        FG001
        num Subjects
        531
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        528
      2. group Id
        FG001
        num Subjects
        530
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        529
      2. group Id
        FG001
        num Subjects
        531
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The following participants were enrolled: had high-risk IB2-IIB (node-positive) or Stage III-IVA locally advanced cervical cancer (LACC); had histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; had not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and was immunotherapy-naïve; had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Complete source fields
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
    FG000
    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
    FG001
    title
    Chemoradiotherapy + Placebo for Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        140
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        400
      2. group Id
        FG001
        num Subjects
        372
      type
      Participants Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        529
      2. group Id
        FG001
        num Subjects
        531
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        528
      2. group Id
        FG001
        num Subjects
        530
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        529
      2. group Id
        FG001
        num Subjects
        531
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The following participants were enrolled: had high-risk IB2-IIB (node-positive) or Stage III-IVA locally advanced cervical cancer (LACC); had histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; had not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and was immunotherapy-naïve; had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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

Preserved source evidence · Not medical advice