Participant flow

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) · Source last updated 2026-02-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

   id

   FG000

   title

   Pembrolizumab+Chemotherapy

2. description

   On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

   id

   FG001

   title

   Placebo+Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         16

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         57

      type

      Sponsor Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         194

      2. group Id

         FG001

         num Subjects

         235

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         308

      2. group Id

         FG001

         num Subjects

         309

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         307

      2. group Id

         FG001

         num Subjects

         309

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         0

      type

      Received Second Course of Pembrolizumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         308

      2. group Id

         FG001

         num Subjects

         309

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

883 participants were screened and 617 participants were randomized to receive either Pembrolizumab+Chemotherapy or Placebo+Chemotherapy.

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Preserved source evidence · Not medical advice