Participant flow

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) · Source last updated 2023-07-17

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 intravenous (IV) on Day 1 of each 3-week cycle. 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

2. description

   Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.

   id

   FG001

   title

   Standard Treatment

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         6

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         209

      2. group Id

         FG001

         num Subjects

         217

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         1

      type

      Transferred to Extension Study

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Did Not Continue on Extension Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         20

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         247

      2. group Id

         FG001

         num Subjects

         248

      type

      STARTED

   2. achievements

      1. comment

         1 participant was randomized but did not receive study treatment.

         group Id

         FG000

         num Subjects

         246

      2. comment

         14 participants were randomized but did not receive study treatment.

         group Id

         FG001

         num Subjects

         234

      type

      Received First Course of Pembrolizumab

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      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

         247

      2. group Id

         FG001

         num Subjects

         248

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

495 participants were randomized 1:1 to receive either pembrolizumab or standard treatment. Per protocol, response/progression or adverse events (AEs) that occurred during the second course of pembrolizumab were not counted towards efficacy outcome measures or safety outcome measures, respectively.

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Preserved source evidence · Not medical advice