Participant flow

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394) · Source last updated 2025-09-30

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

groups

1. description

   Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus best supportive care (BSC).

   id

   FG000

   title

   Pembrolizumab + BSC

2. description

   Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.

   id

   FG001

   title

   Placebo + BSC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         269

      2. group Id

         FG001

         num Subjects

         145

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         7

      type

      Sponsor Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         300

      2. group Id

         FG001

         num Subjects

         153

      comment

      All randomized participants

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         299

      2. group Id

         FG001

         num Subjects

         153

      comment

      First Course Pembrolizumab

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         0

      comment

      Second Course Pembrolizumab

      type

      Second Course

   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

         300

      2. group Id

         FG001

         num Subjects

         153

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Male and female participants at least 18 years of age with advanced hepatocellular carcinoma (HCC) after progression on or intolerance to sorafenib or oxaliplatin-based chemotherapy with no curative option were enrolled in this study.

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Preserved source evidence · Not medical advice