Participant flow

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590) · Source last updated 2024-10-15

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) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-fluorouracil (5-FU) 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

   id

   FG000

   title

   Pembrolizumab + SOC

2. description

   Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

   id

   FG001

   title

   Placebo + SOC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         325

      2. group Id

         FG001

         num Subjects

         361

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         12

      type

      Sponsor Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         373

      2. group Id

         FG001

         num Subjects

         376

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         370

      2. group Id

         FG001

         num Subjects

         370

      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

         373

      2. group Id

         FG001

         num Subjects

         376

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

749 participants were randomized 1:1 to receive either pembrolizumab plus standard of care (SOC) chemotherapy, or placebo plus SOC chemotherapy.

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

Preserved source evidence · Not medical advice