Participant flow

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) · Source last updated 2023-04-13

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). 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 Monotherapy (Pembro Mono)

2. description

   Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. 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

   FG001

   title

   Pembrolizumab + SOC Chemotherapy (Pembro Combo)

3. description

   Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

   id

   FG002

   title

   Placebo + SOC Chemotherapy (SOC)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         224

      2. group Id

         FG001

         num Subjects

         214

      3. group Id

         FG002

         num Subjects

         225

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Screen Failure

   5. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         6

      type

      Transferred to Extension Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         4

      type

      Did Not Continue on Extension Study

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         15

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         256

      2. group Id

         FG001

         num Subjects

         257

      3. group Id

         FG002

         num Subjects

         250

      type

      STARTED

   2. achievements

      1. comment

         1 participant randomized to the pembro combo arm received pembrolizumab monotherapy by mistake.

         group Id

         FG000

         num Subjects

         254

      2. group Id

         FG001

         num Subjects

         250

      3. group Id

         FG002

         num Subjects

         244

      type

      Received First Course of Pembrolizumab

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         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

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         256

      2. group Id

         FG001

         num Subjects

         257

      3. group Id

         FG002

         num Subjects

         250

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of 1,787 screened, 763 were randomized 1:1:1 to the pembrolizumab monotherapy (pembro mono) arm, pembrolizumab plus standard of care (SOC) chemotherapy (pembro combo) arm, or placebo plus SOC chemotherapy (SOC) arm. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.

recruitment Details

Participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who were programmed death-ligand 1 (PD-L1)-positive (Combined Positive Score \[CPS\]≥1) and human epidermal growth factor receptor 2 (HER2/neu)-negative were recruited to the study.

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Preserved source evidence · Not medical advice