Participant flow

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) · Source last updated 2024-08-23

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 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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

   Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort

2. description

   Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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

   Locally Advanced Unresectable cSCC Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         24

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         22

      type

      Sponsor's decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         105

      2. group Id

         FG001

         num Subjects

         54

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Participants That Received a Second Course of Pembrolizumab

   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

         105

      2. group Id

         FG001

         num Subjects

         54

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

There were 2 cohorts in this study and each cohort received the same dose/treatment regimen. Participant flow, baseline characteristics, and outcome measures are presented by cohort. Adverse events were pre-specified to be reported as a single group by intervention for first and second course pembrolizumab.

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Preserved source evidence · Not medical advice