Participant flow

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) · Source last updated 2023-07-27

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

groups

1. description

   Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.

   id

   FG000

   title

   Cohort A - Pembrolizumab 200 mg

2. description

   Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.

   id

   FG001

   title

   Cohort B - Pembrolizumab 200 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         28

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         15

      type

      Transferred to Extension Study

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Site Terminated By Sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      Did Not Continue on Extension Study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         63

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         63

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participant flow as per the database cutoff date of 19FEB2021.

recruitment Details

This study was conducted at 34 clinical sites in 10 countries.

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

Preserved source evidence · Independent clinical review pending · Not medical advice