Participant flow

Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052) · Source last updated 2023-03-02

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 by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.

   id

   FG000

   title

   Pembrolizumab 200 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         19

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         25

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         273

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         39

      type

      Participation in study terminated by Sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Screen failure

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         374

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         370

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      Received Second Course Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         374

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results are based on a database cutoff date of 18-February-2022.

recruitment Details

Participants were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, only data generated during the initial course of treatment contributed to efficacy and safety outcome measures.

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

Preserved source evidence · Not medical advice