Participant flow

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) · Source last updated 2024-11-29

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

groups

1. description

   Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

   id

   FG000

   title

   Pembrolizumab

2. description

   Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         460

      2. group Id

         FG001

         num Subjects

         459

      type

      Ongoing in Study

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         10

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         17

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         487

      2. group Id

         FG001

         num Subjects

         489

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         483

      2. group Id

         FG001

         num Subjects

         486

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         45

      type

      Re-challenged or Switched-over to Pembrolizumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         487

      2. group Id

         FG001

         num Subjects

         489

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Per protocol, response/progression or adverse events (AEs) during re-challenge/switch-over in Part 2 were not counted towards the recurrence-free survival (RFS) outcome measure or safety outcome measures respectively.

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

Preserved source evidence · Not medical advice