Participant flow

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006) · Source last updated 2020-06-02

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

groups

1. description

   Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).

   id

   FG000

   title

   Ipilimumab

2. description

   Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.

   id

   FG001

   title

   Pembrolizumab Q2W

3. description

   Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.

   id

   FG002

   title

   Pembrolizumab Q3W

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         9

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Clinical progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         154

      3. group Id

         FG002

         num Subjects

         147

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         8

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         12

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         278

      2. group Id

         FG001

         num Subjects

         279

      3. group Id

         FG002

         num Subjects

         277

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         256

      2. group Id

         FG001

         num Subjects

         278

      3. group Id

         FG002

         num Subjects

         277

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         71

      2. group Id

         FG001

         num Subjects

         101

      3. group Id

         FG002

         num Subjects

         97

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         207

      2. group Id

         FG001

         num Subjects

         178

      3. group Id

         FG002

         num Subjects

         180

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

834 participants were randomized 1:1:1 to receive ipilimumab Q3W, pembrolizumab Q2W, or pembrolizumab Q3W. For participants receiving pembrolizumab, all safety and efficacy results data reported are for the primary pembrolizumab course received.

recruitment Details

Participants with advanced melanoma were recruited to receive ipilimumab once every 3 weeks (Q3W), or a primary course of pembrolizumab administered every 2 weeks (Q2W) or every 3 weeks (Q3W).

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Preserved source evidence · Not medical advice