Participant flow

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) · Source last updated 2026-06-30

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

groups

1. description

   Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.

   id

   FG000

   title

   Arm A: Pembrolizumab + Surgery

2. description

   Participants receive standard of care surgery alone.

   id

   FG001

   title

   Arm B: Surgery Alone

3. description

   Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.

   id

   FG002

   title

   Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         108

      3. group Id

         FG002

         num Subjects

         37

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         89

      2. group Id

         FG001

         num Subjects

         143

      3. group Id

         FG002

         num Subjects

         130

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         166

      2. group Id

         FG001

         num Subjects

         259

      3. group Id

         FG002

         num Subjects

         170

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         166

      2. group Id

         FG001

         num Subjects

         236

      3. group Id

         FG002

         num Subjects

         170

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         166

      2. group Id

         FG001

         num Subjects

         259

      3. group Id

         FG002

         num Subjects

         170

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in two stages. In Stage 1, the study included two arms, with participants assigned 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). In Stage 2, Arm C (enfortumab vedotin plus pembrolizumab and surgery) was added per Protocol Amendment 2, and participants were randomized 1:1:1 to Arms A, B, and C. As of Protocol Amendment 8, enrollment to Arm A stopped (except in France per ethics committee request), and randomization continued in Arms B and C only.

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

Preserved source evidence · Not medical advice