{"groups":[{"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"},{"description":"Participants receive standard of care surgery alone.","id":"FG001","title":"Arm B: Surgery Alone"},{"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":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"108"},{"groupId":"FG002","numSubjects":"37"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"89"},{"groupId":"FG001","numSubjects":"143"},{"groupId":"FG002","numSubjects":"130"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"166"},{"groupId":"FG001","numSubjects":"259"},{"groupId":"FG002","numSubjects":"170"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"166"},{"groupId":"FG001","numSubjects":"236"},{"groupId":"FG002","numSubjects":"170"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"166"},{"groupId":"FG001","numSubjects":"259"},{"groupId":"FG002","numSubjects":"170"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"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."}