{"groups":[{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","id":"FG000","title":"Pembrolizumab + ST Chemotherapy (Pembro Combo)"},{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","id":"FG001","title":"Pembrolizumab (Pembro)"},{"description":"Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","id":"FG002","title":"ST Chemotherapy (Chemo)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"287"},{"groupId":"FG001","numSubjects":"249"},{"groupId":"FG002","numSubjects":"300"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"25"}],"type":"Transferred to Extension Study"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"24"}],"type":"Did Not Continue on Extension Study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"351"},{"groupId":"FG001","numSubjects":"307"},{"groupId":"FG002","numSubjects":"352"}],"type":"STARTED"},{"achievements":[{"comment":"Includes 2 participants randomized to Pembrolizumab alone","groupId":"FG000","numSubjects":"349"},{"groupId":"FG001","numSubjects":"302"},{"groupId":"FG002","numSubjects":"342"}],"type":"Received First Course of Pembrolizumab"},{"achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"0"}],"type":"Received Second Course of Pembrolizumab"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"351"},{"groupId":"FG001","numSubjects":"307"},{"groupId":"FG002","numSubjects":"352"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"1,010 participants were randomized 1:1:1 to receive pembrolizumab plus chemotherapy, pembrolizumab alone, or chemotherapy alone. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.","recruitmentDetails":"Participants with advanced or metastatic urothelial carcinoma were recruited to examine the efficacy and safety of pembrolizumab plus chemotherapy (pembro combo) versus pembrolizumab alone (pembro) or chemotherapy alone (chemo)."}