{"groups":[{"description":"Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).","id":"FG000","title":"Cohort 1"},{"description":"Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG001","title":"Cohort 2"},{"description":"Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG002","title":"Cohort 3"},{"description":"Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG003","title":"Cohort 4"},{"description":"Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG004","title":"Cohort 5"},{"description":"Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG005","title":"Cohort 6"},{"description":"Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG006","title":"Cohort 7"},{"description":"Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8.\n\nParticipants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.","id":"FG007","title":"Cohort 8"},{"description":"Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled.\n\nDuring the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.","id":"FG008","title":"Cohort 9 Dose Level 1"},{"description":"Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled.\n\nDuring the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.","id":"FG009","title":"Cohort 9 Dose Level 2"},{"description":"Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled.\n\nDuring the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.","id":"FG010","title":"Cohort 9 Dose Level 3"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"35"},{"groupId":"FG005","numSubjects":"12"},{"groupId":"FG006","numSubjects":"35"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"5"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"12"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"2"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"5"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"53"},{"groupId":"FG005","numSubjects":"27"},{"groupId":"FG006","numSubjects":"56"},{"groupId":"FG007","numSubjects":"9"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"comment":"N/A for Cohorts 1-8","groupId":"FG000","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG001","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG002","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG003","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG004","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG005","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG006","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"4"}],"type":"Started Cohort 9 Lead-in Dose-escalation Part"},{"achievements":[{"comment":"N/A for Cohorts 1-8","groupId":"FG000","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG001","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG002","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG003","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG004","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG005","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG006","numSubjects":"0"},{"comment":"N/A for Cohorts 1-8","groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Started Cohort 9 Dose-expansion Part"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"53"},{"groupId":"FG005","numSubjects":"27"},{"groupId":"FG006","numSubjects":"56"},{"groupId":"FG007","numSubjects":"9"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Screening tests and procedures were performed within the 28 days preceding administration of the first dose.","recruitmentDetails":"260 participants were enrolled into this study at investigative sites in the United States."}