Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
Description
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Interventions
Procedure: RC + PLND
Drug: Gemcitabine
Drug: Cisplatin
ACTIVE_COMPARATOR
Description
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Interventions
Procedure: RC + PLND
Drug: Gemcitabine
Drug: Cisplatin
Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
Description
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Interventions
Biological: Pembrolizumab
Biological: Enfortumab vedotin (EV)
Procedure: RC + PLND
EXPERIMENTAL
Description
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Interventions
Biological: Pembrolizumab
Biological: Enfortumab vedotin (EV)
Procedure: RC + PLND