A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

Inclusion Criteria

• Provide written, informed consent to participate in the study and follow the study procedures
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Measurable disease per RECIST 1.1 criteria
• Histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed TCC)
• Fresh biopsy or archival tissue
• No prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC
• Ineligible for cisplatin Key

Exclusion Criteria

• Patients who have an active, known or suspected autoimmune disease
• Patients must not have received prior IL-2 therapy
• Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to Cycle 1 Day 1 Additional protocol-defined inclusion/exclusion criteria applied