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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Primary Outcome 1 - Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months

CONDITION

• Urinary Bladder Neoplasm
• Neoplasm Metastasis

ELIGIBILITY

Key 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Study Director

Role: Study Director

Affiliation: Nektar Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION