for people ages 18 years and up (full criteria)
study started
estimated completion



The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

Official Title

A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients


Urinary Bladder Neoplasm Neoplasm Metastasis Bladder Bladder Cancer CD122 Cisplatin Ineligible Immuno-oncology Immunotherapy Locally Advanced Urothelial Cancer Metastatic Urothelial Cancer mUC Natural Killer Cells Nivolumab NKTR-214 Opdivo® PD-L1 Urothelial Cancer Urothelial Metastatic Urothelial Carcinoma Urothelial Carcinoma Bempegaldesleukin Urinary Bladder Neoplasms Neoplasms Cisplatin


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Other protocol-defined inclusion/exclusion criteria could apply


  • Local Institution - Orange accepting new patients
    Orange California 92868 United States
  • Investigator Site - Whittier accepting new patients
    Whittier California 90603 United States


accepting new patients
Start Date
Completion Date
Nektar Therapeutics
Phase 2
Study Type
Last Updated