Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

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

Keywords

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

Eligibility

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

Locations

  • Local Institution - San Francisco accepting new patients
    San Francisco California 94143 United States
  • Local Institution - Orange in progress, not accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nektar Therapeutics
ID
NCT03785925
Phase
Phase 2
Study Type
Interventional
Last Updated