This study is in progress, not accepting new patients

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

a study on Bladder Cancer Urinary Bladder Tumor Neoplasm Metastasis Transitional Cell Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Vadim Koshkin
Photo of Vadim Koshkin
Vadim Koshkin

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 BEMPEG CPI Combination IL-2 Neoplasms Urinary Bladder 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

Additional protocol-defined inclusion/exclusion criteria will apply

Locations

  • San Francisco VA Medical Center - NAVREF - PPDS
    San Francisco California 94143 United States
  • Innovative Clinical Research Institute, LLC
    Whittier California 90603 United States

Lead Scientist at UCSF

  • Vadim Koshkin
    I am a genitourinary medical oncologist and in this capacity I specialize in caring for patients with bladder, prostate, kidney and testicular cancers.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nektar Therapeutics
ID
NCT03785925
Phase
Phase 2
Study Type
Interventional
Last Updated