Status:
COMPLETED
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Lead Sponsor:
Nektar Therapeutics
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Urinary Bladder Neoplasm
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ineligib...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT03785925
Start Date
April 29 2019
End Date
June 30 2022
Last Update
March 28 2023
Active Locations (70)
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1
San Francisco VA Medical Center - NAVREF - PPDS
San Francisco, California, United States, 94143
2
Innovative Clinical Research Institute, LLC
Whittier, California, United States, 90603
3
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
4
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322