A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nektar Therapeutics
With
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
Clareo Health | A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer