A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Purpose
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.
Conditions
- Urinary Bladder Neoplasm
- Neoplasm Metastasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Combination of bempegaldesleukin (NKTR-214) + nivolumab |
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab. |
|
More Details
- Status
- Completed
- Sponsor
- Nektar Therapeutics