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

ArmDescriptionAssigned Intervention
Experimental
Combination of bempegaldesleukin (NKTR-214) + nivolumab 		Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
  • Biological: Bempegaldesleukin
    Specified dose on specified days
    Other names:
    • NKTR-214
    • BMS-986321
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo®
    • BMS-936658

More Details

Status
Completed
Sponsor
Nektar Therapeutics

Study Contact