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

A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

INTRODUCTION

  • Org Study ID: 18-214-10
  • Secondary ID: CA045-012, 2018-003636-79
  • NTC ID: NCT03785925
  • Sponsor: Nektar Therapeutics

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 ineligible, locally advanced or metastatic urothelial cancer patients.

  • Overall Status
    Active, not recruiting
  • Start Date
    April 29, 2019
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients whose tumors have low programmed cell death ligand (PD-L1) expression

Primary Outcome 1 - Timeframe: Approximately 18 months

CONDITION

  • Urinary Bladder Neoplasm
  • Neoplasm Metastasis

ELIGIBILITY

Key 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
Key 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 will apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Study Director

Role: Study Director

Affiliation: Nektar Therapeutics

Overall Contact

Name: Study Director

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact