Clinical Trials /

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

NCT03785925

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
  • Official Title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: 18-214-10
  • SECONDARY ID: CA045-012
  • SECONDARY ID: 2018-003636-79
  • NCT ID: NCT03785925

Conditions

  • Urinary Bladder Neoplasm
  • Neoplasm Metastasis

Interventions

DrugSynonymsArms
BempegaldesleukinNKTR-214, BMS-986321Combination of bempegaldesleukin (NKTR-214) + nivolumab
NivolumabOpdivo®, BMS-936658Combination of bempegaldesleukin (NKTR-214) + nivolumab

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.

Trial Arms

NameTypeDescriptionInterventions
Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimentalParticipants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
  • Bempegaldesleukin
  • Nivolumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Time Frame:Approximately 18 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:ORR by RECIST 1.1 per BICR in all treated patients
Time Frame:Approximately 18 months
Safety Issue:
Description:
Measure:Duration of Response (DOR) by RECIST 1.1 per BICR in all treated patients and patients whose tumors have low PD-L1 expression
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:ORR and DOR by RECIST 1.1 per Investigator assessment in all treated patients and in patients whose tumors have low PD-L1 expression
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of treatment-related Adverse Events (AEs)
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Nektar Therapeutics

Trial Keywords

  • Bladder
  • Bladder Cancer
  • CD122
  • Cisplatin Ineligible
  • Immuno-oncology
  • Immunotherapy
  • Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer
  • mUC
  • Natural Killer Cells
  • Nivolumab
  • NKTR-214
  • Opdivo®
  • PD-L1
  • Urothelial Cancer
  • Urothelial
  • Metastatic Urothelial Carcinoma
  • Urothelial Carcinoma
  • Bempegaldesleukin
  • BEMPEG
  • CPI Combination
  • IL-2

Last Updated

August 26, 2021