A Phase 2, Randomized, Non-Comparative, Open-Label Study of NKTR-214 in Combination With Nivolumab and of Chemotherapy in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients With Low PD-L1 Expression

Uncategorized

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

Condition: Urinary Bladder Neoplasm, Neoplasm Metastasis

Intervention:

  • Biological: Bempegaldesleukin
  • Biological: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03785925

Sponsor: Nektar Therapeutics

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 6 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: ORR by RECIST 1.1 per BICR in all treated patients
  • Time Frame: Approximately 6 months
  • Safety Issue:
  • 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:
  • 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:
  • Measure: Incidence of treatment-related Adverse Events (AEs)
  • Time Frame: Up to 2 years
  • Safety Issue:

Estimated Enrollment: 205

Study Start Date: April 29, 2019

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 Other protocol-defined inclusion/

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 Other protocol-defined inclusion/exclusion criteria could apply

Contact:

  • Nektar Recruitment
  • 855-482-8676

Locations:

  • Investigator Site – Anchorage
  • Anchorage Alaska 99503 United States
  • Investigator Site – Whittier
  • Whittier California 90603 United States
  • Local Institution – Atlanta
  • Atlanta Georgia 30322 United States
  • Investigator Site – Peoria
  • Peoria Illinois 61615 United States
  • Investigator Site – Billings
  • Billings Montana 59102 United States
  • Local Institution – Allentown
  • Allentown Pennsylvania 18103 United States
  • Investigator Site – Bethlehem
  • Bethlehem Pennsylvania 18015 United States
  • Local Institution – Houston
  • Houston Texas 77030 United States
  • Local Institution – Ciudad Autonoma de Buenos Aire
  • Ciudad Autonoma de Buenos Aire Buenos Aires C1125ABD Argentina
  • Local Institution – San Miguel De Tucumán
  • San Miguel De Tucumán Tucumán 4000 Argentina
  • Local Institution – Córdoba
  • Córdoba X5000HHW Argentina
  • Investigator Site – Auchenflower
  • Auchenflower Queensland 4066 Australia
  • Investigator Site – Kurralta Park
  • Kurralta Park South Australia 5037 Australia
  • Local Institution – Bentleigh East
  • Bentleigh East Victoria 3165 Australia
  • Investigator Site – Nedlands
  • Nedlands Western Australia 6009 Australia
  • Investigator Site – Wien
  • Wien 1020 Austria
  • Local Institution – Helsinki
  • Helsinki 00290 Finland
  • Local Institution – Hyères
  • Hyères 83400 France
  • Local Institution – Le Mans
  • Le Mans 72015 France
  • Local Institution – Saint-Herblain
  • Saint-Herblain 44805 France
  • Local Institution – Strasbourg
  • Strasbourg 67000 France
  • Local Institution – Nürtingen
  • Nürtingen Baden-Württemberg 72622 Germany
  • Local Institution – Athens
  • Athens Attiki 115 28 Greece
  • Local Institution – Athens
  • Athens Attiki 145 64 Greece
  • Local Institution – Larissa
  • Larissa 41110 Greece
  • Local Institution – Thessaloníki
  • Thessaloníki 54622 Greece
  • Investigator Site – Thessaloníki
  • Thessaloníki 54645 Greece
  • Local Institution – Zerifin
  • Zerifin HaMerkaz 70300 Israel
  • Local Institution – Haifa
  • Haifa 31096 Israel
  • Local Institution – Kfar Saba
  • Kfar Saba 44281 Israel
  • Investigator Site – Petah tikva
  • Petah tikva 49100 Israel
  • Local Institution – Tel Aviv
  • Tel Aviv 52620 Israel
  • Local Institution – Meldola
  • Meldola Emilia-Romagna 47014 Italy
  • Local Institution – San Juan
  • San Juan 00921 Puerto Rico
  • Local Institution – Yaroslavl
  • Yaroslavl Yaroslavskaya Oblast 150040 Russian Federation
  • Local Institution – Obninsk
  • Obninsk 249036 Russian Federation
  • Local Institution – Omsk
  • Omsk 644013 Russian Federation
  • Investigator Site – Pushkin
  • Pushkin 196603 Russian Federation
  • Local Institution – Saint Petersburg
  • Saint Petersburg 195271 Russian Federation
  • Local Institution – Volzhskiy
  • Volzhskiy 404120 Russian Federation
  • Local Institution – Barcelona
  • Barcelona Catalonia 08025 Spain
  • Local Institution – Madrid
  • Pozuelo De Alarcón Madrid 28223 Spain
  • Investigator Site – Pamplona
  • Pamplona Navarra 31008 Spain
  • Local Institution – Madrid
  • Madrid 28034 Spain
  • Local Institution – Madrid
  • Madrid 28041 Spain
  • Local Institution – Madrid
  • Madrid 28050 Spain
  • Local Institution – Sevilla
  • Sevilla 41013 Spain
  • Local Institution – Ankara
  • Ankara 6100 Turkey
  • Local Institution – Istanbul
  • Istanbul 34732 Turkey
  • Local Institution – Malatya
  • Malatya 44280 Turkey

View trial on ClinicalTrials.gov

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