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