Bladder Cancer Clinical Trial
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
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.
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 applied
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There are 70 Locations for this study
San Francisco California, 94143, United States
Whittier California, 90603, United States
Aurora Colorado, 80012, United States
Atlanta Georgia, 30322, United States
Newnan Georgia, 30265, United States
Peoria Illinois, 61615, United States
New York New York, 10016, United States
Houston Texas, 77030, United States
Viedma Rio Negro, R8500, Argentina
Rosario Santa Fe, S2000, Argentina
San Miguel De Tucumán Tucumán, 4000, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1426, Argentina
Córdoba , X5000, Argentina
Córdoba , X5002, Argentina
Darlinghurst New South Wales, 2010, Australia
Southport Queensland, 4215, Australia
Kurralta Park South Australia, 5037, Australia
Bentleigh East Victoria, 3165, Australia
Nedlands Western Australia, 6009, Australia
Brasschaat Antwerpen, 2930, Belgium
Wilrijk Antwerpen, 2610, Belgium
Kortrijk , 8500, Belgium
Toronto Ontario, M5G 2, Canada
Helsinki , 00290, Finland
Caen Calvados, 14076, France
Hyères , 83400, France
Le Mans , 72015, France
Paris , 75908, France
Saint-Herblain , 44805, France
Villejuif , 94805, France
Nürtingen Baden-Württemberg, 72622, Germany
Weiden Bavaria, 92637, Germany
Berlin , 10117, Germany
Dresden , 01307, Germany
Athens Attiki, 115 2, Greece
Maroúsi Attiki, 151 2, Greece
Larissa , 41110, Greece
ThessalonÃki , 54645, Greece
Zerifin HaMerkaz, 70300, Israel
Haifa , 31096, Israel
Kefar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 52620, Israel
Meldola Emilia-Romagna, 47014, Italy
Aviano Pordenone, 33081, Italy
Milano , 20133, Italy
Ciudad de mexico Distrito Federal, 03810, Mexico
Cuautitlán Izcalli , 54769, Mexico
Amsterdam , 1066, Netherlands
Coimbra , 3000-, Portugal
Yaroslavl Yaroslavskaya Oblast, 15004, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Pushkin , 19660, Russian Federation
Saint Petersburg , 19527, Russian Federation
Elche Alicante, 03203, Spain
Barcelona Catalonia, 08025, Spain
Pozuelo De Alarcón Madrid, 28223, Spain
Barcelona , 08003, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Ankara , 6100, Turkey
Ä°zmir , 35530, Turkey
Malatya , 44280, Turkey
Sutton Surrey, SM2 5, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
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