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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
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
Study ID: NCT03785925
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
San Francisco VA Medical Center - NAVREF - PPDS, San Francisco, California, United States
Innovative Clinical Research Institute, LLC, Whittier, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Southeastern Regional Medical Center - CTCA - PPDS, Newnan, Georgia, United States
Investigator Site - Peoria, Peoria, Illinois, United States
Laura And Isaac Perlmutter Cancer Center, New York, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Centro de Investigación Clínica - Clínica Viedma, Viedma, Rio Negro, Argentina
Instituto de Oncologia de Rosario, Rosario, Santa Fe, Argentina
CAIPO Centro para la atención integral del paciente oncológico, San Miguel De Tucumán, Tucumán, Argentina
Hospital Alemán, Buenos Aires, , Argentina
Instituto Médico Especializado Alexander Fleming, Buenos Aires, , Argentina
Centro Médico Privado CEMAIC, Córdoba, , Argentina
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A., Córdoba, , Argentina
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Tasman Health Care, Southport, Queensland, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
Monash Health, Monash Medical Centre, Bentleigh East, Victoria, Australia
St John of God Murdoch Hospital, Nedlands, Western Australia, Australia
Algemeen Ziekenhuis Klina, Brasschaat, Antwerpen, Belgium
GasthuisZusters Antwerpen, Wilrijk, Antwerpen, Belgium
AZ Groeninge, Kortrijk, , Belgium
University Health Network, Toronto, Ontario, Canada
Helsingin Yliopistollinen Keskussairaala - PPDS, Helsinki, , Finland
Centre François Baclesse, Caen, Calvados, France
Hôpital Privé TOULON/HYERES Sainte Marguerite, Hyères, , France
Centre Jean Bernard Clinique Victor Hugo, Le Mans, , France
Hôpital Européen Georges Pompidou, Paris, , France
Edog Ico - Ppds, Saint-Herblain, , France
Institut Gustave Roussy, Villejuif, , France
Studienpraxis Urologie, Nürtingen, Baden-Württemberg, Germany
Kliniken Nordoberpfalz AG, Weiden, Bavaria, Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Alexandra Hospital, Athens, Attiki, Greece
Medical Center of Athens, Maroúsi, Attiki, Greece
University General Hospital of Larissa, Larissa, , Greece
Euromedica - PPDS, Thessaloníki, , Greece
Shamir Medical Center Assaf Harofeh, Zerifin, HaMerkaz, Israel
Rambam Medical Center - PPDS, Haifa, , Israel
Meir Medical Center, Kefar Saba, , Israel
Sheba Medical Center - PPDS, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center PPDS, Tel Aviv, , Israel
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola, Emilia-Romagna, Italy
Centro Di Riferimento Oncologico, Aviano, Pordenone, Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
Health Pharma Professional Research S.A de C.V., Ciudad de mexico, Distrito Federal, Mexico
Phylasis Clinicas Research S. de R.L. de C.V., Cuautitlán Izcalli, , Mexico
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra, , Portugal
Regional Clinical Oncology Hospital, Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Federal State Institution Medical Radiology Research Center, Obninsk, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
PMI Euromedservice, Pushkin, , Russian Federation
Railway Clinical Hospital JSC RZhD, Saint Petersburg, , Russian Federation
Hospital General Universitario de Elche, Elche, Alicante, Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal, Pozuelo De Alarcón, Madrid, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Ankara University Medical Faculty - PPDS, Ankara, , Turkey
Izmir Medicalpark Hospital, İzmir, , Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center, Malatya, , Turkey
Royal Marsden Hospital - Surrey, Sutton, Surrey, United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
Name: Study Director
Affiliation: Nektar Therapeutics
Role: STUDY_DIRECTOR