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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | April 29, 2019 | Phase 2 | Interventional |
Primary Outcome 1 - 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
Primary Outcome 1 - Time Frame: Approximately 6 months
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: David Chien, MD
Role: Study Director
Affiliation: Nektar Therapeutics
Name: Nektar Recruitment
Phone: 855-482-8676
Email: StudyInquiry@nektar.com
| Facility | Status | Contact |
|---|---|---|
| Investigator Site - Anchorage Anchorage, Alaska 99503 United States |
Withdrawn | |
| Local Institution - Goodyear Goodyear, Arizona 85338 United States |
Active, not recruiting | |
| Local Institution - Tucson Tucson, Arizona 85710 United States |
Active, not recruiting | |
| Local Institution - Orange Orange, California 92868 United States |
Active, not recruiting | |
| Local Institution - San Francisco San Francisco, California 94143 United States |
Active, not recruiting | |
| Investigator Site - Whittier Whittier, California 90603 United States |
Active, not recruiting | |
| Local Institution - Aurora Aurora, Colorado 80012 United States |
Active, not recruiting | |
| Local Institution - Miami Miami, Florida 33176 United States |
Active, not recruiting | |
| Local Institution - Pensacola Pensacola, Florida 32503 United States |
Active, not recruiting | |
| Local Institution - Sanford Sanford, Florida 32763 United States |
Active, not recruiting | |
| Local Institution - Atlanta Atlanta, Georgia 30322 United States |
Active, not recruiting | |
| Local Institution - Newnan Newnan, Georgia 30265 United States |
Active, not recruiting | |
| Local Institution - Maywood Maywood, Illinois 60153 United States |
Active, not recruiting | |
| Investigator Site - Peoria Peoria, Illinois 61615 United States |
Active, not recruiting | |
| Local Institution - Westwood Westwood, Kansas 66205 United States |
Active, not recruiting | |
| Local Institution - Lexington Lexington, Kentucky 40536 United States |
Active, not recruiting | |
| Investigator Site - Billings Billings, Montana 59102 United States |
Withdrawn | |
| Local Institution - New York New York, New York 10016 United States |
Active, not recruiting | |
| Local Institution - Cincinnati Cincinnati, Ohio 45219 United States |
Active, not recruiting | |
| Local Institution - Portland Portland, Oregon 97239 United States |
Active, not recruiting | |
| Local Institution - Allentown Allentown, Pennsylvania 18103 United States |
Active, not recruiting | |
| Investigator Site - Bethlehem Bethlehem, Pennsylvania 18015 United States |
Active, not recruiting | |
| Local Institution - Philadelphia Philadelphia, Pennsylvania 19107 United States |
Active, not recruiting | |
| Local Institution - Chattanooga Chattanooga, Tennessee 37403 United States |
Active, not recruiting | |
| Local Institution - Houston Houston, Texas 77030 United States |
Active, not recruiting | |
| Local Institution - San Antonio San Antonio, Texas 78229 United States |
Active, not recruiting | |
| Local Institution - Charlottesville Charlottesville, Virginia 22908 United States |
Active, not recruiting | |
| Local Institution - Ciudad Autonoma de Buenos Aire Ciudad Autonoma de Buenos Aire, Buenos Aires C1125ABD Argentina |
Active, not recruiting | |
| Local Institution - Pergamino Pergamino, Buenos Aires 2700 Argentina |
Active, not recruiting | |
| Local Institution - Viedma Viedma, Rio Negro R8500ACE Argentina |
Active, not recruiting | |
| Local Institution - Rosario Rosario, Santa Fe S2000DSK Argentina |
Active, not recruiting | |
| Local Institution - San Miguel De Tucumán San Miguel De Tucumán, Tucumán 4000 Argentina |
Active, not recruiting | |
| Local Institution - Buenos Aires Buenos Aires, C1118AAT Argentina |
Active, not recruiting | |
| Local Institution - Buenos Aires Buenos Aires, C1426ANZ Argentina |
Active, not recruiting | |
| Local Institution - Córdoba Córdoba, X5000HHW Argentina |
Active, not recruiting | |
| Local Institution - Córdoba Córdoba, X5002AOQ Argentina |
Active, not recruiting | |
| Local Institution - Darlinghurst Darlinghurst, New South Wales 2010 Australia |
Active, not recruiting | |
| Investigator Site - Auchenflower Auchenflower, Queensland 4066 Australia |
Active, not recruiting | |
| Local Institution - Southport Southport, Queensland 4215 Australia |
Active, not recruiting | |
| Investigator Site - Kurralta Park Kurralta Park, South Australia 5037 Australia |
Active, not recruiting | |
| Local Institution - Bentleigh East Bentleigh East, Victoria 3165 Australia |
Active, not recruiting | |
| Investigator Site - Nedlands Nedlands, Western Australia 6009 Australia |
Active, not recruiting | |
| Investigator Site - Wien Wien, 1020 Austria |
Active, not recruiting | |
| Local Institution - Wien Wien, 1160 Austria |
Active, not recruiting | |
| Local Institution - Brasschaat Brasschaat, Antwerpen 2930 Belgium |
Active, not recruiting | |
| Local Institution - Edegem Edegem, Antwerpen 2650 Belgium |
Active, not recruiting | |
| Local Institution - Wilrijk Wilrijk, Antwerpen 2610 Belgium |
Active, not recruiting | |
| Local Institution - Kortrijk Kortrijk, Belgium |
Active, not recruiting | |
| Local Institution - Salvador Salvador, Bahia 41820-021 Brazil |
Withdrawn | |
| Local Institution - Ijuí Ijuí, Rio Grande Do Sul 98700-000 Brazil |
Withdrawn | |
| Local Institution - Lajeado Lajeado, Rio Grande Do Sul 95900-000 Brazil |
Withdrawn | |
| Local Institution - Porto Alegre Porto Alegre, Rio Grande Do Sul 90035-903 Brazil |
Withdrawn | |
| Local Institution - Porto Alegre Porto Alegre, Rio Grande Do Sul 90110-270 Brazil |
Withdrawn | |
| Local Institution - Porto Alegre Porto Alegre, Rio Grande Do Sul 91350-200 Brazil |
Withdrawn | |
| Local Institution - São Paulo Barretos, São Paulo 14784-400 Brazil |
Withdrawn | |
| Local Institution - Jaú Jaú, São Paulo 17210-120 Brazil |
Withdrawn | |
| Local Institution - Lages Lages, 88501-001 Brazil |
Withdrawn | |
| Local Institution - São José Do Rio Preto São José Do Rio Preto, 15090-000 Brazil |
Withdrawn | |
| Local Institution - Toronto Toronto, Ontario M5G 2M9 Canada |
Active, not recruiting | |
| Local Institution - Copenhagen Copenhagen, 2100 Denmark |
Active, not recruiting | |
| Local Institution - Næstved Næstved, 4700 Denmark |
Active, not recruiting | |
| Local Institution - Helsinki Helsinki, 00290 Finland |
Active, not recruiting | |
| Local Institution - Caen Caen, Calvados 14076 France |
Active, not recruiting | |
| Local Institution - Hyères Hyères, 83400 France |
Active, not recruiting | |
| Local Institution - Le Mans Le Mans, 72015 France |
Active, not recruiting | |
| Local Institution - Paris Paris, 75908 France |
Active, not recruiting | |
| Local Institution - Saint-Herblain Saint-Herblain, 44805 France |
Active, not recruiting | |
| Local Institution - Strasbourg Strasbourg, 67000 France |
Active, not recruiting | |
| Local Institution - Villejuif Villejuif, 94805 France |
Active, not recruiting | |
| Local Institution - Nürtingen Nürtingen, Baden-Württemberg 72622 Germany |
Active, not recruiting | |
| Local Institution - Tübingen Tübingen, Baden-Württemberg 72076 Germany |
Active, not recruiting | |
| Local Institution - Weiden Weiden, Bavaria 92637 Germany |
Active, not recruiting | |
| Local Institution - Münster Münster, Nordrhein-Westfalen 48149 Germany |
Active, not recruiting | |
| Local Institution - Berlin Berlin, 10117 Germany |
Active, not recruiting | |
| Local Institution - Dresden Dresden, 01307 Germany |
Active, not recruiting | |
| Local Institution - Hamburg Hamburg, 20246 Germany |
Active, not recruiting | |
| Local Institution - Athens Athens, Attiki 115 28 Greece |
Active, not recruiting | |
| Local Institution - Athens Athens, Attiki 145 64 Greece |
Active, not recruiting | |
| Local Institution - Maroúsi Maroúsi, Attiki 151 25 Greece |
Active, not recruiting | |
| Local Institution - Larissa Larissa, 41110 Greece |
Active, not recruiting | |
| Local Institution - Thessaloníki Thessaloníki, 54622 Greece |
Active, not recruiting | |
| Investigator Site - Thessaloníki Thessaloníki, 54645 Greece |
Active, not recruiting | |
| Local Institution - Zerifin Zerifin, HaMerkaz 70300 Israel |
Active, not recruiting | |
| Local Institution - Haifa Haifa, 31096 Israel |
Active, not recruiting | |
| Local Institution - Kfar Saba Kfar Saba, 44281 Israel |
Active, not recruiting | |
| Investigator Site - Petah tikva Petah tikva, 49100 Israel |
Active, not recruiting | |
| Local Institution - Ramat Gan Ramat Gan, 52621 Israel |
Active, not recruiting | |
| Local Institution - Tel Aviv Tel Aviv, 52620 Israel |
Active, not recruiting | |
| Local Institution - Meldola Meldola, Emilia-Romagna 47014 Italy |
Active, not recruiting | |
| Local Institution - Aviano Aviano, Pordenone 33081 Italy |
Active, not recruiting | |
| Local Institution - Arezzo Arezzo, Toscana 52100 Italy |
Active, not recruiting | |
| Local Institution - Milano Milano, 20133 Italy |
Active, not recruiting | |
| Local Institution - Milano Milano, 20162 Italy |
Active, not recruiting | |
| Local Institution - Napoli Napoli, 80131 Italy |
Active, not recruiting | |
| Local Institution - Ciudad de mexico Ciudad de mexico, Distrito Federal 03810 Mexico |
Active, not recruiting | |
| Local Institution - Morelia Morelia, Michoacán 58260 Mexico |
Active, not recruiting | |
| Local Institution - Cuautitlán Izcalli Cuautitlán Izcalli, 54769 Mexico |
Active, not recruiting | |
| Local Institution - Monterrey Monterrey, 64000 Mexico |
Active, not recruiting | |
| Local Institution - Hoofddorp Hoofddorp, Noord-Holland 2134 TM Netherlands |
Active, not recruiting | |
| Local Institution - Amsterdam Amsterdam, 1066 Netherlands |
Active, not recruiting | |
| Local Institution - Groningen Groningen, 9713 GZ Netherlands |
Recruiting | |
| Local Institution - Toruń Toruń, Kujawsko-Pomorskie 87-100 Poland |
Active, not recruiting | |
| Local Institution - Wrocław Wrocław, 53-413 Poland |
Active, not recruiting | |
| Investigator Site - Coimbra Coimbra, 3000-075 Portugal |
Active, not recruiting | |
| Local Institution - Coimbra Coimbra, 3000-075 Portugal |
Active, not recruiting | |
| Local Institution - Lisboa Lisboa, 1649-035 Portugal |
Active, not recruiting | |
| Local Institution - Porto Porto, 4200-072 Portugal |
Active, not recruiting | |
| Local Institution - San Juan San Juan, 00921 Puerto Rico |
Withdrawn | |
| Local Institution - Yaroslavl Yaroslavl, Yaroslavskaya Oblast 150040 Russian Federation |
Active, not recruiting | |
| Local Institution - Obninsk Obninsk, 249036 Russian Federation |
Active, not recruiting | |
| Local Institution - Omsk Omsk, 644013 Russian Federation |
Active, not recruiting | |
| Investigator Site - Pushkin Pushkin, 196603 Russian Federation |
Active, not recruiting | |
| Local Institution - Saint Petersburg Saint Petersburg, 195271 Russian Federation |
Active, not recruiting | |
| Local Institution - Volzhskiy Volzhskiy, 404120 Russian Federation |
Active, not recruiting | |
| Local Institution - Santiago De Compostela Santiago De Compostela, A Coruña 15706 Spain |
Active, not recruiting | |
| Local Institution - Elche Elche, Alicante 03203 Spain |
Active, not recruiting | |
| Local Institution - Barcelona Barcelona, Catalonia 08025 Spain |
Active, not recruiting | |
| Local Institution - Madrid Pozuelo De Alarcón, Madrid 28223 Spain |
Active, not recruiting | |
| Investigator Site - Pamplona Pamplona, Navarra 31008 Spain |
Active, not recruiting | |
| Local Institution - Barcelona Barcelona, 08003 Spain |
Active, not recruiting | |
| Local Institution - Madrid Madrid, 28007 Spain |
Active, not recruiting | |
| Local Institution - Madrid Madrid, 28034 Spain |
Active, not recruiting | |
| Local Institution - Madrid Madrid, 28041 Spain |
Active, not recruiting | |
| Local Institution - Madrid Madrid, 28050 Spain |
Active, not recruiting | |
| Local Institution - Málaga Málaga, 29010 Spain |
Active, not recruiting | |
| Local Institution - Sevilla Sevilla, 41013 Spain |
Active, not recruiting | |
| Local Institution - Valencia Valencia, 46009 Spain |
Active, not recruiting | |
| Local Institution - Ankara Ankara, 6100 Turkey |
Active, not recruiting | |
| Local Institution - Istanbul Istanbul, 34098 Turkey |
Active, not recruiting | |
| Local Institution - Istanbul Istanbul, 34732 Turkey |
Active, not recruiting | |
| Local Institution - İzmir İzmir, 35530 Turkey |
Active, not recruiting | |
| Local Institution - Malatya Malatya, 44280 Turkey |
Active, not recruiting | |
| Local Institution - Wirral Wirral, Cheshire CH63 4JY United Kingdom |
Active, not recruiting | |
| Local Institution - Sutton Sutton, Surrey SM2 5PT United Kingdom |
Active, not recruiting | |
| Local Institution - Leicester Leicester, LE1 5WW United Kingdom |
Active, not recruiting | |
| Local Institution - London London, EC1A 7BE United Kingdom |
Active, not recruiting | |
| Local Institution - London London, SW6 7JT United Kingdom |
Active, not recruiting |
