A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
NCT ID: NCT03785925
Last Updated: 2023-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2019-04-29
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination of bempegaldesleukin (NKTR-214) + nivolumab
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Bempegaldesleukin
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Bempegaldesleukin
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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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, Río Negro Province, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, Argentina
CAIPO Centro para la atención integral del paciente oncológico
San Miguel de Tucumán, Tucumán Province, 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-Wurttemberg, 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, Attica, Greece
Medical Center of Athens
Marousi, Attica, Greece
University General Hospital of Larissa
Larissa, , Greece
Euromedica - PPDS
Thessaloniki, , Greece
Shamir Medical Center Assaf Harofeh
Ẕerifin, Central District, Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Meir Medical Center
Kfar 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
Milan, , Italy
Health Pharma Professional Research S.A de C.V.
Mexico City, Mexico City, 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, Yaroslavl Oblast, Russia
Federal State Institution Medical Radiology Research Center
Obninsk, , Russia
Clinical Oncology Dispensary
Omsk, , Russia
PMI Euromedservice
Pushkin, , Russia
Railway Clinical Hospital JSC RZhD
Saint Petersburg, , Russia
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
Seville, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Ankara University Medical Faculty - PPDS
Ankara, , Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, , Turkey (Türkiye)
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
Royal Marsden Hospital - Surrey
Sutton, Surrey, United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CA045-012
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003636-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18-214-10
Identifier Type: -
Identifier Source: org_study_id
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