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.

View Eligibility Criteria

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 will apply

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT03785925

Recruitment Status:

Completed

Sponsor:

Nektar Therapeutics

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There are 70 Locations for this study

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San Francisco VA Medical Center - NAVREF - PPDS
San Francisco California, 94143, United States
Innovative Clinical Research Institute, LLC
Whittier California, 90603, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Southeastern Regional Medical Center - CTCA - PPDS
Newnan Georgia, 30265, United States
Investigator Site - Peoria
Peoria Illinois, 61615, United States
Laura And Isaac Perlmutter Cancer Center
New York New York, 10016, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Centro de Investigación Clínica - Clínica Viedma
Viedma Rio Negro, R8500, Argentina
Instituto de Oncologia de Rosario
Rosario Santa Fe, S2000, Argentina
CAIPO Centro para la atención integral del paciente oncológico
San Miguel De Tucumán Tucumán, 4000, Argentina
Hospital Alemán
Buenos Aires , C1118, Argentina
Instituto Médico Especializado Alexander Fleming
Buenos Aires , C1426, Argentina
Centro Médico Privado CEMAIC
Córdoba , X5000, Argentina
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
Córdoba , X5002, Argentina
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Tasman Health Care
Southport Queensland, 4215, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Monash Health, Monash Medical Centre
Bentleigh East Victoria, 3165, Australia
St John of God Murdoch Hospital
Nedlands Western Australia, 6009, Australia
Algemeen Ziekenhuis Klina
Brasschaat Antwerpen, 2930, Belgium
GasthuisZusters Antwerpen
Wilrijk Antwerpen, 2610, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
University Health Network
Toronto Ontario, M5G 2, Canada
Helsingin Yliopistollinen Keskussairaala - PPDS
Helsinki , 00290, Finland
Centre François Baclesse
Caen Calvados, 14076, France
Hôpital Privé TOULON/HYERES Sainte Marguerite
Hyères , 83400, France
Centre Jean Bernard Clinique Victor Hugo
Le Mans , 72015, France
Hôpital Européen Georges Pompidou
Paris , 75908, France
Edog Ico - Ppds
Saint-Herblain , 44805, France
Institut Gustave Roussy
Villejuif , 94805, France
Studienpraxis Urologie
Nürtingen Baden-Württemberg, 72622, Germany
Kliniken Nordoberpfalz AG
Weiden Bavaria, 92637, Germany
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Alexandra Hospital
Athens Attiki, 115 2, Greece
Medical Center of Athens
Maroúsi Attiki, 151 2, Greece
University General Hospital of Larissa
Larissa , 41110, Greece
Euromedica - PPDS
Thessaloníki , 54645, Greece
Shamir Medical Center Assaf Harofeh
Zerifin HaMerkaz, 70300, Israel
Rambam Medical Center - PPDS
Haifa , 31096, Israel
Meir Medical Center
Kefar Saba , 44281, Israel
Sheba Medical Center - PPDS
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv , 52620, Israel
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola Emilia-Romagna, 47014, Italy
Centro Di Riferimento Oncologico
Aviano Pordenone, 33081, Italy
Istituto Nazionale Dei Tumori
Milano , 20133, Italy
Health Pharma Professional Research S.A de C.V.
Ciudad de mexico Distrito Federal, 03810, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli , 54769, Mexico
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066, Netherlands
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra , 3000-, Portugal
Regional Clinical Oncology Hospital
Yaroslavl Yaroslavskaya Oblast, 15004, Russian Federation
Federal State Institution Medical Radiology Research Center
Obninsk , 24903, Russian Federation
Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
PMI Euromedservice
Pushkin , 19660, Russian Federation
Railway Clinical Hospital JSC RZhD
Saint Petersburg , 19527, Russian Federation
Hospital General Universitario de Elche
Elche Alicante, 03203, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona Catalonia, 08025, Spain
Hospital Universitario Ramon y Cajal
Pozuelo De Alarcón Madrid, 28223, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio - PPDS
Sevilla , 41013, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Ankara University Medical Faculty - PPDS
Ankara , 6100, Turkey
Izmir Medicalpark Hospital
İzmir , 35530, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya , 44280, Turkey
Royal Marsden Hospital - Surrey
Sutton Surrey, SM2 5, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Barts Health NHS Trust
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT03785925

Recruitment Status:

Completed

Sponsor:


Nektar Therapeutics

How clear is this clinincal trial information?

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