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BRIEF TITLE: Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients


  • Org Study ID: 18-214-10
  • Secondary ID: CA045-012,2018-003636-79
  • NCT ID: NCT03785925
  • NCT Alias:
  • Sponsor: Nektar Therapeutics - Industry
  • Source: Nektar Therapeutics

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.

Overal Status Start Date Phase Study Type
Recruiting April 29, 2019 Phase 2 Interventional

Primary Outcomes:

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

Condition:

  • Urinary Bladder Neoplasm
  • Neoplasm Metastasis

Eligibility

Criteria:
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

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

Other protocol-defined inclusion/exclusion criteria could apply
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Margit Tagliaferri, MD

Role: Study Director

Affiliation: Nektar Therapeutics

Overall Contact

Name: Nektar Recruitment

Phone: 855-482-8676

Email: StudyInquiry@nektar.com

Locations

Facility Status Contact
Investigator Site - Anchorage
Anchorage, Alaska 99503
United States
Recruiting
Local Institution - Tucson
Tucson, Arizona 85710
United States
Recruiting
Local Institution - Orange
Orange, California 92868
United States
Recruiting
Investigator Site - Whittier
Whittier, California 90603
United States
Recruiting
Local Institution - Aurora
Aurora, Colorado 80012
United States
Recruiting
Local Institution - Pensacola
Pensacola, Florida 32503
United States
Recruiting
Local Institution - Sanford
Sanford, Florida 32763
United States
Recruiting
Local Institution - Atlanta
Atlanta, Georgia 30322
United States
Recruiting
Local Institution - Newnan
Newnan, Georgia 30265
United States
Recruiting
Investigator Site - Peoria
Peoria, Illinois 61615
United States
Recruiting
Investigator Site - Billings
Billings, Montana 59102
United States
Recruiting
Local Institution - Allentown
Allentown, Pennsylvania 18103
United States
Recruiting
Investigator Site - Bethlehem
Bethlehem, Pennsylvania 18015
United States
Recruiting
Local Institution - Philadelphia
Philadelphia, Pennsylvania 19107
United States
Recruiting
Local Institution - Chattanooga
Chattanooga, Tennessee 37403
United States
Recruiting
Local Institution - Houston
Houston, Texas 77030
United States
Recruiting
Local Institution - San Antonio
San Antonio, Texas 78229
United States
Recruiting
Local Institution - Ciudad Autonoma de Buenos Aire
Ciudad Autonoma de Buenos Aire, Buenos Aires C1125ABD
Argentina
Recruiting
Local Institution - Pergamino
Pergamino, Buenos Aires 2700
Argentina
Recruiting
Local Institution - Viedma
Viedma, Rio Negro R8500ACE
Argentina
Recruiting
Local Institution - Rosario
Rosario, Santa Fe S2000DSK
Argentina
Recruiting
Local Institution - San Miguel De Tucumán
San Miguel De Tucumán, Tucumán 4000
Argentina
Recruiting
Local Institution - Buenos Aires
Buenos Aires, C1118AAT
Argentina
Recruiting
Local Institution - Buenos Aires
Buenos Aires, C1426ANZ
Argentina
Recruiting
Local Institution - Córdoba
Córdoba, X5000HHW
Argentina
Recruiting
Local Institution - Córdoba
Córdoba, X5002AOQ
Argentina
Recruiting
Local Institution - Darlinghurst
Darlinghurst, New South Wales 2010
Australia
Recruiting
Investigator Site - Auchenflower
Auchenflower, Queensland 4066
Australia
Recruiting
Local Institution - Southport
Southport, Queensland 4215
Australia
Recruiting
Investigator Site - Kurralta Park
Kurralta Park, South Australia 5037
Australia
Recruiting
Local Institution - Bentleigh East
Bentleigh East, Victoria 3165
Australia
Recruiting
Investigator Site - Nedlands
Nedlands, Western Australia 6009
Australia
Recruiting
Investigator Site - Wien
Wien, 1020
Austria
Recruiting
Local Institution - Brasschaat
Brasschaat, Antwerpen 2930
Belgium
Recruiting
Local Institution - Wilrijk
Wilrijk, Antwerpen 2610
Belgium
Recruiting
Local Institution - Kortrijk
Kortrijk,
Belgium
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 - Copenhagen
Copenhagen, 2100
Denmark
Recruiting
Local Institution - Næstved
Næstved, 4700
Denmark
Recruiting
Local Institution - Helsinki
Helsinki, 00290
Finland
Recruiting
Local Institution - Caen
Caen, Calvados 14076
France
Recruiting
Local Institution - Hyères
Hyères, 83400
France
Recruiting
Local Institution - Le Mans
Le Mans, 72015
France
Recruiting
Local Institution - Paris
Paris, 75908
France
Recruiting
Local Institution - Saint-Herblain
Saint-Herblain, 44805
France
Recruiting
Local Institution - Strasbourg
Strasbourg, 67000
France
Recruiting
Local Institution - Villejuif
Villejuif, 94805
France
Recruiting
Local Institution - Nürtingen
Nürtingen, Baden-Württemberg 72622
Germany
Recruiting
Local Institution - Weiden
Weiden, Bavaria 92637
Germany
Recruiting
Local Institution - Münster
Münster, Nordrhein-Westfalen 48149
Germany
Recruiting
Local Institution - Berlin
Berlin, 10117
Germany
Recruiting
Local Institution - Dresden
Dresden, 01307
Germany
Recruiting
Local Institution - Athens
Athens, Attiki 115 28
Greece
Recruiting
Local Institution - Athens
Athens, Attiki 145 64
Greece
Recruiting
Local Institution - Larissa
Larissa, 41110
Greece
Recruiting
Local Institution - Thessaloníki
Thessaloníki, 54622
Greece
Recruiting
Investigator Site - Thessaloníki
Thessaloníki, 54645
Greece
Recruiting
Local Institution - Zerifin
Zerifin, HaMerkaz 70300
Israel
Recruiting
Local Institution - Haifa
Haifa, 31096
Israel
Recruiting
Local Institution - Kfar Saba
Kfar Saba, 44281
Israel
Recruiting
Investigator Site - Petah tikva
Petah tikva, 49100
Israel
Recruiting
Local Institution - Ramat Gan
Ramat Gan, 52621
Israel
Recruiting
Local Institution - Tel Aviv
Tel Aviv, 52620
Israel
Recruiting
Local Institution - Meldola
Meldola, Emilia-Romagna 47014
Italy
Recruiting
Local Institution - Milano
Milano, 20162
Italy
Recruiting
Local Institution - Napoli
Napoli, 80131
Italy
Recruiting
Local Institution - Morelia
Morelia, Michoacán 58260
Mexico
Recruiting
Local Institution - Cuautitlán Izcalli
Cuautitlán Izcalli, 54769
Mexico
Recruiting
Local Institution - Monterrey
Monterrey, 64000
Mexico
Recruiting
Local Institution - Amsterdam
Amsterdam, 1066
Netherlands
Recruiting
Local Institution - Groningen
Groningen, 9713 GZ
Netherlands
Recruiting
Local Institution - Toruń
Toruń, Kujawsko-Pomorskie 87-100
Poland
Recruiting
Local Institution - Coimbra
Coimbra, 3000-075
Portugal
Recruiting
Local Institution - San Juan
San Juan, 00921
Puerto Rico
Recruiting
Local Institution - Yaroslavl
Yaroslavl, Yaroslavskaya Oblast 150040
Russian Federation
Recruiting
Local Institution - Obninsk
Obninsk, 249036
Russian Federation
Recruiting
Local Institution - Omsk
Omsk, 644013
Russian Federation
Recruiting
Investigator Site - Pushkin
Pushkin, 196603
Russian Federation
Recruiting
Local Institution - Saint Petersburg
Saint Petersburg, 195271
Russian Federation
Recruiting
Local Institution - Volzhskiy
Volzhskiy, 404120
Russian Federation
Recruiting
Local Institution - Elche
Elche, Alicante 03203
Spain
Recruiting
Local Institution - Barcelona
Barcelona, Catalonia 08025
Spain
Recruiting
Local Institution - Madrid
Pozuelo De Alarcón, Madrid 28223
Spain
Recruiting
Investigator Site - Pamplona
Pamplona, Navarra 31008
Spain
Recruiting
Local Institution - Madrid
Madrid, 28007
Spain
Recruiting
Local Institution - Madrid
Madrid, 28034
Spain
Recruiting
Local Institution - Madrid
Madrid, 28041
Spain
Recruiting
Local Institution - Madrid
Madrid, 28050
Spain
Recruiting
Local Institution - Sevilla
Sevilla, 41013
Spain
Recruiting
Local Institution - Valencia
Valencia, 46009
Spain
Recruiting
Local Institution - Ankara
Ankara, 6100
Turkey
Recruiting
Local Institution - Istanbul
Istanbul, 34098
Turkey
Recruiting
Local Institution - Istanbul
Istanbul, 34732
Turkey
Recruiting
Local Institution - İzmir
İzmir, 35530
Turkey
Recruiting
Local Institution - Malatya
Malatya, 44280
Turkey
Recruiting
Local Institution - Leicester
Leicester, LE1 5WW
United Kingdom
Recruiting
Local Institution - London
London, SW6 7JT
United Kingdom
Recruiting