A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

Last updated: March 17, 2023
Sponsor: Nektar Therapeutics
Overall Status: Terminated

Phase

3

Condition

Renal Cell Carcinoma

Kidney Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT03729245
17-214-09
CA045002
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Provide written, informed consent to participate in the study and follow the studyprocedures
  • Karnofsky Performance Status (KPS) of at least 70%
  • Measurable disease per mRECIST 1.1 criteria
  • Histologically confirmed RCC with a clear-cell component (may have sarcomatoidfeatures); advanced (not amenable to curative surgery or radiation therapy) ormetastatic (AJCC Stage IV) RCC
  • Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDCprognostic factor must be present to qualify as either intermediate- or poor-riskrenal cell carcinoma.
  • No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) forRCC

Exclusion

Key Exclusion Criteria:

  • An active, known or suspected autoimmune disease that has required systemic treatmentwithin the past 3 months (exceptions exist)
  • Patients who have a known additional malignancy that is progressing or requires activetreatment (exceptions exist)
  • Any tumor invading the wall of a major blood vessels
  • Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal orendobronchial tumor within 28 days prior to randomization
  • Need for >2 medications for management of hypertension (including diuretics)
  • History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), orclinically significant thromboembolic event within 3 months of randomization Additional protocol defined inclusion/exclusion criteria and exceptions apply

Study Design

Total Participants: 623
Study Start date:
December 18, 2018
Estimated Completion Date:
October 19, 2022

Connect with a study center

  • Investigator Site - Pergamino

    Pergamino, Buenos Aires 2700
    Argentina

    Site Not Available

  • Fundacion Koriza

    Santa Rosa, La Pampa 6300
    Argentina

    Site Not Available

  • Centro de Investigación Clínica - Clínica Viedma

    Viedma, Rio Negro R8500ACE
    Argentina

    Site Not Available

  • Centro Médico Austral

    Buenos Aires, C1019ABS
    Argentina

    Site Not Available

  • Centro de Investigación Pergamino S.A

    Buenos Aires, 2700
    Argentina

    Site Not Available

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Centro Médico Privado CEMAIC

    Córdoba, X5000HHW
    Argentina

    Site Not Available

  • Sanatorio Allende S.A.

    Córdoba, X5000JHQ
    Argentina

    Site Not Available

  • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

    Córdoba, X5002AOQ
    Argentina

    Site Not Available

  • Centro Oncologico Riojano Integral (cori)

    La Rioja, F5300COE
    Argentina

    Site Not Available

  • Hospital Provincial Del Centenario

    Rosario, S2002KDS
    Argentina

    Site Not Available

  • CAIPO Centro para la atención integral del paciente oncológico

    San Miguel De Tucumán, 4000
    Argentina

    Site Not Available

  • Sanatorio Parque de Rosario

    Santa Fe, S2000DSV
    Argentina

    Site Not Available

  • Orange Cancer Centre

    Orange, New South Wales 2800
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Macquarie University

    Sydney, New South Wales 2109
    Australia

    Site Not Available

  • Adelaide Cancer Centre

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Barwon Health

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Barwon Health

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • St John of God Murdoch Hospital

    Murdoch, Western Australia 6009
    Australia

    Site Not Available

  • Investigator Site - Nedlands

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Centro de Oncologia Da Bahia

    Salvador, Bahia 41820-021
    Brazil

    Site Not Available

  • Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

    Salvador, Bahia 41950-610
    Brazil

    Site Not Available

  • Cenantron - Centro Avancado de Tratamento Oncologico Ltda

    Belo Horizonte, Minas Gerais 30190-130
    Brazil

    Site Not Available

  • Oncocentro, Belo Horizonte

    Belo Horizonte, Minas Gerais 30360-680
    Brazil

    Site Not Available

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba, Parana 80060-900
    Brazil

    Site Not Available

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande Do Norte 59075-740
    Brazil

    Site Not Available

  • Associação Hospital de Caridade Ijuí

    Ijuí, Rio Grande Do Sul 98700-000
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado, Rio Grande Do Sul 95900-000
    Brazil

    Site Not Available

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande Do Sul 90110-270
    Brazil

    Site Not Available

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90050-170
    Brazil

    Site Not Available

  • Universidade Federal do Rio Grande do Sul - UFRGS

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Clínica de Oncologia de Porto Alegre SS Ltda

    Rio Grande, Rio Grande Do Sul 90430-090
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina 89201-260
    Brazil

    Site Not Available

  • Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, Sao Paulo 14784-400
    Brazil

    Site Not Available

  • Hospital das Clinicas - UNICAMP

    Campinas, Sao Paulo 13083-887
    Brazil

    Site Not Available

  • Fundação do ABC - Faculdade de Medicina do ABC

    Santo André, Sao Paulo 09060-650
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho

    Jaú, São Paulo 17210-120
    Brazil

    Site Not Available

  • Instituto de Pesquisas Clínicas Para Estudos Multicêntricos

    Caxias Do Sul, 95070-560
    Brazil

    Site Not Available

  • Instituto Do Câncer Do Ceará ICC

    Fortaleza, 60430-230
    Brazil

    Site Not Available

  • Animi

    Lages, 88501-001
    Brazil

    Site Not Available

  • Instituto COI de Pesquisa, Educação e Gestão

    Rio De Janeiro, 22793-080
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer

    Rio De Janeiro, 20231-050
    Brazil

    Site Not Available

  • Investigator Site - San Paolo

    San Paolo, 01509-900
    Brazil

    Site Not Available

  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

    São José Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundação Antônio Prudente - AC Camargo Câncer Center

    São Paulo, 01508-010
    Brazil

    Site Not Available

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-903
    Brazil

    Site Not Available

  • Hospital Santa Marcelina

    São Paulo, 08270-120
    Brazil

    Site Not Available

  • Corporacion de Beneficencia Osorno

    Osorno, Los Lagos 5311092
    Chile

    Site Not Available

  • Clinical Research Chile SpA

    Valdivia, Los Rios 5090000
    Chile

    Site Not Available

  • Servicios Médicos URUMED SpA

    Rancagua, 2852424
    Chile

    Site Not Available

  • Clinica Santa Maria

    Santiago, 7520349
    Chile

    Site Not Available

  • Fundación Arturo López Pérez (FALP) - PPDS

    Santiago, 7850000
    Chile

    Site Not Available

  • Oncovida

    Santiago, 7500000
    Chile

    Site Not Available

  • Centro Investigacion Clinica Del Sur

    Temuco, 4810371
    Chile

    Site Not Available

  • Centro de Investigaciones Clínicas Vina del Mar

    Viña Del Mar, 2540364
    Chile

    Site Not Available

  • Oncocentro APYS

    Viña Del Mar, 2520612
    Chile

    Site Not Available

  • Investigator Site - Beijing

    Beijing, 100142
    China

    Site Not Available

  • Investigator Site - Medellín

    Medellín, Antioquia 050034
    Colombia

    Site Not Available

  • Investigator Site - Montería

    Montería, Cordoba 110221
    Colombia

    Site Not Available

  • Investigator Site - Bogotá

    Bogotá, 111321
    Colombia

    Site Not Available

  • Investigator Site - Floridablanca

    Floridablanca, 681004
    Colombia

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong, 2031
    Hong Kong

    Site Not Available

  • Health Pharma Professional Research S.A de C.V.

    Ciudad de Mexico, Distrito Federal 03810
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, Michoacan 58260
    Mexico

    Site Not Available

  • Axis Heilsa S. De R.L. de C.V.

    Monterrey, Nuevo León 64060
    Mexico

    Site Not Available

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000
    Mexico

    Site Not Available

  • Unidad Médica Onco-Hematológica

    Puebla, CP 72530
    Mexico

    Site Not Available

  • SOMECO Sociedad de Metabolismo y Corazón S.C.

    Veracruz, 91900
    Mexico

    Site Not Available

  • Farmacooncologia Especializada SA de CV

    Zapopan, 45050
    Mexico

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Clinica Peruana Americana

    Trujillo, La Lobertad 13000
    Peru

    Site Not Available

  • Clinica Internacional S.A. - Sede San Borja

    Lima, 15036
    Peru

    Site Not Available

  • Hospital Nacional Cayetano Heredia

    Lima, 15102
    Peru

    Site Not Available

  • ONCOCARE S.A.C. (Clinica Aliada)

    Lima, 15036
    Peru

    Site Not Available

  • Altay Regional Oncology Center

    Barnaul, 656049
    Russian Federation

    Site Not Available

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • LLC Evimed

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • Kursk Regional Oncology Centre

    Kursk, 305035
    Russian Federation

    Site Not Available

  • Central Clinical Hospital With Polyclinic of President Administration of RF

    Moscow, 121359
    Russian Federation

    Site Not Available

  • Federal State Institution Medical Radiology Research Center

    Obninsk, 249036
    Russian Federation

    Site Not Available

  • Clinical Oncology Dispensary

    Omsk, 644013
    Russian Federation

    Site Not Available

  • PMI Euromedservice

    Pushkin, 196603
    Russian Federation

    Site Not Available

  • Investigator Site - Rostov-on-Don

    Rostov-on-Don, 344037
    Russian Federation

    Site Not Available

  • Hospital Orkli LLC

    Saint Petersburg, 194044
    Russian Federation

    Site Not Available

  • Railway Clinical Hospital JSC RZhD

    Saint Petersburg, 195271
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"

    Volzhskiy, 404120
    Russian Federation

    Site Not Available

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040
    Russian Federation

    Site Not Available

  • National Cancer Centre

    Singapore, 169610
    Singapore

    Site Not Available

  • Oncocare Cancer Centre

    Singapore, 258500
    Singapore

    Site Not Available

  • Alaska Urological

    Anchorage, Alaska 99503
    United States

    Site Not Available

  • Western Regional Medical Center - CTCA - PPDS

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • North Shore Hematology Oncology Association PC

    East Setauket, New York 11733
    United States

    Site Not Available

  • Investigator Site - New York

    New York, New York 10029
    United States

    Site Not Available

  • North Shore Hematology Oncology Association PC

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Kettering Medical Center

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Providence Cancer Institute, Franz Clinic

    Portland, Oregon 97213
    United States

    Site Not Available

  • Lehigh Valley Physician Group (LVPG) - Hematology Oncology

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Investigator Site - Bethlehem

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Eastern Regional Medical Center - CTCA

    Philadelphia, Pennsylvania 19124
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Investigator Site - Chattanooga

    Chattanooga, Tennessee 37401
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Hospital - PPDS

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Virginia Cancer Specialists (Fairfax) - USOR

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Investigator Site - Leesburg

    Leesburg, Virginia 20176
    United States

    Site Not Available

  • Investigator Site - Tacoma

    Tacoma, Washington 98405
    United States

    Site Not Available

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