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)

PHASE3TerminatedINTERVENTIONAL
Enrollment

623

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

January 7, 2022

Study Completion Date

October 19, 2022

Conditions
Renal Cell CarcinomaMetastatic Renal Cell Carcinoma
Interventions
BIOLOGICAL

bempegaldesleukin

Specified dose on specified days

DRUG

sunitinib

Specified dose on specified days

BIOLOGICAL

nivolumab

Specified dose on specified days

DRUG

cabozantinib

Specified dose on specified days

Trial Locations (96)

1023

Auckland City Hospital, Auckland

2065

Royal North Shore Hospital, Saint Leonards

2109

Macquarie University, Sydney

2700

Centro de Investigación Pergamino S.A, Buenos Aires

2800

Orange Cancer Centre, Orange

3050

Barwon Health, Parkville

4000

CAIPO Centro para la atención integral del paciente oncológico, San Miguel de Tucumán

5037

Adelaide Cancer Centre, Kurralta Park

11776

North Shore Hematology Oncology Association PC, Port Jefferson Station

13000

Clinica Peruana Americana, Trujillo

15036

Clinica Internacional S.A. - Sede San Borja, Lima

ONCOCARE S.A.C. (Clinica Aliada), Lima

15102

Hospital Nacional Cayetano Heredia, Lima

17033

Penn State Milton S Hershey Medical Center, Hershey

18103

Lehigh Valley Physician Group (LVPG) - Hematology Oncology, Allentown

19107

Thomas Jefferson University, Philadelphia

19124

Eastern Regional Medical Center - CTCA, Philadelphia

21201

University of Maryland Greenebaum Cancer Center, Baltimore

30322

Winship Cancer Institute, Emory University, Atlanta

33136

University of Miami, Miami

45429

Kettering Medical Center, Kettering

58260

Centro de Investigacion Clinica Chapultepec S.A. de C.V., Morelia

64000

Accelerium, S. de R.L. de C.V., Monterrey

64060

Axis Heilsa S. De R.L. de C.V., Monterrey

70112

Tulane Medical Center, New Orleans

72205

CARTI Cancer Center, Little Rock

77030

MD Anderson Cancer Center, Houston

84112

Huntsman Cancer Hospital - PPDS, Salt Lake City

85338

Western Regional Medical Center - CTCA - PPDS, Goodyear

89106

Comprehensive Cancer Centers of Nevada, Las Vegas

90603

Innovative Clinical Research Institute, Whittier

91010

City of Hope National Medical Center, Duarte

92868

University of California Irvine, Orange

97213

Providence Cancer Institute, Franz Clinic, Portland

99503

Alaska Urological, Anchorage

121359

Central Clinical Hospital With Polyclinic of President Administration of RF, Moscow

150040

Regional Clinical Oncology Hospital, Yaroslavl

169610

National Cancer Centre, Singapore

194044

Hospital Orkli LLC, Saint Petersburg

195271

Railway Clinical Hospital JSC RZhD, Saint Petersburg

196603

PMI Euromedservice, Pushkin

197136

Hospital Orkli LLC, Saint Petersburg

249036

Federal State Institution Medical Radiology Research Center, Obninsk

258500

Oncocare Cancer Centre, Singapore

305035

Kursk Regional Oncology Centre, Kursk

404120

"State Institution of Healthcare Volgograd Regional Urology and Nephrology Centre", Volzhskiy

454087

Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk

LLC Evimed, Chelyabinsk

644013

Clinical Oncology Dispensary, Omsk

656049

Altay Regional Oncology Center, Barnaul

2520612

Oncocentro APYS, Viña del Mar

2540364

Centro de Investigaciones Clínicas Vina del Mar, Viña del Mar

4810371

Centro Investigacion Clinica Del Sur, Temuco

5090000

Clinical Research Chile SpA, Valdivia

5311092

Corporacion de Beneficencia Osorno, Osorno

7500000

Oncovida, Santiago

7520349

Clinica Santa Maria, Santiago

7850000

Fundación Arturo López Pérez (FALP) - PPDS, Santiago

R8500ACE

Centro de Investigación Clínica - Clínica Viedma, Viedma

C1019ABS

Centro Médico Austral, Buenos Aires

C1426ANZ

Instituto Médico Especializado Alexander Fleming, Buenos Aires

X5000HHW

Centro Médico Privado CEMAIC, Córdoba

X5000JHQ

Sanatorio Allende S.A., Córdoba

X5002AOQ

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

F5300COE

Centro Oncologico Riojano Integral (cori), La Rioja

S2002KDS

Hospital Provincial Del Centenario, Rosario

S2000DSV

Sanatorio Parque de Rosario, Santa Fe

41820-021

Centro de Oncologia Da Bahia, Salvador

41950-610

Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética, Salvador

30190-130

Cenantron - Centro Avancado de Tratamento Oncologico Ltda, Belo Horizonte

30360-680

Oncocentro, Belo Horizonte, Belo Horizonte

80060-900

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba

59075-740

Liga Norte Riograndense Contra O Cancer, Natal

98700-000

Associação Hospital de Caridade Ijuí, Ijuí

95900-000

Hospital Bruno Born, Lajeado

90035-903

Universidade Federal do Rio Grande do Sul - UFRGS, Porto Alegre

90050-170

Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90110-270

Hospital Mae de Deus, Porto Alegre

90610-000

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre

90430-090

Clínica de Oncologia de Porto Alegre SS Ltda, Rio Grande

89201-260

Instituto Joinvilense de Hematologia E Oncologia, Joinville

14784-400

Fundação Pio XII Hospital de Câncer de Barretos, Barretos

13083-887

Hospital das Clinicas - UNICAMP, Campinas

17210-120

Hospital Amaral Carvalho, Jaú

09060-650

Fundação do ABC - Faculdade de Medicina do ABC, Santo André

95070-560

Instituto de Pesquisas Clínicas Para Estudos Multicêntricos, Caxias do Sul

60430-230

Instituto Do Câncer Do Ceará ICC, Fortaleza

88501-001

Animi, Lages

20231-050

Instituto Nacional de Câncer, Rio de Janeiro

22793-080

Instituto COI de Pesquisa, Educação e Gestão, Rio de Janeiro

15090-000

Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto, São José do Rio Preto

01323-903

Hospital Alemão Oswaldo Cruz, São Paulo

01508-010

Fundação Antônio Prudente - AC Camargo Câncer Center, São Paulo

08270-120

Hospital Santa Marcelina, São Paulo

03810

Health Pharma Professional Research S.A de C.V., Mexico City

CP 72530

Unidad Médica Onco-Hematológica, Puebla City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Nektar Therapeutics

INDUSTRY

NCT03729245 - 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) | Biotech Hunter | Biotech Hunter