Kidney Cancer Clinical Trial

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)

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Provide written, informed consent to participate in the study and follow the study procedures
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 sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (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 IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC

Key Exclusion Criteria:

An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
Any tumor invading the wall of a major blood vessels
Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial 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), or clinically significant thromboembolic event within 3 months of randomization

Additional protocol defined inclusion/exclusion criteria and exceptions apply

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

623

Study ID:

NCT03729245

Recruitment Status:

Terminated

Sponsor:

Nektar Therapeutics

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There are 93 Locations for this study

See Locations Near You

Alaska Urological
Anchorage Alaska, 99503, United States
Western Regional Medical Center - CTCA - PPDS
Goodyear Arizona, 85338, United States
CARTI Cancer Center
Little Rock Arkansas, 72205, United States
City of Hope National Medical Center
Duarte California, 91010, United States
University of California Irvine
Orange California, 92868, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
University of Miami
Miami Florida, 33136, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Tulane Medical Center
New Orleans Louisiana, 70112, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89106, United States
North Shore Hematology Oncology Association PC
Port Jefferson Station New York, 11776, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Providence Cancer Institute, Franz Clinic
Portland Oregon, 97213, United States
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
Allentown Pennsylvania, 18103, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Eastern Regional Medical Center - CTCA
Philadelphia Pennsylvania, 19124, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Hospital - PPDS
Salt Lake City Utah, 84112, United States
Centro de Investigación Clínica - Clínica Viedma
Viedma Rio Negro, R8500, Argentina
Centro de Investigación Pergamino S.A
Buenos Aires , 2700, Argentina
Centro Médico Austral
Buenos Aires , C1019, Argentina
Instituto Médico Especializado Alexander Fleming
Buenos Aires , C1426, Argentina
Centro Médico Privado CEMAIC
Córdoba , X5000, Argentina
Sanatorio Allende S.A.
Córdoba , X5000, Argentina
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
Córdoba , X5002, Argentina
Centro Oncologico Riojano Integral (cori)
La Rioja , F5300, Argentina
Hospital Provincial Del Centenario
Rosario , S2002, Argentina
CAIPO Centro para la atención integral del paciente oncológico
San Miguel De Tucumán , 4000, Argentina
Sanatorio Parque de Rosario
Santa Fe , S2000, Argentina
Orange Cancer Centre
Orange New South Wales, 2800, Australia
Royal North Shore Hospital
Saint Leonards New South Wales, 2065, Australia
Macquarie University
Sydney New South Wales, 2109, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Barwon Health
Parkville Victoria, 3050, Australia
Centro de Oncologia Da Bahia
Salvador Bahia, 41820, Brazil
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
Salvador Bahia, 41950, Brazil
Cenantron - Centro Avancado de Tratamento Oncologico Ltda
Belo Horizonte Minas Gerais, 30190, Brazil
Oncocentro, Belo Horizonte
Belo Horizonte Minas Gerais, 30360, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba Parana, 80060, Brazil
Liga Norte Riograndense Contra O Cancer
Natal Rio Grande Do Norte, 59075, Brazil
Associação Hospital de Caridade Ijuí
Ijuí Rio Grande Do Sul, 98700, Brazil
Hospital Bruno Born
Lajeado Rio Grande Do Sul, 95900, Brazil
Universidade Federal do Rio Grande do Sul - UFRGS
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Hospital Mae de Deus
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Clínica de Oncologia de Porto Alegre SS Ltda
Rio Grande Rio Grande Do Sul, 90430, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville Santa Catarina, 89201, Brazil
Fundação Pio XII Hospital de Câncer de Barretos
Barretos Sao Paulo, 14784, Brazil
Hospital das Clinicas - UNICAMP
Campinas Sao Paulo, 13083, Brazil
Fundação do ABC - Faculdade de Medicina do ABC
Santo André Sao Paulo, 09060, Brazil
Hospital Amaral Carvalho
Jaú São Paulo, 17210, Brazil
Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
Caxias Do Sul , 95070, Brazil
Instituto Do Câncer Do Ceará ICC
Fortaleza , 60430, Brazil
Animi
Lages , 88501, Brazil
Instituto Nacional de Câncer
Rio De Janeiro , 20231, Brazil
Instituto COI de Pesquisa, Educação e Gestão
Rio De Janeiro , 22793, Brazil
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
São José Do Rio Preto , 15090, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo , 01323, Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center
São Paulo , 01508, Brazil
Hospital Santa Marcelina
São Paulo , 08270, Brazil
Corporacion de Beneficencia Osorno
Osorno Los Lagos, 53110, Chile
Clinical Research Chile SpA
Valdivia Los Rios, 50900, Chile
Oncovida
Santiago , 75000, Chile
Clinica Santa Maria
Santiago , 75203, Chile
Fundación Arturo López Pérez (FALP) - PPDS
Santiago , 78500, Chile
Centro Investigacion Clinica Del Sur
Temuco , 48103, Chile
Oncocentro APYS
Viña Del Mar , 25206, Chile
Centro de Investigaciones Clínicas Vina del Mar
Viña Del Mar , 25403, Chile
Health Pharma Professional Research S.A de C.V.
Ciudad de Mexico Distrito Federal, 03810, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia Michoacan, 58260, Mexico
Axis Heilsa S. De R.L. de C.V.
Monterrey Nuevo León, 64060, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey , 64000, Mexico
Unidad Médica Onco-Hematológica
Puebla , CP 72, Mexico
Auckland City Hospital
Auckland , 1023, New Zealand
Clinica Peruana Americana
Trujillo La Lobertad, 13000, Peru
Clinica Internacional S.A. - Sede San Borja
Lima , 15036, Peru
ONCOCARE S.A.C. (Clinica Aliada)
Lima , 15036, Peru
Hospital Nacional Cayetano Heredia
Lima , 15102, Peru
Altay Regional Oncology Center
Barnaul , 65604, Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk , 45408, Russian Federation
LLC Evimed
Chelyabinsk , 45408, Russian Federation
Kursk Regional Oncology Centre
Kursk , 30503, Russian Federation
Central Clinical Hospital With Polyclinic of President Administration of RF
Moscow , 12135, 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
Hospital Orkli LLC
Saint Petersburg , 19404, Russian Federation
Railway Clinical Hospital JSC RZhD
Saint Petersburg , 19527, Russian Federation
Hospital Orkli LLC
Saint Petersburg , 19713, Russian Federation
State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
Volzhskiy , 40412, Russian Federation
Regional Clinical Oncology Hospital
Yaroslavl , 15004, Russian Federation
National Cancer Centre
Singapore , 16961, Singapore
Oncocare Cancer Centre
Singapore , 25850, Singapore

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

623

Study ID:

NCT03729245

Recruitment Status:

Terminated

Sponsor:


Nektar Therapeutics

How clear is this clinincal trial information?

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