Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
Study ID: NCT03729245
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Urological, Anchorage, Alaska, United States
Western Regional Medical Center - CTCA - PPDS, Goodyear, Arizona, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
City of Hope National Medical Center, Duarte, California, United States
University of California Irvine, Orange, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
University of Miami, Miami, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Tulane Medical Center, New Orleans, Louisiana, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
North Shore Hematology Oncology Association PC, Port Jefferson Station, New York, United States
Kettering Medical Center, Kettering, Ohio, United States
Providence Cancer Institute, Franz Clinic, Portland, Oregon, United States
Lehigh Valley Physician Group (LVPG) - Hematology Oncology, Allentown, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Eastern Regional Medical Center - CTCA, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Hospital - PPDS, Salt Lake City, Utah, United States
Centro de Investigación Clínica - Clínica Viedma, Viedma, Rio Negro, Argentina
Centro de Investigación Pergamino S.A, Buenos Aires, , Argentina
Centro Médico Austral, Buenos Aires, , Argentina
Instituto Médico Especializado Alexander Fleming, Buenos Aires, , Argentina
Centro Médico Privado CEMAIC, Córdoba, , Argentina
Sanatorio Allende S.A., Córdoba, , Argentina
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A., Córdoba, , Argentina
Centro Oncologico Riojano Integral (cori), La Rioja, , Argentina
Hospital Provincial Del Centenario, Rosario, , Argentina
CAIPO Centro para la atención integral del paciente oncológico, San Miguel De Tucumán, , Argentina
Sanatorio Parque de Rosario, Santa Fe, , Argentina
Orange Cancer Centre, Orange, New South Wales, Australia
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
Macquarie University, Sydney, New South Wales, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
Barwon Health, Parkville, Victoria, Australia
Centro de Oncologia Da Bahia, Salvador, Bahia, Brazil
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética, Salvador, Bahia, Brazil
Cenantron - Centro Avancado de Tratamento Oncologico Ltda, Belo Horizonte, Minas Gerais, Brazil
Oncocentro, Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Liga Norte Riograndense Contra O Cancer, Natal, Rio Grande Do Norte, Brazil
Associação Hospital de Caridade Ijuí, Ijuí, Rio Grande Do Sul, Brazil
Hospital Bruno Born, Lajeado, Rio Grande Do Sul, Brazil
Universidade Federal do Rio Grande do Sul - UFRGS, Porto Alegre, Rio Grande Do Sul, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Mae de Deus, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Oncologia de Porto Alegre SS Ltda, Rio Grande, Rio Grande Do Sul, Brazil
Instituto Joinvilense de Hematologia E Oncologia, Joinville, Santa Catarina, Brazil
Fundação Pio XII Hospital de Câncer de Barretos, Barretos, Sao Paulo, Brazil
Hospital das Clinicas - UNICAMP, Campinas, Sao Paulo, Brazil
Fundação do ABC - Faculdade de Medicina do ABC, Santo André, Sao Paulo, Brazil
Hospital Amaral Carvalho, Jaú, São Paulo, Brazil
Instituto de Pesquisas Clínicas Para Estudos Multicêntricos, Caxias Do Sul, , Brazil
Instituto Do Câncer Do Ceará ICC, Fortaleza, , Brazil
Animi, Lages, , Brazil
Instituto Nacional de Câncer, Rio De Janeiro, , Brazil
Instituto COI de Pesquisa, Educação e Gestão, Rio De Janeiro, , Brazil
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto, São José Do Rio Preto, , Brazil
Hospital Alemão Oswaldo Cruz, São Paulo, , Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center, São Paulo, , Brazil
Hospital Santa Marcelina, São Paulo, , Brazil
Corporacion de Beneficencia Osorno, Osorno, Los Lagos, Chile
Clinical Research Chile SpA, Valdivia, Los Rios, Chile
Oncovida, Santiago, , Chile
Clinica Santa Maria, Santiago, , Chile
Fundación Arturo López Pérez (FALP) - PPDS, Santiago, , Chile
Centro Investigacion Clinica Del Sur, Temuco, , Chile
Oncocentro APYS, Viña Del Mar, , Chile
Centro de Investigaciones Clínicas Vina del Mar, Viña Del Mar, , Chile
Health Pharma Professional Research S.A de C.V., Ciudad de Mexico, Distrito Federal, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V., Morelia, Michoacan, Mexico
Axis Heilsa S. De R.L. de C.V., Monterrey, Nuevo León, Mexico
Accelerium, S. de R.L. de C.V., Monterrey, , Mexico
Unidad Médica Onco-Hematológica, Puebla, , Mexico
Auckland City Hospital, Auckland, , New Zealand
Clinica Peruana Americana, Trujillo, La Lobertad, Peru
Clinica Internacional S.A. - Sede San Borja, Lima, , Peru
ONCOCARE S.A.C. (Clinica Aliada), Lima, , Peru
Hospital Nacional Cayetano Heredia, Lima, , Peru
Altay Regional Oncology Center, Barnaul, , Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, , Russian Federation
LLC Evimed, Chelyabinsk, , Russian Federation
Kursk Regional Oncology Centre, Kursk, , Russian Federation
Central Clinical Hospital With Polyclinic of President Administration of RF, Moscow, , Russian Federation
Federal State Institution Medical Radiology Research Center, Obninsk, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
PMI Euromedservice, Pushkin, , Russian Federation
Hospital Orkli LLC, Saint Petersburg, , Russian Federation
Railway Clinical Hospital JSC RZhD, Saint Petersburg, , Russian Federation
Hospital Orkli LLC, Saint Petersburg, , Russian Federation
State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre", Volzhskiy, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
National Cancer Centre, Singapore, , Singapore
Oncocare Cancer Centre, Singapore, , Singapore
Contact Details
Name: Study Director
Affiliation: Nektar Therapeutics
Role: STUDY_DIRECTOR
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