Phase
Condition
Renal Cell Carcinoma
Kidney Cancer
Carcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Investigator Site - Pergamino
Pergamino, Buenos Aires 2700
ArgentinaSite Not Available
Fundacion Koriza
Santa Rosa, La Pampa 6300
ArgentinaSite Not Available
Centro de Investigación Clínica - Clínica Viedma
Viedma, Rio Negro R8500ACE
ArgentinaSite Not Available
Centro Médico Austral
Buenos Aires, C1019ABS
ArgentinaSite Not Available
Centro de Investigación Pergamino S.A
Buenos Aires, 2700
ArgentinaSite Not Available
Instituto Médico Especializado Alexander Fleming
Buenos Aires, C1426ANZ
ArgentinaSite Not Available
Centro Médico Privado CEMAIC
Córdoba, X5000HHW
ArgentinaSite Not Available
Sanatorio Allende S.A.
Córdoba, X5000JHQ
ArgentinaSite Not Available
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
Córdoba, X5002AOQ
ArgentinaSite Not Available
Centro Oncologico Riojano Integral (cori)
La Rioja, F5300COE
ArgentinaSite Not Available
Hospital Provincial Del Centenario
Rosario, S2002KDS
ArgentinaSite Not Available
CAIPO Centro para la atención integral del paciente oncológico
San Miguel De Tucumán, 4000
ArgentinaSite Not Available
Sanatorio Parque de Rosario
Santa Fe, S2000DSV
ArgentinaSite Not Available
Orange Cancer Centre
Orange, New South Wales 2800
AustraliaSite Not Available
Royal North Shore Hospital
Saint Leonards, New South Wales 2065
AustraliaSite Not Available
Macquarie University
Sydney, New South Wales 2109
AustraliaSite Not Available
Adelaide Cancer Centre
Kurralta Park, South Australia 5037
AustraliaSite Not Available
Barwon Health
Geelong, Victoria 3220
AustraliaSite Not Available
Barwon Health
Parkville, Victoria 3050
AustraliaSite Not Available
St John of God Murdoch Hospital
Murdoch, Western Australia 6009
AustraliaSite Not Available
Investigator Site - Nedlands
Nedlands, Western Australia 6009
AustraliaSite Not Available
Centro de Oncologia Da Bahia
Salvador, Bahia 41820-021
BrazilSite Not Available
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
Salvador, Bahia 41950-610
BrazilSite Not Available
Cenantron - Centro Avancado de Tratamento Oncologico Ltda
Belo Horizonte, Minas Gerais 30190-130
BrazilSite Not Available
Oncocentro, Belo Horizonte
Belo Horizonte, Minas Gerais 30360-680
BrazilSite Not Available
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Parana 80060-900
BrazilSite Not Available
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande Do Norte 59075-740
BrazilSite Not Available
Associação Hospital de Caridade Ijuí
Ijuí, Rio Grande Do Sul 98700-000
BrazilSite Not Available
Hospital Bruno Born
Lajeado, Rio Grande Do Sul 95900-000
BrazilSite Not Available
Hospital Mae de Deus
Porto Alegre, Rio Grande Do Sul 90110-270
BrazilSite Not Available
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90050-170
BrazilSite Not Available
Universidade Federal do Rio Grande do Sul - UFRGS
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Clínica de Oncologia de Porto Alegre SS Ltda
Rio Grande, Rio Grande Do Sul 90430-090
BrazilSite Not Available
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Santa Catarina 89201-260
BrazilSite Not Available
Fundação Pio XII Hospital de Câncer de Barretos
Barretos, Sao Paulo 14784-400
BrazilSite Not Available
Hospital das Clinicas - UNICAMP
Campinas, Sao Paulo 13083-887
BrazilSite Not Available
Fundação do ABC - Faculdade de Medicina do ABC
Santo André, Sao Paulo 09060-650
BrazilSite Not Available
Hospital Amaral Carvalho
Jaú, São Paulo 17210-120
BrazilSite Not Available
Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
Caxias Do Sul, 95070-560
BrazilSite Not Available
Instituto Do Câncer Do Ceará ICC
Fortaleza, 60430-230
BrazilSite Not Available
Animi
Lages, 88501-001
BrazilSite Not Available
Instituto COI de Pesquisa, Educação e Gestão
Rio De Janeiro, 22793-080
BrazilSite Not Available
Instituto Nacional de Câncer
Rio De Janeiro, 20231-050
BrazilSite Not Available
Investigator Site - San Paolo
San Paolo, 01509-900
BrazilSite Not Available
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
São José Do Rio Preto, 15090-000
BrazilSite Not Available
Fundação Antônio Prudente - AC Camargo Câncer Center
São Paulo, 01508-010
BrazilSite Not Available
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-903
BrazilSite Not Available
Hospital Santa Marcelina
São Paulo, 08270-120
BrazilSite Not Available
Corporacion de Beneficencia Osorno
Osorno, Los Lagos 5311092
ChileSite Not Available
Clinical Research Chile SpA
Valdivia, Los Rios 5090000
ChileSite Not Available
Servicios Médicos URUMED SpA
Rancagua, 2852424
ChileSite Not Available
Clinica Santa Maria
Santiago, 7520349
ChileSite Not Available
Fundación Arturo López Pérez (FALP) - PPDS
Santiago, 7850000
ChileSite Not Available
Oncovida
Santiago, 7500000
ChileSite Not Available
Centro Investigacion Clinica Del Sur
Temuco, 4810371
ChileSite Not Available
Centro de Investigaciones Clínicas Vina del Mar
Viña Del Mar, 2540364
ChileSite Not Available
Oncocentro APYS
Viña Del Mar, 2520612
ChileSite Not Available
Investigator Site - Beijing
Beijing, 100142
ChinaSite Not Available
Investigator Site - Medellín
Medellín, Antioquia 050034
ColombiaSite Not Available
Investigator Site - Montería
Montería, Cordoba 110221
ColombiaSite Not Available
Investigator Site - Bogotá
Bogotá, 111321
ColombiaSite Not Available
Investigator Site - Floridablanca
Floridablanca, 681004
ColombiaSite Not Available
Prince of Wales Hospital
Hong Kong, 2031
Hong KongSite Not Available
Health Pharma Professional Research S.A de C.V.
Ciudad de Mexico, Distrito Federal 03810
MexicoSite Not Available
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Michoacan 58260
MexicoSite Not Available
Axis Heilsa S. De R.L. de C.V.
Monterrey, Nuevo León 64060
MexicoSite Not Available
Accelerium, S. de R.L. de C.V.
Monterrey, 64000
MexicoSite Not Available
Unidad Médica Onco-Hematológica
Puebla, CP 72530
MexicoSite Not Available
SOMECO Sociedad de Metabolismo y Corazón S.C.
Veracruz, 91900
MexicoSite Not Available
Farmacooncologia Especializada SA de CV
Zapopan, 45050
MexicoSite Not Available
Auckland City Hospital
Auckland, 1023
New ZealandSite Not Available
Christchurch Hospital
Christchurch, 8011
New ZealandSite Not Available
Clinica Peruana Americana
Trujillo, La Lobertad 13000
PeruSite Not Available
Clinica Internacional S.A. - Sede San Borja
Lima, 15036
PeruSite Not Available
Hospital Nacional Cayetano Heredia
Lima, 15102
PeruSite Not Available
ONCOCARE S.A.C. (Clinica Aliada)
Lima, 15036
PeruSite Not Available
Altay Regional Oncology Center
Barnaul, 656049
Russian FederationSite Not Available
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087
Russian FederationSite Not Available
LLC Evimed
Chelyabinsk, 454087
Russian FederationSite Not Available
Kursk Regional Oncology Centre
Kursk, 305035
Russian FederationSite Not Available
Central Clinical Hospital With Polyclinic of President Administration of RF
Moscow, 121359
Russian FederationSite Not Available
Federal State Institution Medical Radiology Research Center
Obninsk, 249036
Russian FederationSite Not Available
Clinical Oncology Dispensary
Omsk, 644013
Russian FederationSite Not Available
PMI Euromedservice
Pushkin, 196603
Russian FederationSite Not Available
Investigator Site - Rostov-on-Don
Rostov-on-Don, 344037
Russian FederationSite Not Available
Hospital Orkli LLC
Saint Petersburg, 194044
Russian FederationSite Not Available
Railway Clinical Hospital JSC RZhD
Saint Petersburg, 195271
Russian FederationSite Not Available
State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
Volzhskiy, 404120
Russian FederationSite Not Available
Regional Clinical Oncology Hospital
Yaroslavl, 150040
Russian FederationSite Not Available
National Cancer Centre
Singapore, 169610
SingaporeSite Not Available
Oncocare Cancer Centre
Singapore, 258500
SingaporeSite Not Available
Alaska Urological
Anchorage, Alaska 99503
United StatesSite Not Available
Western Regional Medical Center - CTCA - PPDS
Goodyear, Arizona 85338
United StatesSite Not Available
CARTI Cancer Center
Little Rock, Arkansas 72205
United StatesSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of California Irvine
Orange, California 92868
United StatesSite Not Available
Innovative Clinical Research Institute
Whittier, California 90603
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Tulane Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89052
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89106
United StatesSite Not Available
North Shore Hematology Oncology Association PC
East Setauket, New York 11733
United StatesSite Not Available
Investigator Site - New York
New York, New York 10029
United StatesSite Not Available
North Shore Hematology Oncology Association PC
Port Jefferson Station, New York 11776
United StatesSite Not Available
Kettering Medical Center
Kettering, Ohio 45429
United StatesSite Not Available
Providence Cancer Institute, Franz Clinic
Portland, Oregon 97213
United StatesSite Not Available
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
Allentown, Pennsylvania 18103
United StatesSite Not Available
Investigator Site - Bethlehem
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Eastern Regional Medical Center - CTCA
Philadelphia, Pennsylvania 19124
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Investigator Site - Chattanooga
Chattanooga, Tennessee 37401
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Huntsman Cancer Hospital - PPDS
Salt Lake City, Utah 84112
United StatesSite Not Available
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia 22031
United StatesSite Not Available
Investigator Site - Leesburg
Leesburg, Virginia 20176
United StatesSite Not Available
Investigator Site - Tacoma
Tacoma, Washington 98405
United StatesSite Not Available
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