- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1426ANZ
- Instituto Médico Especializado Alexander Fleming
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Buenos Aires, Argentina, C1019ABS
- Centro Medico Austral
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Buenos Aires, Argentina, 2700
- Centro de Investigación Pergamino S.A
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Córdoba, Argentina, X5000JHQ
- Sanatorio Allende S.A.
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Córdoba, Argentina, X5000HHW
- Centro Medico Privado CEMAIC
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Córdoba, Argentina, X5002AOQ
- Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (CORI)
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Rosario, Argentina, S2002KDS
- Hospital Provincial del Centenario
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San Miguel De Tucumán, Argentina, 4000
- CAIPO Centro para la Atencion Integral del Paciente Oncologico
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Santa Fe, Argentina, S2000DSV
- Sanatorio Parque de Rosario
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Rio Negro
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Viedma, Rio Negro, Argentina, R8500ACE
- Centro de Investigación Clínica - Clínica Viedma
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New South Wales
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Orange, New South Wales, Australia, 2800
- Orange Cancer Centre
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Saint Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Sydney, New South Wales, Australia, 2109
- Macquarie University
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Adelaide Cancer Centre
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Victoria
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Parkville, Victoria, Australia, 3050
- Barwon Health
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Caxias Do Sul, Brazil, 95070-560
- Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
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Fortaleza, Brazil, 60430-230
- Instituto Do Câncer Do Ceará ICC
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Lages, Brazil, 88501-001
- ANIMI
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Rio De Janeiro, Brazil, 20231-050
- Instituto Nacional de Câncer
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Rio De Janeiro, Brazil, 22793-080
- Instituto COI de Pesquisa, Educação e Gestão
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São José Do Rio Preto, Brazil, 15090-000
- Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
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São Paulo, Brazil, 01323-903
- Hospital Alemao Oswaldo Cruz
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São Paulo, Brazil, 08270-120
- Hospital Santa Marcelina
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São Paulo, Brazil, 01508-010
- Fundação Antônio Prudente - AC Camargo Câncer Center
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Bahia
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Salvador, Bahia, Brazil, 41820-021
- Centro de Oncologia Da Bahia
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Salvador, Bahia, Brazil, 41950-610
- Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30190-130
- Cenantron - Centro Avancado de Tratamento Oncologico Ltda
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Belo Horizonte, Minas Gerais, Brazil, 30360-680
- Oncocentro, Belo Horizonte
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Parana
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Curitiba, Parana, Brazil, 80060-900
- Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
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Rio Grande Do Norte
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Natal, Rio Grande Do Norte, Brazil, 59075-740
- Liga Norte Riograndense Contra O Câncer
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Rio Grande Do Sul
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Ijuí, Rio Grande Do Sul, Brazil, 98700-000
- Associação Hospital de Caridade Ijuí
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Lajeado, Rio Grande Do Sul, Brazil, 95900-000
- Hospital Bruno Born
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Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
- Hospital Mãe de Deus
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
- Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Universidade Federal do Rio Grande do Sul - UFRGS
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Rio Grande, Rio Grande Do Sul, Brazil, 90430-090
- Clínica de Oncologia de Porto Alegre SS Ltda
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Santa Catarina
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Joinville, Santa Catarina, Brazil, 89201-260
- Instituto Joinvilense de Hematologia e Oncologia
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Sao Paulo
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Barretos, Sao Paulo, Brazil, 14784-400
- Fundacao Pio Xii Hospital de Cancer de Barretos
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Campinas, Sao Paulo, Brazil, 13083-887
- Hospital das Clinicas - UNICAMP
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Santo André, Sao Paulo, Brazil, 09060-650
- Fundacao do ABC - Faculdade de Medicina do ABC
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São Paulo
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Jaú, São Paulo, Brazil, 17210-120
- Hospital Amaral Carvalho
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Santiago, Chile, 7520349
- Clínica Santa María
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Santiago, Chile, 7500000
- Oncovida
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Santiago, Chile, 7850000
- Fundación Arturo López Pérez (FALP) - PPDS
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Temuco, Chile, 4810371
- Centro Investigacion Clinica Del Sur
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Viña Del Mar, Chile, 2540364
- Centro de Investigaciones Clinicas Vina Del Mar
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Viña Del Mar, Chile, 2520612
- Oncocentro APYS
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Los Lagos
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Osorno, Los Lagos, Chile, 5311092
- Corporacion de Beneficencia Osorno
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Los Rios
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Valdivia, Los Rios, Chile, 5090000
- Clinical Research Chile SpA
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Monterrey, Mexico, 64000
- Accelerium, S. de R.L. de C.V.
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Puebla, Mexico, CP 72530
- Unidad Médica Onco-hematológica
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Distrito Federal
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Ciudad de Mexico, Distrito Federal, Mexico, 03810
- Health Pharma Professional Research S.A de C.V.
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Michoacan
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Morelia, Michoacan, Mexico, 58260
- Centro de Investigacion Clinica Chapultepec S.A. de C.V.
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64060
- Axis Heilsa S. de R.L. de C.V.
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Lima, Peru, 15102
- Hospital Nacional Cayetano Heredia
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Lima, Peru, 15036
- Clinica Internacional S.A. - Sede San Borja
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Lima, Peru, 15036
- ONCOCARE S.A.C. (Clinica Aliada)
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La Lobertad
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Trujillo, La Lobertad, Peru, 13000
- Clinica Peruana Americana
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Barnaul, Russian Federation, 656049
- Altay Regional Oncology Center
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Chelyabinsk, Russian Federation, 454087
- Chelyabinsk Regional Clinical Oncology Dispensary
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Chelyabinsk, Russian Federation, 454087
- LLC Evimed
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Kursk, Russian Federation, 305035
- Kursk Regional Oncology Centre
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Moscow, Russian Federation, 121359
- Central Clinical Hospital With Polyclinic of President Administration of RF
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Obninsk, Russian Federation, 249036
- Federal State Institution Medical Radiology Research Center
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Omsk, Russian Federation, 644013
- Clinical Oncology Dispensary
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Pushkin, Russian Federation, 196603
- PMI Euromedservice
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Saint Petersburg, Russian Federation, 195271
- Railway Clinical Hospital JSC RZhD
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Saint Petersburg, Russian Federation, 194044
- Hospital OrKli LLC
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Saint Petersburg, Russian Federation, 197136
- Hospital OrKli LLC
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Volzhskiy, Russian Federation, 404120
- State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
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Yaroslavl, Russian Federation, 150040
- Regional Clinical Oncology Hospital
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Singapore, Singapore, 169610
- National Cancer Centre
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Singapore, Singapore, 258500
- Oncocare Cancer Centre
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Alaska
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Anchorage, Alaska, United States, 99503
- Alaska Urological
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Arizona
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Goodyear, Arizona, United States, 85338
- Western Regional Medical Center - CTCA - PPDS
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Arkansas
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Little Rock, Arkansas, United States, 72205
- CARTI Cancer Center
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California
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Duarte, California, United States, 91010
- City of Hope National Medical Center
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Orange, California, United States, 92868
- University of California Irvine
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Whittier, California, United States, 90603
- Innovative Clinical Research Institute
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute, Emory University
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Greenebaum Cancer Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- Comprehensive Cancer Centers of Nevada
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New York
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Port Jefferson Station, New York, United States, 11776
- North Shore Hematology Oncology Association PC
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Ohio
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Kettering, Ohio, United States, 45429
- Kettering Medical Center
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Oregon
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Portland, Oregon, United States, 97213
- Providence Cancer Institute, Franz Clinic
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Physician Group (LVPG) - Hematology Oncology
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Hershey, Pennsylvania, United States, 17033
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, United States, 19124
- Eastern Regional Medical Center - CTCA
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Hospital - PPDS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Combination of bempegaldesleukin + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
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Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
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Active Comparator: sunitinib or cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months
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ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. |
Approximately 32 months
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Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months
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OS is defined as the time from date of first dose to the date of death from any cause.
Patients without a date of death were censored at their last known alive date.
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Approximately 32 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months
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Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.
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Approximately 32 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Nivolumab
- PD-1
- PD-L1
- Kidney Neoplasms
- IL-2
- Kidney Cancer
- Renal Cancer
- Checkpoint inhibition
- Immune checkpoint inhibitor
- Opdivo®
- NKTR-214
- BEMPEG
- Bempegaldesleukin
- CD122-Biased Agonist
- CD122-Biased Cytokine
- CD122
- Renal Neoplasms
- IL-2 receptor agonist
- Immuno-oncology therapy
- CD122-Preferential
- IL-2 pathway agonist
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Sunitinib
- Nivolumab
Other Study ID Numbers
- 17-214-09
- CA045002 (Other Identifier: Bristol-Myers Squibb Protocol ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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