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).
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
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There are 93 Locations for this study
Anchorage Alaska, 99503, United States
Goodyear Arizona, 85338, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Orange California, 92868, United States
Whittier California, 90603, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21201, United States
Las Vegas Nevada, 89106, United States
Port Jefferson Station New York, 11776, United States
Kettering Ohio, 45429, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18103, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19124, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Viedma Rio Negro, R8500, Argentina
Buenos Aires , 2700, Argentina
Buenos Aires , C1019, Argentina
Buenos Aires , C1426, Argentina
Córdoba , X5000, Argentina
Córdoba , X5000, Argentina
Córdoba , X5002, Argentina
La Rioja , F5300, Argentina
Rosario , S2002, Argentina
San Miguel De Tucumán , 4000, Argentina
Santa Fe , S2000, Argentina
Orange New South Wales, 2800, Australia
Saint Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2109, Australia
Kurralta Park South Australia, 5037, Australia
Parkville Victoria, 3050, Australia
Salvador Bahia, 41820, Brazil
Salvador Bahia, 41950, Brazil
Belo Horizonte Minas Gerais, 30190, Brazil
Belo Horizonte Minas Gerais, 30360, Brazil
Curitiba Parana, 80060, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Ijuí Rio Grande Do Sul, 98700, Brazil
Lajeado Rio Grande Do Sul, 95900, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Rio Grande Rio Grande Do Sul, 90430, Brazil
Joinville Santa Catarina, 89201, Brazil
Barretos Sao Paulo, 14784, Brazil
Campinas Sao Paulo, 13083, Brazil
Santo André Sao Paulo, 09060, Brazil
Jaú São Paulo, 17210, Brazil
Caxias Do Sul , 95070, Brazil
Fortaleza , 60430, Brazil
Lages , 88501, Brazil
Rio De Janeiro , 20231, Brazil
Rio De Janeiro , 22793, Brazil
São José Do Rio Preto , 15090, Brazil
São Paulo , 01323, Brazil
São Paulo , 01508, Brazil
São Paulo , 08270, Brazil
Osorno Los Lagos, 53110, Chile
Valdivia Los Rios, 50900, Chile
Santiago , 75000, Chile
Santiago , 75203, Chile
Santiago , 78500, Chile
Temuco , 48103, Chile
Viña Del Mar , 25206, Chile
Viña Del Mar , 25403, Chile
Ciudad de Mexico Distrito Federal, 03810, Mexico
Morelia Michoacan, 58260, Mexico
Monterrey Nuevo León, 64060, Mexico
Monterrey , 64000, Mexico
Puebla , CP 72, Mexico
Auckland , 1023, New Zealand
Trujillo La Lobertad, 13000, Peru
Lima , 15036, Peru
Lima , 15036, Peru
Lima , 15102, Peru
Barnaul , 65604, Russian Federation
Chelyabinsk , 45408, Russian Federation
Chelyabinsk , 45408, Russian Federation
Kursk , 30503, Russian Federation
Moscow , 12135, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Pushkin , 19660, Russian Federation
Saint Petersburg , 19404, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint Petersburg , 19713, Russian Federation
Volzhskiy , 40412, Russian Federation
Yaroslavl , 15004, Russian Federation
Singapore , 16961, Singapore
Singapore , 25850, Singapore
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