Kidney Cancer Clinical Trial
A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
Summary
This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.
Eligibility Criteria
Inclusion Criteria:
Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
Evaluable Memorial Sloan Kettering Cancer Center risk score
Measurable disease, as defined by RECIST v1.1
Karnofsky performance status greater than or equal to 70%
Adequate hematologic and end-organ function prior to randomization
Exclusion Criteria:
Disease-Specific Exclusions:
Radiotherapy for RCC within 14 days prior to treatment
Active central nervous system disease
Uncontrolled pleural effusion, pericardial effusion, or ascites
Uncontrolled hypercalcemia
Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death
General Medical Exclusions:
Life expectancy less than 12 weeks
Participation in another experimental drug study within 4 weeks prior to treatment
Pregnant or lactating women
Known hypersensitivity to any component of atezolizumab or other study medication
History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
Positive human immunodeficiency virus test
Active or chronic hepatitis B or C
Severe infections within 4 weeks prior to treatment
Exposure to oral or IV antibiotics within 2 weeks prior to treatment
Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation
Exclusion Criteria Related to Medications:
Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment
Bevacizumab- and Sunitinib-Specific Exclusions:
History of hypertensive crisis or hypertensive encephalopathy
Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds
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There are 153 Locations for this study
Tucson Arizona, 85719, United States
Orange California, 92868, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80303, United States
Washington District of Columbia, 20016, United States
Boca Raton Florida, 33486, United States
Port Charlotte Florida, 33980, United States
Saint Petersburg Florida, 33705, United States
Atlanta Georgia, 30318, United States
Chicago Illinois, 60637, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Albany New York, 12208, United States
New York New York, 10065, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44195, United States
Tigard Oregon, 97223, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Roanoke Virginia, 24014, United States
Seattle Washington, 98109, United States
Camperdown New South Wales, 2050, Australia
Macquarie Park New South Wales, 2109, Australia
Waratah New South Wales, 2298, Australia
South Brisbane Queensland, 4101, Australia
Kurralta Park South Australia, 5037, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Banja Luka , 78000, Bosnia and Herzegovina
Ijui RS, 98700, Brazil
Porto Alegre RS, 90050, Brazil
Porto Alegre RS, 90610, Brazil
Sao Paulo SP, 01246, Brazil
Halifax Nova Scotia, B3H 2, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1R 2, Canada
Brno , 656 5, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 4 - Krc , 140 5, Czechia
Aarhus N , 8200, Denmark
Herlev , 2730, Denmark
Odense C , 5000, Denmark
Angers , 49055, France
Bordeaux , 33075, France
Caen , 14076, France
Lille , 59020, France
Lyon , 69373, France
Marseille , 13273, France
Nancy , 54100, France
Paris , 75475, France
Paris , 75908, France
Saint Herblain , 44805, France
Villejuif , 94805, France
Dresden , 01307, Germany
Essen , 45122, Germany
Heidelberg , 69120, Germany
München , 81377, Germany
Tübingen , 72076, Germany
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41100, Italy
Roma Lazio, 00152, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20162, Italy
Pavia Lombardia, 27100, Italy
Arezzo Toscana, 52100, Italy
Aichi , 466-8, Japan
Chiba , 260-8, Japan
Fukuoka , 812-8, Japan
Gunma , 371-8, Japan
Hokkaido , 060-8, Japan
Ibaraki , 305-8, Japan
Iwate , 028-3, Japan
Kanagawa , 236-0, Japan
Kanagawa , 252-0, Japan
Kumamoto , 860-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Osaka , 545-8, Japan
Osaka , 565-0, Japan
Osaka , 589-8, Japan
Tokushima , 770-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Tokyo , 162-0, Japan
Daejeon , 35015, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Queretaro , 76090, Mexico
Toluca , 50180, Mexico
Lublin , 20-09, Poland
Poznan , 60-56, Poland
Warsaw , 02-61, Poland
Warsaw , 04-12, Poland
Barnaul Altaj, 65604, Russian Federation
Nizhni Novgorod Niznij Novgorod, 60300, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 14342, Russian Federation
Singapore , 11759, Singapore
Singapore , 16961, Singapore
Sabadell Barcelona, 8208, Spain
Córdoba Cordoba, 14004, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Taichung , 407, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Chiangmai , 50200, Thailand
Songkhla , 90110, Thailand
Ankara , 06100, Turkey
Edirne , 22770, Turkey
Istanbul , 34300, Turkey
Bebington , CH63 , United Kingdom
Birmingham , B15 2, United Kingdom
Blackburn , BB2 3, United Kingdom
Cambridge , CB2 0, United Kingdom
London , EC1A , United Kingdom
London , NW3 2, United Kingdom
Manchester , M2O 4, United Kingdom
Oxford , OX3 7, United Kingdom
Southampton , SO16 , United Kingdom
Sutton , SM2 5, United Kingdom
Swansea , SA2 8, United Kingdom
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