Kidney Cancer Clinical Trial
A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Summary
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
Eligibility Criteria
Inclusion Criteria:
ECOG performance status of less than or equal to (=) 1
Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
Radical or partial nephrectomy with lymphadenectomy in select participants
Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
Exclusion Criteria:
Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
History of autoimmune disease
Participants with prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
Positive test for HIV
Participants with active hepatitis B or hepatitis C
Active tuberculosis
Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study
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There are 179 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Lancaster California, 93534, United States
Los Angeles California, , United States
Orange California, 92868, United States
South Pasadena California, 91030, United States
Upland California, 91786, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32607, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Maywood Illinois, 60151, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Towson Maryland, 21204, United States
Rochester Minnesota, 55905, United States
Whippany New Jersey, , United States
Albany New York, 12208, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27514, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Mayfield Heights Ohio, 44124, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57104, United States
Chattanooga Tennessee, 37403, United States
Kingsport Tennessee, 37660, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Morgantown West Virginia, 26056, United States
Buenos Aires , C1280, Argentina
Caba , C1118, Argentina
La Rioja , F5300, Argentina
Waratah New South Wales, 2298, Australia
Herston Queensland, 4029, Australia
Kurralta Park South Australia, 5037, Australia
Heidelberg Victoria, 3084, Australia
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Curitiba PR, 81520, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90610, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 01323, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Halifax Nova Scotia, B3H 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M2K 1, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1R 3, Canada
Recoleta , 84203, Chile
Temuco , 48008, Chile
Vina Del Mar , 25205, Chile
Nanjing City , 21110, China
Shanghai City , 20131, China
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
Angers , 49033, France
Creteil , 94010, France
Nantes , 44093, France
Paris , 75674, France
Rennes , 35000, France
Rouen , 76031, France
Strasbourg , 67091, France
Villejuif , 94805, France
Dresden , 01307, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Homburg/Saar , 66424, Germany
München , 81675, Germany
Tübingen , 72076, Germany
Cork , , Ireland
Dublin , 24, Ireland
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Petach Tikva , 49414, Israel
Ramat Gan , 52620, Israel
Tel-Aviv , 64239, Israel
Bologna Emilia-Romagna, 40138, Italy
Meldola Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41100, Italy
Milano Lombardia, 20133, Italy
Pavia Lombardia, 27100, Italy
Arezzo Toscana, 52100, Italy
Padova Veneto, 35128, Italy
Aichi , 466-8, Japan
Aomori , 036-8, Japan
Fukuoka , 812-8, Japan
Hyogo , 650-0, Japan
Ibaraki , 305-8, Japan
Mie , 514-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Tochigi , 329-0, Japan
Tokushima , 770-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Tokyo , 123-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Goyang-si , 10408, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Amsterdam , 1007 , Netherlands
Amsterdam , 1066 , Netherlands
Nijmegen , 6500 , Netherlands
Rotterdam , 3045 , Netherlands
Utrecht , 3543 , Netherlands
Kraków , 30-68, Poland
Kraków , 31-11, Poland
Lublin , 20-09, Poland
Pozna? , 60-56, Poland
Warszawa , 04-07, Poland
Wroclaw , 50-55, Poland
Barnaul Altaj, 65604, Russian Federation
Moscow Moskovskaja Oblast, 12524, Russian Federation
Moscow Moskovskaja Oblast, 14342, Russian Federation
Nizhny Novgorod Niznij Novgorod, 60300, Russian Federation
Saint-Petersburg Sankt Petersburg, 19702, Russian Federation
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Sremska Kamenica , 21204, Serbia
Oviedo Asturias, 33011, Spain
Sant Andreu de La Barca Barcelona, 08740, Spain
Córdoba Cordoba, 14004, Spain
Santiago de Compostela LA Coruña, 15706, Spain
Barcelona , 08036, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Taipei , 10048, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10330, Thailand
Chiangmai , 50200, Thailand
Adana , 01230, Turkey
Ankara , 06500, Turkey
Ankara , 06590, Turkey
Edirne , 22030, Turkey
Sihhiye/Ankara , 06230, Turkey
Kharkiv Kharkiv Governorate, 61037, Ukraine
Dnipropetrovsk , 49102, Ukraine
Lviv , 79034, Ukraine
Sumy , 40005, Ukraine
Zaporizhzhia , 69600, Ukraine
Leicester , LE1 5, United Kingdom
London , NW3 2, United Kingdom
Manchester , M20 3, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
Sheffield , S10 2, United Kingdom
Swansea , SA2 8, United Kingdom
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