A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following... | NCT03024996 | Trialant

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following... | NCT03024996 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Mayo Clinic- Scottsdale

Scottsdale, Arizona 85259, United States

City of Hope National Medical Center

Duarte, California 91010, United States

City of Hope, Antelope Valley

Lancaster, California 93534, United States

UCLA Urology; Urology

Los Angeles, California, United States

University of California Irvine Medical Center

Orange, California 92868, United States

City of Hope-South Pasadena

South Pasadena, California 91030, United States

City of Hope; Upland

Upland, California 91786, United States

University of Colorado Cancer Center

Aurora, Colorado 80045, United States

Yale School of Medicine

New Haven, Connecticut 06510, United States

Florida Cancer Specialists-Broadway, Fort Myers

Fort Myers, Florida 33908, United States

University of Florida

Gainesville, Florida 32607, United States

Univ of Miami, School of Med; Hem/Onc

Miami, Florida 33136, United States

Moffitt Cancer Center

Tampa, Florida 33612, United States

Emory Uni - Winship Cancer Center; Hematology/Oncology

Atlanta, Georgia 30322, United States

The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology

Chicago, Illinois 60637, United States

Loyola University Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois 60151, United States

Norton Cancer Institute

Louisville, Kentucky 40202, United States

Tulane Uni Health Sciences Center

New Orleans, Louisiana 70112, United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121, United States

Chesapeake Urology Research Associates

Towson, Maryland 21204, United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905, United States

Garden State Urology

Whippany, New Jersey, United States

New York Oncology Hematology at Albany Medical Center

Albany, New York 12208, United States

Bellevue Hospital

New York, New York 10016, United States

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York 10016, United States

Mount SInai Medical Center

New York, New York 10029, United States

University of Rochester Medical Center; Urology

Rochester, New York 14642, United States

SUNY Upstate Medical University

Syracuse, New York 13210, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514, United States

Levine Cancer Institute

Charlotte, North Carolina 28204, United States

Fairview Hospital; Cleveland Clinic Cancer Center

Cleveland, Ohio 44111, United States

Cleveland Clinic Foundation; Hematology and Oncology

Cleveland, Ohio 44195, United States

Hillcrest Hospital; Hirsch Cancer Center

Mayfield Heights, Ohio 44124, United States

University of Oklahoma; Stephenson Oklahoma Canc Ctr

Oklahoma City, Oklahoma 73104, United States

Oregon Health & Science Uni

Portland, Oregon 97239, United States

Fox Chase Cancer Center; Hematology/Oncology

Philadelphia, Pennsylvania 19111, United States

Sanford Cancer Cnt Onco Clinic

Sioux Falls, South Dakota 57104, United States

Erlanger Health Systems

Chattanooga, Tennessee 37403, United States

Urology Associates of Kingsport, P.C.

Kingsport, Tennessee 37660, United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203, United States

Vanderbilt University Medical Center; Vanderbilt University

Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390, United States

MD Anderson Cancer Center

Houston, Texas 77030-4095, United States

University of Utah; Huntsman Cancer Hospital

Salt Lake City, Utah 84112, United States

West Virginia University Hospitals Inc

Morgantown, West Virginia 26056, United States

Hospital Britanico; Oncologia

Buenos Aires, C1280AEB, Argentina

Hospital Aleman

Caba, C1118AAT, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales 2298, Australia

Royal Brisbane & Women's Hosp; Cancer Care Serv

Herston, Queensland 4029, Australia

Ashford Cancer Center Research

Kurralta Park, South Australia 5037, Australia

Austin Hospital; Medical Oncology

Heidelberg, Victoria 3084, Australia

Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

Linz, 4020, Austria

Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

Salzburg, 5020, Austria

Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

Vienna, 1090, Austria

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Hospital Erasto Gaertner

Curitiba, Paraná 81520-060, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo 01246-000, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo 01323-903, Brazil

Tom Baker Cancer Centre-Calgary

Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia V1Y 5L3, Canada

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia B3H 2Y9, Canada

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario K1H 8L6, Canada

North York General Hospital; Inpatient Pharmacy

Toronto, Ontario M2K 1E1, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario M4N 3M5, Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 1Z5, Canada

McGill University Health Centre - Glen Site

Montreal, Quebec H4A 3J1, Canada

Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

Sherbrooke, Quebec J1H 5N4, Canada

Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

Québec, G1R 3S1, Canada

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4800827, Chile

ONCOCENTRO APYS; Oncología

Viña del Mar, 2520598, Chile

Jiangsu Cancer Hospital

Nanjing, 211100, China

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, 201315, China

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

General University Hospital; CLINIC OF ONCOLOGY

Prague, 128 08, Czechia

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N, 8200, Denmark

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

CHU d'Angers

Angers, 49033, France

CHU Henri Mondor; Service d'Oncologie Medicale

Créteil, 94010, France

CHU de Nantes - Hotel Dieu

Nantes, 44093, France

Institut Mutualiste Montsouris; Oncologie

Paris, 75674, France

CHU Pontchaillou

Rennes, 35000, France

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Nouvel Hopital Civil - CHU Strasbourg; Urologie

Strasbourg, 67091, France

Institut Gustave Roussy

Villejuif, 94805, France

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

Dresden, 01307, Germany

Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

Hanover, 30625, Germany

Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

Heidelberg, 69120, Germany

Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

Homburg/Saar, 66424, Germany

Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

München, 81675, Germany

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, 72076, Germany

Cork Uni Hospital; Oncology Dept

Cork, Ireland

Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

Dublin, 24, Ireland

Soroka Medical Center; Oncology Dept

Beersheba, 8410100, Israel

Rambam Health Care Campus; Oncology

Haifa, 3109601, Israel

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112000, Israel

Meir Medical Center; Oncology

Kfar Saba, 4428164, Israel

Belinson Medical Center, Division of Oncology

Petah Tikva, 4941492, Israel

Chaim Sheba medical center, Oncology division

Ramat Gan, 5262000, Israel

Sourasky Medical Center; Oncology Department

Tel Aviv, 6423900, Israel

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna 40138, Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna 47014, Italy

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna 41100, Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milan, Lombardy 20133, Italy

Fondazione IRCCS Policlinico San Matteo, Oncologia

Pavia, Lombardy 27100, Italy

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

Arezzo, Tuscany 52100, Italy

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

Padova, Veneto 35128, Italy

Nagoya University Hospital

Aichi, 466-8560, Japan

Hirosaki University Hospital

Aomori, 036-8563, Japan

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Kobe University Hospital

Hyōgo, 650-0017, Japan

University of Tsukuba Hospital

Ibaraki, 305-8576, Japan

Mie University Hospital

Mie, 514-8507, Japan

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Okayama University Hospital

Okayama, 700-8558, Japan

Jichi Medical University Hospital

Tochigi, 329-0498, Japan

Tokushima University Hospital

Tokushima, 770-8503, Japan

Toranomon Hospital

Tokyo, 105-8470, Japan

Tokyo Medical and Dental University Hospital

Tokyo, 113-8519, Japan

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Tokyo Women?s Medical University Adachi Medical Center

Tokyo, 123-8558, Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Keio University Hospital

Tokyo, 160-8582, Japan

VU Medisch Centrum; VU University Medical Center

Amsterdam, 1007 MB, Netherlands

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

UMC Radboud Nijmegen

Nijmegen, 6500 HB, Netherlands

Sint Franciscus Gasthuis; Inwendige Geneeskunde

Rotterdam, 3045 PM, Netherlands

St. Antonius locatie Leidsche Rijn

Utrecht, 3543 AZ, Netherlands

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

Krakow, 31-115, Poland

Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

Lublin, 20-090, Poland

Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

Późna, 60-569, Poland

Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

Warsaw, 04-073, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-556, Poland

Altai Region Oncology Dispensory; Oncology

Barnaul, Altayskiy Kray 656049, Russia

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moscow Oblast 125248, Russia

City Clinical Oncology Hospital

Moscow, Moscow Oblast 143423, Russia

Privolzhsk Regional Medical Center

Nizhny Novgorod, Niznij Novgorod 603001, Russia

City Clinical Oncology Dispensary

Saint Petersburg, Sankt-Peterburg 197022, Russia

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, Sverdlovsk Oblast 620102, Russia

Clinic for Urology, Clinical Center of Serbia; Clinic for Urology

Belgrade, 11000, Serbia

Clinic for Urology; Military Medical Academy

Belgrade, 11000, Serbia

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

National Cancer Center

Goyang-si, 10408, South Korea

Asan Medical Center

Seoul, 05505, South Korea

Samsung Medical Center

Seoul, 135-710, South Korea

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona 08740, Spain

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba 14004, Spain

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña 15706, Spain

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias 33011, Spain

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, 08036, Spain

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

China Medical University Hospital; Urology

Taichung, 40447, Taiwan

Taichung Veterans General Hospital; Division of Urology

Taichung, 407, Taiwan

National Taiwan University Hospital, Department of Urology

Taipei, 10048, Taiwan

TAIPEI VETERANS GENERAL HOSPITAL, Urology

Taipei, 11217, Taiwan

Chang Gung Medical Foundation-Linkou, Urinary Oncology

Taoyuan, 333, Taiwan

Division of Urological surgery; Department of surgery, Chulalongkorn University

Bangkok, 10330, Thailand

Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

Chiang Mai, 50200, Thailand

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, 01230, Turkey (Türkiye)

Gazi University Medical Faculty; Department of ?nternal Medicine

Ankara, 06500, Turkey (Türkiye)

Ankara Uni School of Medicine; Medical Oncology

Ankara, 06590, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

Kharkiv, Kharkiv Governorate 61037, Ukraine

CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

Dnipropetrovsk, 49102, Ukraine

Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction

Lviv, 79034, Ukraine

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, 40005, Ukraine

Zaporizhzhia Regional Clinic

Zaporizhzhya, 69600, Ukraine

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Royal Free Hospital

London, NW3 2QS, United Kingdom

Christie Hospital

Manchester, M20 3BG, United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Singleton Hospital; Pharmacy Department

Swansea, SA2 8QA, United Kingdom