A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
NCT ID: NCT03024996
Last Updated: 2023-08-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
778 participants
INTERVENTIONAL
2017-01-03
2022-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atezolizumab
Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Atezolizumab
Atezolizumab 1200 mg IV infusion q3w
Placebo
Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Placebo
Placebo matching to atezolizumab q3w
Interventions
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Atezolizumab
Atezolizumab 1200 mg IV infusion q3w
Placebo
Placebo matching to atezolizumab q3w
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope, Antelope Valley
Lancaster, California, United States
UCLA Urology; Urology
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
City of Hope-South Pasadena
South Pasadena, California, United States
City of Hope; Upland
Upland, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialists-Broadway, Fort Myers
Fort Myers, Florida, United States
University of Florida
Gainesville, Florida, United States
Univ of Miami, School of Med; Hem/Onc
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory Uni - Winship Cancer Center; Hematology/Oncology
Atlanta, Georgia, United States
The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
Chicago, Illinois, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tulane Uni Health Sciences Center
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Garden State Urology
Whippany, New Jersey, United States
New York Oncology Hematology at Albany Medical Center
Albany, New York, United States
Bellevue Hospital
New York, New York, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Mount SInai Medical Center
New York, New York, United States
University of Rochester Medical Center; Urology
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Fairview Hospital; Cleveland Clinic Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation; Hematology and Oncology
Cleveland, Ohio, United States
Hillcrest Hospital; Hirsch Cancer Center
Mayfield Heights, Ohio, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, United States
Oregon Health & Science Uni
Portland, Oregon, United States
Fox Chase Cancer Center; Hematology/Oncology
Philadelphia, Pennsylvania, United States
Sanford Cancer Cnt Onco Clinic
Sioux Falls, South Dakota, United States
Erlanger Health Systems
Chattanooga, Tennessee, United States
Urology Associates of Kingsport, P.C.
Kingsport, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center; Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah; Huntsman Cancer Hospital
Salt Lake City, Utah, United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States
Hospital Britanico; Oncologia
Buenos Aires, , Argentina
Hospital Aleman
Caba, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston, Queensland, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz, , Austria
Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
Salzburg, , Austria
Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome
Vienna, , Austria
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada
North York General Hospital; Inpatient Pharmacy
Toronto, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
Québec, , Canada
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, , Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, , Chile
ONCOCENTRO APYS; Oncología
Viña del Mar, , Chile
Jiangsu Cancer Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, , Czechia
General University Hospital; CLINIC OF ONCOLOGY
Prague, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, , Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, , Denmark
CHU d'Angers
Angers, , France
CHU Henri Mondor; Service d'Oncologie Medicale
Créteil, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
Institut Mutualiste Montsouris; Oncologie
Paris, , France
CHU Pontchaillou
Rennes, , France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, , France
Nouvel Hopital Civil - CHU Strasbourg; Urologie
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, , Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hanover, , Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg, , Germany
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
Homburg/Saar, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, , Germany
Cork Uni Hospital; Oncology Dept
Cork, , Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin, , Ireland
Soroka Medical Center; Oncology Dept
Beersheba, , Israel
Rambam Health Care Campus; Oncology
Haifa, , Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, , Israel
Meir Medical Center; Oncology
Kfar Saba, , Israel
Belinson Medical Center, Division of Oncology
Petah Tikva, , Israel
Chaim Sheba medical center, Oncology division
Ramat Gan, , Israel
Sourasky Medical Center; Oncology Department
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia, Lombardy, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padua, Veneto, Italy
Nagoya University Hospital
Aichi, , Japan
Hirosaki University Hospital
Aomori, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Kobe University Hospital
Hyōgo, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Mie University Hospital
Mie, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Tokushima University Hospital
Tokushima, , Japan
Toranomon Hospital
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Tokyo Women?s Medical University Adachi Medical Center
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
VU Medisch Centrum; VU University Medical Center
Amsterdam, , Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
UMC Radboud Nijmegen
Nijmegen, , Netherlands
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam, , Netherlands
St. Antonius locatie Leidsche Rijn
Utrecht, , Netherlands
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, , Poland
Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
Lublin, , Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
Późna, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Altai Region Oncology Dispensory; Oncology
Barnaul, Altayskiy Kray, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Moscow Oblast, Russia
City Clinical Oncology Hospital
Moscow, Moscow Oblast, Russia
Privolzhsk Regional Medical Center
Nizhny Novgorod, Niznij Novgorod, Russia
City Clinical Oncology Dispensary
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, Sverdlovsk Oblast, Russia
Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
Belgrade, , Serbia
Clinic for Urology; Military Medical Academy
Belgrade, , Serbia
Oncology Institute of Vojvodina
Kamenitz, , Serbia
National Cancer Center
Goyang-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
China Medical University Hospital; Urology
Taichung, , Taiwan
Taichung Veterans General Hospital; Division of Urology
Taichung, , Taiwan
National Taiwan University Hospital, Department of Urology
Taipei, , Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan District, , Taiwan
Division of Urological surgery; Department of surgery, Chulalongkorn University
Bangkok, , Thailand
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiang Mai, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, , Turkey (Türkiye)
Gazi University Medical Faculty; Department of ?nternal Medicine
Ankara, , Turkey (Türkiye)
Ankara Uni School of Medicine; Medical Oncology
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, , Turkey (Türkiye)
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, Kharkiv Governorate, Ukraine
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, , Ukraine
Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction
Lviv, , Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy, , Ukraine
Zaporizhzhia Regional Clinic
Zaporizhzhia, , Ukraine
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Singleton Hospital; Pharmacy Department
Swansea, , United Kingdom
Countries
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References
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Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.
Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001881-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO39210
Identifier Type: -
Identifier Source: org_study_id
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