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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03024996
Other study ID # WO39210
Secondary ID 2016-001881-27
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 3, 2017
Est. completion date December 8, 2022

Study information

Verified date July 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 778
Est. completion date December 8, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab
Atezolizumab 1200 mg IV infusion q3w
Other:
Placebo
Placebo matching to atezolizumab q3w

Locations

Country Name City State
Argentina Hospital Britanico; Oncologia Buenos Aires
Argentina Hospital Aleman Caba
Argentina Centro Oncologico Riojano Integral (CORI) La Rioja
Australia Austin Hospital; Medical Oncology Heidelberg Victoria
Australia Royal Brisbane & Women's Hosp; Cancer Care Serv Herston Queensland
Australia Ashford Cancer Center Research Kurralta Park South Australia
Australia Calvary Mater Newcastle; Medical Oncology Waratah New South Wales
Austria 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 Wien
Belgium Cliniques Universitaires St-Luc Bruxelles
Belgium UZ Leuven Gasthuisberg Leuven
Brazil Hospital Erasto Gaertner Curitiba PR
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital Alemao Oswaldo Cruz Sao Paulo SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Canada Tom Baker Cancer Centre-Calgary Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Queen Elizabeth II Health Sciences Centre; Oncology Halifax Nova Scotia
Canada BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre) Kelowna British Columbia
Canada McGill University Health Centre - Glen Site Montreal Quebec
Canada The Ottawa Hospital Cancer Centre; Oncology Ottawa Ontario
Canada Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont Sherbrooke Quebec
Canada North York General Hospital; Inpatient Pharmacy Toronto Ontario
Canada Princess Margaret Cancer Center Toronto Ontario
Canada Sunnybrook Odette Cancer Centre Toronto Ontario
Chile Bradford Hill Centro de Investigaciones Clinicas Recoleta
Chile Sociedad de Investigaciones Medicas Ltda (SIM) Temuco
Chile ONCOCENTRO APYS; Oncología Vina Del Mar
China Jiangsu Cancer Hospital Nanjing City
China Fudan University Shanghai Cancer Center; Medical Oncology Shanghai City
Czechia Masarykuv onkologicky ustav Brno
Czechia Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc
Czechia General University Hospital; CLINIC OF ONCOLOGY Praha 2
Czechia Thomayerova nemocnice Praha 4 - Krc
Denmark Aarhus Universitetshospital; Kræftafdelingen Aarhus N
Denmark Herlev Hospital; Afdeling for Kræftbehandling Herlev
France CHU d'Angers Angers
France CHU Henri Mondor; Service d'Oncologie Medicale Creteil
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
Germany Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie Dresden
Germany Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie Hannover
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
Ireland Cork Uni Hospital; Oncology Dept Cork
Ireland Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit Dublin
Israel Soroka Medical Center; Oncology Dept Beer Sheva
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 Petach Tikva
Israel Chaim Sheba medical center, Oncology division Ramat Gan
Israel Sourasky Medical Center; Oncology Department Tel-Aviv
Italy Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Arezzo Toscana
Italy 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 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia
Italy A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna
Italy IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima Padova Veneto
Italy Fondazione IRCCS Policlinico San Matteo, Oncologia Pavia Lombardia
Japan Nagoya University Hospital Aichi
Japan Hirosaki University Hospital Aomori
Japan Kyushu University Hospital Fukuoka
Japan Kobe University Hospital Hyogo
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 Keio University Hospital Tokyo
Japan Nippon Medical School Hospital Tokyo
Japan The Cancer Institute Hospital of JFCR Tokyo
Japan Tokyo Medical and Dental University Hospital Tokyo
Japan Tokyo Women?s Medical University Adachi Medical Center Tokyo
Japan Toranomon Hospital Tokyo
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Netherlands Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Amsterdam
Netherlands VU Medisch Centrum; VU University Medical Center Amsterdam
Netherlands UMC Radboud Nijmegen Nijmegen
Netherlands Sint Franciscus Gasthuis; Inwendige Geneeskunde Rotterdam
Netherlands St. Antonius locatie Leidsche Rijn Utrecht
Poland Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej Kraków
Poland Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii Kraków
Poland Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli Lublin
Poland Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii Pozna?
Poland Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw
Russian Federation Altai Region Oncology Dispensory; Oncology Barnaul Altaj
Russian Federation City Clinical Oncology Hospital Moscow Moskovskaja Oblast
Russian Federation P.A. Herzen Oncological Inst. ; Oncology Moscow Moskovskaja Oblast
Russian Federation Privolzhsk Regional Medical Center Nizhny Novgorod Niznij Novgorod
Russian Federation City Clinical Oncology Dispensary Saint-Petersburg Sankt Petersburg
Russian Federation Sverdlovsk Regional Clinical Hospital 1 Yekaterinburg Sverdlovsk
Serbia Clinic for Urology, Clinical Center of Serbia; Clinic for Urology Belgrade
Serbia Clinic for Urology; Military Medical Academy Belgrade
Serbia Oncology Institute of Vojvodina Sremska Kamenica
Spain Hospital Clínic i Provincial; Servicio de Oncología Barcelona
Spain Institut Catala d Oncologia Hospital Duran i Reynals Barcelona
Spain Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba
Spain Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid
Spain Hospital Ramon y Cajal; Servicio de Oncologia Madrid
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Universitario Clínico San Carlos; Servicio de Oncologia Madrid
Spain Hospital Univ. Central de Asturias; Servicio de Oncologia Oviedo Asturias
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Sant Andreu de La Barca Barcelona
Spain Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña
Taiwan 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
Thailand Division of Urological surgery; Department of surgery, Chulalongkorn University Bangkok
Thailand Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit Chiangmai
Turkey Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Adana
Turkey Ankara Uni School of Medicine; Medical Oncology Ankara
Turkey Gazi University Medical Faculty; Department of ?nternal Medicine Ankara
Turkey Trakya University Medical Faculty Edirne
Turkey Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara
Ukraine CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR Dnipropetrovsk
Ukraine Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4 Kharkiv Kharkiv Governorate
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
United Kingdom 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 States New York Oncology Hematology at Albany Medical Center Albany New York
United States Emory Uni - Winship Cancer Center; Hematology/Oncology Atlanta Georgia
United States University of Colorado Cancer Center Aurora Colorado
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Levine Cancer Institute Charlotte North Carolina
United States Erlanger Health Systems Chattanooga Tennessee
United States The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology Chicago Illinois
United States Cleveland Clinic Foundation; Hematology and Oncology Cleveland Ohio
United States Fairview Hospital; Cleveland Clinic Cancer Center Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States City of Hope National Medical Center Duarte California
United States Florida Cancer Specialists-Broadway, Fort Myers Fort Myers Florida
United States University of Florida Gainesville Florida
United States MD Anderson Cancer Center Houston Texas
United States Urology Associates of Kingsport, P.C. Kingsport Tennessee
United States City of Hope, Antelope Valley Lancaster California
United States UCLA Urology; Urology Los Angeles California
United States Norton Cancer Institute Louisville Kentucky
United States Hillcrest Hospital; Hirsch Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center, Cardinal Bernardin Cancer Center Maywood Illinois
United States Univ of Miami, School of Med; Hem/Onc Miami Florida
United States West Virginia University Hospitals Inc Morgantown West Virginia
United States Sarah Cannon Research Institute Nashville Tennessee
United States Vanderbilt University Medical Center; Vanderbilt University Nashville Tennessee
United States Yale School of Medicine New Haven Connecticut
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Tulane Uni Health Sciences Center New Orleans Louisiana
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 Oklahoma; Stephenson Oklahoma Canc Ctr Oklahoma City Oklahoma
United States University of California Irvine Medical Center Orange California
United States Fox Chase Cancer Center; Hematology/Oncology Philadelphia Pennsylvania
United States Oregon Health & Science Uni Portland Oregon
United States Mayo Clinic - Rochester Rochester Minnesota
United States University of Rochester Medical Center; Urology Rochester New York
United States University of Utah; Huntsman Cancer Hospital Salt Lake City Utah
United States Mayo Clinic- Scottsdale Scottsdale Arizona
United States Sanford Cancer Cnt Onco Clinic Sioux Falls South Dakota
United States City of Hope-South Pasadena South Pasadena California
United States SUNY Upstate Medical University Syracuse New York
United States Moffitt Cancer Center Tampa Florida
United States Chesapeake Urology Research Associates Towson Maryland
United States City of Hope; Upland Upland California
United States Garden State Urology Whippany New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator-assessed Disease-Free Survival (DFS) Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Secondary Overall Survival (OS) OS was defined as the time from randomization to death from any cause. From baseline up to death due to any cause (up to approximately 64 months)
Secondary Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. From baseline until first occurrence of DFS event (up to approximately 64 months)
Secondary Independent Review Facility (IRF)-Assessed DFS IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. From baseline until first documented recurrence event (up to approximately 64 months)
Secondary IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. From baseline until first occurrence of DFS event (up to approximately 64 months)
Secondary IRF-assessed Event-free Survival (EFS) IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions. From baseline until first documented recurrence event (up to approximately 64 months)
Secondary Disease-Specific Survival Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC). From baseline up to death due to RCC (up to approximately 64 months)
Secondary Distant Metastasis-Free Survival Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first. From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
Secondary Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization. Up to 3 years
Secondary Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization. Up to 3 years
Secondary Percentage of Participants With Adverse Events An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs. From baseline up to death due to any cause (up to approximately 71 months)
Secondary Maximum Serum Concentration (Cmax) of Atezolizumab Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary Minimum Serum Concentration (Cmin) of Atezolizumab Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
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