Clinical trial NCT03024996: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-01-19
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Investigator-assessed Disease-Free Survival (DFS)
timeFrame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From baseline up to death due to any cause (up to approximately 64 months)
measure: Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
timeFrame: From baseline until first occurrence of DFS event (up to approximately 64 months)
measure: Independent Review Facility (IRF)-Assessed DFS
timeFrame: From baseline until first documented recurrence event (up to approximately 64 months)
measure: IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
timeFrame: From baseline until first occurrence of DFS event (up to approximately 64 months)
measure: IRF-assessed Event-free Survival (EFS)
timeFrame: From baseline until first documented recurrence event (up to approximately 64 months)
measure: Disease-Specific Survival
timeFrame: From baseline up to death due to RCC (up to approximately 64 months)
measure: Distant Metastasis-Free Survival
timeFrame: From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
measure: Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
timeFrame: Up to 3 years
measure: Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
timeFrame: Up to 3 years
measure: Percentage of Participants With Adverse Events
timeFrame: From baseline up to death due to any cause (up to approximately 71 months)
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
timeFrame: 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)
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
timeFrame: 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)
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
timeFrame: 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)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic- Scottsdale
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Lancaster
country: United States
facility: City of Hope, Antelope Valley
state: California
city: Los Angeles
country: United States
facility: UCLA Urology; Urology
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: South Pasadena
country: United States
facility: City of Hope-South Pasadena
state: California
city: Upland
country: United States
facility: City of Hope; Upland
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists-Broadway, Fort Myers
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Univ of Miami, School of Med; Hem/Onc
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory Uni - Winship Cancer Center; Hematology/Oncology
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Uni Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Whippany
country: United States
facility: Garden State Urology
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology at Albany Medical Center
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: New York
country: United States
facility: Mount SInai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center; Urology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cleveland
country: United States
facility: Fairview Hospital; Cleveland Clinic Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Hematology and Oncology
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital; Hirsch Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science Uni
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center; Hematology/Oncology
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Cnt Onco Clinic
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Health Systems
state: Tennessee
city: Kingsport
country: United States
facility: Urology Associates of Kingsport, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center; Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah; Huntsman Cancer Hospital
state: Utah
city: Morgantown
country: United States
facility: West Virginia University Hospitals Inc
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Britanico; Oncologia
city: Caba
country: Argentina
facility: Hospital Aleman
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hosp; Cancer Care Serv
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital; Medical Oncology
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre; Oncology
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital; Inpatient Pharmacy
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Vina Del Mar
country: Chile
facility: ONCOCENTRO APYS; Oncología
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center; Medical Oncology
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: General University Hospital; CLINIC OF ONCOLOGY
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital; Kræftafdelingen
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Angers
country: France
facility: CHU d'Angers
city: Creteil
country: France
facility: CHU Henri Mondor; Service d'Oncologie Medicale
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Paris
country: France
facility: Institut Mutualiste Montsouris; Oncologie
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Nouvel Hopital Civil - CHU Strasbourg; Urologie
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
city: Heidelberg
country: Germany
facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Klinik für Urologie
city: Cork
country: Ireland
facility: Cork Uni Hospital; Oncology Dept
city: Dublin
country: Ireland
facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Oncology Dept
city: Haifa
country: Israel
facility: Rambam Health Care Campus; Oncology
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Petach Tikva
country: Israel
facility: Belinson Medical Center, Division of Oncology
city: Ramat Gan
country: Israel
facility: Chaim Sheba medical center, Oncology division
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center; Oncology Department
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Oncologia
state: Lombardia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
state: Toscana
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aomori
country: Japan
facility: Hirosaki University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Tokyo Women?s Medical University Adachi Medical Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum; VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMC Radboud Nijmegen
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde
city: Utrecht
country: Netherlands
facility: St. Antonius locatie Leidsche Rijn
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
city: Kraków
country: Poland
facility: Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
city: Pozna?
country: Poland
facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Barnaul
country: Russian Federation
facility: Altai Region Oncology Dispensory; Oncology
state: Altaj
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst. ; Oncology
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsk Regional Medical Center
state: Niznij Novgorod
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
state: Sankt Petersburg
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital 1
state: Sverdlovsk
city: Belgrade
country: Serbia
facility: Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
city: Belgrade
country: Serbia
facility: Clinic for Urology; Military Medical Academy
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Oncología
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Urology
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Division of Urology
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Urology
city: Taipei
country: Taiwan
facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology
city: Bangkok
country: Thailand
facility: Division of Urological surgery; Department of surgery, Chulalongkorn University
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty; Department of ?nternal Medicine
city: Ankara
country: Turkey
facility: Ankara Uni School of Medicine; Medical Oncology
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
state: Kharkiv Governorate
city: Dnipropetrovsk
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
city: Lviv
country: Ukraine
facility: Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia Regional Clinic
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.