A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
NCT ID: NCT02420821
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
915 participants
INTERVENTIONAL
2015-05-20
2021-12-13
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
NONE
Study Groups
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Atezolizumab + Bevacizumab
Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.
Bevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.
Sunitinib
Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.
Sunitinib
Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.
Bevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.
Sunitinib
Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evaluable Memorial Sloan Kettering Cancer Center risk score
* Measurable disease, as defined by RECIST v1.1
* Karnofsky performance status greater than or equal to 70%
* Adequate hematologic and end-organ function prior to randomization
Exclusion Criteria
* Radiotherapy for RCC within 14 days prior to treatment
* Active central nervous system disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death
General Medical Exclusions:
* Life expectancy less than 12 weeks
* Participation in another experimental drug study within 4 weeks prior to treatment
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
* Positive human immunodeficiency virus test
* Active or chronic hepatitis B or C
* Severe infections within 4 weeks prior to treatment
* Exposure to oral or IV antibiotics within 2 weeks prior to treatment
* Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
* Significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplantation
* Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment
Bevacizumab- and Sunitinib-Specific Exclusions:
* History of hypertensive crisis or hypertensive encephalopathy
* Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds
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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University of Arizona Cancer Center
Tucson, Arizona, United States
University of California at Irvine Medical Center; Department of Oncology
Orange, California, United States
University of California
San Francisco, California, United States
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States
Rocky Mountain Cancer Center; Medical Oncology
Boulder, Colorado, United States
Georgetown U; Lombardi Comp Can
Washington D.C., District of Columbia, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton, Florida, United States
Florida Cancer Specialists - Port Charlotte
Port Charlotte, Florida, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York Oncology Hematology,P.C.-Albany
Albany, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Cleveland Clinic Foundation; Taussig Cancer Center
Cleveland, Ohio, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, United States
Vanderbilt Univ Medical Ctr
Nashville, Tennessee, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States
Oncology and Hematology Associates of SW Virginia-Raonoke
Roanoke, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Lifehouse
Camperdown, New South Wales, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia
Icon Cancer Foundation
South Brisbane, Queensland, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia
St John of God Hospital
Murdoch, Western Australia, Australia
University Clinical Centre of the Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
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
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada
Royal Victoria Hospital
Barrie, Ontario, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec Hotel-Dieu de Quebec
Québec, Quebec, Canada
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, , Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, , Denmark
ICO Paul Papin; Oncologie Medicale.
Angers, , France
Hopital Saint Andre; Oncologie 2
Bordeaux, , France
Centre Francois Baclesse; Urologie Gynecologie
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, , France
Centre D'Oncologie de Gentilly; Oncology
Nancy, , France
APHP - Hospital Saint Louis
Paris, , France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, , Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, , Germany
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
Heidelberg, , Germany
Klinikum d.Universität München Campus Großhadern
München, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, , Germany
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli, Campania, 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
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Rome, Lazio, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
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
Nagoya University Hospital; Urology
Aichi, , Japan
Chiba Cancer Center
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Gunma University Hospital
Gunma, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
University of Tsukuba Hospital; Urology
Ibaraki, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka International Cancer Institute; Urology
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Toranomon Hospital
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
The Cancer Institute Hospital, JFCR; Urology
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Tokyo Women's Medical University
Tokyo, , Japan
Cancerología
Querétaro, , Mexico
Centro Oncologico Estatal ISSEMYM
Toluca, , Mexico
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, , Poland
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Poznan, , Poland
Saint Elizabeth's Hospital
Warsaw, , Poland
MAGODENT Sp. z o.o.
Warsaw, , Poland
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
Barnaul, Altayskiy Kray, Russia
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
Nizhny Novgorod, Niznij Novgorod, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, , Russia
City Clinical Oncology Hospital
Moscow, , Russia
National University Hospital
Singapore, , Singapore
National Cancer Centre; Medical Oncology
Singapore, , Singapore
Chungnam National University Hospital
Daejeon, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, , Spain
Hospital Duran i Reynals; Oncologia
Barcelona, , 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 Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
Taichung Veterans General Hospital; Division of Urology
Taichung, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan District, , Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, , Thailand
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiang Mai, , Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, , Thailand
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Clatterbridge Cancer Centre
Bebington, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge, , United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London, , United Kingdom
Royal Free Hospital; Dept of Oncology
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, , United Kingdom
Southampton General Hospital; Medical Oncology
Southampton, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, , United Kingdom
Singleton Hospital; Pharmacy Department
Swansea, , United Kingdom
Countries
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References
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Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981.
Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grullich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naive Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3.
Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-004684-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO29637
Identifier Type: -
Identifier Source: org_study_id
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