Kidney Cancer Clinical Trial

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

Summary

This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
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:

Disease-Specific Exclusions:

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

Exclusion Criteria Related to Medications:

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

915

Study ID:

NCT02420821

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 153 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85719, United States
University of California at Irvine Medical Center; Department of Oncology
Orange California, 92868, United States
University of California
San Francisco California, 94158, United States
University of Colorado; Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Center; Medical Oncology
Boulder Colorado, 80303, United States
Georgetown U; Lombardi Comp Can
Washington District of Columbia, 20016, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Florida Cancer Specialists - Port Charlotte
Port Charlotte Florida, 33980, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
Piedmont Cancer Institute, PC
Atlanta Georgia, 30318, United States
The University of Chicago
Chicago Illinois, 60637, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas Nevada, 89169, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
New York Oncology Hematology,P.C.-Albany
Albany New York, 12208, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Cleveland Clinic Foundation; Taussig Cancer Center
Cleveland Ohio, 44195, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Sarah Cannon Cancer Center and Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt Univ Medical Ctr
Nashville Tennessee, 37232, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
Oncology and Hematology Associates of SW Virginia-Raonoke
Roanoke Virginia, 24014, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Lifehouse
Camperdown New South Wales, 2050, Australia
Macquarie University Hospital
Macquarie Park New South Wales, 2109, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah New South Wales, 2298, Australia
Icon Cancer Foundation
South Brisbane Queensland, 4101, Australia
Ashford Cancer Center Research
Kurralta Park South Australia, 5037, Australia
Austin Hospital; Medical Oncology
Heidelberg Victoria, 3084, Australia
St John of God Hospital
Murdoch Western Australia, 6150, Australia
University Clinical Centre of the Republic of Srpska
Banja Luka , 78000, Bosnia and Herzegovina
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre RS, 90050, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax Nova Scotia, B3H 2, Canada
Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
London Regional Cancer Centre
London Ontario, N6A 4, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
CHU de Quebec Hotel-Dieu de Quebec
Quebec City Quebec, G1R 2, Canada
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc , 779 0, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2 , 128 0, Czechia
Thomayerova nemocnice
Praha 4 - Krc , 140 5, Czechia
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N , 8200, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Hopital Saint Andre; Oncologie 2
Bordeaux , 33075, France
Centre Francois Baclesse; Urologie Gynecologie
Caen , 14076, France
Centre Oscar Lambret
Lille , 59020, France
Centre Léon Bérard
Lyon , 69373, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille , 13273, France
Centre D'Oncologie de Gentilly; Oncology
Nancy , 54100, France
APHP - Hospital Saint Louis
Paris , 75475, France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris , 75908, France
ICO - Site René Gauducheau
Saint Herblain , 44805, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden , 01307, Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen , 45122, Germany
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
Heidelberg , 69120, Germany
Klinikum d.Universität München Campus Großhadern
München , 81377, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli Campania, 80131, 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
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma Lazio, 00152, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano Lombardia, 20162, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia Lombardia, 27100, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo Toscana, 52100, Italy
Nagoya University Hospital; Urology
Aichi , 466-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Gunma University Hospital
Gunma , 371-8, Japan
Hokkaido University Hospital
Hokkaido , 060-8, Japan
University of Tsukuba Hospital; Urology
Ibaraki , 305-8, Japan
Iwate Medical University Hospital
Iwate , 028-3, Japan
Yokohama City University Hospital
Kanagawa , 236-0, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka International Cancer Institute; Urology
Osaka , 541-8, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Tokushima University Hospital
Tokushima , 770-8, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
Tokyo Medical and Dental University Hospital
Tokyo , 113-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital, JFCR; Urology
Tokyo , 135-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Tokyo Women's Medical University
Tokyo , 162-0, Japan
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 003-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Cancerología
Queretaro , 76090, Mexico
Centro Oncologico Estatal ISSEMYM
Toluca , 50180, Mexico
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20-09, Poland
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Poznan , 60-56, Poland
Saint Elizabeth's Hospital
Warsaw , 02-61, Poland
MAGODENT Sp. z o.o.
Warsaw , 04-12, Poland
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
Barnaul Altaj, 65604, Russian Federation
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
Nizhni Novgorod Niznij Novgorod, 60300, Russian Federation
P.A. Herzen Oncological Inst. ; Oncology
Moscow , 12528, Russian Federation
City Clinical Oncology Hospital
Moscow , 14342, Russian Federation
National University Hospital
Singapore , 11759, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital Duran i Reynals; Oncologia
Barcelona , 08907, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Taichung Veterans General Hospital; Division of Urology
Taichung , 407, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei , 100, Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan , 333, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok , 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiangmai , 50200, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla , 90110, Thailand
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne , 22770, Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul , 34300, Turkey
Clatterbridge Cancer Centre
Bebington , CH63 , United Kingdom
Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Royal Blackburn Hospital
Blackburn , BB2 3, United Kingdom
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge , CB2 0, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London , EC1A , United Kingdom
Royal Free Hospital; Dept of Oncology
London , NW3 2, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford , OX3 7, United Kingdom
Southampton General Hospital; Medical Oncology
Southampton , SO16 , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton , SM2 5, United Kingdom
Singleton Hospital; Pharmacy Department
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

915

Study ID:

NCT02420821

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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