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Brief Title: A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Official Title: A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
Study ID: NCT04338269
Brief Summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona, Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UC San Diego Health System, La Jolla, California, United States
UCLA, Los Angeles, California, United States
University of Colorado, Aurora, Colorado, United States
Rocky Mountain Cancer Center - Denver, Littleton, Colorado, United States
Woodlands Medical Specialists, P.A., Pensacola, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building, Baltimore, Maryland, United States
MGH, Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Minnesota Oncology Hematology, Saint Paul, Minnesota, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, Las Vegas, Nevada, United States
Memorial Sloan Kettering - Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
New York Oncology Hematology,P.C.-Albany, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
MSKCC @ West Harrison, Harrison, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Texas Onc-Central Austin CA Ct, Austin, Texas, United States
University Of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists - Gainsville, Gainesville, Virginia, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Inst. Alexander Fleming; Oncologia, Buenos Aires, , Argentina
Hospital Britanico, Ciudad Autonoma Bs As, , Argentina
Centro Medico Austral OMI, Ciudad Autonoma Buenos Aires, , Argentina
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Orange Hospital, Orange, New South Wales, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
Bendigo Cancer Centre, Bendigo, Victoria, Australia
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
CHU Besançon - Hôpital Jean Minjoz, Besançon Cedex, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Centre Francois Baclesse; Oncologie, Caen, , France
Centre Jean Perrin; Oncologie, Clermont Ferrand, , France
Centre Oscar Lambret; Chir Cancerologie General, Lille, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Institut de cancerologie du Gard, Nimes, , France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale, Paris, , France
ICANS, Strasbourg, , France
Institut Gustave Roussy; Oncologie Medicale, Villejuif, , France
Zeisigwaldkliniken Bethanien, Chemnitz, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie, Frankfurt, , Germany
Universitaetsklinikum Freiburg; Urology, Freiburg, , Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie, Halle (Saale), , Germany
Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie, Hamburg, , Germany
Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation, Hannover, , Germany
Universitaetsklinikum Muenster; Urology, Muenster, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik, München, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Universitätsklinikum Ulm; Klinik für Urologie, Ulm, , Germany
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
Athens Medical Center; Dept. of Oncology, Athens, , Greece
Attikon University General Hospital, Chaidari, , Greece
University Hospital of Larissa;Department of Medical Oncology, Larissa, , Greece
Diavalkaniko Hospital, Thessaloniki, , Greece
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica, Napoli, Campania, 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
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica, Roma, Lazio, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica, Pavia, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
Ospedale Di Macerata; Oncologia, Macerata, Marche, Italy
Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare, Candiolo (TO), Piemonte, Italy
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria, Bari, Puglia, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia, Terni, Umbria, Italy
A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche, Verona, Veneto, Italy
Hokkaido University Hospital, Hokkaido, , Japan
University of Tsukuba Hospital, Ibaraki, , Japan
Yokohama City University Hospital, Kanagawa, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Tokushima University Hospital, Tokushima, , Japan
Keio University Hospital, Tokyo, , Japan
Tokyo Women's Medical University Hospital, Tokyo, , Japan
Chungnam National University Hospital, Daejeon, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna, ?ód?, , Poland
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny, Brzozów, , Poland
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej, Bytom, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii, Otwock, , 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
Wojskowy Instytut Medyczny; Klinika Onkologii, Warszawa, , Poland
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii, Wroc?aw, , Poland
Regional Clinical Oncology Hospital, Yaroslavl, Jaroslavl, Russian Federation
St-Petersburg Regional Oncology Dispensary; Oncology, Kuzmolovo, Leningrad, Russian Federation
Branch of the company "Hadassah Medical LTD", Innovatsionnogo Tsentra Skolkovo, Moskovskaja Oblast, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, Moskovskaja Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy, Moscow, Moskovskaja Oblast, Russian Federation
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva, Moskovskaja Oblast, Russian Federation
National Medical Research Center for Surgery named after A.V. Vishnevsky, Moskva, Moskovskaja Oblast, Russian Federation
AV Medical Ltd., Sait-Petersburg Sankt Petersburg, Sankt Petersburg, Russian Federation
Private Healthcare Institution Clinical Hospital RZhD Medicine, St. Petersburg, Sankt Petersburg, Russian Federation
Medical Center Avicenna; Urology, Novosibirsk, , Russian Federation
Hospital Univ. Central de Asturias; Servicio de Oncologia, Oviedo, Asturias, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander, Cantabria, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Hospital Alvaro Cunqueiro; Servicio de Oncologia, Vigo, Pontevedra, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario de Burgos; Oncología, Burgos, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , Spain
Hospital Lucus Augusti; Servicio de Oncologia, Lugo, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia, , Spain
Hospital de Navarra; Servicio de Oncologia, Navarra, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Royal Blackburn Hospital, Blackburn, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
Barts & London School of Med; Medical Oncology, London, , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR