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Brief Title: A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
Study ID: NCT04543617
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Compassionate Care Research Group Inc. Corona, Corona, California, United States
Compassionate Cancer Care Medical Group, Inc, Corona, California, United States
Compassionate Care Research Group Inc. Riverside, Riverside, California, United States
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, United States
Florida Cancer Specialist, North Region, Saint Petersburg, Florida, United States
Mount Sinai Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Great Lakes Cancer Center, Williamsville, New York, United States
MD Anderson Cancer Center; Oncology, Houston, Texas, United States
Fundacion Favaloro, Buenos Aires, , Argentina
Instituto de Investigaciones Metabolicas (Idim), Ciudad Autonoma de Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Austin Health; Cancer Clinical Trial Centre, Heidelberg, Victoria, Australia
St John of God Hospital; Bendat Cancer Centre, Subiaco, Western Australia, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie, Innsbruck, , Austria
Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie, Klagenfurt am Wörthersee, , Austria
Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum, Linz, , Austria
AKH - Medizinische Universität Wien; Department for Internal Medicine I, Wien, , Austria
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Anyang Tumor Hosptial, Anyang City, , China
Cancer Hospital Chinese Academy of Medical Sciences., Beijing, , China
Affiliated Hospital of Bengbu Medical College, Bengbu, , China
Hunan Cancer Hospital, Changsha CITY, , China
Heping Hospital Affiliated to Changzhi Medical College, Changzhi City, , China
Changzhou Cancer hospital, Changzhou, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
Chongqing Sanxia Central Hospital, Chongqing City, , China
Chongqing Cancer Hospital, Chongqing, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Nanfang Hospital, Southern Medical University, Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, , China
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi, Jiangsu Sheng, , China
Jieyang People's Hospital, Jieyang City, , China
Shandong Cancer Hospital, Jinan, , China
Affiliated Hospital of Jining Medical University, Jining, , China
The First People's Hospital of Lian Yun Gang, Lianyungang, , China
Lishui Central Hospital, Lishui City, , China
The First Affiliated Hospital to Henan University of Science and Technology, Luoyang City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai City, , China
Shanghai Chest Hospital, Shanghai, , China
Cancer Hospital of Shantou University Medical College, Shantou, , China
Liaoning cancer Hospital & Institute, Shenyang, , China
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center, Shenzhen City, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang, , China
Tianjin Cancer Hospital, Tianjin, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan City, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Zhongshan Hospital Xiamen University, Xiamen, , China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang City, , China
The Affiliated Hospital of Xuzhou Medical College, Xuzhou, , China
Subei People's Hospital of Jiangsu province; Respiratory, Yangzhou City, , China
Zhejiang Cancer Hospital, Zhejiang, , China
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie, Brest, , France
CHU Dijon Bourgogne Hôpital François Mitterand, Dijon, , France
Hopital Claude Huriez; Medecine Interne Oncologie, Lille, , France
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie, Lyon, , France
Hopital Timone Adultes; Oncologie Digestive, Marseille, , France
Centre Antoine Lacassagne, Nice, , France
European Hospital Georges Pompidou (HEGP), Paris, , France
Hopital Du Haut-Leveque; Gastro-Enterologie, Pessac, , France
Chu La Miletrie; Gastro Enterologie Endoscopies, Poitiers, , France
Hopital Rangueil; Gastro Enterologie Et Nutrition, Toulouse, , France
Universitätsklinikum Essen Klinik f.Strahlentherapie, Essen, , Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie, Essen, , Germany
Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG, Göttingen, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt., Magdeburg, , Germany
Klinikum der Philipps-Universität Marburg, Marburg, , Germany
Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie, Regensburg, , Germany
Evgenidio Hospital "Agia Trias", Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs, , Hungary
Szegedi Tudományegyetem; Onkoterápiás Klinika, Szeged, , Hungary
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Rambam Health Corporation; Oncology Institute, Rambam, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv, , Israel
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica, Napoli, Campania, Italy
Ospedale Degli Infermi - Faenza; Oncologia Medica, Faenza, Emilia-Romagna, Italy
AUSL-IRCCS di Reggio Emilia; Oncologia Medica, Reggio Emilia, Emilia-Romagna, Italy
ASU FC S. M. DELLA MISERICORDIA; Oncologia, Udine, Friuli-Venezia Giulia, Italy
Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy
Aichi Cancer Center Hospital, Aichi, , Japan
National Cancer Center Hospital East, Chiba, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kobe University Hospital, Hyogo, , Japan
Yokohama City University Medical Center, Kanagawa, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tohoku University Hospital, Miyagi, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Osaka University Hospital, Osaka, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
International Cancer Institute (ICI), Eldoret, , Kenya
Aga Khan University Hospital, Nairobi, , Kenya
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Ajou University Medical Center, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Centre Hospitalier Universitaire Hassan II, FES, , Morocco
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakech, , Morocco
Clinique specialise Menara; Oncology Medical, Marrakech, , Morocco
Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical, Rabat, , Morocco
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School, Tauranga, , New Zealand
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz, , Poland
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej, Lublin, , Poland
Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii; ZAK?.I O.KLINICZNY RADIOTERAPII, Olsztyn, , Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie; Odd. Onk. Klin. i Immunoonk., Pozna?, , Poland
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii, Warszawa, , Poland
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii, Wroc?aw, , Poland
HUC; Servico de Oncologia Medica, Coimbra, , Portugal
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia, Porto, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy, Krasnoyarsk, Krasnodar, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy, Moscow, Moskovskaja Oblast, Russian Federation
Scientific Research Institute n.a. N.N. Petrov, Saint Petersburg, Sankt Petersburg, Russian Federation
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF, Sankt-peterburg, Sankt Petersburg, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan, Tatarstan, Russian Federation
City Oncological Hospital, Izhevsk, Udmurtija, Russian Federation
Limited Liability Company "RC Medical", Novosibirsk, , Russian Federation
Regional Oncology Dispensary, Tomsk, , Russian Federation
Wits Donald Gordon Clinical Trial Site, Johannesburg, , South Africa
Limpopo Cancer Research Institute, Polokwane, , South Africa
Cancercare, Port Elizabeth, , South Africa
Eugene Marais Hospital; Oncology, Pretoria, , South Africa
Hospital Univ. Central de Asturias, Oviedo, Asturias, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic I Provincial, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario Carlos Haya, Malaga, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
Inselspital Bern, Insel-Gruppe AG, Bern, , Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology, Kaoisung, , Taiwan
China Medical University Hospital; Oncology and Hematology, Taichung, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
Chi-Mei Medical Centre; Hematology & Oncology, Tainan, , Taiwan
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Vajira Hospital, Bangkok, , Thailand
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Siriraj Hospital; Medical Oncology Unit, Bangkok, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Ankara University Faculty of Medicine Cebeci Hospital, Ankara, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department, Erzurum, , Turkey
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani, Istanbul, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,, Malatya, , Turkey
Van Yuzuncu Yil University Hospital; Medical Oncology, Van, , Turkey
Municipal Noncommercial Institution Regional Center of Oncology, Kharkiv, Kharkiv Governorate, Ukraine
Zhytomyr Regional Oncology Center, Zhytomyr, KIEV Governorate, Ukraine
Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsya, Podolia Governorate, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
Royal Bournemouth Hospital; Oncology, Bournemouth, , United Kingdom
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279, Cambridge, , United Kingdom
Ninewells Hospital; Oncology, London, , United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department, London, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Clatterbridge Cancer Centre, Wirral, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Name: Clinical Trial
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR