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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
Sponsor: Hoffmann-La Roche
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
760
Start Date
2020-09-28
Completion Date
2027-03-31
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab Matching Placebo
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Atezolizumab Matching Placebo
Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Locations (165)
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Great Lakes Cancer Center
Williamsville, New York, United States
Instituto de Investigaciones Metabolicas (Idim)
Buenos Aires, Argentina
Fundacion Favaloro
Buenos Aires, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
St John of God Hospital
Subiaco, Western Australia, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
UZ Antwerpen
Edegem, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
CHU de Liège (Sart Tilman)
Liège, Belgium
Anyang Tumor Hosptial
Anyang, China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China
Affiliated Hospital of Bengbu Medical College
Bengbu, China
Hunan Cancer Hospital
Changsha, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, China
Changzhou Cancer hospital
Changzhou, China
Sichuan Provincial Cancer Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Chongqing Sanxia Central Hospital
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yet-sen University Cancer Center
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Jieyang People's Hospital
Jieyang, 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, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, China
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
Shanghai Chest Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
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, China
Hebei Medical University Fourth Hospital
Shijiazhuang, China
Tianjin Cancer Hospital
Tianjin, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 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, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
Subei People's Hospital of Jiangsu province
Yangzhou, 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
Lille, France
Centre Leon Berard
Lyon, France
Hopital Timone Adultes
Marseille, France
Centre Antoine Lacassagne
Nice, France
European Hospital Georges Pompidou (HEGP)
Paris, France
Hopital Du Haut-Leveque
Pessac, France
Chu La Miletrie
Poitiers, France
Hopital Rangueil
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
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
Heraklion, Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, Greece
Pécsi Tudományegyetem
Pécs, Hungary
Szegedi Tudományegyetem
Szeged, Hungary
Hadassah Ein Karem Hospital
Jerusalem, Israel
Rambam Health Corporation
Rambam, Israel
Tel Aviv Sourasky Medical Ctr
Tel Aviv, Israel
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy
Ospedale Degli Infermi - Faenza
Faenza, Emilia-Romagna, Italy
Asu Fc S. M. Della Misericordia
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
Hyōgo, 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
The University of Osaka 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
The Aga Khan University-Kenya.
Nairobi, Kenya
Centre Hospitalier Universitaire Hassan II
Fes, Morocco
Centre Hospitalier Universitaire Mohamed VI
Marrakesh, Morocco
Institut National D'oncologie Sidi Med Benabdellah
Rabat, Morocco
Tauranga Hospital, Clinical Trials Unit
Tauranga, New Zealand
Centrum Onkologii
Bydgoszcz, Poland
Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli
Lublin, Poland
Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
Olsztyn, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, Poland
NIO im Marii Sklodowskiej-Curie
Warsaw, Poland
Dolno?l?skie Centrum Onkologii
Wroc?aw, Poland
HUC
Coimbra, Portugal
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, Portugal
IPO do Porto
Porto, Portugal
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
Krasnoyarsk, Krasnodarskiy Kray, Russia
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, Moscow Oblast, Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', Tatarstan Republic, Russia
City Oncological Hospital
Izhevsk, Udmurtiya Republic, Russia
Limited Liability Company "RC Medical"
Novosibirsk, Russia
Regional Oncology Dispensary
Tomsk, Russia
Limpopo Cancer Research Institute
Polokwane, South Africa
Cancercare
Port Elizabeth, South Africa
Eugene Marais Hospital
Pretoria, South Africa
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain
Hospital Univ. Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic I Provincial
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
Inselspital Bern, Insel-Gruppe AG
Bern, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Chang Gung Medical Foundation - Kaohsiung;Oncology
Kaohisung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chi-Mei Medical Centre
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Vajira Hospital
Bangkok, Thailand
Chulalongkorn Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Songklanagarind Hospital
Songkhla, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Adana, Turkey (Türkiye)
Ankara University Faculty of Medicine Cebeci Hospital
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, Turkey (Türkiye)
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, Turkey (Türkiye)
Van Yuzuncu Yil University Hospital
Van, Turkey (Türkiye)
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv, Kharkiv Governorate, Ukraine
Zhytomyr Regional Oncology Center
Zhytomyr, KIEV Governorate, Ukraine
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsia, Podolia Governorate, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy, Ukraine
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Ninewells Hospital
London, United Kingdom
Royal Marsden Hospital - Fulham
London, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom