Esophageal Cancer Clinical Trial
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
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).
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
dCRT treatment according to regional oncology guidelines for esophageal cancer
Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
Adequate hematologic and end-organ function prior to randomization
Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.
Key Exclusion Criteria:
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1 and anti-TIGIT therapeutic antibodies
Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
Prior allogeneic stem cell or solid organ transplantation
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.
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There are 221 Locations for this study
Corona California, 92879, United States
Corona California, 92882, United States
Novato California, 94589, United States
Riverside California, 92501, United States
New Haven Connecticut, 06510, United States
Fort Myers Florida, 33901, United States
Miami Beach Florida, 33140, United States
Saint Petersburg Florida, 33705, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67214, United States
Saint Louis Missouri, 63110, United States
New York New York, 10029, United States
New York New York, 10065, United States
Williamsville New York, 14221, United States
Charlotte North Carolina, 28204, United States
Easton Pennsylvania, 18045, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Buenos Aires , C1093, Argentina
Buenos Aires , C1125, Argentina
Ciudad Autonoma de Buenos Aires , C1012, Argentina
La Rioja , F5300, Argentina
Woolloongabba Queensland, 4102, Australia
Heidelberg Victoria, 3084, Australia
Subiaco Western Australia, 6008, Australia
Innsbruck , 6020, Austria
Klagenfurt am Wörthersee , 9020, Austria
Linz , 4010, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Fortaleza CE, 60130, Brazil
Curitiba PR, 80810, Brazil
Ijui RS, 98700, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Anyang City , 45500, China
Beijing , 10002, China
Bengbu , 23300, China
Changsha CITY , 41001, China
Changzhi City , 04600, China
Changzhou , 21300, China
Chengdu , 61004, China
Chengdu , 61004, China
Chongqing City , 40400, China
Chongqing , 40003, China
Fuzhou , 11001, China
Fuzhou , 35001, China
Guangzhou City , 51066, China
Guangzhou , 51051, China
Hangzhou City , 31001, China
Hangzhou , 31000, China
Harbin , 15008, China
Jiangsu Sheng , 21000, China
Jieyang City , 52200, China
Jinan , 25011, China
Jining , 27202, China
Lianyungang , 22202, China
Lishui City , 32300, China
Luoyang , 47100, China
Nanjing City , 21110, China
Nanjing , 21000, China
Shanghai City , 20131, China
Shanghai , 20000, China
Shantou , 51504, China
Shenyang , 11004, China
Shenzhen City , 51805, China
Shenzhen City , 51812, China
Shijiazhuang , 05003, China
Tianjin , 30006, China
Wuhan City , 43002, China
Wuhan , 43007, China
Xiamen , 36100, China
Xiamen , 36100, China
Xinxiang City , 45300, China
Xuzhou , 22100, China
Yangzhou City , 22500, China
Zhejiang , 31002, China
Olomouc , 779 0, Czechia
Praha 10 , 100 3, Czechia
Brest , 29609, France
Caen , 14033, France
Dijon , 21000, France
Lille , 59037, France
Lyon , 69373, France
Marseille , 13385, France
Nice , 06189, France
Paris , 75908, France
Pessac , 33604, France
Poitiers , 86021, France
Toulouse , 31059, France
Vandoeuvre-Les-Nancy , 54519, France
Dresden , 01067, Germany
Essen , 45122, Germany
Essen , 45136, Germany
Göttingen , 37075, Germany
Leipzig , 04103, Germany
Magdeburg , 39120, Germany
Mannheim , 68167, Germany
Marburg , 35032, Germany
Regensburg , 93053, Germany
Tübingen , 72076, Germany
Athens , 115 2, Greece
Athens , 115 2, Greece
Heraklion , 711 1, Greece
Thessaloniki , 546 4, Greece
Budapest , 1083, Hungary
Gyor , 9024, Hungary
Pécs , 7623, Hungary
Szeged , 6720, Hungary
Jerusalem , 91120, Israel
Rambam , 35254, Israel
Tel Aviv , 64239, Israel
Napoli Campania, 80131, Italy
Faenza Emilia-Romagna, 48018, Italy
Reggio Emilia Emilia-Romagna, 42124, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Milano Lombardia, 20132, Italy
Rozzano Lombardia, 20089, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Hiroshima , 734-8, Japan
Hyogo , 650-0, Japan
Kanagawa , 232-0, Japan
Kanagawa , 241-8, Japan
Miyagi , 980-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Osaka , 565-0, Japan
Saitama , 350-1, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Eldoret , 30100, Kenya
Nairobi , 30270, Kenya
Daegu , 41404, Korea, Republic of
Gyeonggi-do , 16499, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 135-7, Korea, Republic of
FES , 30000, Morocco
Marrakech , 40000, Morocco
Marrakech , 40000, Morocco
Rabat , 10100, Morocco
Christchurch , 8011, New Zealand
Tauranga , 3112, New Zealand
Brzozów , 36-20, Poland
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Kraków , 31-20, Poland
Lublin , 20-09, Poland
Olsztyn , 10-22, Poland
Pozna? , 61-86, Poland
Warszawa , 02-03, Poland
Wroc?aw , 53-41, Poland
Coimbra , 3000-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Sankt-peterburg Leningrad, 19702, Russian Federation
Kazan Tatarstan, 42002, Russian Federation
Izhevsk Udmurtija, 42606, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 11547, Russian Federation
Novosibirsk , 63000, Russian Federation
Saint Petersburg , 19775, Russian Federation
St.Petersburg, Pesochny , 19775, Russian Federation
Tomsk , 63406, Russian Federation
Johannesburg , 2041, South Africa
Overport , 4091, South Africa
Polokwane , 0700, South Africa
Port Elizabeth , 6045, South Africa
Pretoria , 0002, South Africa
Pretoria , , South Africa
Oviedo Asturias, 33006, Spain
L?Hospitalet De Llobregat Barcelona, 08908, Spain
A Coruña LA Coruña, 15006, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Cordoba , 14008, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
Valencia , , Spain
Bern , 3010, Switzerland
Zürich , 8091, Switzerland
Kaoisung , 833, Taiwan
Taichung , 404, Taiwan
Tainan , 00704, Taiwan
Tainan , 710, Taiwan
Taipei City , 11220, Taiwan
Zhongzheng Dist. , 10048, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Songkhla , 90110, Thailand
Adana , 01230, Turkey
Ankara , 06700, Turkey
Ankara , 06800, Turkey
Erzurum , 25240, Turkey
Gaziantep , 27310, Turkey
Istanbul , 34098, Turkey
Kadiköy , 34722, Turkey
Malatya , 44280, Turkey
Van , 65000, Turkey
Kharkiv Kharkiv Governorate, 61070, Ukraine
Kherson Kherson Governorate, 73000, Ukraine
Zhytomyr KIEV Governorate, 10007, Ukraine
Vinnytsya Podolia Governorate, 21029, Ukraine
Kyiv , 03115, Ukraine
Sumy , 40005, Ukraine
Bournemouth , BH7 7, United Kingdom
Cambridge , CB2 0, United Kingdom
London , DD1 9, United Kingdom
London , SW3 6, United Kingdom
London , W2 1N, United Kingdom
Sutton , SM2 5, United Kingdom
Swansea , SA2 8, United Kingdom
Wirral , CH63 , United Kingdom
Wolverhampton , WV10 , United Kingdom
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