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 (SKYSCRAPER-07)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Tiragolumab Matching Placebo; Drug: Atezolizumab Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 760
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: YO42137 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • Fundacion Favaloro
  • Ciudad Autonoma de Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabolicas (Idim)
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health; Cancer Clinical Trial Centre
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Hospital; Bendat Cancer Centre
• Austria
  • Innsbruck, Austria, 6020
    • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Klagenfurt am Wörthersee, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie
  • Linz, Austria, 4010
    • Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum
  • Wien, Austria, 1090
    • AKH - Medizinische Universität Wien; Department for Internal Medicine I
• Belgium
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
• China
  • Anyang City, China, 455000
    • Anyang Tumor Hosptial
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Bengbu, China, 233004
    • Affiliated Hospital of Bengbu Medical College
  • Changsha CITY, China, 410013
    • Hunan Cancer Hospital
  • Changzhi City, China, 046000
    • Heping Hospital Affiliated to Changzhi Medical College
  • Changzhou, China, 213000
    • Changzhou Cancer hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610041
    • Sichuan Provincial Cancer Hospital
  • Chongqing, China, 400030
    • Chongqing Cancer Hospital
  • Chongqing City, China, 404000
    • Chongqing Sanxia Central Hospital
  • Fuzhou, China, 350014
    • Fujian cancer hospital
  • Guangzhou, China, 510515
    • Nanfang Hospital, Southern Medical University
  • Guangzhou City, China, 510663
    • Sun Yet-sen University Cancer Center
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Jiangsu Sheng, China, 210008
    • Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
  • Jieyang City, China, 522000
    • Jieyang People's Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Jining, China, 272029
    • Affiliated Hospital of Jining Medical University
  • Lianyungang, China, 222023
    • The First People's Hospital of Lian Yun Gang
  • Lishui City, China, 323000
    • Lishui Central Hospital
  • Luoyang City, China, 471031
    • The First Affiliated Hospital to Henan University of Science and Technology
  • Nanjing City, China, 211100
    • Jiangsu Cancer Hospital
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
  • Shanghai City, China, 201315
    • Fudan University Shanghai Cancer Center; Medical Oncology
  • Shantou, China, 515041
    • Cancer Hospital of Shantou University Medical College
  • Shenyang, China, 110042
    • Liaoning cancer Hospital & Institute
  • Shenzhen City, China, 518127
    • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
  • Shijiazhuang, China, 050035
    • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan City, China, 430022
    • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Xiamen, China, 361003
    • The First Affiliated Hospital of Xiamen University
  • Xiamen, China, 361004
    • Zhongshan Hospital Xiamen University
  • Xinxiang City, China, 453000
    • The First Affiliated Hospital of Xinxiang Medical University
  • Xuzhou, China, 221000
    • The Affiliated Hospital of Xuzhou Medical College
  • Yangzhou City, China, 225001
    • Subei People's Hospital of Jiangsu province; Respiratory
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• France
  • Brest, France, 29609
    • CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
  • Dijon, France, 21000
    • CHU Dijon Bourgogne Hôpital François Mitterand
  • Lille, France, 59037
    • Hopital Claude Huriez; Medecine Interne Oncologie
  • Lyon, France, 69373
    • CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
  • Marseille, France, 13385
    • Hopital Timone Adultes; Oncologie Digestive
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75908
    • European Hospital Georges Pompidou (HEGP)
  • Pessac, France, 33604
    • Hopital Du Haut-Leveque; Gastro-Enterologie
  • Poitiers, France, 86021
    • Chu La Miletrie; Gastro Enterologie Endoscopies
  • Toulouse, France, 31059
    • Hopital Rangueil; Gastro Enterologie Et Nutrition
• Germany
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
  • Essen, Germany, 45122
    • Universitätsklinikum Essen Klinik f.Strahlentherapie
  • Göttingen, Germany, 37075
    • Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Magdeburg, Germany, 39120
    • Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.
  • Marburg, Germany, 35032
    • Klinikum der Philipps-Universität Marburg
  • Regensburg, Germany, 93053
    • Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie
• Greece
  • Athens, Greece, 115 28
    • Evgenidio Hospital "Agia Trias"
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki; Oncology Department
• Hungary
  • Pécs, Hungary, 7623
    • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem; Onkoterápiás Klinika
• Israel
  • Jerusalem, Israel, 9112000
    • Hadassah Ein Karem Hospital; Oncology Dept
  • Rambam, Israel, 3525408
    • Rambam Health Corporation; Oncology Institute
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr; Oncology
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
  • Emilia-Romagna
    • Faenza, Emilia-Romagna, Italy, 48018
      • Ospedale Degli Infermi - Faenza; Oncologia Medica
    • Reggio Emilia, Emilia-Romagna, Italy, 42124
      • AUSL-IRCCS di Reggio Emilia; Oncologia Medica
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • ASU FC S. M. DELLA MISERICORDIA; Oncologia
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Istituto Oncologico Veneto IRCCS
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyogo, Japan, 650-0017
    • Kobe University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center
  • Miyagi, Japan, 980-8574
    • Tohoku University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Saitama, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of Jfcr
• Kenya
  • Eldoret, Kenya, 30100
    • International Cancer Institute (ICI)
  • Nairobi, Kenya, 00100
    • Aga Khan University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Medical Center
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Morocco
  • FES, Morocco, 30000
    • Centre Hospitalier Universitaire Hassan II
  • Marrakech, Morocco, 40000
    • Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
  • Marrakech, Morocco, 40000
    • Clinique specialise Menara; Oncology Medical
  • Rabat, Morocco, 10100
    • Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical
• New Zealand
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Lublin, Poland, 20-090
    • CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej
  • Olsztyn, Poland, 10-228
    • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii; ZAK?.I O.KLINICZNY RADIOTERAPII
  • Pozna?, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie; Odd. Onk. Klin. i Immunoonk.
  • Warszawa, Poland, 02-034
    • NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
  • Wroc?aw, Poland, 53-413
    • Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
• Portugal
  • Coimbra, Portugal, 3000-075
    • HUC; Servico de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
• Russian Federation
  • Novosibirsk, Russian Federation, 630005
    • Limited Liability Company "RC Medical"
  • Tomsk, Russian Federation, 634063
    • Regional Oncology Dispensary
  • Krasnodar
    • Krasnoyarsk, Krasnodar, Russian Federation, 660133
      • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
  • Sankt Petersburg
    • Saint Petersburg, Sankt Petersburg, Russian Federation, 187758
      • Scientific Research Institute n.a. N.N. Petrov
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197022
      • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420029
      • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • Udmurtija
    • Izhevsk, Udmurtija, Russian Federation, 426067
      • City Oncological Hospital
• South Africa
  • Johannesburg, South Africa, 2041
    • Wits Donald Gordon Clinical Trial Site
  • Polokwane, South Africa, 0700
    • Limpopo Cancer Research Institute
  • Port Elizabeth, South Africa, 6045
    • Cancercare
  • Pretoria, South Africa
    • Eugene Marais Hospital; Oncology
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial
  • Cordoba, Spain, 14008
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain
    • Hospital La Fe
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Univ. Central de Asturias
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Insel-Gruppe AG
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
• Taiwan
  • Kaoisung, Taiwan, 833
    • Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
  • Taichung, Taiwan, 404
    • China Medical University Hospital; Oncology and Hematology
  • Tainan, Taiwan, 710
    • Chi-Mei Medical Centre; Hematology & Oncology
  • Tainan, Taiwan, 00704
    • National Cheng Kung University Hospital; Oncology
  • Taipei City, Taiwan, 112201
    • Taipei Veterans General Hospital; Department of Oncology
  • Zhongzheng Dist., Taiwan, 10048
    • National Taiwan University Hospital; Oncology
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital; Medical Oncology
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Bangkok, Thailand, 10700
    • Siriraj Hospital; Medical Oncology Unit
  • Bangkok, Thailand, 10300
    • Vajira Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital; Department of Oncology
• Turkey
  • Adana, Turkey, 01230
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara, Turkey, 06800
    • Ankara City Hospital; Oncology
  • Ankara, Turkey, 06700
    • Ankara University Faculty of Medicine Cebeci Hospital
  • Erzurum, Turkey, 25240
    • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
  • Kadiköy, Turkey, 34722
    • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • Malatya, Turkey, 44280
    • Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
  • Van, Turkey, 65000
    • Van Yuzuncu Yil University Hospital; Medical Oncology
• Ukraine
  • Sumy, Ukraine, 40005
    • RCI Sumy Regional Clinical Oncological Dispensary
  • KIEV Governorate
    • Zhytomyr, KIEV Governorate, Ukraine, 10007
      • Zhytomyr Regional Oncology Center
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61070
      • Municipal Noncommercial Institution Regional Center of Oncology
  • Podolia Governorate
    • Vinnytsya, Podolia Governorate, Ukraine, 21029
      • Vinnytsya Regional Clinical Oncology Dispensary
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Royal Bournemouth Hospital; Oncology
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - Fulham; Oncology Department
  • London, United Kingdom, DD1 9SY
    • Ninewells Hospital; Oncology
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital (Sutton)
  • Wirral, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • California
    • Corona, California, United States, 92882
      • Compassionate Cancer Care Medical Group, Inc
    • Corona, California, United States, 92879
      • Compassionate Care Research Group Inc. Corona
    • Riverside, California, United States, 92501
      • Compassionate Care Research Group Inc. Riverside
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - Fort Myers (Broadway)
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialist, North Region
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Williamsville, New York, United States, 14221
      • Great Lakes Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center; Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Tiragolumab + Atezolizumab; Participants will receive atezolizumab followed by tiragolumab.	Drug: 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.; Other Names: MTIG7192A, RO7092284; Drug: Atezolizumab; Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.; Other Names: Tecentriq, RO5541267
Experimental: Arm B: Tiragolumab Placebo + Atezolizumab; Participants will receive atezolizumab followed by tiragolumab matching placebo.	Drug: Atezolizumab; Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.; Other Names: Tecentriq, RO5541267; Drug: Tiragolumab Matching Placebo; Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo; Participants will receive matching placebos to tiragolumab and atezolizumab.	Drug: Tiragolumab Matching Placebo; Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.; Drug: Atezolizumab Matching Placebo; Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Arm A vs Arm C: Overall Survival (OS)	From randomization to death from any cause (up to approximately 6 years)
Arm B vs Arm C: OS	From randomization to death from any cause (up to approximately 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs)		Up to approximately 6 years
Arm B vs Arm C: Investigator-Assessed PFS		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Arm A vs Arm B: Investigator-Assessed PFS		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Arm A vs Arm B: OS		From randomization to death from any cause (up to approximately 6 years)
Independent Review Facility (IRF)-Assessed PFS		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Investigator-Assessed Confirmed Objective Response Rate (ORR)		From randomization up to approximately 6 years
IRF-Assessed Confirmed ORR		From randomization up to approximately 6 years
Investigator-Assessed Duration of Objective Response (DOR)		From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
IRF-Assessed DOR		From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30	Clinically meaningful changes in physical functioning, role functioning, global health status (GHS)/QoL as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.	Up to approximately 6 years
Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18	Clinically meaningful changes in dysphagia as measured by the EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18). EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consists of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item is scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores will be linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms.	Up to approximately 6 years
Serum Concentration of Tiragolumab		Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to approximately 6 years)
Serum Concentration of Atezolizumab		Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab		Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)
Percentage of Participants With ADAs to Atezolizumab		Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trial, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antibodies, Monoclonal; Atezolizumab
• Other Study ID Numbers: YO42137; 2020-001178-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No