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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 (SKYSCRAPER-07)

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiragolumab
Atezolizumab
Tiragolumab Matching Placebo
Atezolizumab Matching Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Compassionate Care Research Group Inc. Corona
  • Compassionate Cancer Care Medical Group, Inc
  • Compassionate Care Research Group Inc. Riverside
  • Florida Cancer Specialists - Fort Myers (Broadway)
  • Florida Cancer Specialist, North Region
  • Mount Sinai Medical Center
  • Weill Cornell Medical College
  • Great Lakes Cancer Center
  • MD Anderson Cancer Center; Oncology
  • Fundacion Favaloro
  • Instituto de Investigaciones Metabolicas (Idim)
  • Centro Oncologico Riojano Integral (CORI)
  • Princess Alexandra Hospital
  • Austin Health; Cancer Clinical Trial Centre
  • St John of God Hospital; Bendat Cancer Centre
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie
  • Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • AKH - Medizinische Universität Wien; Department for Internal Medicine I
  • UZ Antwerpen
  • UZ Leuven Gasthuisberg
  • CHU Sart-Tilman
  • Anyang Tumor Hosptial
  • Cancer Hospital Chinese Academy of Medical Sciences.
  • Affiliated Hospital of Bengbu Medical College
  • Hunan Cancer Hospital
  • Heping Hospital Affiliated to Changzhi Medical College
  • Changzhou Cancer hospital
  • Sichuan Provincial Cancer Hospital
  • West China Hospital, Sichuan University
  • Chongqing Sanxia Central Hospital
  • Chongqing Cancer Hospital
  • Fujian Cancer Hospital
  • Sun Yet-sen University Cancer Center
  • Nanfang Hospital, Southern Medical University
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
  • Jieyang People's Hospital
  • Shandong Cancer Hospital
  • Affiliated Hospital of Jining Medical University
  • The First People's Hospital of Lian Yun Gang
  • Lishui Central Hospital
  • The First Affiliated Hospital to Henan University of Science and Technology
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center; Medical Oncology
  • Shanghai Chest Hospital
  • Cancer Hospital of Shantou University Medical College
  • Liaoning cancer Hospital & Institute
  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Tianjin Cancer Hospital
  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Hubei Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • Zhongshan Hospital Xiamen University
  • The First Affiliated Hospital of Xinxiang Medical University
  • The Affiliated Hospital of Xuzhou Medical College
  • Subei People's Hospital of Jiangsu province; Respiratory
  • Zhejiang Cancer Hospital
  • CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
  • Hopital Cote De Nacre; Gastro Enterologie
  • CHU Dijon Bourgogne Hôpital François Mitterand
  • Hopital Claude Huriez; Medecine Interne Oncologie
  • CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
  • Hopital Timone Adultes; Oncologie Digestive
  • Centre Antoine Lacassagne
  • European Hospital Georges Pompidou (HEGP)
  • Hopital Du Haut-Leveque; Gastro-Enterologie
  • Chu La Miletrie; Gastro Enterologie Endoscopies
  • Hopital Rangueil; Gastro Enterologie Et Nutrition
  • Städtisches Klinikum Dresden; IV. Medizinische Klinik
  • Universitätsklinikum Essen Klinik f.Strahlentherapie
  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
  • Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
  • Universitaetsklinikum Leipzig
  • Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.
  • Klinikum Mannheim III. Medizinische Klinik
  • Klinikum der Philipps-Universität Marburg
  • Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie
  • Universität Tübingen; Med. Klinik; Innere Medizin I
  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Evgenidio Hospital "Agia Trias"
  • Univ General Hosp Heraklion; Medical Oncology
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
  • Szegedi Tudományegyetem; Onkoterápiás Klinika
  • Hadassah Ein Karem Hospital; Oncology Dept
  • Rambam Health Corporation; Oncology Institute
  • Tel Aviv Sourasky Medical Ctr; Oncology
  • Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
  • Ospedale Degli Infermi - Faenza; Oncologia Medica
  • AUSL-IRCCS di Reggio Emilia; Oncologia Medica
  • ASU FC S. M. DELLA MISERICORDIA; Oncologia
  • Irccs Ospedale San Raffaele;Oncologia Medica
  • Istituto Oncologico Veneto IRCCS
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • Hiroshima University Hospital
  • Kobe University Hospital
  • Yokohama City University Medical Center
  • Kanagawa Cancer Center
  • Tohoku University Hospital
  • Niigata Cancer Center Hospital
  • Osaka International Cancer Institute
  • Osaka University Hospital
  • Saitama Medical University International Medical Center
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • The Cancer Institute Hospital of JFCR
  • Keio University Hospital
  • International Cancer Institute (ICI)
  • Aga Khan University Hospital
  • Kyungpook National University Chilgok Hospital
  • Ajou University Medical Center
  • Chonnam National University Hwasun Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Centre Hospitalier Universitaire Hassan II
  • Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
  • Clinique specialise Menara; Oncology Medical
  • Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical
  • Christchurch Hospital
  • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej
  • SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAK?AD I ODDZIA? KLINICZNY RADIOTERAPII
  • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie; Odd. Onk. Klin. i Immunoonk.
  • NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
  • Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
  • HUC; Servico de Oncologia Medica
  • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • IPO do Porto; Servico de Oncologia Medica
  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
  • Scientific Research Institute n.a. N.N. Petrov
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • City Oncological Hospital
  • Limited Liability Company "RC Medical"
  • Regional Oncology Dispensary
  • Wits Donald Gordon Clinical Trial Site
  • Limpopo Oncology Clinic
  • Cancercare
  • Eugene Marais Hospital; Oncology
  • Hospital Univ. Central de Asturias
  • ICO l?Hospitalet ? Hospital Duran i Reynals
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic I Provincial
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Ramon y Cajal
  • Fundacion Jimenez Diaz; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario Carlos Haya
  • Hospital Clinico Universitario de Valencia
  • Hospital La Fe
  • Inselspital Bern, Insel-Gruppe AG
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
  • China Medical University Hospital; Oncology and Hematology
  • National Cheng Kung University Hospital; Oncology
  • Chi-Mei Medical Centre; Hematology & Oncology
  • Taipei Veterans General Hospital; Department of Oncology
  • National Taiwan University Hospital; Oncology
  • Vajira Hospital
  • Chulalongkorn Hospital; Medical Oncology
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Siriraj Hospital; Medical Oncology Unit
  • Songklanagarind Hospital; Department of Oncology
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara University Faculty of Medicine Cebeci Hospital
  • Ankara City Hospital; Oncology
  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
  • Gaziantep Univ. Med. Fac.
  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
  • Van Yuzuncu Yil University Hospital; Medical Oncology
  • Municipal Noncommercial Institution Regional Center of Oncology
  • Zhytomyr Regional Oncology Center
  • Vinnytsya Regional Clinical Oncology Dispensary
  • RCI Sumy Regional Clinical Oncological Dispensary
  • Royal Bournemouth Hospital; Oncology
  • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
  • Ninewells Hospital; Oncology
  • Royal Marsden Hospital - Fulham; Oncology Department
  • Royal Marsden Hospital (Sutton)
  • Clatterbridge Cancer Centre
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm A: Tiragolumab + Atezolizumab

Arm B: Tiragolumab Placebo + Atezolizumab

Arm C: Tiragolumab Placebo + Atezolizumab Placebo

Arm Description

Participants will receive atezolizumab followed by tiragolumab.

Participants will receive atezolizumab followed by tiragolumab matching placebo.

Participants will receive matching placebos to tiragolumab and atezolizumab.

Outcomes

Primary Outcome Measures

Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
Arm A vs Arm C: Overall Survival (OS)
Arm B vs Arm C: OS

Secondary Outcome Measures

Arm B vs Arm C: Investigator-Assessed PFS
Arm A vs Arm B: Investigator-Assessed PFS
Arm A vs Arm B: OS
Independent Review Facility (IRF)-Assessed PFS
Investigator-Assessed Confirmed Objective Response Rate (ORR)
IRF-Assessed Confirmed ORR
Investigator-Assessed Duration of Objective Response (DOR)
IRF-Assessed DOR
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.
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.
Percentage of Participants With Adverse Events (AEs)
Serum Concentration of Tiragolumab
Serum Concentration of Atezolizumab
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Percentage of Participants With ADAs to Atezolizumab

Full Information

First Posted
September 3, 2020
Last Updated
September 28, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04543617
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
Acronym
SKYSCRAPER-07
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
760 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Tiragolumab + Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab followed by tiragolumab.
Arm Title
Arm B: Tiragolumab Placebo + Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab followed by tiragolumab matching placebo.
Arm Title
Arm C: Tiragolumab Placebo + Atezolizumab Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebos to tiragolumab and atezolizumab.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A, RO7092284
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq, RO5541267
Intervention Description
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab Matching Placebo
Intervention Description
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab Matching Placebo
Intervention Description
Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)
Title
Arm A vs Arm C: Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to approximately 50 months)
Title
Arm B vs Arm C: OS
Time Frame
From randomization to death from any cause (up to approximately 50 months)
Secondary Outcome Measure Information:
Title
Arm B vs Arm C: Investigator-Assessed PFS
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)
Title
Arm A vs Arm B: Investigator-Assessed PFS
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)
Title
Arm A vs Arm B: OS
Time Frame
From randomization to death from any cause (up to approximately 50 months)
Title
Independent Review Facility (IRF)-Assessed PFS
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)
Title
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Time Frame
From randomization up to approximately 50 months
Title
IRF-Assessed Confirmed ORR
Time Frame
From randomization up to approximately 50 months
Title
Investigator-Assessed Duration of Objective Response (DOR)
Time Frame
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 50 months)
Title
IRF-Assessed DOR
Time Frame
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 50 months)
Title
Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30
Description
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.
Time Frame
Up to approximately 50 months
Title
Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18
Description
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.
Time Frame
Up to approximately 50 months
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Up to approximately 50 months
Title
Serum Concentration of Tiragolumab
Time Frame
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 50 months)
Title
Serum Concentration of Atezolizumab
Time Frame
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 50 months)
Title
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Time Frame
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 50 months)
Title
Percentage of Participants With ADAs to Atezolizumab
Time Frame
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 50 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Compassionate Care Research Group Inc. Corona
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Compassionate Care Research Group Inc. Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers (Broadway)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Great Lakes Cancer Center
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
MD Anderson Cancer Center; Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fundacion Favaloro
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas (Idim)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Austin Health; Cancer Clinical Trial Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
St John of God Hospital; Bendat Cancer Centre
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien; Department for Internal Medicine I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Anyang Tumor Hosptial
City
Anyang City
ZIP/Postal Code
455000
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences.
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233004
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi City
ZIP/Postal Code
046000
Country
China
Facility Name
Changzhou Cancer hospital
City
Changzhou
ZIP/Postal Code
213000
Country
China
Facility Name
Sichuan Provincial Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Chongqing Sanxia Central Hospital
City
Chongqing City
ZIP/Postal Code
404000
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
City
Jiangsu Sheng
ZIP/Postal Code
210008
Country
China
Facility Name
Jieyang People's Hospital
City
Jieyang City
ZIP/Postal Code
522000
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
ZIP/Postal Code
272029
Country
China
Facility Name
The First People's Hospital of Lian Yun Gang
City
Lianyungang
ZIP/Postal Code
222023
Country
China
Facility Name
Lishui Central Hospital
City
Lishui City
ZIP/Postal Code
323000
Country
China
Facility Name
The First Affiliated Hospital to Henan University of Science and Technology
City
Luoyang City
ZIP/Postal Code
471031
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Fudan University Shanghai Cancer Center; Medical Oncology
City
Shanghai City
ZIP/Postal Code
201315
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
ZIP/Postal Code
515041
Country
China
Facility Name
Liaoning cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
City
Shenzhen City
ZIP/Postal Code
518127
Country
China
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang City
ZIP/Postal Code
453000
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Subei People's Hospital of Jiangsu province; Respiratory
City
Yangzhou City
ZIP/Postal Code
225001
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Cote De Nacre; Gastro Enterologie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Dijon Bourgogne Hôpital François Mitterand
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Claude Huriez; Medecine Interne Oncologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Timone Adultes; Oncologie Digestive
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
European Hospital Georges Pompidou (HEGP)
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hopital Du Haut-Leveque; Gastro-Enterologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Chu La Miletrie; Gastro Enterologie Endoscopies
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Hopital Rangueil; Gastro Enterologie Et Nutrition
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Städtisches Klinikum Dresden; IV. Medizinische Klinik
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Essen Klinik f.Strahlentherapie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinikum Mannheim III. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universität Tübingen; Med. Klinik; Innere Medizin I
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
Evgenidio Hospital "Agia Trias"
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Facility Name
Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Szegedi Tudományegyetem; Onkoterápiás Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Hadassah Ein Karem Hospital; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Facility Name
Rambam Health Corporation; Oncology Institute
City
Rambam
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Degli Infermi - Faenza; Oncologia Medica
City
Faenza
State/Province
Emilia-Romagna
ZIP/Postal Code
48018
Country
Italy
Facility Name
AUSL-IRCCS di Reggio Emilia; Oncologia Medica
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42124
Country
Italy
Facility Name
ASU FC S. M. DELLA MISERICORDIA; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Irccs Ospedale San Raffaele;Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
International Cancer Institute (ICI)
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Centre Hospitalier Universitaire Hassan II
City
FES
ZIP/Postal Code
30000
Country
Morocco
Facility Name
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Clinique specialise Menara; Oncology Medical
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical
City
Rabat
ZIP/Postal Code
10100
Country
Morocco
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAK?AD I ODDZIA? KLINICZNY RADIOTERAPII
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie; Odd. Onk. Klin. i Immunoonk.
City
Pozna?
ZIP/Postal Code
61-866
Country
Poland
Facility Name
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
HUC; Servico de Oncologia Medica
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
City
Krasnoyarsk
State/Province
Krasnodar
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Scientific Research Institute n.a. N.N. Petrov
City
Saint Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
187758
Country
Russian Federation
Facility Name
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
City Oncological Hospital
City
Izhevsk
State/Province
Udmurtija
ZIP/Postal Code
426067
Country
Russian Federation
Facility Name
Limited Liability Company "RC Medical"
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Regional Oncology Dispensary
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Wits Donald Gordon Clinical Trial Site
City
Johannesburg
ZIP/Postal Code
2041
Country
South Africa
Facility Name
Limpopo Oncology Clinic
City
Polokwane
ZIP/Postal Code
0700
Country
South Africa
Facility Name
Cancercare
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Eugene Marais Hospital; Oncology
City
Pretoria
Country
South Africa
Facility Name
Hospital Univ. Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
ICO l?Hospitalet ? Hospital Duran i Reynals
City
L?Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14008
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Inselspital Bern, Insel-Gruppe AG
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
City
Kaoisung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital; Oncology and Hematology
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Chi-Mei Medical Centre; Hematology & Oncology
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Department of Oncology
City
Taipei City
ZIP/Postal Code
112201
Country
Taiwan
Facility Name
National Taiwan University Hospital; Oncology
City
Zhongzheng Dist.
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital; Medical Oncology Unit
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Ankara University Faculty of Medicine Cebeci Hospital
City
Ankara
ZIP/Postal Code
06700
Country
Turkey
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Gaziantep Univ. Med. Fac.
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Van Yuzuncu Yil University Hospital; Medical Oncology
City
Van
ZIP/Postal Code
65000
Country
Turkey
Facility Name
Municipal Noncommercial Institution Regional Center of Oncology
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Zhytomyr Regional Oncology Center
City
Zhytomyr
State/Province
KIEV Governorate
ZIP/Postal Code
10007
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Oncology Dispensary
City
Vinnytsya
State/Province
Podolia Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
RCI Sumy Regional Clinical Oncological Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Royal Bournemouth Hospital; Oncology
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Ninewells Hospital; Oncology
City
London
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Fulham; Oncology Department
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this 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

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