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).

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT04543617

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 221 Locations for this study

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Compassionate Care Research Group Inc. Corona
Corona California, 92879, United States
Compassionate Cancer Care Medical Group, Inc
Corona California, 92882, United States
Kaiser Permanente Northern California
Novato California, 94589, United States
Compassionate Care Research Group Inc. Riverside
Riverside California, 92501, United States
Smilow Cancer Hospital, Yale-New Haven
New Haven Connecticut, 06510, United States
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers Florida, 33901, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
Uni of Chicago
Chicago Illinois, 60637, United States
University of Iowa
Iowa City Iowa, 52242, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Washington University School of Medicine; Medical Oncology
Saint Louis Missouri, 63110, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Weill Cornell Medical College
New York New York, 10065, United States
Great Lakes Cancer Center
Williamsville New York, 14221, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
St. Luke's Hospital - Anderson Campus
Easton Pennsylvania, 18045, United States
University of Pennsylvania Health System; Cancer Center
Philadelphia Pennsylvania, 19104, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center; Oncology
Houston Texas, 77030, United States
Fundacion Favaloro
Buenos Aires , C1093, Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Instituto de Investigaciones Metabolicas (Idim)
Ciudad Autonoma de Buenos Aires , C1012, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Austin Health; Cancer Clinical Trial Centre
Heidelberg Victoria, 3084, Australia
St John of God Hospital; Bendat Cancer Centre
Subiaco Western Australia, 6008, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck , 6020, Austria
Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie
Klagenfurt am Wörthersee , 9020, Austria
Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum
Linz , 4010, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg , 5020, Austria
AKH - Medizinische Universität Wien; Department for Internal Medicine I
Wien , 1090, Austria
UZ Antwerpen
Edegem , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza CE, 60130, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba PR, 80810, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Anyang Tumor Hosptial
Anyang City , 45500, China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing , 10002, China
Affiliated Hospital of Bengbu Medical College
Bengbu , 23300, China
Hunan Cancer Hospital
Changsha CITY , 41001, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi City , 04600, China
Changzhou Tumor Hospital, Changzhou Fourth People's Hospital
Changzhou , 21300, China
Sichuan Provincial Cancer Hospital
Chengdu , 61004, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Chongqing Sanxia Central Hospital
Chongqing City , 40400, China
Chongqing Cancer Hospital
Chongqing , 40003, China
The 900th Hospital of PLA joint service support force
Fuzhou , 11001, China
Fujian Cancer Hospital
Fuzhou , 35001, China
Sun Yet-sen University Cancer Center
Guangzhou City , 51066, China
Nanfang Hospital, Southern Medical University
Guangzhou , 51051, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou City , 31001, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou , 31000, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
Jiangsu Sheng , 21000, China
Jieyang People's Hospital
Jieyang City , 52200, China
Shandong Cancer Hospital
Jinan , 25011, China
Affiliated Hospital of Jining Medical University
Jining , 27202, China
The First People's Hospital of Lian Yun Gang
Lianyungang , 22202, China
Lishui Central Hospital
Lishui City , 32300, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang , 47100, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Zhongda Hospital Affiliated to Southeast University
Nanjing , 21000, China
Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai City , 20131, China
Shanghai Chest Hospital
Shanghai , 20000, China
Cancer Hospital of Shantou University Medical College
Shantou , 51504, China
Liaoning cancer Hospital & Institute
Shenyang , 11004, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen City , 51805, China
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
Shenzhen City , 51812, China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang , 05003, China
Tianjin Cancer Hospital
Tianjin , 30006, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan City , 43002, China
Hubei Cancer Hospital
Wuhan , 43007, China
The First Affiliated Hospital of Xiamen University
Xiamen , 36100, China
Zhongshan Hospital Xiamen University
Xiamen , 36100, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang City , 45300, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou , 22100, China
Subei People's Hospital of Jiangsu province; Respiratory
Yangzhou City , 22500, China
Zhejiang Cancer Hospital
Zhejiang , 31002, China
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc , 779 0, Czechia
Fakultni nemocnice Kralovske Vinohrady; Radioterapeuticka a onkologicka klinika
Praha 10 , 100 3, Czechia
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
Brest , 29609, France
Hopital Cote De Nacre; Gastro Enterologie
Caen , 14033, France
CHU Dijon Bourgogne Hôpital François Mitterand
Dijon , 21000, France
Hopital Claude Huriez; Medecine Interne Oncologie
Lille , 59037, France
CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie
Lyon , 69373, France
Hopital Timone Adultes; Oncologie Digestive
Marseille , 13385, France
Centre Antoine Lacassagne
Nice , 06189, France
European Hospital Georges Pompidou (HEGP)
Paris , 75908, France
Hopital Du Haut-Leveque; Gastro-Enterologie
Pessac , 33604, France
Chu La Miletrie; Gastro Enterologie Endoscopies
Poitiers , 86021, France
Hopital Rangueil; Gastro Enterologie Et Nutrition
Toulouse , 31059, France
Institut de Cancérologie de Lorraine
Vandoeuvre-Les-Nancy , 54519, France
Städtisches Klinikum Dresden; IV. Medizinische Klinik
Dresden , 01067, Germany
Universitätsklinikum Essen Klinik f.Strahlentherapie
Essen , 45122, Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
Essen , 45136, Germany
Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
Göttingen , 37075, Germany
Universitaetsklinikum Leipzig
Leipzig , 04103, Germany
Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.
Magdeburg , 39120, Germany
Klinikum Mannheim III. Medizinische Klinik
Mannheim , 68167, Germany
Klinikum der Philipps-Universität Marburg
Marburg , 35032, Germany
Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie
Regensburg , 93053, Germany
Universität Tübingen; Med. Klinik; Innere Medizin I
Tübingen , 72076, Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens , 115 2, Greece
Evgenidio Hospital "Agia Trias"
Athens , 115 2, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki , 546 4, Greece
Semmelweis Egyetem; Onkológiai Központ
Budapest , 1083, Hungary
Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
Gyor , 9024, Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs , 7623, Hungary
Szegedi Tudományegyetem; Onkoterápiás Klinika
Szeged , 6720, Hungary
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem , 91120, Israel
Rambam Health Corporation; Oncology Institute
Rambam , 35254, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
Napoli Campania, 80131, Italy
Ospedale Degli Infermi - Faenza; Oncologia Medica
Faenza Emilia-Romagna, 48018, Italy
AUSL-IRCCS di Reggio Emilia; Oncologia Medica
Reggio Emilia Emilia-Romagna, 42124, Italy
ASU FC S. M. DELLA MISERICORDIA; Oncologia
Udine Friuli-Venezia Giulia, 33100, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano Lombardia, 20089, Italy
Istituto Oncologico Veneto IRCCS
Padova Veneto, 35128, Italy
Aichi Cancer Center Hospital
Aichi , 464-8, Japan
National Cancer Center Hospital East
Chiba , 277-8, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
Kobe University Hospital
Hyogo , 650-0, Japan
Yokohama City University Medical Center
Kanagawa , 232-0, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Saitama Medical University International Medical Center
Saitama , 350-1, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
International Cancer Institute (ICI)
Eldoret , 30100, Kenya
Aga Khan University Hospital
Nairobi , 30270, Kenya
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Ajou University Medical Center
Gyeonggi-do , 16499, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Centre Hospitalier Universitaire Hassan II
FES , 30000, Morocco
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakech , 40000, Morocco
Clinique specialise Menara; Oncology Medical
Marrakech , 40000, Morocco
Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical
Rabat , 10100, Morocco
Christchurch Hospital
Christchurch , 8011, New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga , 3112, New Zealand
Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
Brzozów , 36-20, Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz , 85-79, Poland
Szpital Morski im. PCK; Poradnia Onkologiczna
Gdynia , 81-51, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny
Kraków , 31-20, Poland
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej
Lublin , 20-09, Poland
SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAKŁAD I ODDZIAŁ KLINICZNY RADIOTERAPII
Olsztyn , 10-22, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie; Odd. Onk. Klin. i Immunoonk.
Poznań , 61-86, Poland
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
Warszawa , 02-03, Poland
Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii
Wrocław , 53-41, Poland
HUC; Servico de Oncologia Medica
Coimbra , 3000-, Portugal
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
Porto , 4099-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Sankt-peterburg Leningrad, 19702, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan Tatarstan, 42002, Russian Federation
City Oncological Hospital
Izhevsk Udmurtija, 42606, Russian Federation
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
Krasnoyarsk , 66013, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow , 11547, Russian Federation
Limited Liability Company "RC Medical"
Novosibirsk , 63000, Russian Federation
Scientific Research Institute n.a. N.N. Petrov
Saint Petersburg , 19775, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
St.Petersburg, Pesochny , 19775, Russian Federation
Regional Oncology Dispensary
Tomsk , 63406, Russian Federation
Wits Donald Gordon Clinical Trial Site
Johannesburg , 2041, South Africa
East Coast Oncology
Overport , 4091, South Africa
Limpopo Oncology Clinic
Polokwane , 0700, South Africa
Cancercare
Port Elizabeth , 6045, South Africa
University of Pretoria Oncology Department; Medical Oncology
Pretoria , 0002, South Africa
Eugene Marais Hospital; Oncology
Pretoria , , South Africa
Hospital Univ. Central de Asturias
Oviedo Asturias, 33006, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic I Provincial
Barcelona , 08036, Spain
Hospital Universitario Reina Sofia
Cordoba , 14008, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario Carlos Haya
Malaga , 29010, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital La Fe
Valencia , , Spain
Inselspital Bern, Insel-Gruppe AG
Bern , 3010, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
Kaoisung , 833, Taiwan
China Medical University Hospital; Oncology and Hematology
Taichung , 404, Taiwan
National Cheng Kung University Hospital; Oncology
Tainan , 00704, Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
Tainan , 710, Taiwan
Taipei Veterans General Hospital; Department of Oncology
Taipei City , 11220, Taiwan
National Taiwan University Hospital; Oncology
Zhongzheng Dist. , 10048, Taiwan
Vajira Hospital
Bangkok , 10300, Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok , 10400, Thailand
Siriraj Hospital; Medical Oncology Unit
Bangkok , 10700, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla , 90110, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana , 01230, Turkey
Ankara University Faculty of Medicine Cebeci Hospital
Ankara , 06700, Turkey
Ankara City Hospital; Oncology
Ankara , 06800, Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum , 25240, Turkey
Gaziantep Univ. Med. Fac.
Gaziantep , 27310, Turkey
Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani
Istanbul , 34098, Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy , 34722, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
Malatya , 44280, Turkey
Van Yuzuncu Yil University Hospital; Medical Oncology
Van , 65000, Turkey
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv Kharkiv Governorate, 61070, Ukraine
CI of Kherson Regional Council Kherson Regional Oncology Dispensary
Kherson Kherson Governorate, 73000, Ukraine
Zhytomyr Regional Oncology Center
Zhytomyr KIEV Governorate, 10007, Ukraine
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsya Podolia Governorate, 21029, Ukraine
Kyiv City Clinical Oncological Center
Kyiv , 03115, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy , 40005, Ukraine
Royal Bournemouth Hospital; Oncology
Bournemouth , BH7 7, United Kingdom
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
Cambridge , CB2 0, United Kingdom
Ninewells Hospital; Oncology
London , DD1 9, United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department
London , SW3 6, United Kingdom
Imperial College Healthcare NHS Trust
London , W2 1N, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton , SM2 5, United Kingdom
Singleton Hospital; Cancer Institute
Swansea , SA2 8, United Kingdom
Clatterbridge Cancer Centre; Clatterbridge Cancer Centre
Wirral , CH63 , United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT04543617

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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