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JOURNAL ONKOLOGIE – STUDIE
SKYSCRAPER-07

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

Rekrutierend

NCT-Nummer:
NCT04543617

Studienbeginn:
September 2020

Letztes Update:
19.05.2021

Wirkstoff:
Tiragolumab, Atezolizumab, Tiragolumab Matching Placebo, Atezolizumab Matching Placebo

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Esophageal Squamous Cell Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trial
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: YO42137 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 213)

Städtisches Klinikum Dresden; IV. Medizinische Klinik
01067 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Essen Klinik f.Strahlentherapie
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Magdeburg, Klinik für Allgemein-, Viszeral- u. Gefäßchirurgie
39120 Magdeburg
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Mannheim III. Medizinische Klinik
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum der Philipps-Universität Marburg
35032 Marburg
(Hessen)
GermanyRekrutierend» Google-Maps
Universität Tübingen; Med. Klinik; Innere Medizin I
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Kaiser Permanente Northern California
94589 Novato
United StatesNoch nicht rekrutierend» Google-Maps
Smilow Cancer Hospital, Yale-New Haven
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists - Fort Myers (Broadway)
33901 Fort Myers
United StatesRekrutierend» Google-Maps
Mount Sinai Medical Center
33140 Miami Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialist, North Region
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
Uni of Chicago
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
University of Iowa
52242 Iowa City
United StatesNoch nicht rekrutierend» Google-Maps
Cancer Center of Kansas
67214-3728 Wichita
United StatesRekrutierend» Google-Maps
Washington University School of Medicine; Medical Oncology
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Mount Sinai Medical Center
10029 New York
United StatesRekrutierend» Google-Maps
Weill Cornell Medical College
10065 New York
United StatesRekrutierend» Google-Maps
Great Lakes Cancer Center
14221 Williamsville
United StatesRekrutierend» Google-Maps
Levine Cancer Institute
28204 Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
St. Luke's Hospital - Anderson Campus
18045 Easton
United StatesNoch nicht rekrutierend» Google-Maps
University of Pennsylvania Health System; Cancer Center
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Tennessee Oncology; Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center; Oncology
77030 Houston
United StatesRekrutierend» Google-Maps
Fundacion Favaloro
C1093AAS Buenos Aires
ArgentinaRekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps
Instituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Centro Oncologico Riojano Integral (CORI)
F5300COE La Rioja
ArgentinaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Austin Health; Cancer Clinical Trial Centre
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
St John of God Hospital; Bendat Cancer Centre
6008 Subiaco
AustraliaRekrutierend» Google-Maps
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie
9020 Klagenfurt am Wörthersee
AustriaNoch nicht rekrutierend» Google-Maps
Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum
4010 Linz
AustriaRekrutierend» Google-Maps
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
5020 Salzburg
AustriaAktiv, nicht rekrutierend» Google-Maps
AKH - Medizinische Universität Wien; Department for Internal Medicine I
1090 Wien
AustriaRekrutierend» Google-Maps
Instituto de Ensino e Pesquisa Clinica do Ceara
60130-241 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Centro Integrado de Oncologia de Curitiba
80810-050 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Cancer de Barretos
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo - ICESP
01246-000 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Cancer Hospital Chinese Academy of Medical Sciences.
100021 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Affiliated Hospital of Bengbu Medical College
233004 Bengbu
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha City
ChinaNoch nicht rekrutierend» Google-Maps
Changzhou Tumor Hospital, Changzhou Fourth People's Hospital
213000 Changzhou
ChinaRekrutierend» Google-Maps
Sichuan Provincial Cancer Hospital
610041 Chengdu
ChinaRekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
Chongqing Sanxia Central Hospital
404000 Chongqing City
ChinaRekrutierend» Google-Maps
The 900th Hospital of PLA joint service support force
110016 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Cancer Hospital
350014 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
Sun Yet-sen University Cancer Center
510060 Guangzhou
ChinaRekrutierend» Google-Maps
Nanfang Hospital, Southern Medical University
510515 Guangzhou
ChinaRekrutierend» Google-Maps
Sir Run Run Shaw Hospital Zhejiang University
310016 Hangzhou City
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of College of Medicine, Zhejiang University
310003 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaRekrutierend» Google-Maps
Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi
210008 Jiangsu Sheng
ChinaRekrutierend» Google-Maps
Affiliated Hospital of Jining Medical University
272029 Jining
ChinaNoch nicht rekrutierend» Google-Maps
The First People's Hospital of Lian Yun Gang
222023 Lianyungang
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital to Henan University of Science and Technology
471003 Luoyang
ChinaRekrutierend» Google-Maps
Jiangsu Cancer Hospital
211100 Nanjing City
ChinaNoch nicht rekrutierend» Google-Maps
Zhongda Hospital Affiliated to Southeast University
210009 Nanjing
ChinaRekrutierend» Google-Maps
Boao Evergrande international Hoapital in a affiliation with Brigham and Woman's Hospital
Qionghai
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center; Medical Oncology
201315 Shanghai City
ChinaRekrutierend» Google-Maps
Cancer Hospital of Shantou University Medical College
515041 Shantou
ChinaRekrutierend» Google-Maps
Liaoning cancer Hospital & Institute
110042 Shenyang
ChinaRekrutierend» Google-Maps
The University of Hong Kong-Shenzhen Hospital
518053 Shenzhen City
ChinaNoch nicht rekrutierend» Google-Maps
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
518127 Shenzhen City
ChinaRekrutierend» Google-Maps
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
050035 Shijiazhuang
ChinaNoch nicht rekrutierend» Google-Maps
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
430022 Wuhan City
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xiamen University
361003 Xiamen
ChinaRekrutierend» Google-Maps
Zhongshan Hospital Xiamen University
361004 Xiamen
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xinxiang Medical University
453000 Xinxiang City
ChinaNoch nicht rekrutierend» Google-Maps
The Affiliated Hospital of Xuzhou Medical College
221000 Xuzhou
ChinaRekrutierend» Google-Maps
Subei People's Hospital of Jiangsu province; Respiratory
225001 Yangzhou City
ChinaNoch nicht rekrutierend» Google-Maps
Fakultni nemocnice Olomouc; Onkologicka klinika
779 00 Olomouc
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady; Radioterapeuticka a onkologicka klinika
100 34 Praha 10
CzechiaRekrutierend» Google-Maps
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
29609 Brest
FranceRekrutierend» Google-Maps
Hopital Cote De Nacre; Gastro Enterologie
14033 Caen
FranceNoch nicht rekrutierend» Google-Maps
CHU Dijon Bourgogne Hôpital François Mitterand
21000 Dijon
FranceRekrutierend» Google-Maps
Hopital Claude Huriez; Medecine Interne Oncologie
59037 Lille
FranceRekrutierend» Google-Maps
CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie
69373 Lyon
FranceRekrutierend» Google-Maps
Hopital Timone Adultes; Oncologie Digestive
13385 Marseille
FranceRekrutierend» Google-Maps
European Hospital Georges Pompidou (HEGP)
75908 Paris
FranceRekrutierend» Google-Maps
Hopital Du Haut-Leveque; Gastro-Enterologie
33604 Pessac
FranceRekrutierend» Google-Maps
Chu La Miletrie; Gastro Enterologie Endoscopies
86021 Poitiers
FranceNoch nicht rekrutierend» Google-Maps
Hopital Rangueil; Gastro Enterologie Et Nutrition
31059 Toulouse
FranceRekrutierend» Google-Maps
Institut de Cancérologie de Lorraine
54519 Vandoeuvre-Les-Nancy
FranceRekrutierend» Google-Maps
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
115 22 Athens
GreeceRekrutierend» Google-Maps
Evgenidio Hospital "Agia Trias"
115 28 Athens
GreeceRekrutierend» Google-Maps
Univ General Hosp Heraklion; Medical Oncology
711 10 Heraklion
GreeceRekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546450 Thessaloniki
GreeceRekrutierend» Google-Maps
Semmelweis Egyetem; Onkológiai Központ
1083 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
9024 Gyor
HungaryNoch nicht rekrutierend» Google-Maps
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
7623 Pécs
HungaryRekrutierend» Google-Maps
Szegedi Tudományegyetem; Onkoterápiás Klinika
6720 Szeged
HungaryRekrutierend» Google-Maps
Hadassah Ein Karem Hospital; Oncology Dept
9112000 Jerusalem
IsraelRekrutierend» Google-Maps
Rambam Health Corporation; Oncology Institute
3525408 Rambam
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Ctr; Oncology
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
80131 Napoli
ItalyRekrutierend» Google-Maps
Ospedale Degli Infermi - Faenza; Oncologia Medica
48018 Faenza
ItalyRekrutierend» Google-Maps
AUSL-IRCCS di Reggio Emilia; Oncologia Medica
42124 Reggio Emilia
ItalyNoch nicht rekrutierend» Google-Maps
ASU FC S. M. DELLA MISERICORDIA; Oncologia
33100 Udine
ItalyRekrutierend» Google-Maps
Irccs Ospedale San Raffaele;Oncologia Medica
20132 Milano
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
20089 Rozzano
ItalyRekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
Hiroshima University Hospital
734-8551 Hiroshima
JapanRekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Kanagawa
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
Saitama Medical University International Medical Center
350-1298 Saitama
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanRekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Medical Center
16499 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Christchurch Hospital
8011 Christchurch
New ZealandRekrutierend» Google-Maps
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
3112 Tauranga
New ZealandRekrutierend» Google-Maps
Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
36-200 Brzozów
PolandRekrutierend» Google-Maps
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Szpital Morski im. PCK; Poradnia Onkologiczna
81-519 Gdynia
PolandRekrutierend» Google-Maps
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny
31-202 Kraków
PolandRekrutierend» Google-Maps
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej
20-090 Lublin
PolandRekrutierend» Google-Maps
SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAKŁAD I ODDZIAŁ KLINICZNY RADIOTERAPII
10-228 Olsztyn
PolandRekrutierend» Google-Maps
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie; Odd. Onk. Klin. i Immunoonk.
61-866 Poznań
PolandNoch nicht rekrutierend» Google-Maps
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
02-034 Warszawa
PolandRekrutierend» Google-Maps
Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii
53-413 Wrocław
PolandRekrutierend» Google-Maps
HUC; Servico de Oncologia Medica
3000-075 Coimbra
PortugalRekrutierend» Google-Maps
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
4099-001 Porto
PortugalRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalRekrutierend» Google-Maps
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
City Oncological Hospital
426009 Izhevsk
Russian FederationRekrutierend» Google-Maps
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
420029 Kazan
Russian FederationRekrutierend» Google-Maps
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
115478 Moscow
Russian FederationRekrutierend» Google-Maps
Limited Liability Company "RC Medical"
630005 Novosibirsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Scientific Research Institute n.a. N.N. Petrov
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
197758 St.Petersburg, Pesochny
Russian FederationRekrutierend» Google-Maps
Regional Oncology Dispensary
634063 Tomsk
Russian FederationRekrutierend» Google-Maps
Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital
2193 Johannesburg
South AfricaNoch nicht rekrutierend» Google-Maps
University of Pretoria Oncology Department; Medical Oncology
0002 Pretoria
South AfricaNoch nicht rekrutierend» Google-Maps
Eugene Marais Hospital; Oncology
Pretoria
South AfricaRekrutierend» Google-Maps
Hospital Universitario Central de Asturias
33011 Oviedo
SpainRekrutierend» Google-Maps
ICO l'Hospitalet - Hospital Duran i Reynals
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Cordoba
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario Carlos Haya
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
833 Kaoisung
TaiwanRekrutierend» Google-Maps
China Medical University Hospital; Oncology and Hematology
404 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital; Oncology
00704 Tainan
TaiwanRekrutierend» Google-Maps
Chi-Mei Medical Centre; Hematology & Oncology
710 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital; Department of Oncology
112201 Taipei City
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital; Oncology
10048 Zhongzheng Dist.
TaiwanRekrutierend» Google-Maps
Chulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
10400 Bangkok
ThailandRekrutierend» Google-Maps
Siriraj Hospital; Medical Oncology Unit
10700 Bangkok
ThailandRekrutierend» Google-Maps
Songklanagarind Hospital; Department of Oncology
90110 Songkhla
ThailandRekrutierend» Google-Maps
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
01250 Adana
TurkeyRekrutierend» Google-Maps
Ankara University Faculty of Medicine Cebeci Hospital
06700 Ankara
TurkeyRekrutierend» Google-Maps
Ankara City Hospital; Oncology
06800 Ankara
TurkeyRekrutierend» Google-Maps
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
25240 Erzurum
TurkeyRekrutierend» Google-Maps
Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani
34098 Istanbul
TurkeyRekrutierend» Google-Maps
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
44280 Malatya
TurkeyRekrutierend» Google-Maps
Van Yuzuncu Yil University Hospital; Medical Oncology
65000 Van
TurkeyRekrutierend» Google-Maps
Municipal Noncommercial Institution Regional Center of Oncology
61070 Kharkiv
UkraineRekrutierend» Google-Maps
CI of Kherson Regional Council Kherson Regional Oncology Dispensary
73000 Kherson
UkraineRekrutierend» Google-Maps
Zhytomyr Regional Oncology Center
10007 Zhytomyr
UkraineRekrutierend» Google-Maps
Vinnytsya Regional Clinical Oncology Dispensary
21029 Vinnytsya
UkraineNoch nicht rekrutierend» Google-Maps
Kyiv City Clinical Oncological Center
03115 Kyiv
UkraineRekrutierend» Google-Maps
RCI Sumy Regional Clinical Oncological Dispensary
40005 Sumy
UkraineNoch nicht rekrutierend» Google-Maps
Royal Bournemouth Hospital; Oncology
BH7 7DW Bournemouth
United KingdomNoch nicht rekrutierend» Google-Maps
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
Ninewells Hospital; Oncology
DD1 9SY London
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital - Fulham; Oncology Department
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
Imperial College Healthcare NHS Trust
W2 1NY London
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Marsden Hospital (Sutton)
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Singleton Hospital; Cancer Institute
SA2 8QA Swansea
United KingdomNoch nicht rekrutierend» Google-Maps
Clatterbridge Cancer Centre; Clatterbridge Cancer Centre
CH63 4JY Wirral
United KingdomNoch nicht rekrutierend» Google-Maps
New Cross Hospital
WV10 0QP Wolverhampton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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. 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).

Ein-/Ausschlusskriterien

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 and is not expected to

undergo tumor resection during the course of the study

- Definitive concurrent chemoradiation treatment according to regional oncology

guidelines for esophageal cancer

- Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens,

collected prior to initiation of definitive concurrent chemoradiotherapy

- Adequate hematologic and end-organ function

- 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.

Studien-Rationale

Primary outcome:

1. 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))

2. Arm A vs Arm C: Overall Survival (OS) (Time Frame - From randomization to death from any cause (up to approximately 50 months))

3. Arm B vs Arm C: OS (Time Frame - From randomization to death from any cause (up to approximately 50 months))

Secondary outcome:

1. 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))

2. 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))

3. Arm A vs Arm B: OS (Time Frame - From randomization to death from any cause (up to approximately 50 months))

4. 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))

5. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Time Frame - From randomization up to approximately 50 months)

6. IRF-Assessed Confirmed ORR (Time Frame - From randomization up to approximately 50 months)

7. 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))

8. 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))

9. Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30 (Time Frame - Up to approximately 50 months):
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.

10. Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18 (Time Frame - Up to approximately 50 months):
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.

11. Percentage of Participants With Adverse Events (AEs) (Time Frame - Up to approximately 50 months)

12. 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))

13. 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))

14. 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))

15. 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))

Studien-Arme

  • Experimental: Arm A: Tiragolumab + Atezolizumab
    Participants will receive atezolizumab followed by tiragolumab.
  • Experimental: Arm B: Tiragolumab Placebo + Atezolizumab
    Participants will receive atezolizumab followed by tiragolumab matching placebo.
  • Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo
    Participants will receive matching placebos to tiragolumab and atezolizumab.

Geprüfte Regime

  • Tiragolumab (MTIG7192A, RO7092284):
    Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab (Tecentriq, RO5541267):
    Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab Matching Placebo:
    Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Atezolizumab Matching Placebo:
    Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Quelle: ClinicalTrials.gov


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