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
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A: Tiragolumab + Atezolizumab Participants will receive atezolizumab followed by tiragolumab. |
Drug: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
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Experimental: Arm B: Tiragolumab Placebo + Atezolizumab Participants will receive atezolizumab followed by tiragolumab matching placebo. |
Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
Drug: Tiragolumab Matching Placebo
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
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Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo Participants will receive matching placebos to tiragolumab and atezolizumab. |
Drug: Tiragolumab Matching Placebo
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Drug: Atezolizumab Matching Placebo
Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
|
Outcome Measures
Primary Outcome Measures
- Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS) [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- Arm A vs Arm C: Overall Survival (OS) [From randomization to death from any cause (up to approximately 50 months)]
- Arm B vs Arm C: OS [From randomization to death from any cause (up to approximately 50 months)]
Secondary Outcome Measures
- Arm B vs Arm C: Investigator-Assessed PFS [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- Arm A vs Arm B: Investigator-Assessed PFS [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- Arm A vs Arm B: OS [From randomization to death from any cause (up to approximately 50 months)]
- Independent Review Facility (IRF)-Assessed PFS [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- Investigator-Assessed Confirmed Objective Response Rate (ORR) [From randomization up to approximately 50 months]
- IRF-Assessed Confirmed ORR [From randomization up to approximately 50 months]
- Investigator-Assessed Duration of Objective Response (DOR) [From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- IRF-Assessed DOR [From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 50 months)]
- Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30 [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.
- Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18 [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.
- Percentage of Participants With Adverse Events (AEs) [Up to approximately 50 months]
- Serum Concentration of Tiragolumab [Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to approximately 50 months)]
- Serum Concentration of Atezolizumab [Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 50 months)]
- Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab [Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 50 months)]
- Percentage of Participants With ADAs to Atezolizumab [Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 50 months)]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
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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
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dCRT treatment according to regional oncology guidelines for esophageal cancer
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Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
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Adequate hematologic and end-organ function prior to randomization
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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
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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:
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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
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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
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Prior allogeneic stem cell or solid organ transplantation
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Active or history of autoimmune disease or immune deficiency
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History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
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Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
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Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Compassionate Care Research Group Inc. Corona | Corona | California | United States | 92879 |
2 | Compassionate Cancer Care Medical Group, Inc | Corona | California | United States | 92882 |
3 | Kaiser Permanente Northern California | Novato | California | United States | 94589 |
4 | Compassionate Care Research Group Inc. Riverside | Riverside | California | United States | 92501 |
5 | Smilow Cancer Hospital, Yale-New Haven | New Haven | Connecticut | United States | 06510 |
6 | Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida | United States | 33901 |
7 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
8 | Florida Cancer Specialist, North Region | Saint Petersburg | Florida | United States | 33705 |
9 | Uni of Chicago | Chicago | Illinois | United States | 60637 |
10 | University of Iowa | Iowa City | Iowa | United States | 52242 |
11 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214-3728 |
12 | Washington University School of Medicine; Medical Oncology | Saint Louis | Missouri | United States | 63110 |
13 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
14 | Weill Cornell Medical College | New York | New York | United States | 10065 |
15 | Great Lakes Cancer Center | Williamsville | New York | United States | 14221 |
16 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
17 | St. Luke's Hospital - Anderson Campus | Easton | Pennsylvania | United States | 18045 |
18 | University of Pennsylvania Health System; Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
19 | Tennessee Oncology; Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
20 | MD Anderson Cancer Center; Oncology | Houston | Texas | United States | 77030 |
21 | Fundacion Favaloro | Buenos Aires | Argentina | C1093AAS | |
22 | Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | Argentina | C1125ABD | |
23 | Instituto de Investigaciones Metabolicas (Idim) | Ciudad Autonoma de Buenos Aires | Argentina | C1012AAR | |
24 | Centro Oncologico Riojano Integral (CORI) | La Rioja | Argentina | F5300COE | |
25 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
26 | Austin Health; Cancer Clinical Trial Centre | Heidelberg | Victoria | Australia | 3084 |
27 | St John of God Hospital; Bendat Cancer Centre | Subiaco | Western Australia | Australia | 6008 |
28 | Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie | Innsbruck | Austria | 6020 | |
29 | Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie | Klagenfurt am Wörthersee | Austria | 9020 | |
30 | Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum | Linz | Austria | 4010 | |
31 | Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | Austria | 5020 | |
32 | AKH - Medizinische Universität Wien; Department for Internal Medicine I | Wien | Austria | 1090 | |
33 | UZ Antwerpen | Edegem | Belgium | 2650 | |
34 | UZ Gent | Gent | Belgium | 9000 | |
35 | UZ Leuven Gasthuisberg | Leuven | Belgium | 3000 | |
36 | CHU Sart-Tilman | Liège | Belgium | 4000 | |
37 | Instituto de Ensino e Pesquisa Clinica do Ceara | Fortaleza | CE | Brazil | 60130-241 |
38 | Centro Integrado de Oncologia de Curitiba | Curitiba | PR | Brazil | 80810-050 |
39 | Hospital de Caridade de Ijui; Oncologia | Ijui | RS | Brazil | 98700-000 |
40 | Hospital de Cancer de Barretos | Barretos | SP | Brazil | 14784-400 |
41 | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP | Brazil | 01246-000 |
42 | Anyang Tumor Hosptial | Anyang City | China | 455000 | |
43 | Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | China | 100021 | |
44 | Affiliated Hospital of Bengbu Medical College | Bengbu | China | 233004 | |
45 | Hunan Cancer Hospital | Changsha City | China | 410013 | |
46 | Heping Hospital Affiliated to Changzhi Medical College | Changzhi City | China | 046000 | |
47 | Changzhou Tumor Hospital, Changzhou Fourth People's Hospital | Changzhou | China | 213000 | |
48 | Sichuan Provincial Cancer Hospital | Chengdu | China | 610041 | |
49 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
50 | Chongqing Sanxia Central Hospital | Chongqing City | China | 404000 | |
51 | Chongqing Cancer Hospital | Chongqing | China | 400030 | |
52 | The 900th Hospital of PLA joint service support force | Fuzhou | China | 110016 | |
53 | Fujian Cancer Hospital | Fuzhou | China | 350014 | |
54 | Sun Yet-sen University Cancer Center | Guangzhou | China | 510060 | |
55 | Nanfang Hospital, Southern Medical University | Guangzhou | China | 510515 | |
56 | Sir Run Run Shaw Hospital Zhejiang University | Hangzhou City | China | 310016 | |
57 | The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | China | 310003 | |
58 | Harbin Medical University Cancer Hospital | Harbin | China | 150081 | |
59 | Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi | Jiangsu Sheng | China | 210008 | |
60 | Jieyang People's Hospital | Jieyang City | China | 522000 | |
61 | Shandong Cancer Hospital | Jinan | China | 250117 | |
62 | Affiliated Hospital of Jining Medical University | Jining | China | 272029 | |
63 | The First People's Hospital of Lian Yun Gang | Lianyungang | China | 222023 | |
64 | Lishui Central Hospital | Lishui City | China | 323000 | |
65 | The First Affiliated Hospital to Henan University of Science and Technology | Luoyang | China | 471003 | |
66 | Jiangsu Cancer Hospital | Nanjing City | China | 211100 | |
67 | Zhongda Hospital Affiliated to Southeast University | Nanjing | China | 210009 | |
68 | Fudan University Shanghai Cancer Center; Medical Oncology | Shanghai City | China | 201315 | |
69 | Shanghai Chest Hospital | Shanghai | China | 200000 | |
70 | Cancer Hospital of Shantou University Medical College | Shantou | China | 515041 | |
71 | Liaoning cancer Hospital & Institute | Shenyang | China | 110042 | |
72 | The University of Hong Kong-Shenzhen Hospital | Shenzhen City | China | 518053 | |
73 | Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center | Shenzhen City | China | 518127 | |
74 | Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | China | 050035 | |
75 | Tianjin Cancer Hospital | Tianjin | China | 300060 | |
76 | Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan City | China | 430022 | |
77 | Hubei Cancer Hospital | Wuhan | China | 430079 | |
78 | The First Affiliated Hospital of Xiamen University | Xiamen | China | 361003 | |
79 | Zhongshan Hospital Xiamen University | Xiamen | China | 361004 | |
80 | The First Affiliated Hospital of Xinxiang Medical University | Xinxiang City | China | 453000 | |
81 | The Affiliated Hospital of Xuzhou Medical College | Xuzhou | China | 221000 | |
82 | Subei People's Hospital of Jiangsu province; Respiratory | Yangzhou City | China | 225001 | |
83 | Zhejiang Cancer Hospital | Zhejiang | China | 310022 | |
84 | Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | Czechia | 779 00 | |
85 | Fakultni nemocnice Kralovske Vinohrady; Radioterapeuticka a onkologicka klinika | Praha 10 | Czechia | 100 34 | |
86 | CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie | Brest | France | 29609 | |
87 | Hopital Cote De Nacre; Gastro Enterologie | Caen | France | 14033 | |
88 | CHU Dijon Bourgogne Hôpital François Mitterand | Dijon | France | 21000 | |
89 | Hopital Claude Huriez; Medecine Interne Oncologie | Lille | France | 59037 | |
90 | CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie | Lyon | France | 69373 | |
91 | Hopital Timone Adultes; Oncologie Digestive | Marseille | France | 13385 | |
92 | Centre Antoine Lacassagne | Nice | France | 06189 | |
93 | European Hospital Georges Pompidou (HEGP) | Paris | France | 75908 | |
94 | Hopital Du Haut-Leveque; Gastro-Enterologie | Pessac | France | 33604 | |
95 | Chu La Miletrie; Gastro Enterologie Endoscopies | Poitiers | France | 86021 | |
96 | Hopital Rangueil; Gastro Enterologie Et Nutrition | Toulouse | France | 31059 | |
97 | Institut de Cancérologie de Lorraine | Vandoeuvre-Les-Nancy | France | 54519 | |
98 | Städtisches Klinikum Dresden; IV. Medizinische Klinik | Dresden | Germany | 01067 | |
99 | Universitätsklinikum Essen Klinik f.Strahlentherapie | Essen | Germany | 45122 | |
100 | Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie | Essen | Germany | 45136 | |
101 | Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG | Göttingen | Germany | 37075 | |
102 | Universitaetsklinikum Leipzig | Leipzig | Germany | 04103 | |
103 | Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt. | Magdeburg | Germany | 39120 | |
104 | Klinikum Mannheim III. Medizinische Klinik | Mannheim | Germany | 68167 | |
105 | Klinikum der Philipps-Universität Marburg | Marburg | Germany | 35032 | |
106 | Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie | Regensburg | Germany | 93053 | |
107 | Universität Tübingen; Med. Klinik; Innere Medizin I | Tübingen | Germany | 72076 | |
108 | Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | Greece | 115 22 | |
109 | Evgenidio Hospital "Agia Trias" | Athens | Greece | 115 28 | |
110 | Univ General Hosp Heraklion; Medical Oncology | Heraklion | Greece | 711 10 | |
111 | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | Greece | 546 45 | |
112 | Semmelweis Egyetem; Onkológiai Központ | Budapest | Hungary | 1083 | |
113 | Petz Aladar Megyei Oktato Korhaz; Oncoradiologia | Gyor | Hungary | 9024 | |
114 | Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | Hungary | 7623 | |
115 | Szegedi Tudományegyetem; Onkoterápiás Klinika | Szeged | Hungary | 6720 | |
116 | Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | Israel | 9112000 | |
117 | Rambam Health Corporation; Oncology Institute | Rambam | Israel | 3525408 | |
118 | Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | Israel | 6423906 | |
119 | Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica | Napoli | Campania | Italy | 80131 |
120 | Ospedale Degli Infermi - Faenza; Oncologia Medica | Faenza | Emilia-Romagna | Italy | 48018 |
121 | AUSL-IRCCS di Reggio Emilia; Oncologia Medica | Reggio Emilia | Emilia-Romagna | Italy | 42124 |
122 | ASU FC S. M. DELLA MISERICORDIA; Oncologia | Udine | Friuli-Venezia Giulia | Italy | 33100 |
123 | Irccs Ospedale San Raffaele;Oncologia Medica | Milano | Lombardia | Italy | 20132 |
124 | Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardia | Italy | 20089 |
125 | Istituto Oncologico Veneto IRCCS | Padova | Veneto | Italy | 35128 |
126 | Aichi Cancer Center Hospital | Aichi | Japan | 464-8681 | |
127 | National Cancer Center Hospital East | Chiba | Japan | 277-8577 | |
128 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 | |
129 | Kobe University Hospital | Hyogo | Japan | 650-0017 | |
130 | Yokohama City University Medical Center | Kanagawa | Japan | 232-0024 | |
131 | Kanagawa Cancer Center | Kanagawa | Japan | 241-8515 | |
132 | Tohoku University Hospital | Miyagi | Japan | 980-8574 | |
133 | Niigata Cancer Center Hospital | Niigata | Japan | 951-8566 | |
134 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
135 | Osaka University Hospital | Osaka | Japan | 565-0871 | |
136 | Saitama Medical University International Medical Center | Saitama | Japan | 350-1298 | |
137 | Saitama Cancer Center | Saitama | Japan | 362-0806 | |
138 | Shizuoka Cancer Center | Shizuoka | Japan | 411-8777 | |
139 | The Cancer Institute Hospital of JFCR | Tokyo | Japan | 135-8550 | |
140 | Keio University Hospital | Tokyo | Japan | 160-8582 | |
141 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
142 | Ajou University Medical Center | Gyeonggi-do | Korea, Republic of | 16499 | |
143 | Chonnam National University Hwasun Hospital | Jeollanam-do | Korea, Republic of | 58128 | |
144 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
145 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
146 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
147 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
148 | Christchurch Hospital | Christchurch | New Zealand | 8011 | |
149 | Tauranga Hospital, Clinical Trials Unit; BOP Clinical School | Tauranga | New Zealand | 3112 | |
150 | Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol | Brzozów | Poland | 36-200 | |
151 | Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | Poland | 85-796 | |
152 | Szpital Morski im. PCK; Poradnia Onkologiczna | Gdynia | Poland | 81-519 | |
153 | Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny | Kraków | Poland | 31-202 | |
154 | CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej | Lublin | Poland | 20-090 | |
155 | SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAKŁAD I ODDZIAŁ KLINICZNY RADIOTERAPII | Olsztyn | Poland | 10-228 | |
156 | Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie; Odd. Onk. Klin. i Immunoonk. | Poznań | Poland | 61-866 | |
157 | NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii | Warszawa | Poland | 02-034 | |
158 | Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii | Wrocław | Poland | 53-413 | |
159 | HUC; Servico de Oncologia Medica | Coimbra | Portugal | 3000-075 | |
160 | Centro Hospitalar do Porto - Hospital de Santo António; Oncologia | Porto | Portugal | 4099-001 | |
161 | IPO do Porto; Servico de Oncologia Medica | Porto | Portugal | 4200-072 | |
162 | SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Sankt-peterburg | Leningrad | Russian Federation | 197022 |
163 | Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic | Kazan | Tatarstan | Russian Federation | 420029 |
164 | City Oncological Hospital | Izhevsk | Udmurtija | Russian Federation | 426067 |
165 | Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Krasnoyarsk | Russian Federation | 660133 | |
166 | Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy | Moscow | Russian Federation | 115478 | |
167 | Limited Liability Company "RC Medical" | Novosibirsk | Russian Federation | 630005 | |
168 | Scientific Research Institute n.a. N.N. Petrov | Saint Petersburg | Russian Federation | 197758 | |
169 | Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology | St.Petersburg, Pesochny | Russian Federation | 197758 | |
170 | Regional Oncology Dispensary | Tomsk | Russian Federation | 634063 | |
171 | Wits Donald Gordon Clinical Trial Site | Johannesburg | South Africa | 2041 | |
172 | East Coast Oncology | Overport | South Africa | 4091 | |
173 | Limpopo Oncology Clinic | Polokwane | South Africa | 0700 | |
174 | Cancercare | Port Elizabeth | South Africa | 6045 | |
175 | University of Pretoria Oncology Department; Medical Oncology | Pretoria | South Africa | 0002 | |
176 | Eugene Marais Hospital; Oncology | Pretoria | South Africa | ||
177 | Hospital Univ. Central de Asturias | Oviedo | Asturias | Spain | 33006 |
178 | ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | Spain | 08908 |
179 | Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña | LA Coruña | Spain | 15006 |
180 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
181 | Hospital Clinic I Provincial | Barcelona | Spain | 08036 | |
182 | Hospital Universitario Reina Sofia | Cordoba | Spain | 14008 | |
183 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
184 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
185 | Hospital Regional Universitario Carlos Haya | Malaga | Spain | 29010 | |
186 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
187 | Hospital La Fe | Valencia | Spain | ||
188 | Inselspital Bern, Insel-Gruppe AG | Bern | Switzerland | 3010 | |
189 | UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zürich | Switzerland | 8091 | |
190 | Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology | Kaoisung | Taiwan | 833 | |
191 | China Medical University Hospital; Oncology and Hematology | Taichung | Taiwan | 404 | |
192 | National Cheng Kung University Hospital; Oncology | Tainan | Taiwan | 00704 | |
193 | Chi-Mei Medical Centre; Hematology & Oncology | Tainan | Taiwan | 710 | |
194 | Taipei Veterans General Hospital; Department of Oncology | Taipei City | Taiwan | 112201 | |
195 | National Taiwan University Hospital; Oncology | Zhongzheng Dist. | Taiwan | 10048 | |
196 | Vajira Hospital | Bangkok | Thailand | 10300 | |
197 | Chulalongkorn Hospital; Medical Oncology | Bangkok | Thailand | 10330 | |
198 | Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | Thailand | 10400 | |
199 | Siriraj Hospital; Medical Oncology Unit | Bangkok | Thailand | 10700 | |
200 | Songklanagarind Hospital; Department of Oncology | Songkhla | Thailand | 90110 | |
201 | Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | Turkey | 01230 | |
202 | Ankara University Faculty of Medicine Cebeci Hospital | Ankara | Turkey | 06700 | |
203 | Ankara City Hospital; Oncology | Ankara | Turkey | 06800 | |
204 | Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department | Erzurum | Turkey | 25240 | |
205 | Gaziantep Univ. Med. Fac. | Gaziantep | Turkey | 27310 | |
206 | Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani | Istanbul | Turkey | 34098 | |
207 | Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology | Kadiköy | Turkey | 34722 | |
208 | Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu, | Malatya | Turkey | 44280 | |
209 | Van Yuzuncu Yil University Hospital; Medical Oncology | Van | Turkey | 65000 | |
210 | Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv | Kharkiv Governorate | Ukraine | 61070 |
211 | CI of Kherson Regional Council Kherson Regional Oncology Dispensary | Kherson | Kherson Governorate | Ukraine | 73000 |
212 | Zhytomyr Regional Oncology Center | Zhytomyr | KIEV Governorate | Ukraine | 10007 |
213 | Vinnytsya Regional Clinical Oncology Dispensary | Vinnytsya | Podolia Governorate | Ukraine | 21029 |
214 | Kyiv City Clinical Oncological Center | Kyiv | Ukraine | 03115 | |
215 | RCI Sumy Regional Clinical Oncological Dispensary | Sumy | Ukraine | 40005 | |
216 | Royal Bournemouth Hospital; Oncology | Bournemouth | United Kingdom | BH7 7DW | |
217 | Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279 | Cambridge | United Kingdom | CB2 0QQ | |
218 | Ninewells Hospital; Oncology | London | United Kingdom | DD1 9SY | |
219 | Royal Marsden Hospital - Fulham; Oncology Department | London | United Kingdom | SW3 6JJ | |
220 | Imperial College Healthcare NHS Trust | London | United Kingdom | W2 1NY | |
221 | Royal Marsden Hospital (Sutton) | Sutton | United Kingdom | SM2 5PT | |
222 | Singleton Hospital; Cancer Institute | Swansea | United Kingdom | SA2 8QA | |
223 | Clatterbridge Cancer Centre; Clatterbridge Cancer Centre | Wirral | United Kingdom | CH63 4JY | |
224 | New Cross Hospital | Wolverhampton | United Kingdom | WV10 0QP |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trial, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YO42137
- 2020-001178-31