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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04543617
Collaborator
(none)
750
224
3
62.9
3.3
0.1

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 28, 2020
Anticipated Primary Completion Date :
Dec 19, 2024
Anticipated Study Completion Date :
Dec 26, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Tiragolumab + Atezolizumab

Participants will receive atezolizumab followed by tiragolumab.

Drug: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • MTIG7192A, RO7092284
  • Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq, RO5541267
  • Experimental: Arm B: Tiragolumab Placebo + Atezolizumab

    Participants will receive atezolizumab followed by tiragolumab matching placebo.

    Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq, RO5541267
  • Drug: Tiragolumab Matching Placebo
    Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo

    Participants will receive matching placebos to tiragolumab and atezolizumab.

    Drug: Tiragolumab Matching Placebo
    Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Drug: Atezolizumab Matching Placebo
    Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

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

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

    Secondary Outcome Measures

    1. 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)]

    2. 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)]

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

    4. 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)]

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

    6. IRF-Assessed Confirmed ORR [From randomization up to approximately 50 months]

    7. 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)]

    8. 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)]

    9. 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.

    10. 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.

    11. Percentage of Participants With Adverse Events (AEs) [Up to approximately 50 months]

    12. 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)]

    13. 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)]

    14. 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)]

    15. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04543617
    Other Study ID Numbers:
    • YO42137
    • 2020-001178-31
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2022