Clinical trial • Phase III • Oncology
TIRAGOLUMAB for Esophageal squamous cell carcinoma
Phase III trial of TIRAGOLUMAB for Esophageal squamous cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Esophageal squamous cell carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-06-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
Randomised, arms: arm a: tiragolumab + atezolizumab (experimental); arm b: tiragolumab matching placebo + atezolizumab; arm c: double placebo (matching placebos to tiragolumab and atezolizumab). (no dosing details specified in the provided record.)-controlled Phase III trial in Belgium, Germany, Greece and others.
- Randomised
- Yes
- Comparator
- Arms: Arm A: Tiragolumab + Atezolizumab (experimental); Arm B: Tiragolumab matching placebo + Atezolizumab; Arm C: Double placebo (matching placebos to tiragolumab and atezolizumab). (No dosing details specified in the provided record.)
- Biomarker Stratified
- True, PD-L1 (SP263) TIC score
- Target Sample Size
- 590
Stratification factors
- PD-L1 TIC score (PD-L1 SP263)
Eligibility
Recruits 590 adults.
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\n- Definitive concurrent chemoradiotherapy (dCRT) treatment according to regional oncology guidelines (Such as National Comprehensive Cancer Network [NCCN; see Appendix 10 for recommended treatment], European Society for Medical Oncology [ESMO], Chinese Society of Clinical Oncology [CSCO], etc.) for esophageal cancer and with the following criteria: Patients with inoperable cancer must have received at least 2 cycles of platinum-based chemotherapy and radiation therapy consistent with definitive treatment (50-64 Gy) without evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-dCRT) prior to randomization. Patients with cervical esophageal squamous cell carcinoma may receive higher radiation dose (50-66 Gy), as per local oncology guidelines. Randomization into the study must occur within 1-84 days after the last dose of radiation therapy. Use of herbal therapies/traditional Chinese medicines with anti-cancer activity intended to treat the disease under the study must be discontinued prior to randomization.\n- Stage II-IVA per American Joint Committee on Cancer/Union for International Cancer Control, 8th edition, unresectable locally advanced disease (medically or surgery is declined) prior to definitive concurrent chemoradiotherapy (dCRT) – Patients are not expected to undergo tumor resection during the course of the study. – Ineligibility for curative surgery must be based on the documented opinion of the qualified medical, surgical or radiation oncologist. – Stage IVB patients diagnosed with cervical or upper thoracic esophageal squamous cell carcinoma with supraclavicular lymph node metastases only and are deemed suitable for definitive concurrent chemoradiation therapy in the opinion of the treating physician, multidisciplinary team or tumor board are eligible\n- Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens < 12 months old, collected prior to initiation of dCRT in either paraffin blocks (preferred over slides) or approximately 10-15 slides (15 slides preferred) containing unstained, freshly cut, serial sections (of the 10-15 slides, 5 are for the stratification PD-L1 testing). The number of slides provided may also be governed by local regulations (e.g., Human Genetic Resources Administration of China) Tumor tissue must be submitted for PD-L1 (SP263) expression evaluation prior to randomization. Tumor tissue should be of good quality based on total and viable tumor content and be submitted with an associated pathology report. Patients whose tumor tissue is not evaluable for PD-L1 expression are not eligible. For the purpose of stratification, the PD-L1 score of the patient’s tumor will be the highest PD-L1 TIC score among all samples tested from a single patient prior to stratification, if multiple samples are submitted. Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. FFPE tumor specimens in paraffin blocks are preferred. Fine-needle aspiration, brushing, cell pellet from effusions and lavage samples are not acceptable.\n- Patients without hepatitis B virus (HBV) infection or for patients with a positive hepatitis B surface antigen (HBsAg) test and/or a positive total hepatitis B core antibody (HBcAb) test in the absence of a positive hepatitis B surface antibody (HBsAb) test at screening: HBV DNA < 500 IU/mL Patients with detectable HBV DNA should be managed per institutional guidelines. Initiation of anti-HBV therapy should be ≥ 14 days prior to initiation\n- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test will be performed only for patients who have a positive HCV antibody test."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) therapeutic antibodies\n- Any unresolved toxicity of NCI CTCAE Grade ≥ 2 from the prior chemoradiation therapy Patients with irreversible and manageable hearing loss are eligible.\n- Evidence of complete esophageal obstruction not amenable to treatment\n- Histology consistent with small cell esophageal carcinoma, esophageal adenocarcinoma, or mixed carcinoma\n- High risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula, or primary tumor invasion of the great vessels or trachea\n- Prior esophagectomy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with double placebo)","definition_or_measurement_approach":"Investigator-assessed progression-free survival (PFS) per RECIST v1.1 (investigator assessment)."}
- {"endpoint_text":"- 2. Overall survival (for tiragolumab + atezolizumab compared with double placebo)","definition_or_measurement_approach":"Overall survival (OS) assessed by survival status over time (investigator-assessed death date/live status)."}
- {"endpoint_text":"- 3. Overall Survival (for placebo + atezolizumab compared with double placebo)","definition_or_measurement_approach":"Overall survival (OS) assessed by survival status over time (investigator-assessed death date/live status)."}
Secondary endpoints
- {"endpoint_text":"- 1. Progression-Free Survival as determined by the investigator (for placebo + atezolizumab compared with double placebo)","definition_or_measurement_approach":"Investigator-assessed PFS."}
- {"endpoint_text":"- 2. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab)","definition_or_measurement_approach":"Investigator-assessed PFS."}
- {"endpoint_text":"- 3. Overall Survival (for tiragolumab + atezolizumab compared with placebo + atezolizumab)","definition_or_measurement_approach":"Overall survival (OS)."}
- {"endpoint_text":"- 4. Progression-Free Survival as determined by the independent review facility (IRF) (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo)","definition_or_measurement_approach":"PFS determined by an independent review facility (IRF) per imaging review."}
- {"endpoint_text":"- 5. Confirmed ORR as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo)","definition_or_measurement_approach":"Confirmed objective response rate (ORR) per investigator assessment (likely per RECIST criteria)."}
- {"endpoint_text":"- 6. Confirmed ORR as determined by an IRF","definition_or_measurement_approach":"Confirmed ORR assessed by an independent review facility."}
- {"endpoint_text":"- 7. Duration of response as determined by the investigator","definition_or_measurement_approach":"Duration of response (DoR) measured from first documented response to progression or death per investigator."}
- {"endpoint_text":"- 8. Duration of response as determined by the IRF","definition_or_measurement_approach":"Duration of response measured by IRF."}
- {"endpoint_text":"- 9. Proportion of patients with clinically meaningful changes in physical functioning, role functioning, global health status/quality of life, and dysphagia, as measured by the respective scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life-Esophageal Cancer, Module 18 Questionnaire","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-C30 and EORTC QLQ-OES18 scales; proportion with clinically meaningful changes."}
- {"endpoint_text":"- 10. Incidence and severity of adverse events","definition_or_measurement_approach":"Adverse events graded by NCI CTCAE v5.0; incidence and severity summarised."}
- {"endpoint_text":"- 11. Severity for all events will be graded according to NCI CTCAE v5.0, and severity for CRS will also be graded according to the ASTCT consensus grading scale.","definition_or_measurement_approach":"Severity grading: NCI CTCAE v5.0 for all events; CRS graded per ASTCT consensus scale."}
- {"endpoint_text":"- 12. Serum concentration of tiragolumab and atezolizumab at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic serum concentration measurements at specified timepoints."}
- {"endpoint_text":"- 13. Prevalence of anti-drug antibody (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study","definition_or_measurement_approach":"Immunogenicity assessments for anti-drug antibodies to tiragolumab at baseline and during study."}
- {"endpoint_text":"- 14. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study","definition_or_measurement_approach":"Immunogenicity assessments for anti-drug antibodies to atezolizumab at baseline and during study."}
Recruitment
- Planned Sample Size
- 590
- Recruitment Window Months
- 71
- Consent Approach
- Subject information and informed consent forms are available (L1_SIS and ICF documents) in multiple languages (documents in English, Spanish, German, French, Italian, Portuguese, Greek and other local language versions are listed). Specific details on assent, who provides consent, and age-specific consent procedures are not provided in the available record.
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 167
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 662
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Multidisciplinary Oncology Centre
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Oncology
- Principal Investigator Name
- Joëlle Collignon
- Principal Investigator Email
- Joelle.Collignon@chuliege.be
- Contact Person Name
- Joëlle Collignon
- Contact Person Email
- Joelle.Collignon@chuliege.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Principal Investigator Name
- Jeroen Dekervel
- Principal Investigator Email
- Jeroen.Dekervel@uzleuven.be
- Contact Person Name
- Jeroen Dekervel
- Contact Person Email
- Jeroen.Dekervel@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 666
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Internistische Onkologie u Hämatologie
- Principal Investigator Name
- Christian Müller
- Principal Investigator Email
- onkologie@kem-med.com
- Contact Person Name
- Christian Müller
- Contact Person Email
- onkologie@kem-med.com
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Klinik für Innere Medizin, Schwerpunkt Hämatologie, Onkologie u. Immunologie
- Principal Investigator Name
- Jorge Riera Knorrenschild
- Principal Investigator Email
- Jorge.Riera-Knorrenschild@med.uni-marburg.de
- Contact Person Name
- Jorge Riera Knorrenschild
- Contact Person Email
- Jorge.Riera-Knorrenschild@med.uni-marburg.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Universitätsklinikum Magdeburg; Klinik für Gastroenterologie, Hepatologie und Infektiologie
- Principal Investigator Name
- Marino Venerito
- Principal Investigator Email
- m.venerito@med.ovgu.de
- Contact Person Name
- Marino Venerito
- Contact Person Email
- m.venerito@med.ovgu.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Gastroenterologie u Gastrointestinale Onkologie
- Principal Investigator Name
- Alexander König
- Principal Investigator Email
- alexander.koenig@med.uni-goettingen.de
- Contact Person Name
- Alexander König
- Contact Person Email
- alexander.koenig@med.uni-goettingen.de
- Site Name
- Universitaet Leipzig
- Department Name
- Universitäres Krebszentrum Leipzig (UCCL)
- Principal Investigator Name
- Florian Lordick
- Principal Investigator Email
- Direktion.UCCL@medizin.uni-leipzig.de
- Contact Person Name
- Florian Lordick
- Contact Person Email
- Direktion.UCCL@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Strahlentherapie
- Principal Investigator Name
- Thomas Gauler
- Principal Investigator Email
- thomas.gauler@uk-essen.de
- Contact Person Name
- Thomas Gauler
- Contact Person Email
- thomas.gauler@uk-essen.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Strahlentherapie; Universitätsklinikum Regensburg
- Principal Investigator Name
- Felix Steger
- Principal Investigator Email
- f.steger@ukr.de
- Contact Person Name
- Felix Steger
- Contact Person Email
- f.steger@ukr.de
Greece
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Evgenidion Clinic Agia Trias S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Michalis Karamouzis
- Principal Investigator Email
- mkaramouz@med.uoa.gr
- Contact Person Name
- Michalis Karamouzis
- Contact Person Email
- mkaramouz@med.uoa.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 674
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Istituto Oncologico Veneto
- Department Name
- U.O. Oncologia Medica 1
- Principal Investigator Name
- Francesca Bergamo
- Principal Investigator Email
- francesca.bergamo@iov.veneto.it
- Contact Person Name
- Francesca Bergamo
- Contact Person Email
- francesca.bergamo@iov.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Stefano Tamberi
- Principal Investigator Email
- stefano.tamberi@auslromagna.it
- Contact Person Name
- Stefano Tamberi
- Contact Person Email
- stefano.tamberi@auslromagna.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oncologia
- Principal Investigator Name
- Giovanni Cardellino
- Principal Investigator Email
- giovanni.cardellino@asufc.sanita.fvg.it
- Contact Person Name
- Giovanni Cardellino
- Contact Person Email
- giovanni.cardellino@asufc.sanita.fvg.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Divsione Di Oncologia Medica
- Principal Investigator Name
- Ferdinando De Vita
- Principal Investigator Email
- ferdinando.devita@unicampania.it
- Contact Person Name
- Ferdinando De Vita
- Contact Person Email
- ferdinando.devita@unicampania.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 662
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Serviço de Oncologia
- Principal Investigator Name
- Edgar Pratas
- Principal Investigator Email
- uid@ulscoimbra.min-saude.pt
- Contact Person Name
- Edgar Pratas
- Contact Person Email
- uid@ulscoimbra.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Serviço de Oncologia Médica
- Principal Investigator Name
- Paula Ferreira
- Principal Investigator Email
- clinicalstudies@ipoporto.min-saude.pt
- Contact Person Name
- Paula Ferreira
- Contact Person Email
- clinicalstudies@ipoporto.min-saude.pt
Poland
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 672
- Number Of Sites
- 6
- Number Of Participants
- 48
Sites
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Klinika Radioterapii
- Principal Investigator Name
- Ewa Wasilewska-Teśluk
- Principal Investigator Email
- clinicaltrialsoffice@poliklinika.net
- Contact Person Name
- Ewa Wasilewska-Teśluk
- Contact Person Email
- clinicaltrialsoffice@poliklinika.net
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Oddział Onkologii Klinicznej / Chemioterapii
- Principal Investigator Name
- Joanna Herma
- Principal Investigator Email
- badaniakliniczne@dcopih.pl
- Contact Person Name
- Joanna Herma
- Contact Person Email
- badaniakliniczne@dcopih.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii I
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- badania.kliniczne@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Lucjan Wyrwicz
- Principal Investigator Email
- lucjan.wyrwicz@nio.gov.pl
- Contact Person Name
- Lucjan Wyrwicz
- Contact Person Email
- lucjan.wyrwicz@nio.gov.pl
- Site Name
- Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
- Department Name
- Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
- Principal Investigator Name
- Piotr Kolenda
- Principal Investigator Email
- clinicaltrials@wco.pl
- Contact Person Name
- Piotr Kolenda
- Contact Person Email
- clinicaltrials@wco.pl
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oddział Onkologii Klinicznej
- Principal Investigator Name
- Izabela Kordzińska-Cisek
- Principal Investigator Email
- badania.kliniczne@cozl.eu
- Contact Person Name
- Izabela Kordzińska-Cisek
- Contact Person Email
- badania.kliniczne@cozl.eu
France
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 665
- Number Of Sites
- 10
- Number Of Participants
- 45
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service Oncologie Digestive
- Principal Investigator Name
- Laetitia Dahan
- Principal Investigator Email
- laetitia.dahan@ap-hm.fr
- Contact Person Name
- Laetitia Dahan
- Contact Person Email
- laetitia.dahan@ap-hm.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service Oncologie
- Principal Investigator Name
- Jean-Philippe Metges
- Principal Investigator Email
- jean-philippe.metges@chu-brest.fr
- Contact Person Name
- Jean-Philippe Metges
- Contact Person Email
- jean-philippe.metges@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- David Tougeron
- Principal Investigator Email
- David.TOUGERON@chu-poitiers.fr
- Contact Person Name
- David Tougeron
- Contact Person Email
- David.TOUGERON@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- Anthony Turpin
- Principal Investigator Email
- anthony.turpin@chu-lille.fr
- Contact Person Name
- Anthony Turpin
- Contact Person Email
- anthony.turpin@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Service Oncologie Digestive
- Principal Investigator Name
- Jean-Louis Jouve
- Principal Investigator Email
- jean-louis.jouve@chu-dijon.fr
- Contact Person Name
- Jean-Louis Jouve
- Contact Person Email
- jean-louis.jouve@chu-dijon.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- Ludovic Evesque
- Principal Investigator Email
- ludovic.evesque@nice.unicancer.fr
- Contact Person Name
- Ludovic Evesque
- Contact Person Email
- ludovic.evesque@nice.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service Oncologie Digestive
- Principal Investigator Name
- Rosine Guimbaud
- Principal Investigator Email
- oncomedrg.sec@chu-toulouse.fr
- Contact Person Name
- Rosine Guimbaud
- Contact Person Email
- oncomedrg.sec@chu-toulouse.fr
- Site Name
- Centre Leon Berard
- Department Name
- Service Oncologie Digestive
- Principal Investigator Name
- Clélia Coutzac
- Principal Investigator Email
- Clelia.coutzac@lyon.unicancer.fr
- Contact Person Name
- Clélia Coutzac
- Contact Person Email
- Clelia.coutzac@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service Hépato-Gastroentérologie
- Principal Investigator Name
- Eric Terrebonne
- Principal Investigator Email
- eric.terrebonne@chu-bordeaux.fr
- Contact Person Name
- Eric Terrebonne
- Contact Person Email
- eric.terrebonne@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Oncologie Digestive
- Principal Investigator Name
- Aziz Zaanan
- Principal Investigator Email
- aziz.zaanan@aphp.fr
- Contact Person Name
- Aziz Zaanan
- Contact Person Email
- aziz.zaanan@aphp.fr
Austria
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 666
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Internal Medicine I - Medical Oncology and Haematology
- Principal Investigator Name
- Holger Rumpold
- Principal Investigator Email
- studien.bhs@ordensklinikum.at
- Contact Person Name
- Holger Rumpold
- Contact Person Email
- studien.bhs@ordensklinikum.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- University Clinic for Internal Medicine V
- Principal Investigator Name
- Arno Amann
- Principal Investigator Email
- arno.amann@tirol-kliniken.at
- Contact Person Name
- Arno Amann
- Contact Person Email
- arno.amann@tirol-kliniken.at
- Site Name
- Medical University Of Vienna
- Department Name
- Division of Oncology, Department of Medicine I, Medical University of Vienna
- Principal Investigator Name
- Aysegül Ilhan-Mutlu
- Principal Investigator Email
- studienzentrale_onkologie@meduniwien.ac.at
- Contact Person Name
- Aysegül Ilhan-Mutlu
- Contact Person Email
- studienzentrale_onkologie@meduniwien.ac.at
Spain
- Earliest CTIS Part Ii Submission Date
- 26-09-2022
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 666
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Acosta Eyzaguirre
- Principal Investigator Email
- dacosta@vhio.net
- Contact Person Name
- Daniel Acosta Eyzaguirre
- Contact Person Email
- dacosta@vhio.net
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Inmaculada Ales Diaz
- Principal Investigator Email
- inales@hotmail.com
- Contact Person Name
- Inmaculada Ales Diaz
- Contact Person Email
- inales@hotmail.com
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Principal Investigator Name
- Paula Jimenez Fonseca
- Principal Investigator Email
- palucaji@hotmail.com
- Contact Person Name
- Paula Jimenez Fonseca
- Contact Person Email
- palucaji@hotmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- Margarita Reboredo Lopez
- Principal Investigator Email
- Margarita.reboredo.lopez@sergas.es
- Contact Person Name
- Margarita Reboredo Lopez
- Contact Person Email
- Margarita.reboredo.lopez@sergas.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Tamara Sauri
- Principal Investigator Email
- SAURI@CLINIC.cat
- Contact Person Name
- Tamara Sauri
- Contact Person Email
- SAURI@CLINIC.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Jorge Aparicio Urtason
- Principal Investigator Email
- aparicio_josurt@gva.es
- Contact Person Name
- Jorge Aparicio Urtason
- Contact Person Email
- aparicio_josurt@gva.es
- Site Name
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Department Name
- Oncology
- Principal Investigator Name
- Tania Fleitas
- Principal Investigator Email
- tfleitas@incliva.es
- Contact Person Name
- Tania Fleitas
- Contact Person Email
- tfleitas@incliva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Carames Sanchez
- Principal Investigator Email
- CCARAMES@quironsalud.es
- Contact Person Name
- Cristina Carames Sanchez
- Contact Person Email
- CCARAMES@quironsalud.es
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Development Solutions LLC
- Responsibilities
- sponsorDuties codes: [4]
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: [1]
Third parties
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"sponsorDuties codes: [15] (Other Third Party Duty)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"DHL Supply Chain Operations GmbH","duties_or_roles":"sponsorDuties codes: [15] (Other Third Party Duty)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tiragolumab
- Active Substance
- TIRAGOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Maximum Dose
- 600 mg
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation EU/1/17/1220/001
- Maximum Dose
- 1200 mg
- Investigational Product Name
- Tiragolumab Placebo
- Modality
- Other
- Investigational Product Name
- Tecentriq Placebo
- Modality
- Other
- Combination Treatment
- Yes
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