Clinical trial • Phase III • Oncology
BI 770371 for Head and neck squamous cell carcinoma
Phase III trial of BI 770371 for Head and neck squamous cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Head and neck squamous cell carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Other
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 22-05-2025
Trial design
Pembrolizumab alone; BI 770371 + pembrolizumab; BI 770371 + pembrolizumab + cetuximab (doses and schedules not specified)-controlled Phase III trial across 24 sites in Spain, Romania, Hungary and others.
- Comparator
- Pembrolizumab alone; BI 770371 + pembrolizumab; BI 770371 + pembrolizumab + cetuximab (doses and schedules not specified)
- Target Sample Size
- 59
Recruitment
- Planned Sample Size
- 59
- Recruitment Window Months
- 29
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 55
Spain
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 222
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Unidad de Investigación en Terapia Molecular (UITM)
- Contact Person Name
- Katerin Ingrid Rojas
- Contact Person Email
- krojas@vhio.net
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- xxxx
- Contact Person Name
- Antonio Rueda Ramos
- Contact Person Email
- xxxxx@xxxx.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Gema Bruixola Campos
- Contact Person Email
- gema.bruixola@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 270
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncology
- Contact Person Name
- Laurentia Nicoleta Gales
- Contact Person Email
- Laurentia.gales.ext@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Medical Oncology
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 238
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Semmelweis University
- Department Name
- Internal Medicine and Oncology Clinic
- Contact Person Name
- Istvan Takacs
- Contact Person Email
- takacs.istvan@semmelweis.hu
- Site Name
- Clinexpert Kft.
- Department Name
- Bugat Pal Hospital
- Contact Person Name
- Istvan Lang
- Contact Person Email
- prof.lang.istvan@clinexpert.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Department of Thoracic and Abdominal Tumors and Clinical Pharmacology
- Contact Person Name
- Tamas Pinter
- Contact Person Email
- pinter.tamas@oncol.hu
France
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 221
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Service d'Oncologie Médicale
- Contact Person Name
- Jérôme Fayette
- Contact Person Email
- jerome.fayette@lyon.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- DRCI
- Contact Person Name
- Cyril Abdeddaim
- Contact Person Email
- c-abdeddaim@o-lambret.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Unité de Phase I Oncologie labélisée CLIP
- Contact Person Name
- Sébastien Salas
- Contact Person Email
- Sebastien.SALAS@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Contact Person Name
- Léa Loriguet
- Contact Person Email
- lea.loriguet@gustaveroussy.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 207
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für HNO-Heilkunde und Plastische Operationen
- Contact Person Name
- Andreas Dietz
- Contact Person Email
- andreas.dietz@medizin.uni-leipzig.de
- Site Name
- Staedtisches Klinikum Braunschweig gGmbH
- Department Name
- Medizinische Klinik II
- Contact Person Name
- Hendrik Eggers
- Contact Person Email
- h.eggers@skbs.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- HNO-Klinik
- Contact Person Name
- Orlando Guntinas-Lichius
- Contact Person Email
- orlando.guntinas@med.uni-jena.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- für HNO-Heilkunde
- Contact Person Name
- Simon Laban
- Contact Person Email
- simon.laban@uniklinik-ulm.de
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 218
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- S.C. di Oncologia Medica
- Contact Person Name
- Sebastiano CALPONA
- Contact Person Email
- sebastiano.calpona@irst.emr.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- UOC Oncologia
- Contact Person Name
- Roberto Bianco
- Contact Person Email
- robianco@unina.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Medicina-SS Trattamento Tumori Testa e Collo
- Contact Person Name
- Lisa LICITRA
- Contact Person Email
- lisa.licitra@istitutotumori.mi.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro Ricerche Cliniche di Verona - Policlinico G.B. Rossi
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Divisione Oncologia Medica 2
- Contact Person Name
- Lorenza LANDI
- Contact Person Email
- lorenza.landi@ifo.it
Poland
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 210
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology clinic clinical outpatient clinic
- Contact Person Name
- Krzysztof Składowski
- Contact Person Email
- krzysztof.skladowski@gliwice.nio.gov.pl
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oncology
- Contact Person Name
- Marta Piekarska
- Contact Person Email
- mpiekarska@cozl.eu
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 341
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Marchela Koleva
- Contact Person Email
- marchela.koleva.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 770371
- Active Substance
- BI 770371
- Modality
- Other
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Cetuximab
- Active Substance
- Cetuximab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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