Spots Global Cancer Trial Database for A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer
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Trial Identification
Brief Title: A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer
Official Title: An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)
Study ID: NCT05249426
Study Description
Brief Summary: This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Valkyrie Clinical Trials, Los Angeles, California, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CTR Georges-François Leclerc, Dijon, , France
CTR Leon Berard, Lyon, , France
HOP Timone, Marseille, , France
INS Curie, Paris, , France
HOP Civil, Strasbourg, , France
INS Claudius Regaud IUCT-Oncopole, Toulouse, , France
Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan
Hospital Sultan Ismail, Johor Bahru, , Malaysia
University of Malaya Medical Centre, Kuala Lumpur, , Malaysia
Sarawak General Hospital, Kuching, Sarawak, , Malaysia
National Cancer Institute (IKN), Putrajaya, , Malaysia
ARKE SMO S.A. de C.V, Ciudad de Mexico, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, , Mexico
FAICIC S de RL de C.V., Veracruz, , Mexico
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V., Zapopan, , Mexico
ARENSIA Exploratory Medicine, Chisinau, , Moldova, Republic of
Medical University Gdansk, Gdansk, , Poland
Mandziuk Slawomir Specialist Medical Practice, Lublin, , Poland
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut, Bucharest, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca, , Romania
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Ramathibodi Hospital, Bangkok, , Thailand
Songklanagarind Hospital, Songkla, , Thailand
King's College Hospital, London, , United Kingdom
The Royal Marsden Hospital, Chelsea, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Contact Details
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