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)
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.
Head and Neck Squamous Cell Carcinoma (HNSCC)
Investigator´s Choice Chemotherapy
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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