1443-0002 trial of Study drugs in Patients with Cancer

• Research type

  Research Study

• Full 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)

• IRAS ID

  306846

• Contact name

  David Pinato

• Contact email

  david.pinato@imperial.ac.uk

• Sponsor organisation

  Boehringher Ingleheim

• Eudract number

  2021-003473-59

• Clinicaltrials.gov Identifier

  NCT05249426

• Clinicaltrials.gov Identifier

  EudraCT No., 2021-003473-59

• Duration of Study in the UK

  2 years, 5 months, days

• Research summary

  This is 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. This study will be conducted at several sites across multiple countries. Approximately 150 patients will enter treatment.

  After giving Informed Consent and successful completion of the screening period, eligible participants will take BI 765063:
  • in combination with ezabenlimab and cetuximab or chemotherapy in Cohorts A and B, respectively.
  • in combination with ezabenlimab, alone or with BI 836880, in Cohorts C and D respectively.
  • in combination with ezabenlimab and BI 836880 in Cohort E.

  Patients may continue on treatment until disease progression, withdrawal of patient consent, unacceptable toxicity, or 1 year of treatment is completed, whichever occurs first. Patients may stay on the trial drug(s) beyond 1 year of treatment on a caseby-case basis, after discussion with and approval by the Sponsor’s medical representative.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  22/EE/0007

• Date of REC Opinion

  16 Feb 2022

• REC opinion

  Further Information Favourable Opinion