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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
NCT05249426 · View on ClinicalTrials.gov ↗
Study Summary
With an amendment of the protocol, this study is only open to adults with head and neck cancer. Previously also adults with liver cancer joined. 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. 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. With amendments of the protocol, all participants receive cetuximab in addition to BI 765063 and ezabenlimab. Ezabenlimab treatment and any other assigned treatment are given no longer than 2 years. Previously, BI 765063 and ezabenlimab were also given alone, or in combination with chemotherapy, or with BI 836880. 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. They regularly visit the study site where doctors check participants' health and take note of any unwanted effects. The doctors also monitor the size of the tumour.
Conditions Studied
Interventions
- DRUG Cetuximab
- DRUG Ezabenlimab
- DRUG BI 765063
- DRUG BI 836880
- OTHER Investigator´s Choice Chemotherapy
Study Locations (20)
Other
- CTR Georges-François Leclerc — Dijon
- CTR Leon Berard — Lyon
- HOP Timone — Marseille
- INS Curie — Paris
- HOP Civil — Strasbourg
- INS Claudius Regaud IUCT-Oncopole — Toulouse
- Japanese Foundation for Cancer Research — Tokyo, Koto-ku
- Hospital Sultan Ismail — Johor Bahru
- Sarawak General Hospital — Kuching, Sarawak
- ARKE SMO S.A. de C.V — Mexico City
- FAICIC S de RL de C.V. — Veracruz
- Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. — Zapopan
- ARENSIA Exploratory Medicine — Chisinau
- Mandziuk Slawomir Specialist Medical Practice — Lublin
- "Prof. Dr. Alexandru Trestioreanu" Oncology Institut — Bucharest
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" — Cluj-Napoca
- Hospital Universitari Vall D Hebron — Barcelona
- Hospital Duran i Reynals — L'Hospitalet de Llobregat
- Hospital Clínico San Carlos — Madrid
California
- Valkyrie Clinical Trials — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-04-12 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05249426
The ClinicalTrials.gov registry entry for NCT05249426 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma (HNSCC) appearing as the primary indexed condition, and to 5 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05249426 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05249426 about?
NCT05249426 is a clinical study titled "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". With an amendment of the protocol, this study is only open to adults with head and neck cancer. Previously also adults with liver cancer joined. 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...
What is the current status of trial NCT05249426?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-04-12. Estimated completion is 2026-07-31.
What conditions does trial NCT05249426 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma (HNSCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05249426?
The interventions under investigation include: Cetuximab (DRUG), Ezabenlimab (DRUG), BI 765063 (DRUG), BI 836880 (DRUG), Investigator´s Choice Chemotherapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05249426?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05249426 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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