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NCT05249426 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05249426: Active Phase 1 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Boehringer Ingelheim.
NCT05249426 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma (HNSCC) that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 48 participants, below the 247-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05249426, a Phase 1 study of Head and Neck Squamous Cell Carcinoma (HNSCC), is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Objective response (OR) with confirmation, defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1) by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of conse
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 |
What the registry record for NCT05249426 still lists
NCT05249426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 247-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (81% lower).
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.
NCT05249426 names 20 study sites across 2 states, led by Other, California.
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).
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).
Who is sponsoring clinical trial NCT05249426?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05249426's enrollment target sits among peer trials
48 13th of 14 higher than 2 of 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma (HNSCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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