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A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone
NCT06806852 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site. Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cetuximab
- DRUG BI 770371
Study Locations (20)
Other
- Hospital de Amor — Barretos
- Liga Norte Riograndense contra o cancer — Natal
- Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto
- MBAL Sveta Sofia — Sofia
- CTR Oscar Lambret — Lille
- CTR Leon Berard — Lyon
- HOP Timone — Marseille
- Institut Gustave Roussy — Villejuif
- ARENSIA Exploratory Medicine LLC — Tbilisi
- Städtisches Klinikum Braunschweig gGmbH — Braunschweig
- Universitätsklinikum Jena — Jena
- Universität Leipzig — Leipzig
- Universitätsklinikum Ulm — Ulm
- Semmelweis University — Budapest
- National Institute of Oncology — Budapest
Kentucky
- Norton Cancer Institute, Downtown — Louisville
Minnesota
- M Health Fairview Clinics and Surgery Center - Minneapolis — Minneapolis
Ohio
- The Ohio State University Wexner Medical Center — Columbus
New South Wales
- Gosford Hospital — Gosford
Victoria
- Andrew Love Cancer Centre — Geelong
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06806852
The ClinicalTrials.gov registry entry for NCT06806852 describes a study currently listed as 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 90 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 appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab 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: NCT06806852 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Kentucky, Minnesota. 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 NCT06806852 about?
NCT06806852 is a clinical study titled "A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone". This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 77037...
What is the current status of trial NCT06806852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2025-05-14. Estimated completion is 2027-07-31.
What conditions does trial NCT06806852 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06806852?
The interventions under investigation include: Pembrolizumab (DRUG), Cetuximab (DRUG), BI 770371 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06806852?
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 NCT06806852 being conducted?
This trial has 20 study locations across Kentucky, Minnesota, Ohio, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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