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NCT06806852 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06806852: Recruiting Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Boehringer Ingelheim.
NCT06806852 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 90 participants, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06806852, a Phase 1 study of Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
OR 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 version 1.1 (RECIST v1.1). Objective response (OR) will be defined 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 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 |
What NCT06806852 shows while recruiting
NCT06806852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (22% lower).
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.
NCT06806852 names 20 study sites across 6 states, led by Other, Kentucky, Minnesota.
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.
What interventions are being tested in trial NCT06806852?
The interventions under investigation include: Pembrolizumab (DRUG), Cetuximab (DRUG), BI 770371 (DRUG).
Who is sponsoring clinical trial NCT06806852?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06806852's enrollment target sits among peer trials
90 45th of 124 higher than 78 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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