NCT05816785CompletedEarly phase 1
Pilot Study of Imatinib Cetuximab Combo for H & N Cancer
A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to find if levels of a protein called AXL in tumor cells relate to how tumors respond to cetuximab (CTX) combined with imatinib in participants with head and neck cancer. This interventional study will occur in the time between diagnosis of your cancer and surgery to remove your tumor or radiation or chemoradiation treatment of your primary cancer. Participants will undergo a research blood draw and a research biopsy as part of the screening process, and will be in this research study for approximately 13 to 16 months.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 22 Mar 2023
- Start date
- 18 Apr 2023
- Primary completion date
- 8 Aug 2026
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Head and neck cancer
- NCT number
- NCT05816785
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 15
- From 18 Apr 2023 to the primary completion date, 8 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Prior chemotherapy, radiotherapy, or major surgery within 8 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 8 weeks earlier (alopecia and fatigue excluded). Clinical significance to be determined by the study investigator.
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Subjects who are receiving any other investigational agents.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib or CTX.
Other
- Subjects with a diagnosis of nasopharyngeal carcinoma, advanced cutaneous squamous cell carcinoma of the head and neck, or salivary gland tumors are excluded from this study.
Who the study is looking for
- Age \> 18 years at the time of consent.
- Histological confirmation of squamous cell carcinoma of the head and neck.
- For those patients with oropharyngeal cancer, subjects must have either
- HPV-negative status by p16 expression or HPV-DNA Expression.
- HPV-positive status by p16 expression AND a \>10 pack year smoking history.
- Subjects must be appropriate candidates for definitive curative intent treatment, either via surgical resection, definitive radiation therapy alone, or definitive concurrent chemoradiation therapy.
- For the screening research biopsy, subjects must have sufficient tumor volume (approximately 10 cc) to accommodate at minimum 2-3 core samples for the research biopsy.
- For the post-treatment (CTX/Imatinib) research biopsy, subjects who are scheduled to receive definitive radiation therapy (+/- concurrent chemotherapy) are required to have sufficient tumor volume to accommodate at minimum 2-3 core samples for the research biopsy.
- Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.