New study explores drug Combo's effect on head and neck tumors before surgery
NCT ID NCT05816785
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study looks at how a protein called AXL in head and neck tumors responds to a combination of two drugs, imatinib and cetuximab, given before standard treatment. About 15 adults with head and neck cancer will receive the drugs for a short time between diagnosis and surgery or radiation. The main goal is to measure changes in tumor cell activity, not to treat the cancer directly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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15 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib or CTX.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Shorter radiation course tested for advanced head and neck cancer