Head and Neck CancerEarly Phase 1NCT05816785
Pilot Study of Imatinib Cetuximab Combo for H & N Cancer
A Early Phase 1 study testing Cetuximab and Imatinib in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Cetuximab and Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 8 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck
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.
Read the detailed description
This is a 'window of opportunity' pilot study of oral imatinib (400 mg per day) plus cetuximab (CTX) (400mg/m2 loading dose [dose 1] and 250mg/m2 [dose 2]) for patients with head and neck squamous cell carcinoma (HNSCC) undergoing definitive surgery or radiation for treatment of their cancer. The primary objective is to determine the proportion of patients with a response to imatinib plus CTX in pre-treatment and post-treatment samples obtained as part of a window of opportunity clinical study in head and neck cancer (HNC) patients.
- Being tested
- Cetuximab, Imatinib
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Week 1: loading dose of 400mg/m2; Week 2: 250mg/m2
ImatinibDrug
400 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Cetuximab Combination | Experimental | Participants will receive two doses of CTX and a minimum of an 8 day (maximum 14 day) course of imatinib prior to definitive surgery or definitive radiation/chemoradiation. Receives: Drug: Cetuximab; Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki67 from pre- versus post-imatinib/cetuximab treated tumors
The change in Ki67 is calculated as the ratio of pre- to post- treatment Ki67 index
Measured: 6 months after last research biopsy
Secondary outcomes (4)
Adverse Events that are probably related to CTX and imatinib prior to the start of definitive concurrent chemoradiation therapy or surgical resection
Count of adverse events that are probably related to the regimen
Measured: Through study completion, an average of 2 years
Rate of hospital re-admissions
For subjects undergoing definitive surgical resection, rate of hospital re-admissions for wound care or surgical complications attributed to imatinib plus cetuximab (such as fistula or deep cellulitis) within 28 days after surgery
Measured: Up to 28 days after surgery
Objective response rate (ORR)
Measured by clinical examination
Measured: Diagnosis, 48 hours prior to surgery or radiation
Objective response rate (ORR)
Measured by clinical measurements
Measured: Diagnosis, 48 hours prior to surgery or radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start18 Apr 2023
- Primary completion8 Aug 2026
- Study completion8 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Justine Bruce, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816785
- Sponsor's protocol ID
- 2022-1590
- Other IDs
- 1R01CA262292-01A1, NCI-2023-01888, UW22118, SMPH/MEDICINE/HEM-ONC, Protocol Version 7/2/2025
- Status last verified
- Sep 2026
- First submitted
- 22 Mar 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck
- ClinicalTrials.gov ID
- NCT05816785
- Acronym / sponsor ID
- 2022-1590
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 8 Aug 2026 (actual)
- Study completion
- 8 Aug 2026 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 'window of opportunity' pilot study of oral imatinib (400 mg per day) plus cetuximab (CTX) (400mg/m2 loading dose [dose 1] and 250mg/m2 [dose 2]) for patients with head and neck squamous cell carcinoma (HNSCC) undergoing definitive surgery or radiation for treatment of their cancer. The primary objective is to determine the proportion of patients with a response to imatinib plus CTX in pre-treatment and post-treatment samples obtained as part of a window of opportunity clinical study in head and neck cancer (HNC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Cetuximab Combination | Experimental | Drug: Cetuximab, Drug: ImatinibParticipants will receive two doses of CTX and a minimum of an 8 day (maximum 14 day) course of imatinib prior to definitive surgery or definitive radiation/chemoradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years at the time of consent.
- Histological confirmation of squamous cell carcinoma of the head and neck.
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabWeek 1: loading dose of 400mg/m2; Week 2: 250mg/m2 | Drug | Imatinib Cetuximab Combination |
| Imatinib400 mg orally daily | Drug | Imatinib Cetuximab Combination |
Primary outcome
Change in Ki67 from pre- versus post-imatinib/cetuximab treated tumors
Time frame: 6 months after last research biopsy
The change in Ki67 is calculated as the ratio of pre- to post- treatment Ki67 index
4 secondary outcomes
Adverse Events that are probably related to CTX and imatinib prior to the start of definitive concurrent chemoradiation therapy or surgical resection
Time frame: Through study completion, an average of 2 years
Rate of hospital re-admissions
Time frame: Up to 28 days after surgery
Objective response rate (ORR)
Time frame: Diagnosis, 48 hours prior to surgery or radiation
Objective response rate (ORR)
Time frame: Diagnosis, 48 hours prior to surgery or radiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine Bruce, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cetuximab and Imatinib in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ki67 from pre- versus post-imatinib/cetuximab treated tumors (time frame: 6 months after last research biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.