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CompletedNCT05816785Updated Oct 1, 2026

Pilot Study of Imatinib Cetuximab Combo for H & N Cancer

An Early Phase 1 interventional study of Cetuximab and Imatinib in Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by University of Wisconsin, Madison · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of Head and Neck
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 15 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Imatinib Cetuximab Combination

    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.

    Drug: Cetuximab · Drug: Imatinib

Interventions

  • DrugCetuximab

    Week 1: loading dose of 400mg/m2; Week 2: 250mg/m2

  • DrugImatinib

    400 mg orally daily

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months after last research biopsy

Secondary outcomes

  1. 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

    Time frame: Through study completion, an average of 2 years

  2. 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

    Time frame: Up to 28 days after surgery

  3. Objective response rate (ORR)

    Measured by clinical examination

    Time frame: Diagnosis, 48 hours prior to surgery or radiation

  4. Objective response rate (ORR)

    Measured by clinical measurements

    Time frame: Diagnosis, 48 hours prior to surgery or radiation

07

Study locations

1 site
  • University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin 53792, United States
08

References and documents

Study documents

  • Informed consent form · Jul 7, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: documents
1 update, last Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Minor edits only
    + 1 other change: documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05816785
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Apr 18, 2023
Primary completion
Aug 8, 2026
Completion
Aug 8, 2026
Last update
Oct 1, 2026

Study contacts

Justine Bruce, MD
principal investigator · University of Wisconsin, Madison

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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