What side effects are associated with this type of intervention?

Common treatments for Head and Neck Cancers, such as EGFR inhibitors like Cetuximab and Tyrosine Kinase Inhibitors like Imatinib, have several known side effects. Cetuximab can cause ocular issues like trichomegaly, poliosis, and keratitis, as well as skin reactions and gastrointestinal problems. Imatinib typically causes nausea, fatigue, edema, and muscle cramps. Both treatments may also lead to skin reactions and gastrointestinal disturbances.

What prior FDA approvals exist?

Cetuximab, an EGFR inhibitor, has been approved for the treatment of head and neck cancers, either alone or in combination with chemotherapy. It has shown significant improvements in overall survival and progression-free survival when combined with chemotherapy. Imatinib, a tyrosine kinase inhibitor, is being studied in combination with Cetuximab for its potential benefits in head and neck cancers. Other similar treatments include the use of pembrolizumab, an immune checkpoint inhibitor, which has been approved for use with or without chemotherapy in patients with metastatic or recurrent squamous cell carcinoma of the head and neck.

What other types of research exist?

Promising alternatives to Cetuximab and Imatinib for head and neck cancer patients include Afatinib and Allitinib, both of which are irreversible EGFR inhibitors. Afatinib has demonstrated antiproliferative activity and clinical efficacy in preclinical models and clinical trials. Allitinib has shown higher cytotoxicity compared to Afatinib and Cetuximab in head and neck squamous cell carcinoma (HNSCC) cell lines. Additionally, Pembrolizumab, an immune checkpoint inhibitor, has shown promise in treating advanced salivary gland carcinoma and may be considered for head and neck cancers.

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Monoclonal Antibodies

Imatinib + Cetuximab for Head and Neck Cancer

Q: What is the mechanism of action of this treatment?

Cetuximab is a monoclonal antibody that targets and inhibits the epidermal growth factor receptor (EGFR), which is often overexpressed in head and neck cancers, leading to uncontrolled cell growth. Imatinib, on the other hand, is a tyrosine kinase inhibitor that blocks specific enzymes involved in the signaling pathways that promote cancer cell proliferation and survival. These mechanisms are crucial for head and neck cancer patients because they directly interfere with the molecular drivers of tumor growth and resistance, potentially improving treatment outcomes and offering new therapeutic options for those who may not respond to conventional therapies.

Phase < 1

Recruiting

Led By Justine Bruce, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Summary

This trial tests a combination of two drugs, imatinib and cetuximab, in patients with head and neck cancer who are about to undergo surgery or radiation. Researchers want to see if a specific protein in the tumor cells affects how well the treatment works. Participants will be involved in the study for over a year. Imatinib has been used for several years in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).

Who is the study for?

Adults over 18 with squamous cell carcinoma of the head and neck, who are candidates for curative surgery or chemoradiation. They must have a tumor large enough for biopsy samples and adequate organ function. Excluded are those with certain other cancers, recent major treatments, ongoing investigational drug use, allergies to study drugs, or severe medical conditions.

What is being tested?

This trial tests if protein AXL levels in tumors predict response to cetuximab combined with imatinib in head and neck cancer patients. Participants will be studied from diagnosis until up to 16 months after treatment involving surgery or chemoradiation.

What are the potential side effects?

Possible side effects include allergic reactions related to either imatinib or cetuximab (such as skin rashes), as well as general risks associated with biopsies like bleeding and infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Ki67 from pre- versus post-imatinib/cetuximab treated tumors

Secondary study objectives

Adverse Events that are probably related to CTX and imatinib prior to the start of definitive concurrent chemoradiation therapy or surgical resection

Objective response rate (ORR)

Rate of hospital re-admissions

Trial Design

1Treatment groups

Experimental Treatment

Group I: Imatinib Cetuximab CombinationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imatinib

2011

Completed Phase 3

~3940

Cetuximab

2011

Completed Phase 3

~2480

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cetuximab is a monoclonal antibody that targets and inhibits the epidermal growth factor receptor (EGFR), which is often overexpressed in head and neck cancers, leading to uncontrolled cell growth. Imatinib, on the other hand, is a tyrosine kinase inhibitor that blocks specific enzymes involved in the signaling pathways that promote cancer cell proliferation and survival. These mechanisms are crucial for head and neck cancer patients because they directly interfere with the molecular drivers of tumor growth and resistance, potentially improving treatment outcomes and offering new therapeutic options for those who may not respond to conventional therapies.

Cetuximab Resistance in Squamous Carcinomas of the Upper Aerodigestive Tract Is Driven by Receptor Tyrosine Kinase Plasticity: Potential for mAb Mixtures.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,210 Previous Clinical Trials

3,157,724 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,985 Total Patients Enrolled

Justine Bruce, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

5 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05816785 — Phase < 1

Squamous Cell Carcinoma Research Study Groups: Imatinib Cetuximab Combination

Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05816785 — Phase < 1

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05816785 — Phase < 1

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