NCT05816785

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cetuximab	Week 1: loading dose of 400mg/m2; Week 2: 250mg/m2
DRUG	Imatinib	400 mg orally daily

Timeline

• Start date: 2023-04-18
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-04-18
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study