Cabozantinib + Cetuximab for Head and Neck Cancer

Palo Alto (17 mi)

Overseen byLoren Michel, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

Eligibility Criteria

Adults with incurable head and neck squamous cell carcinoma, who have measurable disease and are in good physical condition (ECOG 0 or 1). They must not be pregnant, have had certain treatments recently, or have serious health issues that could interfere with the trial. Participants should agree to use contraception during the study.

Inclusion Criteria

I understand the study requirements and have signed the consent form.

I am 18 years old or older.

My blood tests and organ functions are within normal ranges.

I am not pregnant and can become pregnant.

I am fully active or can carry out light work.

My cancer has spread or returned and cannot be removed by surgery.

My cancer is a type of squamous cell carcinoma located in the head or neck.

Exclusion Criteria

I have received more than 70 Gy of radiation to my neck or head in the last 2 months.

I am currently taking blood thinners.

My tumor is growing into or around major blood vessels.

I have symptoms of an underactive thyroid.

I need ongoing treatment with strong CYP3A4 inducers.

My liver function is significantly impaired.

I do not have any severe, uncontrolled illnesses.

I have a serious wound, ulcer, or bone fracture that isn't healing.

I have not had radiation therapy recently.

I have been treated with cabozantinib before.

I cannot swallow whole pills.

Treatment Details

The trial is testing different doses of cabozantinib combined with cetuximab to see how safe they are for treating recurrent or metastatic head and neck cancer. The effects on patients at these varying doses will be closely monitored.

1Treatment groups

Experimental Treatment

Group I: Cabozantinib in Combination With CetuximabExperimental Treatment2 Interventions

Cetuximab will be administered at 500 mg/m\^2 intravenously every other week. Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: