Cetuximab + Afatinib for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAarti Bhatia, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a single arm Phase II study for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who are previously treated with a platinum based regimen or with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of the combination of cetuximab and afatinib.

Eligibility Criteria

This trial is for adults with advanced squamous cell carcinoma of the head and neck that has returned or spread after platinum-based chemotherapy or immune checkpoint inhibitor treatment. Participants must have measurable disease, be in a stable condition (ECOG ≤2), and have proper organ function. Pregnant women, those with certain allergies, untreated viral hepatitis or HIV, recent radiotherapy recipients, and individuals on prohibited medications are excluded.

Inclusion Criteria

My cancer got worse within 6 months after finishing platinum-based treatment.

Adequate organ function including Hemoglobin ≥ 8 g/dl, ANC ≥1000 / mm3, Platelet count ≥75,000 / mm3, Estimated creatinine clearance > 45ml / min, Total Bilirubin ≤ 1.5 times upper limit of normal, AST or ALT ≤ three times the upper limit of normal, Ability to understand and the willingness to sign a written informed consent that is consistent with ICH-GCP guidelines, Negative urine or serum pregnancy test for women of childbearing potential

My cancer in the head or neck area is advanced and cannot be cured with surgery or radiation.

+4 more

Exclusion Criteria

I have a serious lung condition affecting the tissue and space around the air sacs.

I have untreated viral hepatitis or HIV.

I have completed treatment for brain metastases.

+9 more

Participant Groups

The study tests combining two drugs—cetuximab and afatinib—to treat recurrent or metastatic head and neck cancer. It's a Phase II trial to see how effective this drug duo is when other treatments like chemo haven't worked.

1Treatment groups

Experimental Treatment

Group I: All subjectsExperimental Treatment2 Interventions

Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.

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

🇺🇸 Approved in United States as Gilotrif for: