Study on Adding Cetuximab to Pembrolizumab for Treating Returning or Spreading Head and Neck Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06589804

This clinical trial is testing whether adding the drug cetuximab to the standard treatment pembrolizumab can better treat head and neck cancer that has returned or spread after previous treatment.

Patient Parameters

Parameter	Options

Program Overview

This study is exploring if combining cetuximab with pembrolizumab is more effective than using pembrolizumab alone for patients with head and neck squamous cell carcinoma (HNSCC) that has come back or spread. Cetuximab is a type of medication that targets a protein on tumor cells, potentially stopping their growth. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. The trial aims to see if the combination of these two drugs can improve treatment outcomes for patients with recurrent or metastatic HNSCC.

Description

The main goal of this study is to find out if using cetuximab with pembrolizumab can help patients with head and neck cancer live longer compared to using pembrolizumab alone. Researchers will also look at how well the cancer responds to the treatments, how long the response lasts, and the safety of the drug combination. Patients will be randomly assigned to one of two groups: one group will receive pembrolizumab alone, and the other group will receive both cetuximab and pembrolizumab. Both groups will undergo regular scans and may have blood samples taken to monitor their progress. After finishing the treatment, patients will have follow-up visits for up to five years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

Diagnosed with head and neck squamous cell carcinoma (HNSCC).
Cancer has returned or spread and cannot be cured with local treatments.
Primary tumor located in the oral cavity, oropharynx, larynx, or hypopharynx.
Cancer must have progressed during or within 6 months after previous treatment with chemotherapy and radiation.
Tumor must be PD-L1 positive with a combined positive score (CPS) of 1 or higher.
Completed any radiation therapy at least 10 days before joining the study.
No prior treatment for recurrent or metastatic cancer.
Previous treatment with pembrolizumab or cetuximab is allowed if it was more than 6 months ago and the cancer did not progress during that time.
No live vaccines within 30 days before joining the study.
No severe allergies to pembrolizumab or cetuximab.
No recent use of high-dose steroids or other immune-suppressing drugs.
For oropharyngeal cancer, must test negative for HPV.
Age 18 or older.
Good overall health with an ECOG performance status of 0 to 2.
Adequate blood cell counts and organ function based on specific tests.
Not pregnant or nursing, and women of childbearing potential must have a negative pregnancy test before joining.
Patients with other cancers can join if it does not interfere with this study.
Patients with treated and stable brain metastases can join.
HIV-positive patients on effective treatment with undetectable viral load can join.
Patients with controlled hepatitis B or cured hepatitis C can join.
No history of severe heart disease or active lung disease.
No history of organ transplantation.

Locations

FACILITY	ZIP	CITY	STATE
Saint Alphonsus Cancer Care Center-Boise	83706	Boise	Idaho
Saint Alphonsus Cancer Care Center-Caldwell	83605	Caldwell	Idaho
Kootenai Health - Coeur d'Alene	83814	Coeur d'Alene	Idaho
Saint Alphonsus Cancer Care Center-Nampa	83687	Nampa	Idaho
Kootenai Clinic Cancer Services - Post Falls	83854	Post Falls	Idaho
Kootenai Clinic Cancer Services - Sandpoint	83864	Sandpoint	Idaho
Memorial Hospital East	62269	Shiloh	Illinois
Mary Greeley Medical Center	50010	Ames	Iowa
McFarland Clinic - Ames	50010	Ames	Iowa
McFarland Clinic - Boone	50036	Boone	Iowa

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