Study of petosemtamab with pembrolizumab compared to pembrolizumab alone in patients with head and neck cancer who have not received previous treatment for advanced disease
This study focuses on patients with head and neck squamous cell carcinoma that has either come back (recurrent) or spread to other parts of the body (metastatic). The cancer in these patients must show a specific marker called PD-L1. The study will test two treatment approaches: one group will receive a combination of two medications – petosemtamab and pembrolizumab, while another group will receive pembrolizumab alone.
Both medications are given through an intravenous infusion (directly into a vein). Petosemtamab can be given at doses up to 1500 milligrams per day, while pembrolizumab can be given at doses up to 400 milligrams per day. The purpose of this study is to determine if combining these two medications works better than using pembrolizumab by itself for patients who have not received previous treatment for their advanced cancer.
The treatment period may last up to 24 months. During the study, patients will have regular check-ups to monitor their health and how well the treatment is working. The study will look at how long patients live and whether their tumors shrink in response to the treatment.
1Initial assessment
Your eligibility for the trial will be confirmed through medical tests and examinations
The medical team will check if you have head and neck cancer that has spread or come back locally
A tissue sample will be tested in a laboratory to check if your tumor has a specific marker called PD-L1
Your heart function will be checked to ensure it is working at 50% or better
Various organ function tests will be performed to ensure you meet the health requirements
2Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group 1: Treatment with both petosemtamab and pembrolizumab given through intravenous infusion
Group 2: Treatment with pembrolizumab alone given through intravenous infusion
3Treatment period
You will receive your assigned treatment through an intravenous infusion (medication given directly into your vein)
Regular visits will be scheduled to monitor your health and assess how your cancer responds to treatment
Imaging scans will be performed to measure any changes in your tumor
Your doctor will monitor any side effects you may experience
4Follow-up assessments
Regular check-ups will continue to track your progress
Imaging scans will be performed to assess how your tumor responds to treatment
Your overall health and survival will be monitored
The study will continue until February 2028
Who Can Join the Study?
Must sign an informed consent form before any study procedures begin
Must be at least 18 years old
Must have confirmed head and neck squamous cell carcinoma (a type of cancer) that has either spread to other parts of the body or returned locally and cannot be cured with local treatment. The cancer must be in one of these areas: oropharynx (back of the throat), oral cavity (mouth), hypopharynx (lower throat), or larynx (voice box)
Must have tumors that express a specific protein called PD-L1 at certain levels, which will be tested in a laboratory
Must not have received previous systemic treatment (treatment that affects the whole body) for cancer that has spread or returned. Previous treatment for earlier-stage disease is allowed if the cancer did not progress for at least 6 months after platinum-based therapy
Must provide a tumor tissue sample for testing
Must have cancer that can be measured using imaging scans
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal assistance)
Must have a life expectancy of at least 12 weeks
Must have good heart function (ejection fraction of 50% or higher)
Must have adequate organ function as determined by medical tests
People who are HIV positive may participate if they meet certain additional requirements
Who Cannot Join the Study?
History of treatment with anti-PD-1 or anti-PD-L1 therapy (types of immunotherapy)
Previous treatment with EGFR inhibitors (targeted cancer therapy)
Active brain metastases (cancer that has spread to the brain) or spinal cord compression
Uncontrolled or significant heart disease
Active autoimmune disease requiring systemic treatment
History of organ transplant
Active infection requiring therapy, including hepatitis B, hepatitis C, or HIV
Other active cancers requiring treatment within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer)
Pregnancy or breastfeeding
Known allergies or severe reactions to study medications
Participation in another clinical trial within 4 weeks before starting this study
Mental conditions that could interfere with study compliance
Any condition that, in the opinion of the study doctor, would make participation unsafe
Petosemtamab is a medication being studied for treating head and neck cancer. It targets specific proteins on cancer cells and is designed to help the immune system fight cancer more effectively. This medication is being tested in combination with another drug to see if it works better than standard treatment alone.
Pembrolizumab is an immunotherapy medication that helps the body’s immune system detect and fight cancer cells. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. This medication is already approved for treating various types of cancer, including head and neck cancer.
Head and Neck Squamous Cell Carcinoma (HNSCC) – A type of cancer that begins in the flat squamous cells that line the moist surfaces inside the head and neck region. This cancer can develop in various areas including the mouth, throat, larynx, and nasal cavity. The cancer typically starts in the squamous cells and can spread to nearby tissues and lymph nodes. When it becomes recurrent, it means the cancer has returned after initial treatment, while metastatic indicates it has spread to other parts of the body. The disease can affect normal functions like eating, speaking, and breathing.
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