A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
This research study is investigating new ways to treat a specific type of head and neck cancer called squamous cell carcinoma. This is for people whose cancer has returned (recurrent) or spread to other parts of the body (metastatic), and where local treatments like surgery or radiation are no longer an option. The study is comparing three different treatment approaches: pembrolizumab (an immunotherapy drug) combined with epacadostat, pembrolizumab on its own, and a standard treatment called the EXTREME regimen. Researchers want to see how well these treatments shrink tumours and if they are safe to use. This is a Phase 3 study, meaning it's a key stage to confirm if these new treatments are effective and safe for future use.
At a glance
What is this study about?
This clinical trial is designed to investigate new treatment options for a type of cancer that affects the head and neck, specifically called squamous cell carcinoma. This particular study is for patients whose cancer has either come back after previous treatment (recurrent) or has spread to other parts of the body (metastatic). For these patients, treatments that focus on a specific area, like surgery or radiation, are not typically effective.
The main goal of this study is to see how well new treatments work compared to a standard treatment. Researchers are looking at three different approaches. One involves a drug called pembrolizumab, which is an immunotherapy that helps your body's immune system fight cancer. This is being tested both on its own and in combination with another drug called epacadostat. These new treatments are being compared to a widely used standard treatment known as the EXTREME regimen. By comparing them, doctors hope to find better and safer ways to help patients with this type of cancer.
This is a Phase 3 study, which means it's a large-scale trial aiming to confirm if these new drugs are effective and safe enough to be considered for wider use in the future. The study will pay close attention to how much the tumours shrink (called 'Objective Response Rate') and also keep a careful eye on any side effects or unwanted reactions patients might experience while on the treatment.
Key takeaways
- This study explores new treatments for advanced head and neck cancer.
- It compares two new drug combinations with a standard treatment.
- The aim is to find out if new treatments are more effective and safe.
- Pembrolizumab is an immunotherapy that helps your immune system target cancer.
- You would receive treatment through infusions at regular hospital visits.
- This is a Phase 3 study, a key step in approving new medicines.
Who may be eligible?
To join this study, people must have a specific type of head and neck cancer called squamous cell carcinoma, which has either returned after being treated before or has spread to other parts of the body. Doctors must believe that local treatments, like surgery or radiation, would not be able to cure the cancer at this stage.
Participants must be at least 18 years old. Both men and women can take part in this research. Before you can join, the study team will carry out a number of checks to make sure the trial is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Do you have confirmed head and neck squamous cell carcinoma?
- Has your cancer come back or spread to other parts of your body?
- Do your doctors consider your cancer incurable with local therapies alone?
What does participation involve?
If you decide to join this study, you'll receive one of three different treatment combinations: pembrolizumab with epacadostat, pembrolizumab alone, or the EXTREME regimen (which includes cetuximab, cisplatin or carboplatin, and fluorouracil). All these drugs are given through an infusion, which means they are put directly into your bloodstream, usually through a drip. You will have regular visits to the hospital for your treatment infusions and check-ups. During these visits, the study team will perform various tests, such as blood tests and scans, to monitor how you are responding to the treatment and to check for any side effects. The total length of your participation will depend on how you respond to the treatment and the study's design. You will also have follow-up appointments after your main treatment period to continue monitoring your health.
Potential risks and benefits
Locations (2)
- —UnverifiedPortugal
- —UnverifiedSpain
Common questions
What is head and neck squamous cell carcinoma?
It's a type of cancer that starts in the flat, scale-like cells on the surface of the head and neck. In this study, it's for cancer that has come back or spread.
What does 'recurrent or metastatic' mean?
'Recurrent' means the cancer has returned after being treated before. 'Metastatic' means the cancer has spread from where it started to other parts of the body.
What is immunotherapy like pembrolizumab?
Immunotherapy is a type of treatment that helps your body's own immune system fight cancer cells. Pembrolizumab is a specific type of immunotherapy drug.
What is the 'EXTREME regimen'?
The EXTREME regimen is a standard combination of chemotherapy drugs and a targeted drug used to treat certain advanced head and neck cancers.
Will I know which treatment I'm getting?
This is an 'open-label' study, which means both you and your study doctor will know which specific treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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