Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
This study is for people with advanced head and neck cancer where the cancer has returned or spread and can't be cured with regular treatments. The research is focusing on a medicine called pembrolizumab, which is given every three weeks for up to two years. It's designed for people who are already feeling quite unwell due to their illness (we call this a 'performance status of 2'). Researchers want to see if this medicine can help these patients and understand any side effects. Taking part means you'll receive the study medicine alongside the best supportive care to help you feel comfortable.
At a glance
What is this study about?
This study is looking into a treatment called pembrolizumab for a type of cancer that starts in the head and neck area. This particular study is for people whose head and neck cancer has either come back after treatment or has spread to other parts of the body. Unfortunately, for these patients, the cancer can't be cured with typical local treatments.
Pembrolizumab is a modern type of medicine that works with your body's immune system to fight cancer. The researchers want to find out how effective this medicine is for patients who are already quite unwell because of their cancer. They'll also be carefully checking for any side effects to make sure it's safe to use.
Taking part in this study means you would receive pembrolizumab alongside the best care available to help manage your symptoms and improve your comfort. This is a "Phase II" study, which means it's one of the earlier stages of testing a new treatment, focusing on how well it works and ensuring its safety.
Key takeaways
- This study is for advanced head and neck cancer that has returned or spread.
- It tests a medicine called pembrolizumab, which boosts your immune system.
- You would receive the treatment every three weeks, along with supportive care.
- The study aims to see how well the medicine works and if it's safe.
- Participation could last up to two years.
- You can stop taking part at any time.
Who may be eligible?
To be able to join this study, you would need to have head and neck cancer that has been confirmed by a doctor, and it must have either returned or spread. It's also important that your doctors believe your cancer can't be cured with local treatments like surgery or radiation. You need to be at least 18 years old and your general health should be such that you are able to move around and do some daily activities, but you might need some help.
There are also some things that would mean you couldn't join. For example, if your cancer could still be cured with other treatments, or if you've already had a similar medicine called an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. You also can't be pregnant or breastfeeding. The medical team will check your blood tests to make sure your body's organs, like your kidneys and liver, are working well enough.
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.
- Do you have head and neck cancer that has come back or spread?
- Are you at least 18 years old?
- Are you able to move around and do some daily tasks, even if you need some help?
- Have you NOT had a similar type of immunotherapy medicine before (like anti-PD-1 or anti-PD-L1)?
- Are you NOT pregnant or breastfeeding?
- Are you willing and able to visit the hospital regularly for appointments?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, pembrolizumab, through a drip. This would happen every three weeks for up to two years, as long as the treatment is helping you and you're not having serious side effects. Along with the medicine, you'll also get the best supportive care to help manage any symptoms you might have. You'll have regular visits to the hospital for assessments like blood tests and scans to see how the treatment is working and to check your health. You'll also need to agree to use effective birth control during treatment and for a few months afterwards. The total duration of your treatment and follow-up could be up to 24 months, with ongoing monitoring by the study team.
Potential risks and benefits
Locations (12)
- Aberdeen Royal Infirmary (NHS Grampian)Verified postcodeAberdeen, United Kingdom
- Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)Verified postcodeBristol, United Kingdom
- Western General Hospital (NHS Lothian)Verified postcodeEdinburgh, United Kingdom
- East Suffolk and North Essex NHS Foundation TrustVerified postcodeIpswich, United Kingdom
- Guy's and St Thomas' NHS Foundation TrustVerified postcodeLondon, United Kingdom
- University College London HospitalVerified postcodeLondon, United Kingdom
- The Christie NHS Foundation TrustVerified postcodeManchester, United Kingdom
- The Clatterbridge Cancer Centre NHS Foundation TrustVerified postcodeMetropolitan Borough of Wirral, United Kingdom
- East and North Hertfordshire NHS TrustVerified postcodeNorthwood, United Kingdom
- Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)Verified postcodeRomford, United Kingdom
- Musgrove Park Hospital (Somerset NHS Foundation Trust)Verified postcodeTaunton, United Kingdom
- Royal Cornwall Hospital TrustVerified postcodeTruro, United Kingdom
Common questions
What is head and neck squamous cell carcinoma?
It's a common type of cancer that starts in the moist lining of the head and neck area, like the mouth, throat, or voice box.
What is pembrolizumab?
It's a modern cancer medicine that helps your body's own immune system find and fight cancer cells.
What does 'recurrent or metastatic' mean?
Recurrent means the cancer has come back after treatment. Metastatic means the cancer has spread from where it started to other parts of the body.
What does 'best supportive care' involve?
This is treatment given to manage your symptoms, improve your comfort, and maintain your quality of life, without aiming to cure the cancer itself.
How long will I be on the study treatment?
You could receive the treatment for up to two years, as long as it's helping you and you're managing any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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