PEVOsq: Phase II basket trial evaluating the efficacy of a combination of pembrolizumab and vorinostat in patients with recurrent and/or metastatic squamous cell carcinoma
This study is investigating a new combination treatment for specific types of squamous cell carcinoma, a kind of skin cancer. These are cancers of the vulva/vagina, head and neck, penis, cervix, and anus, especially when they have come back or spread. The treatment involves a drug called KEYTRUDA. Researchers want to see how many patients respond to this combination, meaning their cancer either shrinks or stops growing. This is a Phase II study, which means it's testing if the treatment is effective and safe in a larger group of people after earlier small studies showed promise.
At a glance
What is this study about?
This clinical trial, called "PEVOsq," is designed to explore a new way to treat certain types of cancer. Specifically, it's focusing on squamous cell carcinoma, which is a common type of skin cancer that can affect different parts of the body, such as the vulva, vagina, head, neck, penis, cervix, and anus. The study is for patients whose cancer has come back after previous treatment or has spread to other parts of the body.
The main goal of the study is to see how well a combination of two drugs, pembrolizumab (known as KEYTRUDA) and vorinostat, works to fight these cancers. Researchers are particularly interested in the 'Overall Response Rate' (ORR). This simply means they want to find out what percentage of patients experience a significant reduction in their tumor size or if their tumors completely disappear after receiving the treatment.
This is a 'Phase II' trial, which means it’s a crucial step in testing new treatments. It tells us if the treatment is effective and helps doctors understand its safety and how patients react to it. If the results are positive, it could lead to further, larger studies, potentially bringing new treatment options to patients in the future.
Key takeaways
- This study is testing a new combination treatment for certain types of squamous cell carcinoma.
- It focuses on cancers that have come back or spread.
- The treatment involves a drug called KEYTRUDA.
- The main goal is to see how many patients respond positively to the treatment.
- Anyone 18 years or older with the specific cancer types can be considered.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to participate.
Beyond age and gender, specific medical criteria will be carefully checked by the study doctors. For example, you would need to have certain types of squamous cell carcinoma (of the vulva/vagina, head and neck, penis, cervix, or anus) that have either come back or spread to other parts of your body.
The study team will review your medical history and perform some tests to make sure that the treatment is suitable and safe for you, and that you meet all the necessary requirements to participate.
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 18 years old or older?
- Have you been diagnosed with squamous cell carcinoma of the vulva/vagina, head and neck, penis, cervix, or anus?
- Has your cancer come back or spread to other parts of your body?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you generally able to take part in a clinical trial and follow its instructions?
What does participation involve?
If you decide to take part in this study, you will receive the study treatment, which involves an infusion of KEYTRUDA. The treatment will be given on a regular schedule, and you will have appointments for these infusions at the hospital or clinic.
Throughout the study, you will have regular check-ups with the study doctors and nurses. These appointments will include physical examinations, blood tests, and scans (like X-rays or CT scans) to monitor your health and how the treatment is affecting your cancer. These scans are important for checking if your tumours are shrinking or if the treatment is otherwise working. You will also be asked about any side effects you might experience.
The study also involves follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation, including treatment and follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is squamous cell carcinoma?
It's a type of cancer that starts in the flat, scale-like cells on the surface of the skin or in the lining of certain organs.
What does 'recurrent and/or metastatic' mean?
It means the cancer has either returned after being treated before, or it has spread from where it started to other parts of the body.
What is pembrolizumab (KEYTRUDA)?
It's a type of cancer treatment called immunotherapy, which helps your own immune system fight the cancer cells.
What is a Phase II trial?
It's a stage in clinical research that tests if a new treatment is effective and safe in a larger group of people after smaller initial studies showed promise.
How often will I need to visit the hospital?
The study team will provide a detailed schedule of visits for treatment and check-ups, which will be regular throughout your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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