A Phase II single-arm study of pembrolizumab plus lenvatinib in previously treated classic Kaposi sarcoma (CKS)
This study is a Phase II clinical trial investigating a new combination of two drugs, pembrolizumab (also known as KEYTRUDA) and lenvatinib, for people with a specific type of cancer called classic Kaposi sarcoma. This is for patients whose cancer is advanced, cannot be removed by surgery, and has either returned after standard treatments or didn't respond to them. The main goal is to see how many people respond to this new treatment. Researchers will also look at how long the treatment keeps the cancer under control, how long people live, and if it affects their quality of life. Safety and any side effects will also be carefully monitored throughout the study.
At a glance
What is this study about?
This study is designed for individuals living with advanced classic Kaposi sarcoma. This is a type of cancer that can develop in people with weakened immune systems, but the 'classic' form often affects older men of Mediterranean, Eastern European, or Jewish descent. The study is specifically recruiting people whose cancer is considered 'unresectable,' meaning it can't be removed by surgery, and who have already undergone standard treatments that either didn't work or the cancer came back afterwards.
The main purpose of this research is to evaluate a new treatment approach that combines two existing drugs: pembrolizumab and lenvatinib. Pembrolizumab is an immunotherapy that works by helping your body's immune system fight cancer, while lenvatinib is a targeted therapy designed to block certain signals that help cancer cells grow and spread. By combining these two treatments, researchers hope to see a better response than with single treatments.
This is a Phase II study, which means it's one of the earlier steps in testing a new treatment. The main thing the researchers want to find out is the 'overall response rate' – in simple terms, how many patients treated with this combination show that their cancer has shrunk or stopped growing. They will also be tracking other important aspects like how long the treatment keeps the cancer from growing (progression-free survival), how long people live (overall survival), and how the treatment affects their general health and well-being (quality of life). Safety and any side effects are also a very important part of what the researchers will be watching closely.
Key takeaways
- This study is testing two new cancer drugs together for advanced Kaposi sarcoma.
- It's for people whose cancer has returned or didn't respond to previous treatments.
- The main goal is to see how effectively the combination shrinks or stops the cancer.
- Researchers will also track safety, quality of life, and how long the treatment works.
- It's a 'Phase II' study, an early step in finding new treatments.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There is no upper age limit, and the study is open to both men and women.
Your diagnosis must be classic Kaposi sarcoma that is advanced and cannot be removed by surgery. Crucially, your cancer must have either come back after you've had previous standard treatments, or it didn't respond to those treatments in the first place.
There will be other specific medical requirements that your doctor will check to make sure participating in the study is safe and appropriate 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 18 years or older?
- Do you have advanced classic Kaposi sarcoma that cannot be removed by surgery?
- Has your Kaposi sarcoma come back after previous treatment, or did it not respond to treatments you've already had?
- Are you able to attend regular appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive two drugs: lenvatinib and KEYTRUDA (pembrolizumab). These will be given according to a specific schedule set by the study doctors. You will have regular appointments for check-ups, which will likely include blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. These assessments will help the doctors understand both the benefits and any side effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and your overall health, but you will be monitored throughout and after the treatment period.
Potential risks and benefits
Locations (1)
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Common questions
What is Kaposi sarcoma?
Kaposi sarcoma is a type of cancer that causes patches of abnormal tissue to grow under the skin, in the lining of the mouth, nose, and throat, in lymph nodes, or in other organs.
What is a 'Phase II' study?
A Phase II study is an early stage of clinical research where doctors test a new treatment on a larger group of people to see if it works and to further evaluate its safety.
What do 'relapsed' or 'refractory' mean?
'Relapsed' means the cancer came back after treatment, and 'refractory' means the cancer didn't respond or stopped responding to previous treatments.
What are pembrolizumab and lenvatinib?
These are two different types of cancer drugs. Pembrolizumab helps your body's immune system fight the cancer, and lenvatinib targets specific pathways that help cancer cells grow.
Will I definitely get the new treatment?
Yes, in this specific type of study (single-arm), everyone who is eligible and joins will receive the combination of pembrolizumab and lenvatinib.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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