Mechanisms of Resistance to anti-PD-1 Therapy in cutaneous Squamous Cell Carcinomas: Impact of Tumor Cell Plasticity on Promoting Myeloid Suppressor Cell Infiltration. A phase II single arm, unicenter study of cemiplimab in patients with locally advanced cSCCs.
This study is for people with a type of advanced skin cancer called cutaneous squamous cell carcinoma. Researchers are giving participants a medicine called cemiplimab, also known as Libtayo, to see how well it works. The main goal is to understand why this medicine helps some people, but not others. To do this, they will be looking closely at blood and tumour samples from patients. They will examine things like genes and immune cells to find patterns that explain how the treatment works. This information could help doctors in the future to better predict who will benefit most from cemiplimab and to develop even better treatments for skin cancer.
At a glance
What is this study about?
This research study is about a type of skin cancer called cutaneous squamous cell carcinoma (cSCC). This is a common form of skin cancer, and sometimes it can become advanced, meaning it has grown or spread. Doctors are using a medicine called cemiplimab, also known by its brand name Libtayo, which is given as an infusion (drip).
The main idea behind this study is to understand *how* cemiplimab works in people with advanced cSCC. We know that this medicine can be effective for some patients, but not for everyone. The researchers want to look very closely at what's happening inside the body, specifically in blood and tumour samples. They will be examining things like the body's immune system, the genes within the cancer cells, and how the tumour looks under a microscope. By studying these tiny details, they hope to find certain 'signs' or 'clues' that help explain why the treatment is successful for some and less so for others.
Ultimately, the goal is to learn more about the cancer and how it responds to cemiplimab. This deeper understanding could be really important. It might help doctors in the future to choose the best treatments for individual patients, or even help to develop new and more effective medicines for cSCC. It's like trying to solve a puzzle so that one day, we can fit all the pieces together to get the best outcome for patients.
Key takeaways
- This study is for advanced skin cancer (cutaneous squamous cell carcinoma).
- It uses a medicine called cemiplimab (Libtayo) given by infusion.
- The main aim is to understand *how* the medicine works by studying samples.
- It could help doctors choose better treatments in the future.
- Participants must be 18 or older with advanced cSCC.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can take part.
This study is open to both men and women.
The main condition for joining is that you must have a type of advanced skin cancer called cutaneous squamous cell carcinoma (cSCC). The doctors involved in the study will be able to confirm if your specific situation fits the requirements for participation.
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?
- Do you have a type of advanced skin cancer called cutaneous squamous cell carcinoma (cSCC)?
- Are you able to attend regular hospital appointments for treatment and tests?
- Are you prepared to have blood tests and potentially tumour biopsies?
What does participation involve?
If you decide to join this study, you would receive the study medicine, cemiplimab, as an infusion (a drip into your vein). This medicine is given at a hospital or clinic. You would have regular appointments for these infusions and for check-ups with the study doctors and nurses. During these visits, there would be blood tests and possibly repeat biopsies (small tissue samples) from your tumour. These tests are important for the researchers to understand how the medicine is working for you. The study team will explain exactly how many visits you'll need, how long each part of the study will last, and what kind of monitoring will be involved, including any follow-up appointments after you stop treatment.
Potential risks and benefits
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Common questions
What is cemiplimab (Libtayo)?
Cemiplimab, also known as Libtayo, is a medicine used to treat certain types of cancer, including advanced skin cancer. It works by helping your body's own immune system fight the cancer cells.
What does a 'Phase II' study mean?
A Phase II study means researchers are looking more closely at how well a new treatment works and its safety in a larger group of people, after earlier smaller studies have shown it might be helpful.
Will I get the actual medicine or a placebo?
In this specific study, everyone who participates will receive the study medicine, cemiplimab. There is no placebo (dummy treatment) involved.
What kind of tests will I have?
You'll have regular blood tests and possibly small tissue samples (biopsies) taken from your tumour. These will help the researchers understand how the medicine is affecting your body and the cancer.
How long will I be in the study?
The study team will give you a clear idea of the expected duration of treatment and follow-up, which can vary for each person. They will explain this fully if you are considering joining.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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