A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
This study is looking at a new medicine called cemiplimab, known by its brand name Libtayo, for people with a common type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that is at a more advanced stage. It's a Phase 2 study, meaning researchers are further investigating if the medicine works and is safe. The main goal is to see if giving Libtayo before surgery can make the cancer completely disappear from the part of the body where it started. They will check this by looking at tissue samples under a microscope after surgery. The study also wants to see how well the treatment shrinks the cancer, how long people stay free of cancer, if the treatment changes surgical plans, and any side effects people might experience.
At a glance
What is this study about?
This study is about a kind of skin cancer called cutaneous squamous cell carcinoma, often shortened to CSCC. This is a common type of skin cancer. The study is for people whose CSCC is considered Stage 2, 3, or 4, which means it might be larger, have spread to nearby lymph nodes, but hasn't spread to distant parts of the body.
The main medicine being tested is called cemiplimab, which you might know as Libtayo. This medicine is given intravenously, meaning into a vein, and it's a type of treatment that helps your body's own immune system fight the cancer. In this study, doctors are giving Libtayo *before* surgery. This is sometimes called 'neoadjuvant' treatment. The main thing they want to find out is if this pre-surgery treatment can make all the cancer cells disappear from the original tumour site when looked at closely under a microscope after surgery. This is called a 'pathologic complete response'.
Beyond simply seeing if the cancer disappears, the study will also look at other important things. This includes how much the tumour shrinks before surgery, how long people remain free of cancer or how long they live, and if the treatment changes the plans for surgery or what other treatments might be needed afterwards. The researchers will also keep a close eye on any side effects or unwanted reactions people might have to the medicine, to make sure it's safe.
Key takeaways
- This study evaluates Libtayo (cemiplimab) before surgery for advanced skin cancer (CSCC).
- The main goal is to see if the medicine makes cancer completely disappear from the tumour site.
- It's a Phase 2 study focused on both effectiveness and safety.
- Eligible participants are adults with Stage 2-4 CSCC (not spread distantly).
- Your health will be closely monitored throughout the study.
- Participation involves IV infusions and regular check-ups.
Who may be eligible?
To join this study, you generally need to be an adult, 18 years old or older, with a diagnosis of cutaneous squamous cell carcinoma (CSCC) that is at a Stage 2, 3, or 4 (but hasn't spread to distant parts of the body).
If your CSCC has already spread to other non-nearby organs, or if you've had certain other medical conditions or treatments, this study might not be suitable for you. This is to ensure the study is safe and that results are clear.
Both men and women can take part. The research team will review your full medical history to confirm if this study is the right fit 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 old or older?
- Have you been diagnosed with cutaneous squamous cell carcinoma (CSCC)?
- Is your CSCC considered Stage 2, 3, or 4?
- Has your CSCC not spread to distant parts of your body?
- Have you discussed your overall health with your doctor?
What does participation involve?
If you take part in this study, you will receive doses of the medicine Libtayo, given as an infusion into your vein. This will happen before you have surgery to remove your skin cancer. You will have regular appointments for check-ups and to receive your treatment.
Throughout the study, you'll have various tests, which might include blood tests, scans, and physical examinations. Doctors will closely monitor your general health and how the treatment is affecting you, especially looking for any side effects. After your surgery, doctors will examine the removed tissue closely under a microscope. There will also be follow-up appointments after your treatment and surgery to track your progress and long-term health. The total duration of your active participation, including treatment and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is cutaneous squamous cell carcinoma (CSCC)?
It's a common type of skin cancer that can grow on parts of the body exposed to the sun.
What is Libtayo (cemiplimab)?
It's a medication that helps your body's immune system fight cancer cells. It's given through a drip into your vein.
What does 'neoadjuvant' mean?
It means the treatment is given before the main treatment, which in this case is surgery for CSCC.
What is a 'pathologic complete response'?
It means all the cancer cells have disappeared from the original tumour site when checked closely under a microscope after surgery.
Why are doctors doing this study?
Doctors want to find out if giving Libtayo before surgery can help clear the cancer cells and improve treatment results for people with advanced CSCC.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.