Intralesional Cemiplimab for Adult Patients with Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
This is an early-stage research study, sometimes called a Phase 1 trial, where doctors are testing a new approach to treat two common types of skin cancer: cutaneous squamous cell carcinoma and basal cell carcinoma. The medicine being studied is called cemiplimab. Usually, cemiplimab is given into a vein, but in this study, doctors want to see if injecting it directly into the cancer itself (which is called 'intralesional') is safe and if it can help shrink the tumour. This is one of the very first times this specific way of giving the medicine has been tried in people, so the main goals are to check for safety and to understand how the body reacts to it when given this way. It's for adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is about a new way to treat specific types of skin cancer: cutaneous squamous cell carcinoma and basal cell carcinoma. These are two common forms of skin cancer. The medicine being tested is called cemiplimab. You might have heard of it because it's already used for some types of cancer, usually given through a drip into a vein.
However, in this study, doctors are trying something different. They are injecting the cemiplimab directly into the cancer itself, rather than into the bloodstream. This is called 'intralesional' treatment. The idea behind this is to deliver the medicine right where it's needed most, potentially affecting the cancer cells more directly while possibly reducing side effects elsewhere in the body. Since this is an early-stage study, the main aims are to find out if this new way of giving the medicine is safe and what kind of effects it has on the cancer.
Learning whether this approach is safe and how the body responds to it is a crucial first step. If it shows promise, it could lead to new treatment options for patients with these types of skin cancers in the future. It's important to remember that this is very early research, so we are still learning a lot about this treatment method.
Key takeaways
- This is an early-stage study testing a new way to give cemiplimab for skin cancer.
- The medicine is injected directly into the tumour, not given through a drip.
- It's for adults with cutaneous squamous cell carcinoma or basal cell carcinoma.
- The main goal is to check if this new method is safe and how it works.
- Participation involves regular clinic visits and close monitoring.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.
However, having certain types of health conditions or taking particular medicines might mean you can't join. The doctors running the study will thoroughly check your health and medical history to make sure that taking part would be safe for you. They will also need to confirm that you have either cutaneous squamous cell carcinoma or basal cell carcinoma.
- Are you 18 years old or older?
- Do you have a diagnosis of cutaneous squamous cell carcinoma or basal cell carcinoma?
- Are you comfortable with receiving injections directly into your skin cancer?
- Are you able to attend regular clinic appointments for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, the first step involves screening tests to make sure the study is right for you. This might include blood tests and other checks. You would then receive the study medicine, cemiplimab, injected directly into your skin cancer. The research team would explain exactly how often and for how long you would receive these injections.
Throughout the study, you would come in for regular visits to the clinic. During these visits, doctors and nurses would carefully monitor your health, check for any side effects, and see how your cancer is responding to the treatment. This would involve repeat examinations, and possibly more blood tests or scans. There would also be a follow-up period after your treatment finishes to continue monitoring your health and the long-term effects of the study medicine. The total length of your participation would be explained fully before you join.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is cemiplimab?
Cemiplimab is a medicine used to treat certain cancers by helping your body's immune system fight cancer cells.
What does 'intralesional' mean?
It means the medicine is injected directly into the cancer tumour on your skin, rather than into a vein.
Is this a new treatment for skin cancer?
While cemiplimab is used for some skin cancers, injecting it directly into the tumour in this way is a new method being tested in this study.
How long does the study last?
The total duration of your participation, including treatment and follow-up, will be clearly explained by the study team.
Will I get paid to be in the study?
Generally, participants are not paid for taking part in trials, but some studies may cover travel expenses. This will be clarified by the study team.
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.