A Phase II study of intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients with presence of injectable lesions.
This study is a Phase II clinical trial looking into a new way to treat specific types of skin cancer that are advanced in one area but haven't spread to other parts of the body. These cancers are called Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (cSCC). The treatment involves injecting two medications, Darleukin and Fibromun, directly into the skin cancer. This study is designed for patients who cannot have or do not want standard surgery or radiation therapy. The main goal is to see how much the skin cancer shrinks or disappears after treatment, and researchers will also look at how safe the treatment is and how long patients stay free from cancer progression.
At a glance
What is this study about?
This clinical trial is designed for people who have certain types of skin cancer called Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (cSCC). These are common kinds of skin cancer. Specifically, the study is for people whose skin cancer is quite advanced in one area (locally advanced) but hasn't spread to other parts of their body, and where the cancer can be easily injected. It's also for those who, after discussions with their care team, can't have surgery or radiation therapy, or who have decided against these standard treatments.
The main aim of the study is to test a new treatment that uses two special medications called Darleukin and Fibromun. These medicines are injected directly into the skin cancer itself. The researchers want to find out how effective this treatment is at shrinking or getting rid of the cancer. They will carefully measure how many patients' cancers show a good response, either by shrinking significantly or disappearing completely.
Apart from how well the treatment works, the study will also look at how safe it is for patients. They will monitor any side effects that might occur. The study will also track how long patients remain free from their cancer getting worse and will check for any new lesions or if the cancer spreads. This is a 'Phase II' study, which means it's an earlier stage of research focused on finding out if a new treatment is effective and safe in a larger group of people.
Key takeaways
- New treatment for specific advanced skin cancers (BCC/cSCC).
- Medications injected directly into the cancer.
- For patients not suitable for or choosing against surgery/radiation.
- Aims to shrink or get rid of the cancer.
- Also assesses safety and how long cancer remains stable.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. The study is open to both men and women.
You must have a specific type of skin cancer: either Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (cSCC). This cancer must be 'high-risk' and 'locally advanced,' meaning it's quite serious in one area but hasn't spread to other parts of your body, and it must be suitable for injections.
Importantly, you need to be a patient who either can't have surgery or radiation therapy based on your doctors' advice, or you have chosen not to have those treatments. Your doctor will have already checked your cancer type through a tissue sample.
- Are you 18 years old or older?
- Do you have Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (cSCC) that is locally advanced but hasn't spread?
- Has a doctor confirmed your skin cancer type with a biopsy?
- Have you been told you can't have surgery or radiation therapy, or have you decided against them?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll receive the study medications, Darleukin and Fibromun, which will be injected directly into your skin cancer. The research team will regularly check how your cancer is responding to the treatment using specific measurements and possibly tissue samples if your cancer is removed. They will also keep a close eye on your general health and any side effects you might experience. The total duration of your participation will depend on your individual response and how long the researchers need to follow your progress, which could involve follow-up appointments over several months or longer.
Potential risks and benefits
Locations (2)
- —Poland
- —Germany
Common questions
What kind of skin cancer is this study for?
This study is for specific types of non-melanoma skin cancer called Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (cSCC) that are advanced but haven't spread.
What does 'intratumoral administration' mean?
It means the study medications are injected directly into the skin cancer itself, rather than taken by mouth or through a vein.
Why would someone join this study instead of having surgery?
This study is for patients who may not be able to have surgery or radiation therapy, or who have decided not to have these standard treatments.
What are Darleukin and Fibromun?
Darleukin and Fibromun are the names of the two special medications being tested in this study. They are designed to act on the cancer when injected directly.
What is the main goal of the study?
The main goal is to see how well the injected medications shrink or get rid of the skin cancer, and to understand how safe they are.
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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