A trial looking at cemiplimab for basal cell skin cancer (IMPACT)
Cancer type:
Status:
Phase:
This trial is looking at a drug called cemiplimab as a first treatment for 
that has grown into surrounding tissues. Cancer that has spread into nearby tissue is locally advanced cancer.
This trial is for people who can’t have surgery or radiotherapy to treat basal cell skin cancer.
More about this trial
The main treatment for basal cell cancer (BCC) is surgery. You might also have radiotherapy. Sometimes it isn’t possible to have these treatments. This might be because the cancer has:
- spread into the surrounding tissue or into the deeper layers of the skin
- come back in the same area
- got bigger
Doctors are looking for new treatments for people in this situation. In this trial they are looking at a drug called cemiplimab.
Cemiplimab is an immunotherapy. It helps the to find and kill cancer cells. It is already an approved treatment for some other types of skin cancer.
We know from previous research that cemiplimab helped some people who had BCC that had spread. They had cemiplimab after previous treatment for BCC that had stopped working. Researchers now want to see how it works for basal cell skin cancer as a first treatment. So they are doing this trial to find out more.
The main aims of the trial are to find out:
- how well cemiplimab works for basal cell skin cancer
- more about the side effects
- how treatment affects
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have
basal cell skin cancer that has spread into surrounding tissues and you can’t have surgery to remove it or radiotherapy to treat it - have at least one area of skin cancer that can be assessed during the trial to see whether cemiplimab is working. Your doctor will know if you do.
- have satisfactory blood test results
- are fit and active but you might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have basal cell skin cancer that has spread elsewhere in the body or you have a condition called
Gorlin syndrome - have had a type of cancer growth blocker in the past called a PI3K inhibitor. For example a drug called idelalisib. Your doctor will know this.
- have had certain types of immunotherapy that are called PD-1 or PD-L1 inhibitors. Your doctor will know this.
- have had treatment for cancer in the 30 days before you have cemiplimab or there is a plan to have another cancer treatment during the trial. You can join the trial if you are having radiotherapy for symptoms (
palliative radiotherapy ). - have had another cancer in the last 5 years. You can take part if it has a low risk of spreading to another part of the body or has been successfully treated. You can take part if you have had chronic lymphocytic leukaemia (CLL) and you have not had treatment to the whole body in the last 6 months.
- have had treatment to stimulate the immune system within 28 days of starting cemiplimab. Your doctor will know about this. You can take part if you had treatment with imiquimod cream, another treatment you apply to the skin or one that is injected into the area of cancer.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had steroid treatment to damp down the
immune system in the last 4 weeks unless it was a low dose. You might be able to take part if you have had short courses of steroid treatment. - have or had an
autoimmune condition in the last 5 years that needed treatment apart from certain ones - have HIV that isn’t controlled with medication, an active hepatitis B or hepatitis C infection or any other infection that needs treatment
- have had inflammation of the lung tissues (
pneumonitis ) in the last 5 years - have had treatment that stimulates the immune system in the last month or it hasn’t cleared your body yet
- have had any other medical condition or mental health problem that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have had a bad allergic reaction to medications that contain a substance called polysorbate 80. Your doctor will know this.
- have had a
live vaccine within 30 days of starting trial treatment. You can have the approved COVID-19 vaccines as these aren’t live. - are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The trial team need 41 people in the UK to take part.
You have cemiplimab as a drip into a vein. It takes about 30 to 60 minutes each time. You will be at the hospital for longer than this.
You have cemiplimab once every 3 weeks for up to 2 years.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The researchers might ask to access any tissue samples () taken as part of your routine care. They plan to keep the sample to use in future research. You can say no to this. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out some questionnaires:
- before you start treatment
- at set times during treatment
- at set times after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see a doctor and have some tests before you can take part in the trial. These include:
You may have already had some of these tests before you agreed to join the trial. Your doctor will also ask to take photographs of the areas of cancer on the skin. It won’t be possible to identify you from the photos.
You have cemiplimab at the hospital in the outpatient department. You won’t need to stay overnight.
The team take photos of your skin cancer every 3 months. You might also have a CT or MRI scan every 3 months. This depends on your individual situation and the team will talk to you about this.
Follow up visits
You see the trial team when you stop treatment for a check up at:
- 1 month
- 3 months
The team then follow you:
- every 3 months for a year and then
- every 6 months in the second year
You might see them at a routine hospital appointment or they may call you to see how you are getting on.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
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Cemiplimab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of cemiplimab include:
- feeling or being sick
- a drop in the number of red blood cells causing an increased risk of tiredness and breathlessness (
anaemia ) - loss of appetite
- diarrhoea
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Amarnath Challapalli
Supported by
Regeneron
University Hospitals Bristol and Weston NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
