A trial of IMCgp100 for melanoma that cannot be removed

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Melanoma

Skin cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a drug called IMCgp100 for melanoma that cannot be removed with surgery, or has spread to other parts of the body.

Doctors often treat melanoma with surgery. But sometimes it cannot be completely removed or has spread to other parts of the body. Researchers are looking for new treatments to help people in this situation.

In this trial, they are looking at a new drug called IMCgp100 which is a type of immunotherapy Open a glossary item . It targets melanoma cells and helps the immune system to find and attack them. This is the first time the drug has been tested in people.

The aims of the study are to

Find the highest safe dose of IMCgp100
Learn more about the side effects and what happens to the drug in your body
See if IMCgp100 helps people with melanoma

Who can enter

You can enter this trial if you

Have melanoma that is stage 3 and cannot be removed with surgery, or has spread to another part of your body (stage 4) and there are no other standard treatments available to you
Have a protein in your blood called HLA-A2 (about half the population have this protein but the trial doctors will check by doing a blood test)
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are willing to use a reliable form of contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have melanoma that has spread to your brain and needs treatment
Have had surgery in the last 4 weeks, apart from surgery to remove melanoma from your skin
Have had radiotherapy in the last 4 weeks, or in the last 2 weeks if it was to just to a small area
Have had chemotherapy, immunotherapy, or an experimental drug in the last 4 weeks
Have not recovered from side effects of earlier treatment, unless they are very mild
Have had any other type of cancer in the last 5 years, apart from carcinoma in situ or non melanoma skin cancer that has been completely removed, or another cancer if your doctor thinks it is now cured
Have raised pressure inside your skull (intracranial pressure)
Have inflammation of your eye (uveitis)
Have had a heart attack in the last year or have certain other heart problems
Have liver problems – the doctors will do liver function tests to check this
Have bleeding problems or take drugs to thin your blood (anti coagulants)
Have had fits (seizures) in your adult life
Have had your spleen removed or have another condition that damps down your immune system, including organ transplant
Have any other medical condition that the trial doctors think would make it unsafe for you to take part
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is trial is in 2 parts.

In part 1, doctors look for the highest safe dose of IMCgp100. The first patients taking part have a very low dose. If they don't have any serious side effects, the next few patients have a higher dose. And so on, until the researchers find the highest safe dose. This is called a dose escalation study.

You can have IMCgp100 in 2 different ways. Some people have IMCgp100 once a week for 8 weeks. Each period of 8 weeks is called a cycle of treatment.

Some people have IMCgp100 on 4 consecutive days. Then 3 weeks later, they have it for another 4 days. For them, this 6 week period is a cycle of treatment.

If you don't have bad side effects, you may be able to carry on having cycles of treatment for up to 6 or 7 months.

You have IMCgp100 through a drip into a vein. It can take up to 30 minutes each time.

In part 2, the researchers want to learn more about how well IMCgp100 works. Some people will have weekly IMCgp100. Some people will have daily IMCgp100. You have the highest safe dose for that way of having treatment that was found in the first part of the trial.

Whether you have weekly or daily doses of IMCgp100 will depend on when you join the trial. Your doctor will explain this to you.

Hospital visits

You see the trial doctors and have some tests before you start treatment. The tests include

Physical examination including hearing tests and an eye test
Heart trace (ECG )
Heart ultrasound (echocardiogram )
Urine test
CT scan
MRI scan

Before your first dose of IMCgp100, the study team will photograph any areas of melanoma on your skin. And they may ask your permission to take a biopsy Open a glossary item .

If you have weekly IMCgp100, you will need to stay in hospital for 24 hours after the first dose.

If you have daily doses of IMCgp100, you will need to stay in hospital for the first 4 days.

You have a number of tests and scans throughout the treatment including blood tests, ECGs, skin photography and biopsies. You also have eye tests and hearing tests. Some people in part 2 of the trial will be asked to have a lumbar puncture Open a glossary item . This is so the researchers can discover more about how IMCgp100 works in the body.

When you finish treatment, the study team will continue to check how you are every few months.

Side effects

This is the first time IMCgp100 has been tested in people and there may be side effects we don’t know about yet. A small number of people have now had IMCgp100 and the side effects seen have included

Skin rash (if you develop a skin rash during the study, photographs may be taken)
A drop in the number of white blood cells causing an increased risk of infection
A drop in blood pressure
Temporary breathing difficulties
Flu like symptoms
A condition called vitiligo, which causes white patches on the skin

IMCgp100 may also cause inflammation of the eye or ear, which can cause changes to your vision and problems with your hearing or balance.It is possible you could have a more severe allergic reaction.