A trial of a new drug called IMCgp100 for people with a type of eye cancer called uveal melanoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Eye cancer
Melanoma
Melanoma of the eye
Secondary cancers
Status:
Closed
Phase:
Phase 2
This trial is for people with uveal melanoma that has spread to other parts of the body (advanced uveal melanoma). It is for people who are going to have treatment for the first time.
More about this trial
Most melanomas start in the skin, but they can also start in other parts of the body, including the eye. Melanoma that starts in the middle tissue layer of the eye (the choroid), the iris and the ciliary body is called uveal melanoma.
Dacarbazine is a chemotherapy drug. It is a possible treatment for uveal melanoma. You may also have treatment with immunotherapy drugs such as:
Ipilimumab and pembrolizumab work by stimulating the immune system to recognise and attack cancer cells.
IMCgp100 is a new type of immunotherapy. It works by stimulating certain immune system cells called T-cells to find and kill the cancer.
Everyone taking part in this trial receives 1 of the following:
- IMCgp100
- dacarbazine, ipilimumab or pembrolizumab (standard treatment)
The main aim of this trial is to find out whether IMCgp100 is better than the standard treatment for people with advanced uveal melanoma (metastatic).
Who can enter
The following bullet points list 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 uveal melanoma that has spread to other parts of the body
- you are going to have treatment for the 1st time unless it was surgery to remove all of the cancer spread in the liver or treatment given to make the main treatment work better (adjuvant or neo adjuvant treatment)
- you are HLA-A*0201 positive (the study doctors will check for this gene by doing a blood test)
- you have at least 1 area of cancer that can be measured on a scan
- you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- you have satisfactory blood test results
- you are at least 18 years old
- you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility that you or your partner could become pregnant
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- have cancer spread in your brain or the spinal cord, unless you have had treatment, it has been stable for the past month and you stopped taking steroids more than 3 weeks ago
- are sensitive to pembrolizumab, ipilimumab, dacarbazine or any other similar drugs
- have had another cancer unless you have finished treatment for it more than 2 years ago and there are no signs of it coming back, or you had a non melanoma skin cancer of carcinoma in situ that has been successfully treated
- have had a major surgery in the past 2 weeks
- have had radiotherapy in the past 2 weeks unless it was a small dose to help with symptoms (palliative radiotherapy)
- have taken G-CSF or any other similar drug in the past 2 weeks
Medical conditions
You:
- have problems with your heart such as hypertension that isn’t controlled, an abnormal heartbeat (arrhythmias), congestive heart failure or you have had a heart attack in the past 6 months
- have lung problems such as interstitial lung disease or pneumonitis that needed treatment with steroids
- have problems with your adrenal glands which means you don’t make enough hormones such as cortisol
- have problems with your bowel such as colitis or inflammatory bowel disease
- take steroids or any other drug that damps down your immune system (immunosuppressants)
- have an active infection that needs treatment that reaches the whole body
- have HIV
- have hepatitis B or hepatitis C
- are pregnant or breastfeeding
- have any other medical condition that doctors think could affect you taking part
Trial design
This is a phase 2 trial. Researchers need up to 327 people to take part.
It is a randomised trial. Everyone taking part is put into 1 of the following treatment groups by a computer:
- IMCgp100
- dacarbazine, ipilimumab or pembrolizumab (standard treatment)
Neither you nor your doctor will be able to decide which group you are in. And you are 2 times more likely to have IMCgp100 than the standard treatment.
IMCgp100
You receive IMCgp100 as a drip into your bloodstream (intravenously). It takes about 15 to 20 minutes to have it.
You have IMCgp100 every week. This continues for as long as it is helping you and the side effects aren’t too bad. You start with a low dose to check how you tolerate the treatment. You have a slightly higher dose for the second treatment and again at the third treatment. You then have this dose for the rest of the study.
The first 3 times you have IMCgp100, you stay in hospital overnight. Doctors want to monitor you and check for any side effects you may have.
Standard treatment
You have 1 of the following drugs:
- dacarbazine
- ipilimumab
- pembrolizumab
Your doctor can tell you which treatment you will have.
You have dacarbazine and pembrolizumab as a drip into your vein, every 3 weeks. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
You also have ipilimumab as a drip into your vein every 3 weeks. You have up to 4 ipilimumab treatments. It takes around 3 months.
Quality of life
Everyone taking part completes quality of life questionnaires before the start of treatment and then:
- at set times during the trial
- after you finish treatment
The questionnaires ask about how you have been feeling and what side effects you have had.
Blood tests
You have some extra blood tests if you join the IMCgp100 group. Researchers want to:
- find out what happens to IMCgp100 in your body
- find out how much of IMCgp100 is in your body at certain times after treatment
- look at how the immune system responds to IMCgp100
You have the extra blood tests before the start of treatment, at set times during the trial and when you finish treatment.
Tissue sample
The trial team will ask to use a sample of your cancer taken at the time of your diagnosis (archival tumour sample).
They ask you to have a biopsy if there isn’t a suitable sample available. You don’t have to agree to have a biopsy if you don’t want to.
Doctors want to look at the cancer and the proteins on the outside of cancer cells.
Hospital visits
You see a doctor and have some tests before taking part. The tests might include:
During treatment, you see the trial team every week if you are in the IMCgp100 group. You see them every 3 weeks if you join the standard treatment group. You have blood tests and a physical examination every time you see them.
You have a CT scan or MRI scan every 12 weeks (3 months). This continues for as long as the treatment is helping you and the side effects aren’t too bad. If you have ipilimumab, you have treatment for a maximum of 3 months.
You see the trial team after you finish treatment. This is called the end of treatment visit. You have blood tests and a physical examination. You then see or speak with the trial team every 3 months. If you stop treatment before your cancer starts to grow again, you will continue to have CT scans or MRI scans every 12 weeks (3 months).
Side effects
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about the possible side effects before you start the trial.
Doctors think that the most common side effects of IMCgp100 are:
- rash, dry skin, red skin, skin sloughing and flaking, skin darkening, whitened skin or vitiligo
- itching of skin and generalised itching or generalised rash or skin eruptions
- swelling of the face, body and eyes
- fever and chills
- fatigue or tiredness
- nausea, the feeling of throwing up and vomiting (throwing up)
- low blood pressure
- headache, dizziness and forgetfulness
- low white blood cells (immune cells in the bloodstream)
- pain in the abdomen (belly), extremities (arms or legs), pain in muscles, joints or bones
- diarrhoea
- flu like illness
- elevations of liver enzymes and liver proteins in the bloodstream
- decreased appetite
- flushing
- tingling of the skin and a tingling sensation in the fingers and hands
- hair colour changes and hair loss
We have information about the possible side effects of:
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr Joseph Sacco
Dr Paul Nathan
Dr Jeffrey Evans
Supported by
Immunocore
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15581
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
