A study of IMM-101 and nivolumab for people with advanced melanoma

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

Cancer type:

Melanoma

Secondary cancers

Skin cancer

Status:

Closed

Phase:

Phase 2

This study is looking at adding IMM-101 to nivolumab for melanoma that has grown into surrounding tissues or spread elsewhere in the body. This is called advanced melanoma.

More about this trial

Nivolumab is a usual treatment for advanced melanoma. You might have it alongside another drug called ipilimumab. But sometimes treatment stops working.

So, researchers are looking for ways to improve treatment for advanced melanoma when:

you haven’t had treatment yet
other treatments have stopped working

In this study, they are looking at adding a drug called IMM-101 to nivolumab.

Nivolumab is a type of targeted drug called an immunotherapy. IMM-101 is also a type of immunotherapy. It works in a slightly different way to nivolumab. Both help stimulate the immune system to find and kill cancer cells.

The study is divided into 2 groups:

group A is for people who haven’t had treatment for advanced melanoma
group B is for people whose advanced melanoma got worse during immunotherapy treatment

The aims of the study are to:

find out if giving IMM-101 as well as nivolumab means the treatment works for more people when immunotherapy like nivolumab hasn't worked so far
learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part (main entry conditions)

You may be able to join this study if all of the following apply.

You:

have advanced melanoma that has grown into surrounding tissue and can’t be removed with surgery or it has spread elsewhere in the body
have melanoma that the doctor can measure on a scan
haven’t had radiotherapy in the 2 weeks before joining the study
are suitable to have nivolumab
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 at least 18 years old
are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant

As well as the main entry conditions, to join group A the following must also apply, you:

haven’t had treatment for advanced melanoma
are willing to give a new sample if there isn’t a suitable tumour sample available for the study team to do some tests on

As well as the main entry conditions, to join group B, the following must also apply. You:

are having or have had an immunotherapy drug such as nivolumab but the cancer is getting or got worse during this treatment
had your last dose of immunotherapy within 8 weeks of joining the study
have had treatment such as dabrafenib and trametinib in the past if you were identified as suitable for such treatment
haven’t got any moderate to severe side effects from past treatment with nivolumab, pembrolizumab or similar immunotherapy

Who can’t take part

You cannot join this study if any of these apply.

Cancer related

You:

have melanoma of the eye
have cancer spread to the brain or spinal cord that is causing symptoms. You might be able to join group B if you have had successful treatment and it hasn’t got worse in the last 8 weeks
have had IMM-101 in the past
are having or have had treatment with an experimental drug in the last 4 weeks
have had any other cancer apart from basal cell skin cancer, squamous cell skin cancer, CIS of the cervix or any other cancer more than 5 years ago unless it has been successfully treated and there haven’t been any signs of it since

Medical conditions

You:

have an active infection that needs treatment
have or have had a lung condition called pneumonitis
have an autoimmune disease and you need treatment with drugs that dampen down the immune system such as steroids
have a condition requiring you to take more than 10mg of steroids each day, or other drugs that dampen down the immune system, in the 14 days before the start of the study, or you have had a long acting steroid in the 6 weeks before having tests that check your eligibility for the study
have hepatitis B or hepatitis C
have HIV
have any other medical condition or mental health problem that the study team think would affect you taking part

Other

You:

have had a blood transfusion within 4 weeks of having tests to check your suitability for the study
are pregnant or breastfeeding
have had an allergic reaction to a drug like IMM-101 or a monoclonal antibody drug
have had a live vaccination within 30 days of joining the study

As well as the main entry conditions, you cannot join group A if:

you have already had an immunotherapy drug or a similar drug

As well as the main entry conditions, you cannot join group B if the following apply:

you have had more than 1 combination of treatment for advanced melanoma before having immunotherapy
your doctor doesn’t think you are suitable to have further nivolumab because of side effects

Trial design

This is a phase 2 study. It is taking place at St George’s University Hospital in London.

The study is divided into 2 groups:

group A is for people who haven’t had treatment for advanced melanoma
group B is for people whose advanced melanoma got worse during immunotherapy treatment

The researchers need 18 people to join group A and 8 people to join group B.

Everyone has IMM-101 and nivolumab. Some patients in group B may change to IMM-101 and ipilimumab during the study.

IMM-101

IMM-101 is an injection into your upper arm. You have IMM-101 as follows:

1 injection once every 2 weeks for the first 3 doses
no injections for 4 weeks
1 injection once every 2 weeks for the next 3 doses
1 injection once every 4 weeks after that

The study team will monitor you for 2 hours after the first injection to check you don’t have a bad reaction. They check your blood pressure, pulse and temperature at regular intervals.

Nivolumab

You have nivolumab as a drip into a vein. You have it once every 2 weeks.

You have treatment for as long as it is working, and the side effects aren’t too bad. The longest you can have treatment for on this study is 18 months.

You stop treatment if your cancer gets worse. In group B, some people might change from nivolumab to ipilimumab if their cancer gets worse and you haven’t already had this. You have up to 4 doses of ipilimumab and then you can continue with IMM-101 on its own. The study team can tell you more if this applies. If not, your doctor will talk to you about other treatment options.

Samples for research

You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:

see how well the treatment is working
look for biomarkers to predict who will benefit from treatment

The study team will ask you to give an extra tissue sample (biopsy) at 3 months if you join group A.

They will also ask for some extra tissue samples if you join group B. But you don’t have to agree to this if you don’t want to. You can still take part in the study.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

physical examination
blood samples
urine samples
heart trace (ECG)
CT scan or MRI scan

In group A, the study team will ask you to give a tissue sample (biopsy) if there isn’t a suitable sample available when you join the study.

You have all your treatment at the hospital outpatient department. So, you shouldn’t need to stay overnight.

During treatment, you have a CT scan:

at 6 weeks for group B and at 3 months for group A
then every 2 months for a year for both groups

This may increase to every 3 months after that for both groups if the study team feel this is the right thing for you.

When you finish study treatment, you see the study team 1 month later.

Side effects

Only a small number of people have had IMM-101. So, there may be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The possible side effects of IMM-101 are: