A trial looking at nivolumab and ipilimumab for people with melanoma (CA209915)

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

Cancer type:

Children's cancers

Melanoma

Status:

Closed

Phase:

Phase 3

This trial is for people over the age of 15 who have had surgery to completely remove their melanoma skin cancer (complete resection).

The stage of a cancer tells you how big it is and how far it’s spread. People in this trial have stage 3b to stage 4.

More about this trial

Surgery is the main treatment for melanoma. When doctors remove all of the cancer it is called a complete resection.

But sometimes the cancer comes back after surgery. In this trial doctors want to find out if having nivolumab and ipilimumab after surgery can stop melanoma from coming back.

Nivolumab (Opdivo) and ipilimumab (Yervoy) are 2 types of targeted cancer drugs (immunotherapy). They work in slightly different ways but both help the body’s immune system to kill cancer cells.

In this trial, you have 1 of the following:

nivolumab, ipilimumab and dummy drug (placebo )
nivolumab and dummy drug
ipilimumab and dummy drug

The main aims of this trial are to:

find out how well nivolumab and ipilimumab work as a treatment
learn more about the side effects
find out more about people’s quality of life
find out what happens to nivolumab and ipilimumab in the body
look for proteins (biomarkers ) to see why treatments work better for some people than others

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.

You may be able to join this trial if all of the following apply:

you have been diagnosed with melanoma that has spread to lymph nodes or other parts of the body (stage 3B to stage 4)
you have had surgery to remove all of the cancer in the last 12 weeks (3 months)
you have had a physical examination and a CT scan or MRI scan in the past 4 weeks and doctors think there is no cancer left
you have satisfactory blood tests results
you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
there is a suitable sample of cancer available that your doctor can test for a biomarker called PD-L1
you are at least 15 years old
you weigh more than 40kg

Women must be willing to use reliable contraception during treatment and for 5 months afterwards if there is any possibility of becoming pregnant.

Men must be willing to use reliable contraception during treatment and for 7 months afterwards, if there is any possibility their partner could become pregnant.

You cannot join this trial if any of these apply.

Cancer related

you have melanoma that started in the eye (uveal melanoma)
your melanoma has spread to the brain unless you have had treatment, there is no sign of the cancer for the past month and you haven’t needed steroids in the last 2 weeks
you have had any treatment for melanoma apart from surgery, radiotherapy for melanoma that has spread to the brain or the drug interferon (you must have stopped it more than 6 months ago)
you have had treatment after surgery, apart from radiotherapy for melanoma that has spread to the brain
you have had another cancer in the past 3 years apart from early cancers (carcinoma in situ ) of the prostate, cervix and breast or basal or squamous cell skin cancer that have been successfully treated

Medical conditions

you have had surgery with a general anaesthetic in the past 4 weeks or an operation with a local anaesthetic in the last 3 days
you have an autoimmune disease unless it is vitiligo, type 1 diabetes, hair loss (alopecia), a thyroid problem that is controlled by medication or a skin condition called psoriasis that doesn’t need treatment
you have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks (unless this was a cream, an inhaler or a very small dose)
you are known to be sensitive to ipilimumab, nivolumab or anything they contain
you have had a severe allergic reaction to monoclonal antibodies such as ipilimumab or nivolumab
you have HIV
you have hepatitis B or hepatitis C
you have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part in this trial

Other

you are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 1,125 people to take part worldwide and hope that around 47 people from the UK will take part.

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

nivolumab, ipilimumab and dummy drug (arm A)
nivolumab and dummy drug (arm B)
ipilimumab and dummy drug (arm C)

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which group you are in. This is a double blind trial Open a glossary item .

You are 2 times more likely to have arm A and arm B than arm C.

study diagram

Everyone has nivolumab, ipilimumab and the dummy drug as a drip into a vein. On some visits you have 1 drip, and on others you have 2 drips. It can take up to 4 hours each time.

You continue to have treatment for as long as there is no sign of the cancer coming back and the side effects aren’t too bad. This can be for up to 1 year.

Quality of life
Everybody taking part in this trial completes a quality of life questionnaire before starting treatment and:

at set times during treatment
1 month after finishing treatment
then every 3 months

This questionnaire asks about how you have been feeling and about any side effects you have had.

Blood tests
You have some extra blood tests as part of this trial. Researchers want to:

look for certain proteins called biomarkers to see why treatments work better for some people than others
find out what happens to nivolumab and ipilimumab in the body
see if your immune system makes proteins that recognise nivolumab and ipilimumab

You have the extra blood tests before starting treatment, at set times during the trial and then 1 and 3 months after the end of treatment.

Stool (poo) samples
The research team might ask you to give 3 stool samples. They want to look at the types of bacteria Open a glossary item in your gut.

You give a stool sample 1 week after the start of treatment and then after:

7 weeks
29 weeks (almost 8 months)

You do not have to agree to give stool samples if you don’t want to. You can still take part in this trial.

Tissue sample
Doctors will ask for a tissue sample of your cancer that was taken during surgery. They want to:

check for a protein called PD-L1
look for certain immune system cells such as lymphocytes

Doctors might also ask you to give a new tissue sample (a biopsy Open a glossary item ) if your cancer comes back.

You do not have to agree to give the new tissue sample if you don’t want to. You can still take part in this trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
blood tests
urine test
a CT scan or MRI scan
a PET-CT scan
heart trace (ECG )

During the trial, you see the doctor for blood tests and a physical examination before each treatment with nivolumab, ipilimumab or dummy drug.

You have a CT scan or MRI scan every 3 months for 6 months. You then have a CT scan or MRI scan every 6 months. This continues for as long as you don’t have signs of the cancer coming back.

When you finish treatment, you see the doctor after 1 and 3 months. You have blood tests and a physical examination. You then see or speak with the trial team every 3 months.

Side effects

The trial team monitor you while you are having treatment and between treatments. They will give you a phone number to call them if you are worried about anything.

The team will tell you about all the possible side effects before you start the trial.

The most common side effects of nivolumab are: