"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of nivolumab for advanced melanoma that has got worse despite other treatments (CA209037)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called nivolumab (also known as BMS-936558) for melanoma that can’t be removed with surgery, or has spread to another part of the body and is getting worse despite having other treatments.
If melanoma can’t be removed with surgery or has spread to another part of your body, it is called advanced melanoma. Doctors can treat advanced melanoma with chemotherapy or biological therapy. But melanoma may continue to grow despite having these treatments and researchers are looking for ways to help people in this situation.
In this trial, they are looking at a drug called nivolumab and comparing it with chemotherapy drugs that doctors already use to treat advanced melanoma.
People taking part in this trial have melanoma that has got worse since having treatment with a drug called ipilimumab or another drug that works in the same way. If their melanoma has a certain change to a gene called BRAF, they must have also had a drug called a BRAF inhibitor such as vemurafenib or dabrafenib.
The aims of the trial are to
- See if nivolumab helps people with advanced melanoma more than chemotherapy
- Learn more about the side effects
Who can enter
You may be able to enter this trial if
- You have melanoma that has spread into
lymph nodesand can’t be removed with surgery or has spread to another part of your body
- Your melanoma can be measured on a scan and the trial team know whether the BRAF gene is normal or changed
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- There is a sample of your melanoma available for the researchers to study
- You finished any chemotherapy or
immunotherapyat least 4 weeks ago and have recovered from side effects
- You finished having ipilimumab at least 6 weeks ago
- You have satisfactory blood test results
- You are willing to use reliable contraception during the trial and some months afterwards if there is any chance you or your partner could become pregnant – the trial team will give you more information about this
As well as the above, your melanoma must have got worse despite having at least 2 other treatments for advanced melanoma.
- If your melanoma has a normal BRAF gene, one of the treatments must have been ipilimumab or another drug that works in the same way. If you had this after surgery to remove melanoma to try to stop it coming back, but your melanoma did come back within 6 months, this can be counted as 1 of the 2 treatments
- If your melanoma has a particular change to the BRAF gene, you must have had ipilimumab (or similar drug) and a drug called a BRAF inhibitor such as vemurafenib or dabrafenib. If you had either of these after surgery to remove melanoma to try to stop it coming back, but your melanoma did come back within 6 months, this can be counted as 1 of the 2 treatments
You cannot enter this trial if you
- Have melanoma of the eye (ocular melanoma)
- Have melanoma that has spread to your brain or spinal cord unless it has been treated, has not got any worse in the last 8 weeks and if you take steroids, you have been on a low dose for at least 2 weeks
- Have taken part in another trial of nivolumab (BMS-936558)
- Have already had dacarbazine and carboplatin with paclitaxel (you can take part if you have had just one of these treatments)
- Have an
- Have had a very bad reaction to ipilimumab or a similar drug
- Have had radiotherapy in the last 2 weeks
- Have had another drug that works in a similar way to nivolumab (the trial team can advise you about this)
- Need to have surgery in the very near future
- Have any other medical condition that the trial team think would make it unsafe for you to take part
- Have had any other cancer, apart from non melanoma skin cancer, cancer of the breast, bladder, stomach, bowel or cervix if it was a very early stage (
cancer in situ), or any other cancer that was successfully treated at least 2 years ago and your doctors don’t expect you to need any more treatment for it during this trial
This international phase 3 trial will recruit about 390 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. There will be twice as many people in group A as there are in group B.
- People in group A have nivolumab
- People in group B have either dacarbazine or carboplatin and paclitaxel
If you are in group B, your doctor will decide which of the 2 chemotherapy treatments is best for you.
You have all the drugs in this trial through a drip into a vein. You have nivolumab once every 2 weeks. You have dacarbazine, or carboplatin and paclitaxel, once every 3 weeks.
As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it helps you.
During treatment, the trial team will ask you to fill out a computerised questionnaire asking about side effects and how you’ve been feeling. This is called a quality of life study.
- People having nivolumab fill out the questionnaires every 4 weeks for the first 6 months and then every 6 weeks after that
- People having chemotherapy fill them out every 3 weeks for the first 6 months and then every 6 weeks after that
You see the trial team and have some tests before you start treatment. The tests include
As well as taking a biopsy, the researchers will also get samples of any tissue removed when you had surgery or a biopsy in the past.
The number of hospital visits you have depends on which group you are in and how long you carry on having treatment for.
During treatment, you see the trial team and have regular blood tests. You have a CT or MRI scan about 9 weeks after your first treatment and then every 6 weeks after that. If you continue to have the trial treatment for longer than a year, you then have a scan once every 3 months.
When you finish treatment, you see the trial team about a month later and again about 3 months after that. The trial team will then want to see how you are every 3 months. It may be possible to do this by phone, but they might want you to have more scans.
As nivolumab is a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects have included
- Tiredness (fatigue)
- Skin reactions such as rash, itching, redness or dry skin
- Feeling sick
- Loss of appetite
- A drop in the number of red blood cells causing tiredness and breathlessness
- High temperature (fever)
The most common side effects of dacarbazine include
- Loss of appetite
- Feeling or being sick
- A drop in the number of white blood cells causing an increased risk of infection
The most common side effects of carboplatin and paclitaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Fever and infections
- Feeling or being sick
- Hair loss
- Numbness and tingling in your hands and feet (peripheral neuropathy)
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.
Professor Ruth Plummer
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)