A trial looking at spartalizumab in combination with other treatments for 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 trial is for people whose melanoma is getting worse despite standard of care treatment. 

It is open to people whose melanoma can’t be removed with surgery or has spread elsewhere in the body.  

This is called advanced melanoma.

More about this trial

You might have 2 drugs called nivolumab or pembrolizumab for melanoma skin cancer that has spread. These are usual treatments but sometimes they stop working. So, researchers are looking for new treatments. This trial, looks at whether adding other drugs to spartalizumab improves treatment outcomes. 
 
Spartalizumab (PDR001) is a an immunotherapy that works in a similar way to nivolumab and pembrolizumab. So, you’ll have spartalizumab with 1 of the following:
  • LAG525 
  • capmatinib 
  • canakinumab 
As well as the above treatments, other newer treatments might be added. The trial team can tell you more about this.  
 
LAG525 is also a type of immunotherapy. These drugs work in slightly different ways to help the immune system Open a glossary item to attack the cancer and stop it from growing.
 
Capmatinib is a targeted drug called a cancer growth blocker. It blocks a protein called c-MET. It stops signals that the cancer cells use to divide and grow.
 
Canakinumab is a drug that helps people with inflammatory conditions by reducing inflammation. In a recent trial of people with heart problems, there was some evidence that it might slow the growth of certain cancers. The trial team think it might help people with advanced melanoma. But they want to find out more. 
 
The main aims of the trial are to:
  • see which treatment combination works best 
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your trial 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: 
  • you have melanoma that can’t be removed with surgery, has spread to nearby lymph nodes Open a glossary item or elsewhere in the body (stage 3B to stage 4)
  • the melanoma spread happened in the past 3 months 
And you have had treatment as follows: 
  • nivolumab or a similar drug in combination with another drug such as pembrolizumab that has stopped working if you don’t have a change in the BRAF gene in your melanoma cells 
or 
  • nivolumab or a similar drug in combination with another drug such as pembrolizumab, treatment with a BRAF inhibitor such as dabrafenib on its own or with a MEK inhibitor such as trametinib if you have a change in a gene called BRAF in your melanoma cells 
As well as the above, the following must also apply. 
 
You:
  • had your last dose of nivolumab, pembrolizumab or a similar drug more than 4 weeks ago and for dabrafenib, trametinib or a similar drug more than 2 weeks ago
  • have at least 1 area of cancer that doctors can measure on a scan
  • have an area of melanoma that the doctors can take a sample from 
  • are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • have satisfactory blood test results  
  • are willing to use reliable contraception during treatment and for 150 days afterwards if you are a woman and 7 days afterwards if you are a man if there is any chance you or your partner could become pregnant 
  • are at least 18 years old 
Who can’t take part
 
You cannot join this trial if the following apply. 
 
Cancer related
You can’t take part if you:
  • have uveal or mucosal melanoma
  • have already had treatment for advanced melanoma that reached your whole body (systemic treatment) apart from drugs such as nivolumab, pembrolizumab, trametinib or dabrafenib
  • have a melanoma of the eye or a rare type of melanoma called mucosal melanoma 
  • have cancer that has spread to the brain unless it has been successfully treated with stereotactic radiotherapy Open a glossary item, surgery or gamma knife therapy Open a glossary item 
  • have had any other cancer in the last 3 years apart from basal cell skin cancer Open a glossary item or squamous cell skin cancer Open a glossary item, that has been successfully treated  
  • have side effects from past treatments that haven’t got better unless they are mild 
Medical conditions
You can’t take part if you: 
  • are having steroid treatment that is more than 10mg per day, apart from nose sprays, inhalers, creams or eye drops
  • have an auto immune disease Open a glossary item or the doctors suspect you have one apart from vitiligo, diabetes type 1 on stable insulin, you are having hormone replacement for a thyroid problem or you have psoriasis that doesn’t need treatment
  • have had a heart problem such as a heart attack or you have inflammation of the heart muscle (myocarditis)
  • have had a stem cell transplant with someone else’s cells (allogeneic transplant Open a glossary item) or an organ transplant such as a liver or kidney
  • an active infection that needs treatment 
  • have had a live vaccination in the last 3 months
  • are allergic to or sensitive to any of the drugs in the trial
  • have a lung condition called interstitial lung disease or pneumonitis
  • have HIV
  • have an active hepatitis B infection or you have hepatitis C
  • have any other medical condition or mental health problem that the trial team think would affect you taking part
Other 
You can’t take part if you:
  • are pregnant or breastfeeding 
As well as the above, for people having capmatinib in combination with spartalizumab the following can’t apply. 
 
You:
  • have certain heart problems such as a heart attack or any heart problems that are picked up when you have tests to enter the trial 
  • have a problem with your digestive system Open a glossary item such as uncontrolled sickness or diarrhoea that means you can’t absorb the drug properly
  • are taking medication that blocks an enzyme called CYP3A4 unless the medication can be changed or stopped

Trial design

This is a phase 2 trial. It is taking place worldwide. The researchers need 185 people to take part including 24 from the UK.
 
It is a randomised trial. You are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 
 
You have 1 of the following treatment combinations:
  • spartalizumab and LAG525 (group 1)
  • spartalizumab and capmatinib (group 2)
  • spartalizumab and canakinumab (group 3) 

Other newer drugs might be added as they become available. But the trial team can tell you more about this. 
 
You have treatment in cycles. Each 4 week period is called a cycle of treatment.  
 
Spartalizumab and LAG525 (group 1)
You have spartalizumab as a drip into a vein. You have it once every 4 weeks. It takes about 30 minutes each time. 
 
You have LAG525 as a drip into a vein. You have it once every 4 weeks on the same day as spartalizumab. It takes about 30 minutes each time. 
 
Spartalizumab and capmatinib (group 2)
You have spartalizumab as a drip into a vein. You have it once every 4 weeks. 
 
Capmatinib is a tablet. You take the tablets twice a day, every day. The trial team will give you a fresh supply of tablets each month. 
 
Spartalizumab and canakinumab (group 3)
You have spartalizumab as a drip into a vein. You have it once every 4 weeks.
 
Canakinumab is an injection you have under the skin. You have 2 injections into the fat of the thigh or tummy (abdomen). You have them once every 4 weeks on the same day you have spartalizumab.
 
Everyone has treatment for as long as it is working and the side effects aren’t too bad. You stop treatment if your melanoma gets worse. Your doctor will discuss other treatment options with you.
 
Samples for research
You give some extra blood and tissue samples during treatment. You give these at specific times and the trial team will give you more information about this. They plan to use the samples to:
  • see how well the treatment is working
  • find out what happens to the drugs in the body
  • look for biomarkers Open a glossary item to predict who will benefit from treatment
  • look at genes Open a glossary item to help understand more about melanoma 
The doctors will ask permission to collect and store some of your blood and a sample of your cancer (a tissue sample). This is for future research. Researchers will use them to understand more about this treatment and how it works. You don’t have to agree to this if you don’t want to. 

Hospital visits

You see a doctor and have some tests before you can take part. These include:
  • physical examination
  • blood samples
  • urine sample
  • heart trace Open a glossary item (ECG)
  • giving a tissue sample (biopsy Open a glossary item)
  • CT scan or MRI scan
The trial team will take photographs of any unusual looking marks or lesions on your skin.
 
People having capmatinib tablets take these at home. You have all other treatment at the hospital on the day ward. 
 
You will have about 3 hospital visits in the first month of treatment. After that you go to hospital once a month for treatment and a check up. 
 
You have a CT or MRI scan:
  • at 12 weeks
  • every 2 months until your melanoma starts to grow again 
Follow up
After your last treatment you have follow up visits once a month for 6 months. After that the trial doctor or nurse will call you every 3 months to see how you are. 

Side effects

As this trial is looking at new drugs and combinations of treatment, there may be some side effects we don’t know about yet. The trial 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. 
 
Spartalizumab is an immunotherapy drug. This treatment affects the immune system. This may cause inflammation in different parts of the body such as the lung or bowels. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
 
The most common symptoms include:
  • skin rash
  • diarrhoea or constipation
  • tummy pain 
  • shortness of breath 
  • loss of appetite
  • high temperature (fever)
The most common side effects of LAG525 in combination with spartalizumab include:
The most common possible side effects of capmatinib in combination with spartalizumab include:
  • swelling of certain parts of the body
  • kidney problems
  • tiredness 
  • feeling or being sick
  • skin rash or itchy skin 
  • liver problems
  • tummy pain
  • loss of appetite
The most common side effects of canakinumab in combination with spartalizumab include:
  • tiredness 
  • loss of appetite
The trial team will go through all the possible side effects before you join the trial. 

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.

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Paul Nathan

Supported by

Novartis

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15963

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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