A study of relatlimab and nivolumab for certain types of advanced cancer (CA224020)

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

Cancer type:

Melanoma
Secondary cancers

Status:

Closed

Phase:

Phase 1/2

This study is looking at a new drug called relatlimab to see how well it works alongside nivolumab for certain types of advanced cancer. It is for people whose cancer has spread elsewhere in the body and/or it can’t be removed by surgery.

More about this trial

Researchers are looking for new ways to treat people with advanced solid tumours Open a glossary item when standard treatments have stopped working. In this study, they are looking at nivolumab and relatlimab.
 
Nivolumab and relatlimab (also called BMS986106) are both types of monoclonal antibody drugs. They work on the immune system and are also called immunotherapies. They work in slightly different ways to trigger the immune system to attack and kill cancer cells. 
 
We know from research that nivolumab works for several different types of cancers. Researchers think that adding relatlimab to nivolumab will work better for certain cancer types than nivolumab alone. But they aren’t sure, so want to find out more. 
 
The study was open to people with a number of different types of cancer. Currently, it is only open to people who have advanced melanoma skin cancer.
The main aims of the study are to find out:
  • how well treatment works 
  • how safe it is 
  • 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
You can take part in this study if all of the following apply. You:
  • have advanced melanoma cancer skin cancer
  • have not received anticancer therapy yet for your melanoma cancer
  • have cancer that has spread elsewhere in the body and/or can’t be removed with surgery
  • have a solid tumour that the doctors can’t treat with the aim to cure
  • have at least 1 area of cancer that the doctor can see on a scan 
  • are willing to give a new tissue sample (biopsy Open a glossary item) for the study team to do some tests on
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • are willing to use reliable contraception during treatment and for up to 24 weeks if there is any chance you could become pregnant or up 33 weeks if your partner could become pregnant
  • are at least 18 years old (although for melanoma, some teenagers might be able to join)
Who can’t take part
You cannot join this study if any of these apply. 
 
Cancer related 
You:
  • have melanoma of the eye (uveal melanoma)
  • have cancer that has spread to the brain unless it has been treated, an MRI scan shows it hasn’t got worse within 28 days of starting treatment in the study and you haven’t taken steroids for least 2 weeks before starting treatment
  • have had radiotherapy for symptoms or a type of radiotherapy called gamma knife surgery in the 2 weeks before starting treatment
  • have had chemotherapy in the last 4 weeks or it hasn’t completely cleared your body or you have had growth factors Open a glossary item
  • have had another cancer in the last 3 years apart from some very early cancers that have been successfully treated
  • have had any serious side effects from past treatment with monoclonal antibodies such as nivolumab or similar drugs
  • have had treatment with relatlimab or a similar drug in the past
Medical conditions
You:
  • have an autoimmune disease Open a glossary item unless it is vitiligo, type 1 diabetes, hair loss, thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment or any condition that isn’t expected to come back
  • need to have extra oxygen every day
  • have problems with your heart, such as a heart attack or stroke in the last 6 months, angina that is not well controlled in the last 3 months, an abnormal heart rhythm that is serious, QTc prolongation, congestive heart failure, a heart artery bypass operation or any other serious heart condition
  • have had inflammation of the tissues around the brain or uncontrolled fits (seizures)
  • have HIV
  • have hepatis B or hepatitis C
  • have an active infection that needs treatment 
  • have had steroid treatment that is 10mg per day or more in the 2 weeks before starting study treatment 
  • have had major surgery in the last 2 weeks
  • have any other medical condition or mental health problem that could affect you taking part
Other
You:
  • are pregnant or breastfeeding 
  • have had a live vaccination Open a glossary item in the last 2 weeks

Trial design

This phase 1/2 study is taking place worldwide. Between 260 and 450 people will take part including 60 people from the UK. 
 
Everyone has relatlimab and nivolumab. You have treatment once every 4 weeks 
 
You have all treatment as a drip into a vein. You have treatment in cycles. Each period of treatment is 8 weeks.  There is no limit to the number of cycles you can have. 
 
You will continue to have treatment if it’s working and the side effects aren’t too bad. 
 
Research samples
You give some extra blood and tissue 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 
  • find what happens to the drugs in the body
  • look at genes Open a glossary item to help understand more about your cancer type
  • look for biomarkers Open a glossary item to predict who will benefit from treatment 
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 do not have to agree to give these samples 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 in the study. These include: 
  • a physical examination
  • having a tissue sample (a biopsy Open a glossary item)
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • chest x-ray
  • CT scan or MRI scan
You might also have a bone scan.
 
You have your treatment in the hospital outpatient department. You shouldn’t need to stay overnight.
 
After your last treatment, you have follow up visits at:
  • 1 month 
  • 2 months 
  • 4 months
The study team may contact you by phone in between these visits to see how you are getting on. And to check if you have started any new cancer treatments. They will continue to follow you up every 3 months for up to 5 years. 
 
You have a CT or MRI scan every 3 months if the cancer goes away or gets a bit smaller. You might be able to continue treatment even if your cancer gets worse while you are having treatment. You might continue treatment if your cancer goes away completely. The study team can tell you more about this. 
 

Side effects

Relatlimab is a new drug, so there might be side effects we don’t know about yet. Only a very few people have had this drug so far. The study team will give you a phone number to call them if you are worried about anything. The most common side effects include:
  • tiredness (fatigue)
  • dizziness
  • cough
  • a drop in the number of red blood cells (anaemia)
  • diarrhoea 
  • high temperatures (fever)
  • loss of appetite or weight loss
  • dry mouth
  • headache
  • skin rash or itchy skin
  • muscle pain, back pain or pain in the hands or feet 
  • feeling or being sick
  • tummy pain
  • difficulty breathing 
  • urine infections
The most common side effects of having the combination of nivolumab and relatlimab include:
  • tiredness
  • feeling sick
  • diarrhoea
We have more information about nivolumab.
 

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 James Larkin

Supported by

Bristol-Myers Squibb

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15385

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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