A study of nivolumab for cancer that has spread (CA209358 Metastatic group)

Cancer type:

Cervical cancer
Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasopharyngeal cancer
Non melanoma skin cancer
Pharyngeal cancer
Skin cancer
Squamous cell skin cancer
Stomach cancer
Vaginal cancer
Vulval cancer

Status:

Open

Phase:

Phase 1/2

This study is to find what effect nivolumab has on certain cancers that have spread to another part of the body or came back after treatment.  

There are 2 groups in this study

  • people who are having other anti cancer treatment (the Neo adjuvant group)
  • people whose cancer has spread (the Metastatic group)

This summary is for the Metastatic group. We have information for the Neo adjuvant group.

More about this trial

In this the Metastatic group researchers are looking at giving nivolumab only and in combination with ipilimumab.

Nivolumab is a type of biological therapy called a monoclonal antibody. It works by triggering the immune system Open a glossary item to attack and kill cancer cells. 

We know from research that nivolumab works for people who have melanoma that has spread and some types of lung cancer. 

Ipilimumab is also a monoclonal antibody that works in the same way as nivolumab. It is used to treat melanoma that has spread.

Researchers think that combining nivolumab with ipilimumab might be better for certain cancers than nivolumab only. 

In this study they want to look at 

  • merkel cell skin cancer
  • cervical cancer
  • vulval cancer
  • vaginal cancer 
  • mouth cancer
  • laryngeal cancer
  • pharyngeal cancer
  • stomach (gastric) cancer
  • gastro oesophageal junction cancer

The main aims of this study are to find

  • how well nivolumab works for these cancers
  • how well the combination of nivolumab and ipilimumab works for these cancers
  • how safe nivolumab and the combination is 
  • how well people cope with nivolulmab and the combination

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. 

You may be able to join this study if you have one of the following

Or you have a squamous cell cancer Open a glossary item of one of the following

And 

  • Following previous treatment your cancer has either spread to another part of your body or come back 
  • You have had no more than 2 different types of treatment for your cancer that has come back or spread
  • You have an area of cancer that can be measured on a scan Open a glossary item
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1
  • You must be willing to use reliable contraception during treatment and for up to 31 weeks afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this study if any of these apply. 

  • You have cancer that has spread to the brain unless it has been treated, an MRI scan Open a glossary item shows it hasn’t got worse in the past 4 weeks and within 28 days of starting treatment in the study and you aren’t taking more than 10 mg of steroids for at least 2 weeks before starting treatment
  • Your cancer or an affected lymph node Open a glossary item is attached to the main blood vessel in the neck, the part of the spine in the neck or at the base of the skull 
  • You have had any cancer treatment including as part of a clinical trial in the past 4 weeks
  • You have been treated with an anti cancer vaccine as part of a clinical trial
  • You still have moderate to severe side effects from any treatment, apart from hair loss and tiredness
  • You have had a cancer in the past 3 years apart from successfully treated early cancers Open a glossary item
  • You have an autoimmune disease Open a glossary item apart from conditions that you have hormone replacement for such as vitiligo, diabetes or underactive thyroid or any condition that isn’t expected to come back 
  • You are taking medication that reaches your whole body, such as steroids, that affect how your immune system Open a glossary item works
  • You have HIV, hepatitis B or hepatitis C
  • You are allergic to nivolumab or any of its ingredients
  • You have had a severe allergic reaction to any monoclonal antibody 
  • You are pregnant or breastfeeding

Trial design

This is an international phase 1/2 study. The team need 415 people to join the Metastatic group.

You are put into 1 of 3 treatment groups depending on your cancer type. Your doctor will talk to you about which group you are in. The 3 groups are:

  • nivolumab only
  • nivolumab and ipilimumab
  • 4 treatments of nivolumab and ipilimumab followed by nivolumab only

You have nivolumab as an injection into a vein every 2 weeks.

You have ipilimumab as an injection into a vein every 6 weeks or 3 weeks if you are having the 4 treatments only.  

You continue to have treatment as long as it is helping and the side effects aren’t too bad. 

Quality of life 
The researchers will ask you to fill out a questionnaire 

  • when you start nivolumab
  • every 8 weeks for 8 months
  • then every 3 months while having treatment
  • 1 month after finishing treatment
  • 2 months after
  • then every 3 months

The questionnaires will ask about how you have being feeling and any side effects. This is a quality of life study

Tissue and blood samples
The study team will ask for a sample of tissue that was removed when you had surgery or a biopsy Open a glossary item. They will take another sample of tissue (biopsy) around week 5. 

They will also ask for extra blood samples. They will use these to look for substances (biomarkers Open a glossary item) in the blood that might tell them how well nivolumab is working

Hospital visits

You see the doctor to have tests before taking part in this study. These tests include

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • A scan Open a glossary item such as a CT scan or MRI scan

During treatment you see the doctor every 2 weeks for a physical examination and blood tests. You have a scan every 8 weeks for a year and then 12 weeks until your cancer starts to get worse. 

After stopping treatment you see the doctor at

  • 1 month 
  • 2 months
  • Then every 3 months

Side effects

The most common side effects of nivolumab are 

The most common side effects of ipilimumab are

  • diarrhoea or constipation
  • swelling, tenderness and irritation of the bowel (colitis) 
  • raised level of liver enzymes Open a glossary item
  • tiredness
  • skin rash or itchy skin 
  • feeling or being sick
  • high temperatures
  • tummy pain
  • headache 
  • problems with the adrenal glands Open a glossary item or pituitary gland Open a glossary item

We have more information about nivolumab and ipilimumab

Your doctor will talk to you about the side effects before you agree to take part. 

Location

Birmingham
Glasgow
London

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

Professor Jeff Evans

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14152

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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