A study of nivolumab before other treatment for cancer (CA209358 Neo adjuvant 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
Vaginal cancer
Vulval cancer

Status:

Open

Phase:

Phase 1/2

This study is to find out what effect giving nivolumab before surgery or chemotherapy and radiotherapy together (chemoradiotherapy) has on certain cancers.  

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 Neo adjuvant group. We have information for the Metastatic group.

More about this trial

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. 

In this study researchers want to look at 

  • merkel cell skin cancer
  • cervical cancer
  • vulval cancer
  • vaginal cancer 
  • mouth cancer
  • laryngeal cancer
  • pharyngeal cancer

You have nivolumab before having any other treatment for your cancer. 

The main aims of this study are to find

  • how well nivolumab works for these cancers
  • how safe it is
  • how well people cope with the drug

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 a squamous cell cancer Open a glossary item of one of the following

And  

  • Your cancer can be removed by surgery or you are to have chemoradiotherapy 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 a 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 another 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 researchers need 84 people to join the Neo adjuvant group. 

You have nivolumab as an injection into a vein. You have it every 2 weeks. You have a total of 2 doses before starting your other treatment. 

After having nivolumab some people might have surgery to remove their cancer. The researchers will take a sample of tissue from what was removed.
 
People who don't have surgery will have a sample of tissue (biopsy) taken of their cancer.

You might be able to start nivolumab again if your cancer spreads and it can’t be removed by surgery. 

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

  • when you have nivolumab
  • 1 month after 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

Extra blood and tissue samples
The team will ask for extra blood samples. They will use these to look for substances (biomarker Open a glossary item) in the blood that might tell them how well nivolumab is working. 

Another sample of tissue will be asked for if your cancer gets worse or spreads. You don’t have to agree to have this done.

Hospital visits

You see the doctor to have some tests before taking part. These tests include 

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

Before having nivolumab you see the doctor for a physical examination and blood tests. 

After having nivolumab you see the doctor 

  • Before you have surgery or a biopsy taken
  • 1 month after finishing nivolumab
  • 2 months
  • 4 months
  • 8 months
  • 1 year
  • Then every 3 months 

Side effects

The most common side effects of nivolumab are 

We have more information about nivolumab

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:

14117

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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