A trial looking at nivolumab for mesothelioma (CONFIRM)

Cancer type:

Mesothelioma

Status:

Open

Phase:

Phase 3

This trial is looking at nivolumab to treat mesothelioma that has come back after chemotherapy treatment (relapsed).

Cancer Research UK supports this trial. 

More about this trial

Doctors treat mesothelioma with chemotherapy. After chemotherapy if the mesothelioma comes back the aim is to control symptoms. This is called active symptom control.

Researchers want to find out if nivolumab can help these people.

Nivolumab is a type of immunotherapy drug called a monoclonal antibody. It works by stimulating the body’s immune system Open a glossary item to recognise and kill cancer cells.

We know from research that nivolumab could help people whose mesothelioma has come back after chemotherapy. But it isn’t known if it as good as active symptom control.

In this trial most people will have nivolumab and some will have a dummy drug (placebo Open a glossary item).

The main aims of the trial are to find:

  • how well nivolumab works for people whose mesothelioma has come back after chemotherapy
  • how safe it is
  • how it affects quality of life Open a glossary item

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply.

  • You have mesothelioma that has come back after chemotherapy treatment
  • You have had treatment with at least 2 different courses of chemotherapy
  • You have had a CT scan Open a glossary item that shows your mesothelioma is getting worse
  • Your mesothelioma can be measured on a scan
  • You are willing to provide a sample of tissue and blood for the trial
  • You have satisfactory blood test results
  • You are able to take care of yourself (performance status 0 or 1)
  • You are willing to use 2 forms of reliable contraception during treatment and for 7 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply.

Cancer related

  • Your mesothelioma has spread to your brain or spinal cord unless this has been treated and you haven’t had any symptoms for at least 2 weeks of being put into your treatment group for this trial (randomisation). If you are taking steroids you must be taking 10 mg or less, or be on a decreasing dose of 10 mg or less at least 2 weeks before starting treatment
  • Your mesothelioma has spread to the lining of your brain (carcinomatous meningitis)
  • You have had radiotherapy to relieve cancer symptoms (palliative radiotherapy) within 2 weeks of starting treatment
  • You have had any cancer treatment such as chemotherapy, surgery and radiotherapy within 4 weeks of starting treatment
  • You have another cancer that needs treatment during the trial
  • You have had another cancer unless it has been successfully treated and there has been no sign of it for at least 2 years apart from non melanoma skin cancer Open a glossary item and some in situ cancers Open a glossary item
  • You have had treatment that works in a similar way to nivolumab for example ipilimumab or you have taken part in another trial of nivolumab or ipilimumab

Medical conditions

  • You still have side effects of any cancer treatment apart from hair loss and tiredness (fatigue)
  • You have, or might have, an autoimmune disease Open a glossary item apart from type 1 diabetes, too little thyroid hormones made by the thyroid gland (hypothyroidism) that needs hormone replacement, a skin condition called psoriasis that doesn’t need treatment that reaches the whole body (systemic treatment) or any other condition that your doctor doesn’t expect to return
  • You are taking more than 10mg a day of steroids apart from creams and inhalers or as a replacement for an adrenal gland that isn’t working
  • You are taking any other medications that affect the immune system within 2 weeks of starting treatment
  • You had major surgery or an injury and have not fully recovered within 2 weeks of starting treatment
  • You have an infection that needs treatment
  • You have another medical condition that the trial team think could affect you taking part in the trial
  • You have HIV, AIDS, hepatitis B or hepatitis C

Other

  • You are allergic to nivolumab or similar drugs (monoclonal antibodies)
  • You have a problem with alcohol or drugs
  • You are pregnant or breastfeeding

Trial design

This a phase 3 trial. The researchers need 336 people to join.  

It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you or your doctor can choose which group you are in. And neither you or your doctor will know which group you are in. This is called a double blinded trial. The groups are:

  • nivolumab
  • a dummy drug (placebo Open a glossary item)

2 out of 3 people will be in the nivolumab group. 

CONFIRM Trial Diagram

You have nivolumab, or the dummy drug, as a drip into a vein every 2 weeks. You have it over 30 minutes.

You continue treatment for up to a year unless the side effects are too bad or the mesothelioma comes back.

Quality of life
You fill in a questionnaire when you agree to take part and again when you start treatment and then during treatment at:

  • 6 weeks
  • 12 weeks

Then when you finish treatment you complete a questionnaire after:

  • 1 month
  • 6 months
  • 1 year

The questions ask about how you feel and any side effects you might have. This is called a quality of life questionnaire.

Samples
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. You will need to have a biopsy if this isn’t available.

Blood samples for the trial will be taken when you have blood tests as part of your routine care.

Hospital visits

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

  • a physical examination
  • blood tests
  • CT scan

During treatment you see the doctor every 2 weeks for a physical examination and blood tests. You have a CT scan at 6 and 12 weeks.

A month after finishing treatment you see the doctor to see how you are and for blood tests. Women will continue to see the doctor every 4 weeks for 5 months to have a pregnancy test.

You are followed up by a member of the trial team every 3 months. This could be by phone.

Your doctor will tell you how often they want to see you.

Side effects

The most common side effects of nivolumab are:

Your doctor will talk to you about the side effects of nivolumab.

We have more information on nivolumab

Location

Aberdeen
Bournemouth
Cardiff
Glasgow
Harrogate
Lancaster
Leicester
Manchester
Southampton

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 Dean Fennell

Supported by

Cancer Research UK
Southampton Clinical Trials Unit
University of Southampton

Other information

This is Cancer Research UK trial number CRUK/16/022.

We have more information on Professor Dean Fennell.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14672

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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