A trial of nivolumab for follicular lymphoma (CA209140)

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

Cancer type:

Blood cancers

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called nivolumab for people with follicular lymphoma. It is for people whose lymphoma has come back or is no longer responding to treatment.

More about this trial

Follicular lymphoma is a type of non Hodgkin lymphoma (NHL). Doctors usually treat follicular lymphoma with chemotherapy and a monoclonal antibody drug called rituximab. But sometimes treatment can stop working and the lymphoma can come back. So doctors are looking for new treatments for people in this situation. In this trial, they are looking at a drug called nivolumab.

Nivolumab is also a monoclonal antibody. It may help the body’s immune system to attack lymphoma cells.

The aims of the trial are to find out

How well nivolumab works for people with follicular lymphoma
More about the side effects

Who can enter

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

You have follicular lymphoma that is grade 1, 2 or 3a
You have had at least 2 different types of treatment for follicular lymphoma in the past that included a drug called rituximab and chemotherapy
Your lymphoma did not respond to treatment or came back after treatment
You have at least one area of lymphoma that can be seen on a scan and measures at least 1½ cm across
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
You have satisfactory blood test results
You are at least 18 years old
You are willing to use 2 different types of reliable contraception during treatment and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant

You cannot join this trial if any of these apply. You

Have lymphoma that has spread to your brain or spinal cord
Have lymphoma that has changed from a low grade lymphoma to a high grade lymphoma
Have a lung condition called interstitial lung disease
Have an autoimmune disease
Have had a stem cell transplant in the past
Need to have steroid treatment for some reason
Are allergic to the study drug or to other monoclonal antibodies
Have had major surgery or chemotherapy in the last 2 weeks
Have had a type of drug called a nitrosurea in the last 6 weeks, or drugs called immunoconjugates in the last 2½ months (your doctor can advise you about this)
Have had certain other drugs that help your immune system to attack your cancer cells (the trial team can advise you about this)
Have had a monoclonal antibody in the last 4 weeks
Have had radiotherapy to your chest in the last 6 months, or radiotherapy to other parts of your body in the last 3 weeks
Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated
Are hepatitis B, hepatitis C or HIV positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 90 people. Everybody taking part will have nivolumab.

For this trial, the researchers need a piece of bone marrow Open a glossary item taken when you had a bone marrow test. If this isn’t available then you’ll need to have another bone marrow test. You must agree to this to take part in this trial.

You have nivolumab every 2 weeks through a drip into a vein. It takes an hour each time. You can continue to have treatment as long as it is helping you and the side effects aren’t too bad.

The trial team will ask you to fill out a questionnaire before you start treatment and at regular times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You will see the doctor and have some tests before you start treatment. The tests include

A physical examination
Heart trace (ECG )
Blood tests
Urine tests
Bone marrow test
CT scan or MRI scan
PET scan

Every 2 weeks you see the doctor for a checkup and have some blood tests. You have a CT or MRI scan every 2 months.

You see the trial doctor for a checkup, have blood tests and a CT or MRI scan 4 weeks after you finish treatment. After that, the trial team may see you every 3 months at your routine hospital appointments or they may phone you at home to see how you are getting on.

Side effects

The most common side effects of nivolumab include

Tiredness (fatigue)
Dry, itchy skin, redness, a rash
Diarrhoea
Feeling or being sick
Loss of appetite
A drop in blood cells causing an increased risk of infection, bruising or bleeding
High temperature (fever)
Stomach pain
Stiff or painful joints