A trial of nivolumab for diffuse large B cell lymphoma (CA209139)

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

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called nivolumab for people with diffuse large B cell lymphoma (DLBCL). It is for people whose lymphoma has come back or is no longer responding to treatment.

Diffuse large B cell lymphoma (DLBCL) is a type of non Hodgkin lymphoma. It is the most common type of high grade non Hodgkin lymphoma.

Doctors usually treat DLBCL with a combination of chemotherapy called CHOP and a drug called rituximab.This treatment is called R-CHOP. Some people with high grade non Hodgkin lymphoma may have high dose chemotherapy Open a glossary item and a stem cell transplant instead.

But sometimes DLBCL does not go away, or comes back after treatment. So doctors are looking for new treatments for people in this situation. In this trial researchers are looking at a drug called nivolumab.

Nivolumab is a type of drug called 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 diffuse large B cell 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 diffuse large B cell lymphoma that has continued to get worse despite treatment or has come back after treatment, or your lymphoma has changed (transformed) from low grade into high grade lymphoma
Have had high dose chemotherapy and a stem cell transplant with your own stem cells or if this wasn’t a suitable treatment for you, your lymphoma came back or stopped responding to treatment after at least 2 different types of chemotherapy
Have at least one area of lymphoma that can be seen on a scan and measures more than 1½ cm across
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
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 a lung condition called interstitial lung disease
Have an autoimmune disease
Need to have steroids for some reason
Are allergic to the study drug or to other monoclonal antibodies
Have had a stem cell transplant with your own stem cells in the last 3 months
Have had a stem cell transplant with donor cells in the past
Have had major surgery or chemotherapy in the last 2 weeks
Have had a type of drug called a nitrosourea 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
Had a high dose of a chemotherapy drug called carmustine before your stem cell transplant (your doctor can advise you about this)
Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated
Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
Are hepatitis B, hepatitis C or HIV positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 120 people to join. Everybody taking part will have nivolumab.

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

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

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 some blood tests before having nivolumab. 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
Every 3 months after that

Side effects

The most common side effects of nivolumab include

Tiredness (fatigue)
Dry, itchy skin, redness or 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