A trial of nivolumab for Hodgkin lymphoma (CA209205)

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

Cancer type:

Hodgkin lymphoma
Lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called nivolumab for the treatment of Hodgkin lymphoma. It is for people who have Hodgkin lymphoma that has come back after a stem cell transplant using their own cells (autologous stem cell transplant).

Doctors can treat Hodgkin lymphoma with a stem cell transplant. Unfortunately Hodgkin lymphoma sometimes comes back after a transplant. Researchers are looking for new treatments to help people in this situation. In this trial they are looking at a drug called nivolumab.

Nivolumab is a type of biological therapy called a monoclonal antibody. It may help your immune system to look for and stop the lymphoma cells affecting your immune system.

The aims of this trial are to find out

  • How well nivolumab works for people who have Hodgkin lymphoma that has come back after having a stem cell transplant using their own cells
  • What effect nivolumab has on the immune system
  • More about the side effects of nivolumab

Who can enter

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

  • Have classical Hodgkin lymphoma
  • Have had high dose chemotherapy followed by a transplant of your own stem cells (autologous stem cell transplant) and your lymphoma continued to get worse during treatment or came back afterwards
  • Had your stem cell transplant more than 3 months ago
  • Have an area of lymphoma that can be seen on a scan and measures at least 15mm in diameter
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are willing to use reliable contraception during treatment and for 8 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

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

  • Have had a drug called brentuximab vedotin before you had your stem cell transplant using your own cells (your doctor can tell you this)
  • Have lymphoma that has spread to your brain or spinal cord
  • Have a type of Hodgkin lymphoma called nodular lymphocyte predominant type
  • Have had a stem cell transplant using cells from a donor
  • Have had major surgery in the last 2 weeks
  • Have had chemotherapy in the last 4 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 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 severe lung damage caused by previous treatment with chemotherapy or radiotherapy (the trial team will test for this)
  • Have a lung condition called interstitial lung disease
  • Have had another cancer in the last 3 years apart from some early cancers that have been successfully treated (the trial team can advise you about this)
  • Have an autoimmune disease
  • Are taking medication that dampens down your immune system apart from a low dose of steroids, inhalers or creams
  • Have HIV, hepatitis B or hepatitis C
  • Are allergic to nivolumab or any other monoclonal antibody
  • Are pregnant or breastfeeding

Trial design

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

You have nivolumab as an injection into a vein every 2 weeks. It usually takes about an hour. You continue having nivolumab 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.

At the beginning of the trial, the researchers will ask for a sample of your lymphoma that was removed when you had surgery or a biopsy. If you haven’t had a biopsy before you must agree to have one done to take part in this trial.

They will also ask for extra blood samples to look for substances in your blood (biomarkers) that may tell how well nivolumab is working.

You will also have CT and PET scans during treatment to see if your lymphoma is responding or not.

Hospital visits

You will see the trial doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • Bone marrow test if needed
  • Urine test
  • Tests to see how well your lungs are working (lung function tests)
  • A test to see how well your thyroid gland works
  • CT scan or MRI scan
  • PET scan

You see the doctor every 2 weeks to have treatment. You have a check up and blood tests before each treatment. You have a CT scan or MRI scan every 3 months for a year, then every 4 months for another year and then every 6 months until your lymphoma gets worse. You have a PET scan at 4 months and 6 months. You may have another PET scan at 11 months if any lymphoma is still there.

When you finish treatment, you see the trial doctor and have

  • A physical examination
  • Blood tests
  • A test to see how well your thyroid gland works

You then see the doctor every 3 months for a check up until your lymphoma comes back. Afterwards a member of the trial team will telephone you regularly to see how you are.

Side effects

The most common side effects of nivolumab include

Your doctor will talk to you about all the possible side effects before you agree to take part in this trial.

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 John Radford

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 12477

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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