A trial of nivolumab for Hodgkin lymphoma (ANIMATE)

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

Cancer type:

Blood cancers

Hodgkin lymphoma

Lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at whether nivolumab can improve treatment before a stem cell transplant for people with Hodgkin lymphoma.

More about this trial

Chemotherapy is the usual first treatment for Hodgkin lymphoma. But sometimes the lymphoma comes back (relapses). Or the chemotherapy doesn’t work very well (refractory).

The usual treatment if this happens is to have more chemotherapy. This is called salvage treatment. After salvage treatment you might then have a transplant using your own stem cells. This is an autologous stem cell transplant.

But for some people the salvage treatment doesn’t work well enough. So researchers are looking for ways to improve salvage therapy. In this trial, they are looking at a drug called nivolumab.

Nivolumab is a type of immunotherapy. It stimulates the body’s immune system to fight cancer cells.

This trial is in 2 parts. In part 1, you have salvage chemotherapy as usual. You then have a scan to see how well it worked. Part 2 is for people whose salvage treatment hasn’t worked well enough to have a stem cell transplant. In part 2 you have nivolumab.

The aims of this trial are to:

see how well nivolumab works as a salvage treatment
see the number of people that are suitable to have a stem cell transplant following nivolumab treatment
learn more about the side effects of nivolumab

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.

Who can take part

Part 1 (to register to join the trial)

You may be able to join part 1 of this trial if all of the following apply.

You:

have Hodgkin lymphoma that has come back after your first chemotherapy treatment or it didn’t work very well
are due to have, are having or have had (within 14 days), 2 cycles of chemotherapy as your first or second salvage treatment
are well enough to have a stem cell transplant with your own cells
are willing to use reliable contraception if there is any chance you or your partner could become pregnant
are at least 16 years old

Part 2 (trial treatment)

You might be able to join part 2 and have nivolumab if the following apply.

You:

joined part 1 of this trial
have had 2 cycles of salvage chemotherapy for Hodgkin lymphoma (or 4 cycles of treatment if you had a drug called brentuximab vedotin)
had the salvage chemotherapy but a PET-CT scan showed it didn’t work well enough to go on and have a stem cell transplant
are well enough to have more chemotherapy
are well enough to take part and 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 with nivolumab and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
have satisfactory blood test results

Who can’t take part

Part 1

You cannot join part 1 of this trial if any of these apply.

You:

have a type of Hodgkin lymphoma called nodular lymphocyte Hodgkin lymphoma
have inflammation of the bowel or lung
have an autoimmune condition apart from vitiligo, diabetes, or a problem with your thyroid gland that doesn’t need treatment
are allergic to drugs called monoclonal antibodies
have had surgery within 4 weeks of joining the trial
have had a heart problem such as a heart attack in the last 6 months
have had any other cancer in the last 3 years apart from basal cell skin cancer, squamous cell skin cancer or certain early cancers
have an active hepatitis B or hepatitis C infection
have HIV
are pregnant or breastfeeding

Part 2

You can’t join part 2 and have nivolumab if the following apply.

You:

had salvage chemotherapy and the chemotherapy worked well
had chemotherapy, radiotherapy or steroids of more than 10mg a day within 14 days of having a PET-CT scan
have an active infection that needs treatment
are having treatment to dampen down your immune system apart from creams, nose sprays or low dose steroids
are having or have had an experimental treatment as part of another trial with 28 days of starting nivolumab
have side effects from treatment that haven’t got better apart from hair loss or moderate tiredness
are pregnant or breastfeeding

Trial design

This phase 2 trial is taking place in the UK. The researchers need up to 120 people to join. Of those, they hope to treat about 30 people with nivolumab.

There are 2 parts to this trial:

part 1 is for people having the usual salvage chemotherapy
part 2 is for people whose salvage chemotherapy doesn’t work well enough to have a stem cell transplant

Part 1 (register to join the trial)

In part 1, you have salvage chemotherapy as usual. You then have some scans to see how well it worked. These are the usual scans and include a PET-CT scan. The trial doctors will compare these results with scans you had before salvage chemotherapy.

You:

might be suitable to join part 2 to have nivolumab if chemotherapy hasn’t worked well enough
won’t be able to join part 2 if salvage chemotherapy worked well. You might go on to have a stem cell transplant.

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Part 2 (trial treatment)

You have nivolumab as a drip into a vein. You have it once every 2 weeks. You have treatment in cycles. Each 2 week period is a cycle of treatment. You have a maximum of 8 cycles in total. It takes about an hour each time.

After 4 cycles of treatment, you have some more scans to check how well it worked.

Depending on the results, 1 of the following will apply.

You:

won’t have any more nivolumab if the scan shows treatment seems to have worked – you might then have a stem cell transplant
will have 4 more cycles of nivolumab if it hasn’t worked well enough after the first 4 cycles
stop treatment if your lymphoma got worse - your doctor will discuss other treatment options with you

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For people having further nivolumab, you have more scans after treatment. Depending on these results, you:

might then have a stem cell transplant if treatment worked well
won’t have a stem cell transplant if treatment didn’t work well enough - your doctor will talk to you about other treatment options

Samples for research

You give 6 extra blood samples during treatment. You give the samples at specific times and the trial team will give you more information about this. They plan to use the samples to:

see how well the treatment is working
look for biomarkers to predict who will benefit from treatment

The doctors will ask permission to collect 1 extra tissue samples if nivolumab hasn’t worked after 8 cycles. You don’t have to agree to give this sample if you don’t want to. You can still take part in the trial.

Hospital visits

You see a doctor and have some tests before you join the trial. These include:

medical history assessment
pregnancy test

You have some further tests before you join part 2 of the trial to have nivolumab. These include:

physical examination
blood tests
heart trace (ECG)
a test to measure your breathing
pregnancy test
PET-CT scan
CT scan

Not all hospitals have PET-CT scanners. So, you might need to go to a different hospital to have the PET- CT scan.

You have 2 more breathing tests if you have nivolumab. You have this after treatment and 1 year later. This is because nivolumab can damage the lungs. So the trial team check this and that if there is any damage it gets better.

Follow up appointments

When you finish nivolumab, you have a check up every month for 3 months.

Everyone who joins the trial has follow up:

every 3 months for a year
once a year for up to 2 years

Side effects

This is the first time people with Hodgkin lymphoma are having nivolumab before a stem cell transplant. So there might be some side effects we don’t know about yet. The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Nivolumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.

Some common side effects of nivolumab include:

tiredness (fatigue)
feeling sick
loss of appetite
weakness or lack of energy

Other ‘immune’ symptoms can range from mild to severe and include:

itchy skin or skin rash
diarrhoea
stomach pain and cramping
blood in your poo
tiredness
weight gain or weight loss
heart palpitations
yellowing of the eyes (jaundice)
shortness of breath

The trial team will go through all the possible side effects of treatment. They’ll monitor you for any of the above symptoms and treat them straight away.