A trial of nivolumab for Hodgkin lymphoma (ANIMATE)

Cancer type:

Blood cancers
Hodgkin lymphoma
Lymphoma

Status:

Open

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. Open a glossary item
 
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 Open a glossary item  apart from vitiligo, diabetes, or a problem with your thyroid gland that doesn’t need treatment
  • are allergic to drugs called monoclonal antibodies Open a glossary item
  • 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 Open a glossary item, squamous cell skin cancer  Open a glossary itemor 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 Open a glossary item 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  Open a glossary itemapart 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. 

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
     


 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 Open a glossary item 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) Open a glossary item
  • 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 will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The most common side effects of nivolumab include:
Please note, as nivolumab activates the immune system, the stimulated immune system can sometimes attack normal cells of the body. For example, this might cause: 
  • inflammation of the lungs
  • inflammation of the bowel 
Symptoms can range from mild to severe and some can be life threatening.
The symptoms include:
  • itchy skin or skin rash
  • diarrhoea
  • stomach pain
  • 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 
 
If you suddenly feel unwell between hospital visits and especially if you develop any of the immune symptoms please do contact the trial team immediately for advice. 

Location

Leicester
London
Norfolk
Oxford
Sutton

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

Dr Graham Collins

Supported by

Cancer Research UK & UCL Cancer Trials Centre
Bristol-Myers Squibb
University College London

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15560

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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