ANIMATE: a phase 2 study of nivolumab for relapsed or refractory classical Hodgkin lymphoma

This trial is testing a targeted drug called nivolumab in people with classical Hodgkin lymphoma who have not responded to treatment (refractory lymphoma) or whose lymphoma has come back (relapsed) after previous treatment.


Purpose of trial

The aim of the trial is to find out whether nivolumab is safe and effective for people with relapsed or refractory classical Hodgkin lymphoma who do not have a complete response to salvage therapy.

People who respond to salvage therapy for relapsed or refractory Hodgkin lymphoma might have a stem cell transplant if they are fit enough. This trial aims to find out if using nivolumab to treat relapsed and refractory classical Hodgkin lymphoma that has not responded to salvage therapy can help more people progress to stem cell transplant.


Treatment

Nivolumab is a type of drug called a checkpoint inhibitor. It blocks an interaction between lymphoma cells and your own immune cells that turns your immune cells off. Blocking this interaction lets your immune cells recognise and destroy the lymphoma cells.

The treatment you have in this trial depends on the results of PET-CT scans.

Everybody in the trial has two cycles of standard salvage therapy (or three to four cycles if your treatment includes brentuximab vedotin).

Then you have a PET-CT scan.

If your scan shows you have completely responded to treatment, you do not have nivolumab. Your doctor will talk to you about the best treatment options for you. You will still be followed up by the clinical trial team.

If your scan shows you have not completely responded to treatment, you have treatment with nivolumab as follows:

  • You have four cycles of nivolumab.
  • After four cycles, you have a PET-CT scan to see if you have responded to treatment.
  • If your scan shows you have completely responded to treatment, or if your lymphoma has got worse, you do not have any more cycles of nivolumab. Your doctor will talk to you about the best treatment options for you. If you have completely responded to treatment, you might be able to have a stem cell transplant.
  • If your scan shows you have not completely responded to treatment but your lymphoma has not got worse, you have four more cycles of nivolumab.
  • After you finish all the cycles of nivolumab, your doctor will talk to you about the best treatment options for you. If you have completely responded to treatment, you might be able to have a stem cell transplant.

Nivolumab is given intravenously (by injection into a vein). Each treatment cycle lasts 2 weeks.


Who can enter

Your consultant can give you advice on whether you might be suitable for this trial.

Around 120 people are needed for this trial.

You may be able to enter if:

  • You have relapsed or refractory classical Hodgkin lymphoma.
  • You have previously had one course of treatment for your lymphoma.
  • You are about to receive salvage therapy, or you have received your first two cycles of salvage therapy (four cycles if you are being treated with brentuximab vedotin) within the last 2 weeks.
  • You are fit enough to have a stem cell transplant.
  • You are well enough to take part in the trial.
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
  • You are 16 or over.

You won’t be able to enter if:

  • You have nodular lymphocyte predominant Hodgkin lymphoma.
  • You’ve had surgery in the last 4 weeks.
  • You’ve had a heart attack, heart bypass surgery, unstable angina, stroke or mini-stroke in the last 6 months.
  • You have HIV, hepatitis C or hepatitis B.
  • You have had another cancer in the last 3 years, except certain localised cancers.
  • You have an autoimmune disease (except certain conditions that don’t need drugs that suppress your immune system).
  • You’ve ever had uncontrolled allergy or anaphylaxis (severe allergic reaction).
  • You’ve ever had colitis, inflammatory bowel disease or pneumonitis (inflammation of the air sacs of the lungs).
  • You are pregnant or breastfeeding.
  • You are allergic to monoclonal antibody treatment.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03337919.

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