Purpose of trial
The aim of this trial is to test if the combination of nivolumab and brentuximab vedotin is safe and effective for children and young people with classical Hodgkin lymphoma that has relapsed (come back after treatment) or was refractory (didn’t respond) to treatment.
People who do not respond well to this combination are then given brentuximab vedotin and bendamustine to test whether this combination can help.
Nivolumab is an immune checkpoint inhibitor – it works by helping the immune system recognise and attack the lymphoma.
Brentuximab vedotin is an antibody joined to a strong chemotherapy drug – an antibody-drug conjugate.
Bendamustine is a chemotherapy drug.
All of these drugs are already used to treat classical Hodgkin lymphoma.
Everyone in this trial has nivolumab and brentuximab vedotin.
Both drugs are given intravenously (through a drip into a vein). Treatment is given in cycles of 3 weeks. In the first cycle:
- brentuximab vedotin is given on day 1
- nivolumab is given on day 8.
After that, both drugs are given on the first day of each cycle.
Everyone in this trial has at least 2 cycles of treatment with brentuximab with nivolumab. You have a PET scan after 2 and 4 cycles of treatment.
There are several treatment options if you have a complete response (no evidence of lymphoma) after 4 cycles of brentuximab vedotin and nivolumab:
- autologous stem cell transplant (using your own stem cells)
- no further treatment needed.
Your doctor can decide what treatment is best for you depending on your individual circumstances, for example how widespread your lymphoma was.
If you do not have a complete response after 4 cycles of brentuximab and nivolumab, you are given two cycles of bendamustine and brentuximab vedotin. If you have a complete response to bendamustine and brentuximab vedotin, you might then be given radiotherapy. If you do not respond to this combination, your doctor can discuss other treatment options with you.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 80 people are needed for this trial.
You may be able to enter if:
- You have classical Hodgkin lymphoma
- Your lymphoma has relapsed (come back) or was refractory (didn’t respond) to previous treatment.
- You have had at least one previous treatment for your lymphoma that did not work.
- Your doctor assesses you as fit enough to enter the trial.
- You are 5–30-years-old.
You will not be able to enter if:
- You have had more than one course of anti-cancer treatment for your lymphoma.
- You have not had any previous treatment for your lymphoma.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have an autoimmune disease (a disease where your body attacks itself). Your doctor can advise if this applies to you.
- You have had a stem cell transplant for Hodgkin lymphoma or you have had an organ transplant.
- You have been treated with a checkpoint inhibitor or a similar drug before.
More information about this trial is available at clinicaltrials.gov.