Purpose of trial
The aim of this trial is to see if a new drug called avelumab is safe and effective in treating people with DLBCL that has relapsed (come back) or was refractory (didn’t respond) to previous treatment.
This trial also aims to find out more about how avelumab behaves in the body.
This trial is in 2 parts. In the first part (phase 1), several drug combinations are being tested in a small number of people. The drug combinations being tested are:
- avelumab, utomilumab and rituximab
- avelumab, utomilumab and azacitidine
- avelumab, rituximab and bendamustine.
The most effective and safe combination is then tested in a larger group of people in the second part (phase 3) of this trial. In this part of the trial, the selected drug combination is compared with a standard treatment of chemotherapy and antibody therapy for relapsed and refractory DLBCL:
- rituximab and bendamustine, or
- rituximab, gemcitabine and oxaliplatin.
This is a randomised trial and you are assigned to a treatment group at random. You cannot choose which treatment group you are in. Your doctor can choose which of the 2 standard treatment options is most suitable for you if you are assigned to the standard treatment group.
Avelumab is an immune checkpoint inhibitor – it works by helping the immune system recognise and attack the lymphoma.
Utomilumab is an experimental antibody treatment.
Rituximab is an antibody treatment already used to treat many people with DLBCL.
Azacitidine, gemcitabine, oxaliplatin and bendamustine are chemotherapy drugs.
A cycle of treatment is 28 days and you have drugs on some days of each cycle. The trial doctor can give you more information about what each treatment combination involves. You can have up to six cycles of treatment if you are not having rituximab. If you are having rituximab as part of your treatment, you have up to eight cycles of treatment.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 304 people are needed for this trial.
You may be able to enter if:
- You have relapsed or refractory DLBCL.
- You have had 2–4 previous courses of treatment for DLBCL, including at least one course that included rituximab. People who are not suitable for intensive second line chemotherapy must have received at least one previous course of treatment that included rituximab.
- A biopsy sample of your lymphoma is available.
- You are well enough to look after yourself and up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your blood and other health test results are satisfactory.
- Your lymphoma is measurable with the tests used in the trial.
- You are aged 18 or over.
You will not be able to enter if:
- You have transformed lymphoma (a low-grade lymphoma that has changed into a faster-growing type of lymphoma).
- You have Burkitt lymphoma.
- Your lymphoma is in your central nervous system (CNS; brain, spinal cord or eye).
- You have had an organ transplant or a donor (allogeneic) stem cell transplant.
- You have been treated with a checkpoint inhibitor or similar drug before.
More information about this trial is available at clinicaltrials.gov.