AVENuE: a phase 2 trial of avelumab for untreated advanced classical Hodgkin lymphoma

This trial is testing a treatment called avelumab in people with advanced classical Hodgkin lymphoma who have not been treated before.


Purpose of trial

The aim of this trial is to find out if a new treatment called avelumab, given before chemotherapy, is a safe and effective treatment for people with advanced classical Hodgkin lymphoma who have not been treated before.


Treatment

Avelumab is an immune checkpoint inhibitor – it works by helping the immune system recognise and attack the lymphoma. You have it as an injection into a vein (intravenously) every 2 weeks.

Everybody in this trial receives four doses of avelumab followed by a PET/CT scan. You then have two cycles of ABVD chemotherapy and another PET/CT scan.

  • If the PET/CT scan shows you have responded to treatment, you then have four cycles of AVD chemotherapy (ABVD without the bleomycin).
  • If the PET/CT scan shows you have not responded to treatment, you have more intense treatment with BEACOPP or BEACOPPesc chemotherapy. The number of cycles you have depends on how you respond to treatment.
  • You might also have radiotherapy if your doctor thinks you would benefit from it.

Who can enter

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

Around 47 people are needed for this trial.

You may be able to enter if:

  • You have classical Hodgkin lymphoma that has not been treated before.
  • Your lymphoma is high-risk stage 2 (stage 2 lymphoma with B symptoms, bulky disease or lymphoma in more than three places in your body), stage 3 or stage 4.
  • You have a biopsy sample that is suitable for the tests used in the trial.
  • You are fit and well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
  • You are willing and able to stick to the trial treatment and attend all study visits, tests and scans.
  • You are between 16 and 60 years old.

You won’t be able to enter if:

  • You have nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL).
  • You have symptoms caused by your lymphoma pressing on organs or tissues.
  • You need urgent treatment.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have any health problems that might interfere with the study treatment.
  • You have significant side effects from previous treatment. 
  • You’ve had major surgery in the last 4 weeks.
  • You’ve had treatment with drugs that suppress your immune system (immunosuppressants) in the last 2 months, except inhaled, topical or low-dose steroids.
  • You have HIV, hepatitis C or hepatitis B.
  • You have or have had colitis, inflammatory bowel disease, pneumonitis or an autoimmune disorder (with certain exceptions).
  • You’ve had a heart attack, unstable angina, bypass surgery, stroke or mini-stroke in the last 6 months.
  • You have had a solid cancer in the last 3 years, except certain localised cancers.
  • You’ve been treated for a blood cancer before.
  • You’ve had an organ transplant or a stem cell transplant using donor stem cells (allogeneic stem cell transplant).
  • You’ve had chemotherapy or radiotherapy in the last 15 days.
  • You’ve had any live vaccines in the last 30 days.
  • You are being treated for an infection.
  • You are pregnant or breastfeeding.
  • Any of the study drugs are not suitable for you.
  • You’ve had a bad reaction to antibody therapy in the past.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03617666.