JAVELIN HL: a phase 1 trial to find the best dose of avelumab for people with relapsed or refractory advanced-stage classical Hodgkin lymphoma

This trial is now closed. It is no longer recruiting participants.


Purpose of trial

The aim of this trial is to find the best dose of avelumab for treating people with classical Hodgkin lymphoma 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
  • how the body excretes (gets rid of) avelumab
  • more about the side effects of avelumab
  • if avelumab is effective for people with classical Hodgkin lymphoma.

Part 1 of the trial is recruiting people who have already had a stem cell transplant or can't have one. Part 2 of the trial is only recruiting people who have had a donor (allogeneic) stem cell transplant


Treatments

Avelumab is an immune checkpoint inhibitor – it helps the immune system recognise and attack the lymphoma.

Everyone in this trial has avelumab.

Different doses and dosing schedules are being tested.

This trial is in two parts.

  • Part 1 has five different dose groups; a different dose or dosing schedule of avelumab is being tested in each.
  • In part 2, the best doses from part 1 are tested in larger groups of people.

You enter either part 1 or part 2 of the trial.

You have avelumab once every 2 weeks or once every 3 weeks, depending which group you are assigned to. Avelumab is given intravenously (into a vein). You continue to have treatment with avelumab for as long as it is benefiting you.


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 classical Hodgkin lymphoma.
  • You have had a stem cell transplant or you are not suitable for a stem cell transplant. Participants in part 2 of the trial must have had an allogeneic (donor) stem cell transplant.
  • A biopsy sample of your lymphoma is available.
  • You finished your last treatment for classical Hodgkin lymphoma at least 4 weeks ago.
  • 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 had an allogeneic stem cell transplant within the last 12 months (part 1) or the last 4 months (part 2).
  • You are taking immunosuppressive drugs (drugs that dampen down the immune system).
  • You currently have graft-versus-host disease (GvHD), or you had GvHD in the last 3 months, or you have ever had severe GvHD (grade 3 or 4), or you have had chronic GvHD that lasted for more than 6 months and needed treatment with systemic (whole-body) immunosuppressive drugs.
  • You had a donor lymphocyte infusion in the last 3 months.
  • You have been treated with a checkpoint inhibitor in the past year unless this was prior to having an allogeneic stem cell transplant.
  • You previously had serious side effects due to a checkpoint inhibitor.

Further information

More information about this trial is available at clinicaltrials.gov.