KEYNOTE-204: a phase 3 trial comparing pembrolizumab with brentuximab vedotin in people with relapsed or refractory classical Hodgkin lymphoma

This trial is testing which of two targeted treatments gives the best outcomes for people with classical Hodgkin lymphoma that has relapsed (come back) or didn’t respond to previous treatment.


Purpose of trial

The aim of this trial is to compare the safety and effectiveness of:

Both drugs are already approved to treat people with classical Hodgkin lymphoma.


Treatments

Pembrolizumab is an immune checkpoint inhibitor – it works by helping the immune system recognise and kill the lymphoma.

Brentuximab vedotin is an antibody joined to a strong chemotherapy drug – an antibody-drug conjugate.

Both treatments are given intravenously (into a vein).

Participants are randomised to decide which treatment they receive. You cannot choose which treatment you receive and neither can your doctor. You are told which treatment you are receiving and given information about it.

Treatment is given in 3-week cycles. Everyone in the trial has treatment on Day 1 of each cycle. You can have up to 35 cycles, given over 2 years.


Who can enter

Your consultant can advise you whether you might be suitable for this trial.

A total of 300 people are needed for this trial.

You may be able to enter if:

  • You have classical Hodgkin lymphoma that has relapsed (come back) or is refractory (not responding to treatment). #You have not previously received brentuximab vedotin. You may be able to enter if you have previously had brentuximab vedotin and your lymphoma responded to it.
  • A sample of your biopsy is available for tests.
  • Your lymphoma is measurable by the tests used in the trial. 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. If you have pembrolizumab, you must continue contraception for at least 120 days after your last dose of treatment. If you have brentuximab vedotin, you must continue contraception for at least 180 days after your last dose of treatment.
  • Your blood and other health test results are satisfactory.
  • You are 18 or over.

You will not be able to enter if:

  • You are allergic to the trial treatments or any of their ingredients.
  • You are taking part in another trial involving treatment or you have taken part in another trial in the last 4 weeks.
  • Your immune system is not working well (is suppressed), you have an autoimmune disorder that has required systemic (whole-body) treatment in the last 2 years or you are receiving medicines that suppress your immune system.
  • You have had antibody treatment, chemotherapy, targeted treatments or radiotherapy in the last 4 weeks.
  • You have not recovered from the side effects of previous treatments.
  • You’ve had an allogeneic stem cell transplant in the last 5 years or you currently have graft-versus-host disease (GvHD).
  • You have had another cancer in the last 3 years, except certain localised cancers.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You have or have had pneumonitis (lung inflammation) that was not due to an infection and required steroid treatment.
  • You have an infection that requires intravenous treatment.
  • You have been treated with a drug similar to pembrolizumab before.
  • You are pregnant or breastfeeding.
  • You have HIV (if already known), active hepatitis B virus, hepatitis C virus or tuberculosis.
  • You’ve had a live vaccine in the last 30 days.
  • You have any other health problems that your doctor thinks make it unsafe for you to take part in the trial.
  • You are eligible for a stem cell transplant.

Further information

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