
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at a new drug called MK-4280A for Hodgkin lymphoma.
It is open to people with a type of Hodgkin lymphoma called classical Hodgkin lymphoma that has:
Doctors can treat classical Hodgkin lymphoma with:
Unfortunately for some people, their lymphoma can come back after treatment (relapse). Or the treatment doesn’t work (refractory). Researchers are looking for other treatments to help these people.
In this trial, they are looking at a drug called MK-4280A. This drug is a combination of MK-4280 (favezelimab) and pembrolizumab. Both of these are immunotherapy drugs. They work by helping the find and kill cancer cells.
MK-4280 is still an experimental drug and is not used as a routine treatment for cancer at the moment. Doctors already treat some cancers, including Hodgkin lymphoma, with pembrolizumab.
In this trial, half the people will have MK-4280A and the other half will have chemotherapy. The researchers will compare MK-4280A with chemotherapy to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The team need up to 360 people to take part worldwide with 6 people from the UK.
It is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor chooses which group you go into. The 2 groups are:
You have MK-4280A as a drip into a vein. You have it once a week every 3 weeks. Each 3 week period is a . You have MK-4280A for up to 35 cycles (about 2 years).
If you are in the chemotherapy group, your doctor will tell you whether you going to have bendamustine or gemcitabine.
You have bendamustine as a drip into a vein. You have it on the first and second day of each treatment cycle. A treatment cycle is either 3 weeks or 4 weeks. Your doctor will tell how long your cycle of treatment is. You have bendamustine for up to 6 treatment cycles. So your treatment will last between 18 and 24 weeks.
You have gemcitabine as a drip into a vein. A treatment cycle is 3 weeks. You have gemcitabine on the first and second day of each treatment cycle. You have gemcitabine for up to 6 cycles of treatment. So you have treatment for about 18 weeks.
You continue having your treatment:
Crossover treatment
For people having chemotherapy if it stops working and your cancer gets worse you might be able to have up to 35 cycles (about 2 years) of MK-4280A. This is called crossover treatment. Your doctor will discuss this with you.
Quality of life
You fill in questionnaires before you start treatment and then at regular times:
The questions ask about:
These are quality of life questionnaires.
Samples for research
The team take blood samples and tissue samples () at the start of and during the trial. Where possible they take these samples when you have the samples taken as part of your routine care.
They use these samples to look for substances () such as
and proteins. This might tell them:
They will also ask to store these samples for future research.
You don’t have to agree to give these samples.
You see the doctor to have tests before taking part. These tests include:
You might need to have a bone marrow test before and during the trial. Your doctor will tell you if this is necessary and how often it might be.
You see the doctor regularly during treatment. This is:
You see the doctor a month after finishing treatment and then:
Your doctor will then tell you how often they want to see you.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
MK-4280A can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
MK-4280A is a new drug and there might be side effects we don’t know about yet. The common side effects reported so far are:
Bendamustine and gemcitabine are chemotherapy drugs. Some of the most common side effects of chemotherapy include:
We have more information about bendamustine, gemcitabine and their side effects.
Your doctor will talk to you about the possible side effects of the treatments and answer any questions you have before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Graham Collins
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”