A trial looking at MK-4280A for Hodgkin lymphoma
Cancer type:
Status:
Phase:
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:
- come back after treatment or got worse during treatment
- and there are no further treatment options available
More about this trial
Doctors can treat classical Hodgkin lymphoma with:
- chemotherapy
- radiotherapy
- steroids
- high dose chemotherapy followed by a stem cell or bone marrow transplant
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:
- how well MK-4280A works
- about the side effects of MK-4280A
- how it affects
quality of life
Who can enter
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:
- have classical Hodgkin lymphoma that has got worse during treatment or has come back after treatment. And there are no other treatment options available.
- have had at least 3 months (2 doses) of a
checkpoint inhibitor treatment that blocks PD-L1. Your doctor will know if you have had this. - have lymphoma that is seen on a
scan using a contrast medium called FDG. Your doctor will know about this. - have an affected lymph node that the doctor can measure on a scan and is a certain size or bigger. Your doctor will know about this.
- are willing to use contraception during treatment and for a certain time after if there is any chance you or your partner could become pregnant
- have a previous sample of tissue (
biopsy ) from an affected lymph node that the trial team can access or if not you are willing to have a fresh biopsy taken - are able to have one of the chemotherapies bendamustine or gemcitabine. Your doctor will know if you can.
- are up and about for at least half the day, can look after yourself but might not be able to work (performance status 0, 1 or 2)
- have satisfactory blood test results
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have or had lymphoma spread to the brain or the spinal cord
- have
systemic treatment within the 4 weeks before being put into a trial treatment group (randomisation ). This includes taking experimental drugs or using devices as part of another clinical trial. - have radiotherapy within 2 weeks of starting trial treatment or you are taking corticosteroids for radiotherapy side effects
- have another cancer that has got worse or needed treatment in the past 3 years. This is apart from
non melanoma skin cancer and carcinoma in situ (CIS) that was successfully treated. This does not include CIS of the bladder. - have had a stem cell transplant from a donor (
allogeneic transplant ) within the past 5 years. If your transplant was more than 5 years ago you must not have any symptoms of graft versus host disease (GvHD). If you had GvHD you must not be taking any medication for it for at least the past 2 months. - have had bad to severe side effects affecting to the
immune system from previous checkpoint inhibitors
Medical conditions
You cannot join this trial if any of these apply. You:
- have an immune system that isn’t working very well. Or you are taking medication that damps down (suppresses) the immune system within 7 days of starting trial treatment. This is apart from a small dose of steroids.
- have an active
autoimmune disease that needed systemic treatment within the past 2 years. This is apart from certain ones. Your doctor will know which these are. - had inflammation of the lung or lining of the lung that needed steroids or you have inflammation of the lung or lining of the lung
- have a rare medical condition called haemorrhagic lymphohistiocytosis
- have an active medical condition that causes seizures (fits) that is not well controlled
- have an active infection needing systemic treatment. Or you have HIV, active hepatitis B or hepatitis C.
- have had a LAG 3 targeted checkpoint inhibitor. Your doctor will know if you have.
- have ongoing moderate to severe side effects from previous treatment
- have not recovered from major surgery or you have ongoing complications
- have active
heart problems that could affect you taking part - have had a
stroke less than 6 months ago - have any other medical condition, mental health problem or social situation that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to any of the treatments used in the trial or any of their ingredients
- have a
live vaccine within 30 days of starting trial treatment. The COVID-19 vaccines and some seasonal flu vaccines are not live vaccines. - are pregnant or breastfeeding
Trial design
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:
- MK-4280A
- bendamustine or gemcitabine chemotherapy
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:
- as long as it is helping
- the side effects aren’t too bad
- as long as you don’t start another cancer 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:
- during treatment
- after treatment
- during follow up
The questions ask about:
- your general health and wellbeing
- what you are able to do in your daily life
- side effects
- symptoms
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:
- how well the treatment is working
- more about classical Hodgkin lymphoma
They will also ask to store these samples for future research.
You don’t have to agree to give these samples.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- PET scan
- CT scan or MRI scan
- heart trace (ECG)
- urine test
- a fresh tissue sample (biopsy) if a previous biopsy isn’t available for the team to access
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:
- to see how you are
- for blood tests
- to ask about side effects
- for scans
You see the doctor a month after finishing treatment and then:
- every 3 months for 2 years after starting treatment
- then every 6 months till 5 years after starting treatment
Your doctor will then tell you how often they want to see you.
Side effects
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.
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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:
- itchy skin and skin rash
- tiredness (fatigue)
- a low level of thyroid hormone that may cause tiredness, weight gain, feeling cold and constipation
- diarrhoea
Bendamustine and gemcitabine are chemotherapy drugs. Some of the most common side effects of chemotherapy include:
- tiredness (fatigue)
- a drop in blood cells causing shortness of breath, an increased risk of infection and an increased risk of bruising and bleeding
- feeling or being sick
- changes to appetite
- changes to hair
- changes to skin and nails
- diarrhoea or constipation
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.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Graham Collins
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
