A trial looking at MK-3475A for certain types of lymphoma (MK-3475A-F65)
Cancer type:
Status:
Phase:
This trial is looking at a new drug called MK-3475A for lymphoma that has come back or is getting worse despite treatment.
It is for people who have one of the following types of lymphoma:
- the most common type of Hodgkin lymphoma called classical Hodgkin lymphoma
- primary mediastinal large B-cell lymphoma
More about this trial
You might have pembrolizumab to treat classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma. Large B-cell lymphoma is a type of non-Hodgkin lymphoma. If large B-cell lymphoma starts in in the centre of your chest, it is called primary mediastinal large B cell lymphoma.
Doctors are looking for ways to improve treatment for lymphoma. In this trial, they are looking at MK-3475A. It is a combination of 2 drugs called pembrolizumab and MK-5180.
MK-5180 is also called hyaluronidase. It is a new drug that helps the body to absorb pembrolizumab and distribute it around the body. The usual way to have pembrolizumab is as a drip into a vein. In this trial, you have MK-3475A as an injection under the skin.
The main aims of the trial are to find out:
- how safe it is to have MK-3475A
- how well MK-3475A works
- what happens to MK-3475A in the body
- what the side effects are
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 or primary mediastinal large B-cell lymphoma that has got worse or treatment had stopped working
- have lymphoma that can be measured on a scan
- have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are fit and active but might not be able to do heavy physical work (performance status 0 to 1)
- are at least 18 years old
Who can’t take part
Cancer related
You can’t take part if any of the following apply. You:
- have cancer that has spread to the brain, spinal cord or thin layer of tissues that cover the brain. Your doctor will know this.
- are currently having another cancer treatment. This could include
immunotherapy , chemotherapy or a
targeted cancer drug - have had a type of drug called a
monoclonal antibody within 4 weeks of starting trial treatment. You can’t take part if you have side effects from having a monoclonal antibody in the past that are moderate to severe.
- have had an immunotherapy or a similar treatment in the past. Your doctor will know this.
- have had any other cancer treatment to the whole body within 4 weeks of starting trial treatment
- have had radiotherapy within 2 weeks of starting trial treatment or you have side effects from radiotherapy and need to have steroids
- have another cancer that is getting worse or you needed treatment for another cancer in the last 2 years
- are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of joining this trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have a significant
heart problem that could affect you taking part. The trial team will check if you have a heart condition before you join the trial.
- have HIV that isn’t well controlled with medication. You can’t take part if you have had Kaposi’s sarcoma, Multicentric Castleman’s disease or both.
- have hepatitis B or hepatitis C that isn’t under control or you have hepatitis B and hepatitis C at the same time
- have fluid around your heart or lungs
- have a problem with how your
immune system works or you had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatment unless it was a low dose.
- have an
autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this.
- have scarring on the lungs or active inflammation of the lungs (
pneumonitis ) or you have had this in the past
- have an active infection that needs treatment to the whole body
- have had an
organ transplant in the past or a
stem cell transplant with somebody else’s cells in the last 5 years. You might be able to take part if you had the stem cell transplant more than 5 years ago as long as you don’t have
graft versus host disease . Your doctor will know about this.
- haven’t fully recovered from major surgery or you have complications following surgery
- have another medical condition or mental health condition that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have had a
live vaccine within 30 days of the start of treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
- are allergic to pembrolizumab, MK-5180 (hyaluronidase) or anything they contain
- are pregnant or breastfeeding
Trial design
This phase 2 trial is taking place worldwide. The trial team need 60 people to take part including 6 to 8 people from the UK.
Everyone has MK-3475A. You have it as an injection under the skin once every 6 weeks. You have treatment for up to 2 years.
You stop trial treatment if your lymphoma gets worse. Your doctor will talk to you about other treatment options. You might stop MK-3475A after at least 4 injections if your lymphoma goes away completely. Your doctor will talk to you about this if it applies to you.
Samples for research
The researchers may ask for samples of during the trial. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about lymphoma
- look for substances called
biomarkers to help work out why treatment might work for some people and not for others
- see if you develop antibodies to treatment
The team will also ask your permission to store some samples for future research. You don’t have to agree to this.
Hospital visits
You see the doctor for a and have tests before you can take part. These include:
- blood tests
- urine tests
- a heart trace (
ECG )
- a CT scan or MRI scan
- a PET scan
- a bone scan
- a bone marrow test. This is only if there isn’t a sample the team can use from a previous bone marrow test. The trial doctor will discuss this with you.
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
You may also have bone marrow tests during the trial. This would be part of your standard of care. Your doctor can tell you how often you might have these.
Trial scans
You have a PET scan, CT scan or MRI scan every 3 months for 2 years.
You stop having the trial scans if your lymphoma gets worse.
Follow up
You see the trial doctor once or twice within a month of stopping treatment.
After that the team see how you are getting on once every 3 months. You might see them at the hospital for a check up or they may call you to see how you are getting on.
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.
MK-3475A is a new drug. So we don’t know what all the side effects are. Only a few hundred people have had MK-3475A so far.
In this trial, you have MK-3475A as an injection under the skin. The trial team think the side effects of having pembrolizumab in this way will be similar to having it as a drip into a vein. Having it as a drip into a vein is the usual way to have pembrolizumab.
The most common side effects of having MK-3475A as an injection under the skin include:
- tiredness (fatigue)
- feeling sick
- a drop in the number of red blood cells (
anaemia )
- itchy skin or skin rash
- liver changes
- diarrhoea or constipation
- feeling sick
- cough
MK-3475A can also cause the following side effects at the injection site:
- a change to the skin colour or rash
- redness and swelling
- pain
- itchiness
Pembrolizumab 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. |
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 Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040