A trial of pembrolizumab for Hodgkin lymphoma (KEYNOTE667)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at pembrolizumab after chemotherapy. It is open to children from 3 years old to young adults 25 years old who have classical Hodgkin lymphoma.
We use the term ‘you’ in the summary but if you are a parent we are referring to your child.
More about this trial
Doctors can treat classical Hodgkin lymphoma with chemotherapy.
Pembrolizumab is an 
. It works by stimulating the body’s to fight cancer.
Researchers think that using pembrolizumab might reduce the amount of chemotherapy people need to treat classical Hodgkin lymphoma.
In this trial you have an initial (induction chemotherapy). You then have a to see how well the chemotherapy worked. Whether you stay in the trial depends on how well the chemotherapy works.
If the chemotherapy worked well enough you no longer take part in the trial. Your doctor will talk to you about what your next treatment is.
If the chemotherapy didn’t work well enough you stay in the trial. You have more chemotherapy followed by pembrolizumab.
This trial is for people with classical Hodgkin lymphoma. The aim of this trial is to find out how well chemotherapy followed by pembrolizumab works.
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 newly diagnosed classical Hodgkin lymphoma
- have an area of lymphoma that the doctor can see on a scan and measure
- are willing to use contraception during treatment and for a time after if you are sexually active and you or your partner could become pregnant
- are 3 years old to 16 years old and can take part in quiet play and activities (Lansky performance score 50 and above) or you are over 16 years old and you might need quite a lot of help to care for yourself (Karnofsky performance score 50 and above)
- have satisfactory blood test results
- are between 3 years old and 25 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have nodular lymphocyte predominate Hodgkin lymphoma
- have Hodgkin lymphoma that has spread to the brain or spinal cord
- have had another treatment for cancer
- have had an immunotherapy or have taken part in another clinical trial using pembrolizumab
- have ongoing side effects from other treatment apart from mild side effects
- have another cancer that is getting worse or needs treatment. This is apart from successfully treated
non melanoma skin cancer , in situ carcinoma of the cervix or in situ carcinoma of the breast
Medical conditions
You cannot join this trial if any of these apply. You:
- have had an
organ transplant - have had a stem cell transplant using a donor’s stem cells (
allogeneic transplant ). This is unless it was over 5 years ago and you don’t have symptoms of graft versus host disease (GvHD). - have a
heart problem that means it isn’t working well enough. You have a test for this. Your doctor can tell you the result. - have taken part in another clinical trial using an experimental drug or device within 4 weeks of starting treatment in this trial
- have an immune system that isn’t working well or you are taking medication that affects how well your immune system works. This is apart from a small dose of steroids.
- are allergic to any of the treatments or what they are made
- have an
autoimmune disease that has needed treatment in the past 2 years. This is apart from having medication to replace a substance in the body. - have inflammation of the lungs or had have steroids in the past to treat inflammation of the lungs
- have an infection that needs treatment
- have HIV, hepatitis B or hepatitis C
- have had tuberculosis (TB)
- have any other medical condition or mental health problem that your doctor or the trial team thinks could affect you takin part
Other
You cannot join this trial if any of these apply. You:
• have a within 30 days of starting treatment
• are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The trial team need 340 people worldwide to join with about 18 people from the UK.
You have 2 . Each cycle is 4 weeks long. Which chemotherapy you have depends on whether you are at a high chance (high risk) or low chance (low risk) of your lymphoma coming back. Your doctor will know what your risk is.
High risk
You have:
- vincristine
- etoposide
- a steroid (prednisolone or prednisone)
- doxorubicin
You have vincristine, etoposide and doxorubicin as a drip into a vein. Prednisolone and prednisone are tablets.
Low risk
You have ABVD chemotherapy. This is:
- doxorubicin (Adriamycin)
- bleomycin
- vincristine
- dacarbazine
You have ABVD as a drip into a vein.
You have:
- vincristine
- etoposide
- a steroid (prednisolone or prednisone)
- doxorubicin
You have vincristine, etoposide, doxorubicin and dacarbazine as a drip into a vein. Prednisolone and prednisone are tablets.
After the 2 cycles you have a:
- PET scan
- CT scan or an MRI scan
This is to see how well the chemotherapy worked. You go into 1 of 2 groups depending on how well the chemotherapy worked.
Rapid Early Responder (RER)
In this group you won’t have pembrolizumab or any further trial treatment. Your doctor will talk to you about what is the best treatment for you.
You see the doctor as part of the trial when you finish treatment and then about a month later. This is to see how you are. Your doctor will then tell you how often they want to see you.
Slow Early Responders (SER)
In this group you have more chemotherapy and pembrolizumab. Which chemotherapy depends on whether you are in the high risk group or the low risk group.
High risk (SER)
You have 4 cycles of chemotherapy. Each cycle is 4 weeks long. You have:
- cyclophosphamide
- vincristine
- a steroid (prednisolone or prednisone)
- dacarbazine
You have cyclophosphamide, vincristine and dacarbazine as drip into a vein. You have the steroid as a tablet.
You might have radiotherapy depending on how well the chemotherapy works. Your doctor will talk to you about this.
Pembrolizumab
You have pembrolizumab as a drip into a vein. You have it every 3 weeks. Each 3 week period is a cycle of treatment. You have pembrolizumab for about 1 year.
Radiotherapy
You have a PET scan to see how well the treatment worked. You have radiotherapy if the treatment didn’t work well enough. Your doctor will tell you about this.
Low risk (SER)
You have 2 cycles of chemotherapy. Each cycle is 4 weeks. You have:
- doxorubicin
- vincristine
- dacarbazine
You have all of these as a drip into a vein.
Pembrolizumab
You have pembrolizumab as a drip into a vein. You have it every 3 weeks. Each 3 week period is a cycle of treatment. You have pembrolizumab for at least 8 cycles but it might be up to 1 year. You have regular scans during treatment to find out how well it is going. When a scan shows no sign of lymphoma you only have another 2 cycles of pembrolizumab.
Research samples
Everyone gives blood samples and tissue samples during the trial. Your doctor will tell how many and how often.
Researchers will use these samples to look for substances () in the blood and tissue that might tell them:
- how well treatment is working
- who might benefit best from treatment
- what happens to the chemotherapy in the body
- how chemotherapy affects the body
- more about Hodgkin lymphoma
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- test to see how well your lungs work (
lung function test ) - heart trace (
ECG ) - heart scan (
ECHO or MUGA ) - swab from inside the mouth
- PET scan, a CT scan or an MRI scan
- a sample fo the lynphoma tissue (
biopsy )
You see the doctor every 4 weeks during treatment to see how you are.
You have a scan and heart scan at the end of each course of chemotherapy.
After treatment you see the doctor every 3 months for a year and have a scan. You then see the doctor:
- every 4 months for year 2 and year 3
- and then every 6 months for year 4 and year 5
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.
| Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The common side effects of pembrolizumab are:
- rash, itching and loss of skin colour
- diarrhoea
- cough
- joint and back pain
- pain in your tummy (abdomen)
- the
thyroid gland not making enough hormones. This can cause tiredness, weight gain, feeling cold or constipation. - a low amount of salt in the blood. This can cause tiredness, confusion, headaches, muscle cramps and or feeling sick.
We have information on:
- doxorubicin (Adriamycin)
- bleomycin
- vincristine
- dacarbazine
- etoposide
- steroid (prednisolone or prednisone)
- radiotherapy for Hodgkin lymphoma
Your doctor or a member of the trial team will talk to you about the side effects of all the treatments before you agree to take part.
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
Dr Stephen Daw
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
