A Phase 2 Study of Pembrolizumab (MK-3475) every 6 weeks (Q6W) in Participants with Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
This research study, called a Phase 2 trial, is looking at a medicine named Keytruda (pembrolizumab) for adults in the UK who have classical Hodgkin’s lymphoma or primary mediastinal large B-cell lymphoma. These are types of cancer that affect the body's immune system. The study is for people whose cancer has either returned after treatment or didn't get better with previous treatments. Researchers want to find out how effective Keytruda is at shrinking the lymphoma and how long those effects last. They will also be carefully checking for any side effects to make sure the medicine is safe to use. This kind of study helps us understand if new treatments could eventually become available to more patients.
At a glance
What is this study about?
This study is a Phase 2 clinical trial, which means it's an important step in testing a new medicine called Keytruda (also known as pembrolizumab). It's focused on adult patients in the UK who have two specific types of blood cancer: classical Hodgkin’s lymphoma or primary mediastinal large B-cell lymphoma. These are cancers that affect a part of your immune system. The study is particularly for those whose cancer has either come back after previous treatments or didn't respond well to those treatments.
The main goal is to see how many people experience their lymphoma shrinking or disappearing after taking Keytruda. This is called the 'objective response rate'. Doctors will be carefully checking this to understand if the treatment is working. They will also look at how long any positive response lasts, which helps them understand the long-term potential of the medicine.
Beyond how well the medicine works, safety is extremely important. The researchers will be closely monitoring participants for any side effects, often called 'adverse events', to understand the full picture of the medicine's benefits and risks. Information from studies like this helps doctors decide if Keytruda could be a good treatment option for more people with these conditions in the future.
Key takeaways
- This study is for adults with specific types of Hodgkin’s or large B-cell lymphoma that have returned or not responded to treatment.
- It's testing a new medicine called Keytruda, given every six weeks.
- The main aim is to see if Keytruda can shrink the lymphoma and for how long.
- Researchers will also carefully monitor any side effects to ensure safety.
- Participation involves regular clinic visits for infusions, tests, and monitoring.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.
This study is specifically for people who have been diagnosed with either classical Hodgkin’s lymphoma or primary mediastinal large B-cell lymphoma. Crucially, your lymphoma must have either already come back after previous treatments (this is called 'relapsed') or it didn't improve with the treatments you've already had (this is called 'refractory').
Both men and women can take part in this study. There might be other medical criteria that your doctor will check to make sure the study is a good fit for you and safe for your health.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with classical Hodgkin’s lymphoma or primary mediastinal large B-cell lymphoma?
- Has your lymphoma come back after previous treatment, or did it not get better with treatment?
- Are you able to attend regular clinic appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, Keytruda, as an infusion (drip) into your vein every six weeks. Your medical team will schedule regular visits to the clinic to monitor your health and how you are responding to the treatment. These visits will involve blood tests to check how your body is handling the medicine and to look for any side effects. You will also have scans or other tests to see if the lymphoma is shrinking or staying stable.
The study involves ongoing assessment to track how long the treatment effect lasts and to ensure your safety. While the exact total duration will vary for each person, you will continue treatment as long as it is benefiting you and you are not experiencing significant side effects. There will also be follow-up appointments after you stop receiving the study medicine to continue monitoring your health.
Potential risks and benefits
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Common questions
What is Keytruda?
Keytruda is an experimental medicine being tested in this study. It's designed to help your own immune system fight cancer cells.
What does 'relapsed or refractory' mean?
It means your cancer has either come back after treatment or didn't get better with previous treatments.
How often will I receive the treatment?
The medicine, Keytruda, will be given as a drip into your vein every six weeks.
Will I know if the medicine is working?
Yes, your doctors will regularly check your lymphoma with scans and tests to see how you are responding.
Can I stop participating in the study if I want to?
Absolutely, you can withdraw from the study at any time, for any reason, without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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