A Phase 2 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
This research study, called KEYFORM-008, is for adults with a type of cancer called Classical Hodgkin Lymphoma. This is for people whose cancer has either come back after treatment or didn't get better with their previous treatments, especially those that targeted PD-1 or PD-L1 pathways. The study is comparing a new combination medicine, MK-4280A, to standard chemotherapy options like Gemcitabine or Bendamustine. We want to find out if MK-4280A is better at preventing the cancer from growing or spreading. Researchers will also look at how long people live, how many have their cancer shrink, and any side effects.
At a glance
What is this study about?
This study is looking into new treatments for a type of cancer called Classical Hodgkin Lymphoma. This is a cancer that affects the lymphatic system, which is part of your body's immune system. Sometimes, after initial treatments, this cancer can come back (this is called 'relapsed') or it might not respond well to the treatments given (this is called 'refractory'). If you've already had treatments that target specific pathways in cancer cells, like PD-1 or PD-L1 inhibitors, and your cancer still isn't under control, then this study might be for you.
The main goal of this study is to see if a new combination medicine, called MK-4280A, can keep the cancer from growing or spreading for a longer time compared to standard chemotherapy options. MK-4280A combines two different medicines, favezelimab and pembrolizumab, which are designed to help your body's immune system fight the cancer. The standard chemotherapy options in this study are medicines like Gemcitabine or Bendamustine, which are commonly used to treat Hodgkin Lymphoma.
By comparing these treatments, the researchers hope to find a more effective way to manage Classical Hodgkin Lymphoma that has been difficult to treat. They will carefully monitor how the cancer responds to treatment, how long people live, and what side effects might occur. This kind of study helps doctors understand which treatments work best for different people.
Key takeaways
- This study is for adults with Classical Hodgkin Lymphoma that has come back or not responded to previous treatments.
- It compares a new combination medicine (MK-4280A) to standard chemotherapy.
- The main aim is to see if MK-4280A can keep the cancer from growing for longer.
- Participants will be randomly assigned to one of the treatments.
- You will have regular medical check-ups and scans to monitor your health and the cancer.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you must have been diagnosed with Classical Hodgkin Lymphoma, and your cancer must have either returned after previous treatments or not responded to them. This is especially true if you've already had treatments that target certain immune pathways (like PD-1 or PD-L1 inhibitors) and they haven't worked well enough.
The research team will have a full list of specific health requirements and other factors to check if the study is right for you. It's important to discuss your full medical history with your doctor to see if you meet all the criteria.
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?
- Do you have Classical Hodgkin Lymphoma?
- Has your Hodgkin Lymphoma come back or not responded to previous treatments?
- Have you previously been treated with a PD-1/PD-L1 cancer medicine?
- Are you able to attend regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will be assigned to receive either the new combination medicine (MK-4280A) or one of the standard chemotherapy treatments (Gemcitabine or Bendamustine). This decision is made randomly, like flipping a coin. You will have regular visits to the hospital or clinic for treatments and check-ups. During these visits, doctors will perform physical examinations, take blood samples, and conduct scans (like CT scans) to see how your body is responding to the treatment and to monitor the cancer.
The treatment will continue for a certain period, and you'll have follow-up appointments even after treatment finishes, to track your health and the long-term effects of the therapy. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it could involve ongoing visits and monitoring for some time.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is Classical Hodgkin Lymphoma?
It's a type of cancer that starts in white blood cells called lymphocytes, affecting the lymphatic system, which is part of your body's immune system.
What does 'relapsed or refractory' mean?
Relapsed means the cancer came back after treatment. Refractory means the cancer didn't respond or stop growing with previous treatments.
What is MK-4280A?
It's a new combination medicine being tested, made of two drugs: favezelimab and pembrolizumab. These are designed to help your immune system fight cancer.
Will I get the new medicine or standard chemotherapy?
Participants are randomly assigned to receive either the new medicine (MK-4280A) or common chemotherapy drugs like Gemcitabine or Bendamustine. You won't choose.
What is the main goal of this study?
The main goal is to see if the new MK-4280A combination can stop the cancer from growing for longer compared to standard chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.