Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
This research study is for children and young adults aged 3 to 25 who have been recently diagnosed with classical Hodgkin Lymphoma. It aims to find out if a new medicine called pembrolizumab, when given alongside standard chemotherapy, is safe and effective. The study is particularly interested in patients who have classical Hodgkin Lymphoma and haven't responded quickly to their first round of chemotherapy. Researchers will be looking at how well this combination treatment works and if there are any side effects. By understanding this, doctors hope to improve treatment options for young people with this type of cancer.
At a glance
What is this study about?
Hodgkin Lymphoma is a type of cancer that affects the body's immune system. While there are good treatments available, sometimes the first round of chemotherapy doesn't work as quickly or as well as doctors hope, especially in children and young adults. This can be a worrying time for patients and their families.
This study, called KEYNOTE-667, is trying to find better ways to treat classical Hodgkin Lymphoma in young people (aged 3 to 25) who are newly diagnosed. It's looking at a new drug called pembrolizumab, which is a type of immunotherapy. Immunotherapy helps your body's own immune system fight cancer cells.
The researchers want to see if adding pembrolizumab to standard chemotherapy treatments is both safe and effective for these patients. They are particularly interested in cases where the initial chemotherapy hasn't shown a quick response. The information gathered from this study will help doctors understand if this combination treatment could be a good new option.
Key takeaways
- This study is testing a new drug (pembrolizumab) for young people with Hodgkin Lymphoma.
- It combines the new drug with standard chemotherapy.
- It's for those whose cancer isn't responding quickly to initial treatment.
- Participants are aged 3 to 25 and have newly diagnosed classical Hodgkin Lymphoma.
- The study aims to understand safety and how well the treatment works.
Who may be eligible?
To be considered for this study, you must be a child or young adult between 3 and 25 years old and have a new diagnosis of classical Hodgkin Lymphoma. Doctors will look at the stage of your cancer to determine which group you might fit into within the study. It's important that your cancer can be measured by doctors.
There are also some general health requirements, meaning your body and organs need to be working well enough to take part. If you've had an organ transplant or specific stem cell treatments in the past five years, or if you've already had treatments using similar new drugs, you won't be able to join this particular study. Women who are pregnant or breastfeeding cannot participate.
Certain precautions regarding contraception are also in place for both male and female participants of childbearing potential to ensure safety during the study period.
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 between 3 and 25 years old?
- Do you have a new diagnosis of classical Hodgkin Lymphoma?
- Has your doctor said you're a 'slow early responder' to your first chemotherapy?
- Are you generally healthy enough for treatment, with working organs?
- Have you NOT had a solid organ transplant or certain stem cell transplants recently?
What does participation involve?
If you decide to take part in this study, you will receive a new drug called pembrolizumab along with standard chemotherapy, which might include medicines like doxorubicin, vinblastine, or dacarbazine, among others. Some patients might also receive radiotherapy, which uses X-rays to treat cancer.
You will have regular visits to the hospital for treatment and check-ups. During these visits, doctors will monitor your health closely, perform tests, and assess how the treatment is working. The study will carefully follow your progress to see the effects of the treatment. The total duration of your participation in the study will depend on your specific treatment plan and how you respond to the medications, but it will involve ongoing assessments and follow-up.
Potential risks and benefits
Locations (93)
- Children's Hospital of Alabama ( Site 0023)Verified postcodeBirmingham, United States
- Phoenix Childrens Hospital ( Site 0034)Verified postcodePhoenix, United States
- Arkansas Children's Hospital ( Site 0046)Verified postcodeLittle Rock, United States
- Kaiser - Orange County ( Site 0084)Verified postcodeAnaheim, United States
- Kaiser Permanente ( Site 0082)Verified postcodeDowney, United States
- Kaiser - Fontana ( Site 0083)Verified postcodeFontana, United States
- MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( SiVerified postcodeLong Beach, United States
- Kaiser Permanente Downey Medical Center ( Site 0024)Verified postcodeLos Angeles, United States
- Kaiser Permanente - Oakland ( Site 0047)Verified postcodeOakland, United States
- Kaiser Permanente - Roseville ( Site 0080)Verified postcodeRoseville, United States
- Kaiser Permanente - Santa Clara ( Site 0079)Verified postcodeSanta Clara, United States
- Children's Hospital - Colorado ( Site 0028)Verified postcodeAurora, United States
Common questions
What is Hodgkin Lymphoma?
It's a type of cancer that develops in a part of your immune system called the lymphatic system.
What is pembrolizumab?
It's a newer type of medicine called immunotherapy that helps your own body's immune system fight cancer.
Who is this study for?
It's for children and young adults (3-25 years old) newly diagnosed with classical Hodgkin Lymphoma who aren't responding quickly to initial treatment.
Will I still get normal chemotherapy?
Yes, this study combines pembrolizumab with standard chemotherapy treatments.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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