A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
This research study is investigating a drug called pembrolizumab for children and teenagers (from 6 months to 17 years old) who have advanced cancers like melanoma (a type of skin cancer), lymphoma (a blood cancer), or other solid tumours. These are cancers that have either spread, come back after treatment, or didn't get better with previous treatments. Pembrolizumab is a type of 'immunotherapy'. This means it works by boosting the body's own immune system to recognise and fight cancer cells. The study aims to find out if different doses of pembrolizumab can make these cancers shrink or disappear. It's a Phase 1 and 2 study, meaning it's still in the earlier stages of testing to check for safety and how well it works.
At a glance
What is this study about?
This study, known as KEYNOTE-051, is looking into a medicine called pembrolizumab for children and teenagers who have certain advanced cancers. These include types of melanoma (a skin cancer), lymphoma (a blood cancer), and other solid tumours. When we say 'advanced', it means the cancer has spread within the body or can't be removed by surgery. It also includes cancers that have either come back after previously getting better ('relapsed') or those that didn't respond at all to earlier treatments ('refractory').
Pembrolizumab is an immunotherapy. Think of your immune system as your body's private army, fighting off germs and diseases. Sometimes, cancer cells can hide from this army. Immunotherapy like pembrolizumab helps to train and strengthen your immune system so it can better find and attack these cancer cells. Researchers want to see if this medicine can make these difficult-to-treat cancers in young people shrink or even disappear.
This is an important study because it's looking for new and better ways to treat cancers in children and teenagers when standard treatments haven't worked or aren't available. Although some parts of the study are now closed to new participants (for example, certain types of solid tumours or specific age groups for melanoma), researchers are still learning valuable information about pembrolizumab and its potential to help young patients fight cancer.
Key takeaways
- This study evaluates pembrolizumab for advanced cancers in children and teens.
- Pembrolizumab is an immunotherapy, helping the immune system fight cancer.
- It targets cancers that have spread, returned, or not responded to prior treatments.
- The study aims to see if the medicine can shrink these cancers.
- Participation involves regular clinic visits for treatment and monitoring.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To be considered for this study, participants generally need to be between 6 months and under 18 years old. They must have a type of advanced solid cancer or lymphoma that can't be cured with standard treatments, or where standard treatments haven't worked, or are not suitable. Doctors will also need to review previous medical records and possibly tissue samples from the cancer.
There are also specific health requirements, such as having certain levels of organ function that are considered healthy enough for the treatment. Additionally, participants should be able to move around fairly well – for younger children, this is checked using a 'Lansky Play Scale', and for older teens, a 'Karnofsky score'.
There are some reasons why someone might not be able to join. For example, if they are already in another study with an experimental treatment, or if they have certain serious underlying health conditions. Female participants who can get pregnant will need to take a pregnancy test and use effective contraception during and after the study for a certain period.
- Are you between 6 months and 17 years old?
- Do you have an advanced solid tumour, melanoma, or lymphoma that hasn't responded to other treatments?
- Are you generally well enough to take part, based on your doctor's assessment?
- Are you able to attend regular clinic visits for treatment and check-ups?
- Are you not currently part of another clinical trial for an experimental treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive the study medicine, pembrolizumab. The treatment usually involves regular visits to the clinic to receive the drug and for check-ups. During these visits, the medical team will carry out various assessments. This could include physical exams, blood tests, and scans to monitor how you are doing and how the treatment is affecting your cancer.
The duration of your participation in the study would depend on how you respond to the treatment and the study plan. Even after treatment has finished, there will likely be a follow-up period to keep an eye on your health and the long-term effects of the medication. You could expect more information on the exact number of visits, tests, and total time commitment if you are considered for the study.
Potential risks and benefits
Locations (17)
- Call for Information (Investigational Site 0019)Aurora, United States· Recruiting
- Call for Information (Investigational Site 0024)Chicago, United States· Recruiting
- Call for Information (Investigational Site 0026)Boston, United States· Recruiting
- Call for Information (Investigational Site 0031)New York, United States· Recruiting
- Call for Information (Investigational Site 0070)Fargo, United States· Recruiting
- Call for Information (Investigational Site 0071)Sioux Falls, United States· Recruiting
- Call for Information (Investigational Site 0054)Dallas, United States· Recruiting
- MSD BrasilSão Paulo, Brazil· Recruiting
- MSD FranceParis, France· Recruiting
- MSD Sharp & Dohme GmbHMünchen, Germany· Recruiting
- Merck Sharp & Dohme Co. Ltd.Hod HaSharon, Israel· Recruiting
- MSD Italia S.r.l.Rome, Italy· Recruiting
+5 more sites — see the official record for the full list.
Common questions
What is an 'advanced' solid tumour or lymphoma?
An advanced tumour means the cancer has either spread in the body, can't be removed with surgery, or has come back after treatment or didn't respond to previous treatments.
What is immunotherapy?
Immunotherapy is a treatment that helps your body's own immune system to recognise and fight cancer cells more effectively.
What does 'Phase 1' and 'Phase 2' mean for a study?
These are early stages of testing. Phase 1 mainly checks for safety and the right dose, while Phase 2 looks at how well the treatment works for certain conditions, as well as safety.
Who can join this study?
The study is for children and teenagers aged 6 months to 17 years old with certain types of advanced cancers that have not responded to other treatments. There are specific health criteria too.
Can I stop participating in the study if I want to?
Yes, absolutely. You have the right to leave the study at any time, for any reason, and it will not affect your ongoing medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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