Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
This research study is looking into a new treatment, MK-4830, for adults with several types of advanced cancer, including pancreatic, lung, kidney, stomach, ovarian, and a type of brain cancer. It will be tested alone and in combination with an existing medicine called Pembrolizumab (also known as Keytruda). This is a very early-stage study, meaning it’s one of the first times these treatments are being given to people. The main goals are to check if the medicines are safe, how people react to them, and how the body handles the new drug. It's an important step in figuring out if these treatments could help people with advanced cancers in the future.
At a glance
What is this study about?
This study, called MK-4830-001, is a research project designed to learn more about a new potential cancer medicine known as MK-4830. When a new medicine is developed, it goes through several stages of testing to make sure it's safe and effective. This study is in a very early stage, sometimes called 'Phase I' or 'human pharmacology,' which means it's one of the first times this new medicine is being given to people.
The main purpose of this study is to understand how MK-4830 works in the body and to find out if it's safe. Researchers will be testing MK-4830 in two ways: first, by itself as a single treatment, and then in combination with another medicine that is already used for some cancers, called Pembrolizumab (you might know it as Keytruda). They are looking at how these treatments affect the body and what dose might be best.
This study includes adults with several different types of advanced cancers, such as pancreatic cancer, advanced lung cancer, kidney cancer, stomach cancer, and ovarian cancer, among others. By carefully observing how people with these cancers respond, doctors hope to gather important information that could lead to new treatment options in the future. It's a crucial step in developing new medicines to fight cancer.
Key takeaways
- Tests a new medicine, MK-4830, for advanced cancers.
- Compares MK-4830 alone and with Pembrolizumab.
- Focuses on safety and how the treatment works (Phase I study).
- Open to adults 18+ with specific advanced solid tumours.
- Participation involves regular clinic visits for monitoring.
- Aims to find new ways to treat cancer in the future.
Who may be eligible?
This study is open to adult men and women, aged 18 and over, who have specific types of advanced cancer. The specific cancers include pancreatic cancer, certain types of brain tumours (glioblastoma), head and neck cancer, lung cancer, kidney cancer, stomach cancer, ovarian cancer, a type of breast cancer (triple-negative), and mesothelioma.
Because this is an early-stage study, there will be very specific health requirements that you must meet to ensure your safety and that the results of the study are clear. These will involve various medical tests and checks to make sure your body can handle the new medicines.
Your study doctor will discuss all of these requirements with you in detail. It’s important to remember that even if you have one of the listed cancer types, other health factors will determine if you can join. You cannot have received certain previous treatments or have other health conditions that might interfere with the study medicines.
- Are you 18 years old or older?
- Do you have advanced pancreatic cancer?
- Do you have a type of advanced lung (NSCLC), kidney (RCC), stomach (Gastric/GEJ), or ovarian cancer?
- Do you have advanced head and neck cancer (HNSCC) or a type of breast cancer (TNBC)?
- Do you have advanced mesothelioma or a type of brain tumour (glioblastoma) that cannot be removed by surgery?
- Are you able to attend regular clinic appointments for tests and treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will have regular visits to the clinic for check-ups. These visits will involve various tests, such as blood tests, scans (like CT or MRI scans), and physical examinations, to see how you are responding to the treatment and to monitor your health. You will receive the study medication, MK-4830 (alone or with Pembrolizumab), according to a specific schedule decided by the research team.
The total amount of time you will spend in the study can vary. You will receive the treatment for a set period, and then there will be follow-up appointments to track your health even after you stop taking the study medicines. The team will explain the full schedule of visits, tests, and follow-ups so you know exactly what to expect. This is usually explained in an informed consent form that you will read and discuss with the study team.
Potential risks and benefits
Locations (4)
- —Greece
- —France
- —Spain
- —Poland
Common questions
What is MK-4830?
MK-4830 is a new medicine being tested in this study to see if it can help treat advanced cancers.
What is Pembrolizumab?
Pembrolizumab (Keytruda) is an existing medicine already used to treat some cancers, and in this study, it's being tested with MK-4830.
Why is this study important?
This study helps doctors learn if MK-4830 is safe and how it works in people, which is a key step in developing new cancer treatments.
Will I get better if I join this study?
There's no guarantee that you will get better from taking part, as this is an early-stage study. However, the information learned might help others in the future.
Who can join this study?
Adults aged 18 or older with certain types of advanced cancer may be able to join, if they meet specific health requirements.
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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