A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

To join this study, you need to be at least 18 years old and have advanced melanoma that has been completely removed by surgery. This surgery must have happened within the last 13 weeks. Your body should also be generally healthy enough to take part, meaning your organs are working well, and you should be able to get around and do most of your daily activities without too much trouble.

There are also some things that would mean you can't join. For example, if you have a known history of eye melanoma or specific severe allergies to pembrolizumab or its ingredients. Having certain autoimmune diseases (where your body's immune system attacks itself) or having had particular treatments like live vaccines or other similar cancer drugs recently would also prevent you from participating. Your study doctor will check all these details carefully.

It's important to remember that these are just some of the main points, and your doctor will consider all aspects of your health and medical history to confirm if this study is suitable for you.

If you decide to take part in this study, you would first go through a screening period, which is part of the total 28 weeks you could be involved. During this time, doctors will check to make sure the study is right for you. If you qualify, you'll be randomly assigned to receive one of three treatments: GME751, or Keytruda approved in either the US or Europe. You won't get to choose which group you are in, and it's like drawing lots, with an equal chance of being in any of the three groups.

The treatment itself will last for 24 weeks. This means you will receive the study medication over four cycles, with each cycle lasting six weeks. Throughout this period, you will have regular visits for check-ups and assessments to monitor your health, how you are responding to the treatment, and if you experience any side effects. You might need blood tests or other examinations as part of these visits.

If your melanoma comes back, if the treatment causes side effects that are too difficult to manage, or for other medical reasons, you might need to stop the study treatment early. However, if you are doing well on the treatment and your melanoma hasn't returned, you may be able to continue receiving pembrolizumab after the study, depending on the rules in your country.