A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02C
This study is for adults in the UK who have advanced melanoma, a serious type of skin cancer. It's called KEYMAKER-U02: Substudy 02C. The study is divided into two parts, Phase 1 and Phase 2, and tests several new experimental medicines, either on their own or alongside an established cancer treatment called Pembrolizumab (also known as Keytruda). Researchers want to find out how safe these new treatments are by looking at any side effects patients might experience. They also want to see how effective the treatments are at reducing the cancer. This is an "open-label" study, meaning both you and your study doctor will know which treatment you are receiving.
At a glance
What is this study about?
This study, called KEYMAKER-U02: Substudy 02C, is for adults with advanced melanoma. Melanoma is a type of skin cancer that has spread or is considered high-risk. The study is part of a larger research effort to find better treatments for this condition. It's designed to investigate several new medicines, either given on their own or in combination with an existing medicine called Pembrolizumab, which is already used to treat melanoma.
The main aims of this study are to understand how safe these new treatments are. The researchers will closely monitor participants for any side effects that might occur. They also want to see how well the treatments work against the cancer. They will measure whether the treatments help to get rid of the cancer, or part of it, before surgery if surgery is planned. This information helps doctors decide which new treatments might be helpful for future patients.
This is an "open-label" study, which means that if you take part, both you and your study doctor will know which specific treatment you are receiving. It's important to remember this is a research study – the treatments being tested are experimental, meaning they are not yet widely available and doctors are still learning about them.
Key takeaways
- This study is testing new treatments for advanced melanoma.
- It aims to find out how safe and effective these new treatments are.
- Some treatments are given alone, others with an existing drug (Pembrolizumab).
- You would know which treatment you are getting ('open-label').
- Participation involves regular hospital visits, tests, and follow-up.
- You can stop taking part at any time without affecting your medical care.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have a specific type of advanced melanoma. This means your melanoma has either spread to nearby lymph nodes or other tissues, or is considered to be at a high risk of coming back after treatment. Both men and women can take part.
There will be other detailed health requirements that your study doctor will discuss with you. These are in place to make sure the study treatments are as safe as possible for you and that the results of the study are clear. For example, you might need to have certain blood test results or not have other serious health problems.
Your doctor will carefully review your medical history and perform tests to see if this study is suitable for you.
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?
- Have you been diagnosed with advanced melanoma?
- Are you able to attend regular hospital appointments?
- Are you comfortable with receiving an experimental treatment?
What does participation involve?
If you decide to take part, you'll receive one of the experimental treatments or Pembrolizumab, either alone or in combination. You'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits will help the study team keep a close eye on any side effects and track the cancer's response. The total duration of your participation will depend on the specific treatment plan you receive and how well you tolerate the medicine, but it will involve multiple visits over several months, with follow-up appointments continuing for some time after treatment ends.
Potential risks and benefits
Locations (2)
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Common questions
What is advanced melanoma?
Advanced melanoma is a type of skin cancer that has spread from where it first started, usually to nearby lymph nodes or other parts of the body.
What is Pembrolizumab (Keytruda)?
Pembrolizumab is a medicine already used to treat certain cancers, including melanoma. It works by helping your body's immune system fight cancer cells.
What does 'Open-Label' mean in a study?
Open-label means that everyone involved – you, your doctor, and the study team – will know exactly which treatment you are receiving.
Will I definitely get a new experimental drug?
You might receive one of the new experimental drugs, either on its own or with Pembrolizumab, or you might receive Pembrolizumab alone, depending on which part of the study you are in.
Is this a cure for melanoma?
This is a research study to investigate new treatments. While the aim is to improve outcomes for patients, it's not guaranteed to be a cure.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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