A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizuma Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B
This study, called KEYMAKER-U02 Substudy 02B, is investigating new ways to treat advanced melanoma, a serious form of skin cancer. Specifically, it's for people whose melanoma has stopped responding to a type of immunotherapy called PD-1 inhibitors, like pembrolizumab (Keytruda). The main goal is to test the safety of several different new medications, both on their own and when combined with pembrolizumab. Researchers will also be checking to see how well these treatments shrink the cancer and for how long. It's a phased study, meaning it looks at safety first, then effectiveness. This research aims to find better treatment options for people with this challenging form of melanoma.
At a glance
What is this study about?
This research study, known as KEYMAKER-U02 Substudy 02B, is focused on finding better treatments for a type of skin cancer called melanoma. This particular study is for people whose melanoma has become difficult to treat, specifically when it has stopped responding to a common immunotherapy drug called pembrolizumab (Keytruda), or similar treatments known as PD-1 inhibitors. When a cancer stops responding, doctors say it is 'refractory'.
The study will look at several new medications, sometimes given alone, and sometimes given alongside pembrolizumab. The main things the doctors want to check are the safety of these new treatments and any side effects they might cause. They will also be carefully watching to see if the treatments shrink the cancer or stop it from growing. This is a "Phase 1/2" study, which means it starts by carefully testing the safety of different doses, and then expands to see how effective the treatments are.
Developing new treatments is very important for people with advanced melanoma that is no longer responding to standard care. Studies like this help doctors understand which new medicines are safe and have the best chance of helping patients in the future. The results from this research will help guide future treatment options for this challenging type of cancer.
Key takeaways
- This study is for advanced melanoma that hasn't responded to standard treatments.
- It aims to test new medications for safety and effectiveness.
- Some treatments are given alone, others with pembrolizumab (Keytruda).
- Close monitoring for side effects is a key part of the study.
- The study seeks better options for a challenging type of cancer.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to meet certain conditions. The main one is that you must have melanoma that has previously been treated with a PD-1 inhibitor (like pembrolizumab) but is no longer responding to it.
Participants in the study must be 18 years old or older. Both men and women are welcome to take part. There will be other specific health checks and medical requirements that your doctor will discuss with you to make sure the study is a safe and suitable option.
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.
- Do I have melanoma?
- Has my melanoma stopped responding to treatments like pembrolizumab (Keytruda)?
- Am I 18 years old or older?
- Am I able to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, you will receive one or more of the study medications, which will be given as a drip into your arm (infusion) or as tablets. You will have regular appointments where doctors and nurses will monitor your health very closely. These appointments will involve blood tests, physical examinations, and scans to see how the treatment is affecting your cancer. Throughout the study, the medical team will keep a close eye on any side effects you might experience.
The number of visits and the total length of time you'll be in the study will depend on the specific treatment you receive and how your cancer responds. There will also be a follow-up period after you finish the treatment part of the study to continue monitoring your health. What is involved for you personally will be explained in detail by the study team, so you know exactly what to expect.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedHungary
Common questions
What kind of cancer is this study for?
This study is for people with melanoma, a type of skin cancer, that has not responded to previous treatments like pembrolizumab (Keytruda).
What are the main goals of this study?
The main goals are to find out how safe these new treatments are and to see if they can shrink or control the melanoma.
What drugs are being tested?
The study tests several new medications, sometimes alone and sometimes with pembrolizumab (Keytruda).
How old do I need to be to join?
You need to be 18 years old or older to take part in this study.
Can I leave the study if I change my mind?
Yes, you can 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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