Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

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 02D

This study, known as KEYMAKER-U02, focuses on adults aged 18 and over who have advanced melanoma, a serious form of skin cancer. Crucially, the cancer in these patients has spread to their brain. The study is investigating different treatment approaches. Some patients will receive a well-known cancer drug called pembrolizumab (also known as Keytruda) on its own. Others will receive pembrolizumab combined with a newer investigational drug called Lenvatinib, or another investigational medicine called MK-1308A. The main goal is to see how safe these treatments are and how well they work to shrink the cancer. This includes looking at side effects, how long the treatment keeps the cancer under control, and how long people respond to the treatment, especially in the brain.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

23 Jan 2024

Advanced melanoma with brain metastases PD-1 refractory or PD-1 naive

What is this study about?

This research study, called KEYMAKER-U02, is designed for adults who have advanced melanoma, a type of skin cancer that has spread to the brain. This is a difficult cancer to treat, and doctors are always looking for better options. Some patients in this study have already tried a common treatment called PD-1 therapy (like pembrolizumab) and their cancer didn't respond, or it stopped working. Other patients haven't tried PD-1 therapy yet.

Researchers want to find out if new combinations of existing drugs, or entirely new drugs, can help to shrink the cancer, particularly in the brain, and improve patients' health. They are testing different treatments in groups of patients. One group might receive pembrolizumab (which is a common immunotherapy drug) on its own. Other groups might receive pembrolizumab alongside other investigational drugs like Lenvatinib or MK-1308A. These different treatment arms are a way to efficiently test several approaches at once.

The main things the researchers are looking at are the safety of these treatments – meaning how many side effects people experience and how serious they are – and also how well the treatments work. This is measured by how many people see their cancer shrink or disappear, how long that response lasts, and how long people live without their cancer getting worse. They are particularly interested in how the treatments affect the cancer in the brain. This type of study, called a Phase 1/2 study, helps doctors understand if a new treatment is safe enough to proceed to larger studies, and if it shows any promise in treating the disease.

Key takeaways

This study is for adults with advanced melanoma that has spread to the brain.
It's testing different treatment options, including pembrolizumab alone or with other new drugs.
The main goals are to check the safety and how well the treatments work.
Participation involves regular clinic visits for treatment, monitoring, and scans.
You can stop participating in the study at any time.

Who may be eligible?

This study is specifically for adults, aged 18 and older, who have a type of skin cancer called advanced melanoma. A key requirement is that the melanoma must have spread to the brain.

It's suitable for both men and women. Some patients who are considered for this study may have already received a type of immunotherapy called PD-1 therapy (like pembrolizumab), but their cancer either didn't respond or got worse. Other patients may not have had this type of treatment yet.

There will also be other specific medical checks and requirements before you can join, to make sure the treatment is as safe as possible for you. These will be discussed in detail by the study team.

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?
Do you have advanced melanoma?
Has your melanoma spread to your brain?
Are you willing to have regular hospital visits, tests, and scans?
Have you discussed this study with your personal doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive one of the study treatments – either pembrolizumab alone, or pembrolizumab combined with Lenvatinib or MK-1308A. You would have regular visits to the clinic for check-ups, blood tests, scans, and to receive your medication, which is given as an infusion (drip). The exact schedule of visits would depend on which treatment arm you are in.

Throughout the study, doctors and nurses would carefully monitor you for any side effects and to see how your cancer is responding to the treatment. This will involve imaging scans to check the size of tumours, especially in the brain. The total duration of your participation would depend on how your body responds to the treatment and the decisions made by your medical team, but it could involve ongoing treatment and follow-up.

Potential risks and benefits

Participating in this study might offer a chance to receive new or different treatments for advanced melanoma that has spread to the brain, which could potentially slow down or shrink your cancer, and ideally improve your health. However, like all medicines, the study drugs can cause side effects, some of which might be serious. The doctors will carefully monitor you for these and will explain them to you fully. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Poland
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Unverified
Greece
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Unverified
Spain
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Unverified
Italy
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Unverified
France

Common questions

What is advanced melanoma?

Advanced melanoma is a serious type of skin cancer that has grown and spread from its original site to other parts of the body, including the brain.

What is an 'investigational agent'?

An 'investigational agent' is a drug that is still being tested in clinical studies and is not yet available as a standard treatment.

What does 'PD-1 refractory' mean?

It means the cancer did not respond to, or became resistant to, a common type of immunotherapy treatment that targets the PD-1 pathway.

What is a 'Phase 1/2' study?

It's a study that firstly checks if a treatment is safe (Phase 1) and then begins to look at how well it works (Phase 2), combining these steps for efficiency.

Will I definitely get a new drug?

You will receive one of the study treatments, which could be pembrolizumab alone, or in combination with one of the newer investigational drugs. Your doctor will explain which treatment arm you might be part of.