Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6

The ARTISTRY-6 study is a clinical trial focused on advanced melanoma, which is a type of skin cancer that has spread. It's also looking at melanoma that starts in moist linings of the body, like the nose or mouth. Researchers want to understand how effective a new drug, Nemvaleukin Alfa, is at treating these cancers. They are testing it by itself and also in combination with an existing treatment called Pembrolizumab (also known as KEYTRUDA). The main goal is to see if these treatments can shrink the tumours. They will also be looking at how long these benefits last, if the cancer stays stable, and importantly, the safety of these medicines and any side effects people might experience.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Mural Oncology Inc.

Enrolment target

Start

14 Oct 2024

Advanced cutaneous melanoma and Advanced mucosal melanoma

What is this study about?

This study, named ARTISTRY-6, is designed to explore new treatment options for advanced melanoma, a serious form of skin cancer. Advanced melanoma means the cancer has spread from where it started. The study is also looking at mucosal melanoma, which is a rare type that develops in the moist linings of the body, such as inside the nose, mouth, or other internal organs.

The main focus of ARTISTRY-6 is a new medicine called Nemvaleukin Alfa. Researchers are testing this drug in different ways: some patients will receive Nemvaleukin Alfa on its own, while others will receive it alongside another well-known cancer treatment called Pembrolizumab (you might know this as KEYTRUDA). The hope is that these treatments can help to stop the cancer from growing or even shrink the tumours.

This kind of study is called a 'Phase 2' trial. This means that earlier tests have shown the drug to be generally safe, and now researchers want to see how well it works and gather more information on its safety. By participating, patients contribute to learning more about potential new treatments for these types of melanoma, which could help others in the future.

Key takeaways

This study is testing new treatments for advanced skin and mucosal melanoma.
It uses a new drug, Nemvaleukin Alfa, alone or with Pembrolizumab (KEYTRUDA).
The main aim is to see if these treatments shrink tumours and are safe.
It's a Phase 2 trial, meaning researchers are gathering more information on effectiveness and safety.
Participation involves regular hospital visits for treatment and monitoring.
You have the right to leave the study at any time.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with advanced cutaneous (skin) melanoma or advanced mucosal melanoma that has spread within their body.

There will be other, more detailed health requirements that your doctor will check. These are in place to make sure the study is safe for you and that the results are as clear as possible. Things like your overall health, any other medical conditions you have, and previous treatments will be carefully reviewed.

Basically, the study is looking for adults with specific types of advanced melanoma to see if the new treatments might be helpful for them.

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 a diagnosis of advanced cutaneous (skin) melanoma?
Or do you have a diagnosis of advanced mucosal melanoma?
Have you discussed your overall health with your doctor regarding clinical trials?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll have regular visits to the treatment centre. During these visits, the medical team will give you the study medication, either Nemvaleukin Alfa alone or with Pembrolizumab, through a drip (infusion). You'll also have various tests, like blood samples, check-ups of your heart (ECGs), and monitoring of your weight and general health. The doctors will regularly check how your cancer is responding to the treatment, likely through scans, and carefully record any side effects you might experience.

These assessments are important for understanding how the treatment is working and ensuring your safety. The total time you spend on the study can vary depending on how you respond to the treatment and for how long. The medical team will explain the full schedule of visits and procedures, including how long the follow-up period might be.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to new treatments before they are widely available. While the treatments being tested are hoped to be effective for your advanced melanoma, there's no guarantee they will work for everyone, and your condition may not improve. As with all medications, there might be side effects – some could be mild, while others might be more serious. The study team will carefully monitor you for any side effects and provide appropriate care. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Italy

Common questions

What is Nemvaleukin Alfa?

Nemvaleukin Alfa is a new drug being tested in this study to see if it can help treat advanced melanoma by working with your body's immune system.

What is Pembrolizumab (KEYTRUDA)?

Pembrolizumab is a medicine already used to treat some cancers, including melanoma. It helps your immune system fight cancer cells.

What does 'advanced' melanoma mean?

'Advanced' means the melanoma has grown and spread to other parts of your body, rather than just being in one place.

Will I definitely get the new drug?

Yes, everyone in this study will receive Nemvaleukin Alfa, either by itself or together with Pembrolizumab.

How often will I need to visit the hospital?

The study involves regular visits for treatments and check-ups, and the medical team will give you a detailed schedule of these appointments.