Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open label, single arm trial evaluating the efficacy and safety of EVX-01 in combination with pembrolizumab in checkpoint inhibitor treatment naïve adults with unresectable or metastatic melanoma

This research study is for adults with advanced melanoma, a type of skin cancer, that has spread or can't be removed by surgery. These patients haven't had previous treatment with similar cancer drugs. The study is testing a new drug called EVX-01 when given together with an existing approved drug, pembrolizumab (also known as Keytruda). Researchers want to find out if this combination can make tumours shrink or stop growing, and to check for any side effects. This is a Phase II study, meaning it's an earlier stage of drug testing focused on how well the treatment works and its safety in a group of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Evaxion A/S

Enrolment target

Start

17 Jun 2024

unresectable or metastatic melanoma

What is this study about?

This study is investigating a new treatment approach for people with advanced melanoma. Melanoma is a serious type of skin cancer, and sometimes it can spread to other parts of the body (this is called metastatic melanoma) or grow in a way that surgery can't fully remove it (unresectable melanoma).

The main idea behind this study is to see if combining a new drug, EVX-01, with an already approved cancer medication called pembrolizumab (you might know it as Keytruda) can be more effective. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer. The researchers want to understand how well this combination treatment can shrink tumours or stop them from growing, and also to learn about any potential side effects.

This is called an 'open-label, single-arm' study, which means everyone in the study will receive the same treatment (the combination of EVX-01 and pembrolizumab), and both you and your doctors will know which treatment you are getting. It's a Phase II trial, which means the study is focused on gathering more information about the treatment's effectiveness and safety in a group of patients, following earlier safety tests.

Key takeaways

This study is for adults with advanced melanoma.
It tests a new drug, EVX-01, with an existing drug, pembrolizumab (Keytruda).
The aim is to see if this combination shrinks tumours and is safe.
Participants will receive both study drugs and have regular check-ups over 24 months.
This is an earlier stage (Phase II) clinical trial.

Who may be eligible?

To be considered for this study, participants generally need to be adults, aged 18 or older.

Crucially, you would have to have advanced melanoma that either cannot be removed surgically or has spread to other parts of your body. Also, you must not have received any previous treatment with certain types of cancer drugs that affect the immune system (called checkpoint inhibitors). This helps the researchers understand the effects of the new combination treatment more clearly.

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 melanoma that has spread or cannot be removed by surgery?
Have you NOT previously received a type of immunotherapy called a checkpoint inhibitor for your melanoma?
Are you otherwise well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll receive doses of both EVX-01 and pembrolizumab (Keytruda). The treatment will be given for up to 24 months. During this time, you'll have regular medical appointments, which will include examinations, blood tests, and scans (like CT or MRI scans) to check how the treatment is working and to monitor for any side effects. These assessments will help the doctors see if your tumour is shrinking or staying stable. The study will also look at how your immune system responds to EVX-01. The exact number and frequency of visits would be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving close medical attention and access to a new treatment combination that might help shrink or control your melanoma. However, there are also potential risks; new drugs can have side effects that are not yet fully known or can be uncomfortable or serious. The study will monitor you closely for any unwanted effects. It's important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is EVX-01?

EVX-01 is a new medication being tested to see if it can help fight melanoma, especially when combined with another treatment.

What is pembrolizumab (Keytruda)?

Pembrolizumab is an approved medication that works with your immune system to help it find and fight cancer cells.

What does 'unresectable or metastatic melanoma' mean?

This means your melanoma has spread to other parts of your body, or it's in a place where surgery can't completely remove it.

What is a 'Phase II' clinical trial?

Phase II trials are an earlier stage of drug testing focusing on whether a new treatment works, and how safe it is, in a group of people.

Will I know if I'm getting the study drugs?

Yes, this is an 'open-label' study, so you and your doctors will know you are receiving both EVX-01 and pembrolizumab.