AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases

This study is for people with advanced melanoma, a serious form of skin cancer, that has spread and can’t be removed by surgery. It focuses on patients whose cancer has not improved or has gotten worse after treatment with a type of immunotherapy called anti-PD1 checkpoint inhibitors. Researchers are testing combinations of a drug called pembrolizumab (also known as KEYTRUDA) with new injection therapies. These new therapies (Darleukin and Fibromun) are given directly into the cancer tumours themselves. The main goal is to see if these treatments can shrink the tumours over two years. The study aims to find more effective ways to help people whose melanoma has been difficult to treat.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Philogen S.p.A.

Enrolment target

Start

14 Jan 2026

Patients with diagnosis of unresectable clinical stage III or IV metastatic melanoma with presence of injectable cutaneous subcutaneous or nodal lesions and resistant to or progressing upon anti-PD1 immunotherapy

What is this study about?

This research study is about finding new and better ways to treat a type of skin cancer called melanoma, specifically when it's advanced and has spread to other parts of the body (stage III or IV). It's for people whose melanoma can't be removed by surgery and hasn’t responded well to a common type of treatment called anti-PD1 immunotherapy, or whose cancer has started to grow again after such treatment.

The study combines a widely used immunotherapy drug, pembrolizumab (also known as KEYTRUDA), with other new treatments. These new treatments, called L19IL2 and L19TNF (which you might see listed as Darleukin and Fibromun), are given as injections directly into the cancer tumours themselves. The idea is that by targeting the tumour directly, these treatments might help the immune system fight the cancer more effectively when combined with pembrolizumab.

By trying these new combinations, doctors hope to find out if they can shrink the tumours in patients who haven't had success with previous treatments. The researchers will be closely watching how well the tumours respond over a period of up to two years. This is a Phase II study, which means it's an important step in determining if these new treatments are safe and effective enough to be studied in a larger group of people in the future.

Key takeaways

This study is for advanced melanoma that hasn't responded to standard immunotherapy.
It combines an existing drug (pembrolizumab) with new injected treatments.
The new treatments are given directly into the tumours.
The main goal is to see if these combined treatments can shrink tumours.
Participation lasts up to two years with regular check-ups and scans.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, 18 years or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with advanced melanoma (stage III or IV) that doctors agree cannot be removed by surgery. Another important point is that your cancer must be located in places where the new treatment injections can be given, such as in visible skin tumours, lumps just under the skin, or affected lymph nodes.

Finally, your melanoma must have either not responded to previous treatment with anti-PD1 immunotherapy (like pembrolizumab) or it must have started to grow again after you were treated with it. This study is specifically looking for people who are facing challenges with their current melanoma treatment options.

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 (stage III or IV) that surgery can't remove?
Does your melanoma have visible, injectable tumours (on skin, under skin, or in lymph nodes)?
Has your melanoma not responded to previous anti-PD1 immunotherapy, or has it gotten worse after such treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive regular treatments and check-ups over a period of up to two years. You would receive pembrolizumab through a drip into your arm, like a standard infusion. The other study medications (Darleukin or Fibromun, or a combination) would be given as injections directly into your accessible cancer tumours.

Throughout the study, you would have appointments for health checks, blood tests, and scans (like CT or MRI) to see how the treatment is working and to monitor your general health. Researchers would be carefully looking to see if your tumours are shrinking. After the main treatment period, there would be follow-up visits to continue tracking your health and the long-term effects of the treatment. The exact number of visits and tests would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining access to new treatments that are not yet widely available. These treatments might help to shrink your tumours, especially if standard therapies haven't worked for you. However, there are also potential risks; you might experience side effects from the medications, which could range from mild to serious. It’s important to remember that the new treatments might not work for everyone, and sometimes they may not be more effective than current approaches. You will always have the right 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
Italy
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Unverified
Germany

Common questions

What is advanced melanoma?

Advanced melanoma is a type of skin cancer that has spread from where it started to other parts of the body, or cannot be removed by surgery.

What is anti-PD1 immunotherapy?

This is a type of treatment that helps your own body's immune system fight cancer cells. Pembrolizumab (KEYTRUDA) is an example of this.

What do 'intratumoural injections' mean?

It means the study medicine is injected directly into the cancer tumour itself, rather than into a vein or taken as a pill.

Will I know which treatment I'm getting?

This is a 'randomised' study, meaning you would be put into one of three treatment groups by chance. You wouldn't be able to choose your group.

How long will the treatment last?

The treatment would be given for a period of time, and researchers would monitor your progress and health for up to two years.