Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor

This study is investigating a new medicine called Acasunlimab. It’s being tested alone and in combination with an existing drug, Pembrolizumab (also known as Keytruda). This study is for people in the UK who have a type of skin cancer called cutaneous melanoma. Specifically, it's for melanoma that is advanced, has spread to other parts of the body, or has returned after previous treatments with other anti-cancer drugs called 'checkpoint inhibitors.' The main aim is to see how well Acasunlimab works in shrinking the cancer (how many people respond). It's a Phase II study, meaning researchers are learning more about the medication's effectiveness and safety in a larger group of people after initial safety tests.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Genmab A/S

Enrolment target

129

Start

23 Oct 2025

Cutaneous Melanoma Relapsed/Refractory Locally Advanced Unresectable Melanoma (Stage IIIB IIIC or IIID)Metastatic Cutaneous Melanoma (Stage IV)

What is this study about?

This study is focused on people who have a type of skin cancer called cutaneous melanoma. This is melanoma that has either come back, spread to nearby areas, or spread to other parts of the body. Importantly, this study is for those whose melanoma has continued to grow or has returned even after they've had treatment with a specific type of anti-cancer drug known as a 'checkpoint inhibitor.' These drugs work by helping your own immune system fight the cancer.

The researchers are testing a new medicine called Acasunlimab. They want to see how well it works on its own, and also how it works when given together with another established medicine called Pembrolizumab (Keytruda). Pembrolizumab is another type of checkpoint inhibitor. This study is trying to find out if these treatments can help to shrink the melanoma or stop it from growing.

This is a 'Phase II' study, which means it's one of the earlier stages of drug testing in people. The main goals are to learn more about how effective Acasunlimab is (how many patients' cancers respond to the treatment) and to continue to check its safety in a larger group of patients. The information gathered from studies like this helps doctors understand if new treatments could become standard options for patients in the future.

Key takeaways

This study is testing a new medicine, Acasunlimab, for advanced melanoma.
It's for people whose melanoma has progressed after previous checkpoint inhibitor treatment.
Researchers want to see how well Acasunlimab works and if it's safe.
You would receive Acasunlimab, possibly with Pembrolizumab (Keytruda), via IV drip.
Participation involves regular hospital visits for treatment, tests, and monitoring.

Who may be eligible?

In general, this study is looking for adults aged 18 or older who have advanced cutaneous melanoma. This means your melanoma is either locally advanced (has spread significantly in the area where it started) or has spread to other parts of your body. A key requirement is that your melanoma must have continued to grow or come back after you've already received treatment with a type of drug called a 'checkpoint inhibitor'.

There will be other medical checks to make sure the study treatment is safe for you. These might include blood tests, scans, and a review of your overall health. You won't be able to join if you have certain other medical conditions or if you've recently had other types of cancer treatment.

The research team will review all your medical information to see if you meet all the specific criteria for this study. They will explain everything clearly if you are interested in taking part.

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 over?
Do you have cutaneous melanoma that is advanced or has spread?
Has your melanoma come back or progressed after you've had treatment with a 'checkpoint inhibitor' drug?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either Acasunlimab by itself, or Acasunlimab along with Pembrolizumab (Keytruda). Both of these medicines are given through a drip into a vein (an infusion). The study will involve regular visits to the hospital for these infusions, physical examinations, blood tests, and scans (like CT or MRI). These tests help the researchers monitor your health, check how your body is responding to the treatment, and look for any side effects.

The duration of your participation will depend on how you respond to the treatment and whether you experience any side effects. You will continue treatment as long as it is benefiting you and is safe. Even if you stop the treatment, you will likely have follow-up visits or phone calls for a period afterwards to monitor your health. The medical team will explain the full schedule of visits and procedures if you are considering joining.

Potential risks and benefits

Taking part in a clinical study may offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring by medical experts. However, there are also potential risks, including side effects from the study medicines and the need for frequent hospital visits and tests. The specific side effects for Acasunlimab are still being understood, but they could be similar to those seen with other cancer drugs. Your health and safety are the top priority, and the research team will explain all known side effects and risks. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
France
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Unverified
Spain
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Unverified
Netherlands
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Unverified
Germany

Common questions

What is cutaneous melanoma?

It's a type of skin cancer that starts in the cells that give your skin colour. 'Cutaneous' just means it's on the skin.

What is a 'checkpoint inhibitor'?

These are medicines that help your body's immune system recognise and fight cancer cells more effectively.

What does 'relapsed/refractory' mean?

It means the cancer has either come back after treatment, or hasn't responded well to previous treatments.

What is a 'Phase II' study?

It's an early stage of research where doctors learn more about how well a new medicine works and check for side effects in a larger group of people.

Will I definitely get the new medicine?

Yes, in this study, all participants will receive Acasunlimab, either alone or with Pembrolizumab (Keytruda). This study does not include a placebo (dummy drug).