RecruitingNAINTERVENTIONAL

The Multicentre Selective Lymphadenectomy Trial - 3

This study looks at a type of skin cancer called melanoma that has spread to nearby lymph nodes (Stage III). Doctors want to find out if a less extensive surgery is as effective as the current standard surgery (removing all lymph nodes in an area) after patients have received initial immune-boosting medicines. Patients will first get six weeks of these medicines to help their body fight the cancer. Then, they will either have a single, largest affected lymph node removed, or they'll have all the lymph nodes in the area taken out. The main aim is to check if the two-year cancer-free survival rates are similar. Researchers also want to see if the smaller surgery leads to fewer problems like wound issues and swelling, better quality of life, and lower healthcare costs.

At a glance

Status

Recruiting

Phase

Sponsor

Melanoma Institute Australia

Enrolment target

1,500

Start

01 Oct 2025

Estimated completion

01 Aug 2040

Cutaneous Melanoma, Stage III

What is this study about?

When melanoma, a type of skin cancer, spreads to the lymph nodes, it's called Stage III melanoma. The usual treatment for this has been an operation to remove all the lymph nodes in the affected area, like your armpit, neck, or groin. This is a big surgery and can sometimes lead to problems such as swelling from fluid build-up or issues with the wound.

In recent years, new medicines called immunotherapy have shown great promise. These drugs help your body's own immune system to find and fight cancer cells more effectively. Doctors are now giving these powerful medicines before surgery – this is called 'neoadjuvant therapy.' Giving immunotherapy first can shrink the cancer and reduce the number of cancer cells in the lymph nodes before they are removed, which is a very positive sign for long-term recovery.

This study wants to explore if, after receiving neoadjuvant immunotherapy, a smaller operation might be just as good as the larger, standard surgery. Instead of removing all lymph nodes, this smaller surgery involves taking out only the main affected lymph node, which doctors identify before treatment. The aim is to see if this less invasive approach can still prevent the cancer from coming back for at least two years, but with fewer side effects and a better quality of life for patients. It could also mean less time in hospital and lower overall costs for healthcare.

Key takeaways

This study compares two surgical options for Stage III melanoma after immunotherapy.
The goal is to see if a less extensive surgery is just as effective as the standard one.
It aims to reduce surgical side effects and improve quality of life.
Patients first receive 6 weeks of immune-boosting medication.
The study also looks at healthcare benefits of the different approaches.

Who may be eligible?

This study is open to men and women aged 18 and over who have agreed to take part. You must have melanoma that has spread to your lymph nodes (Stage III) but hasn't spread further into your body. This spread to lymph nodes must be clear and confirmed by tests.

Your cancer must be treatable with surgery, and you need to have at least one lymph node that doctors can identify as affected, either because it's swollen, shows up on scans, or has been confirmed by a small tissue sample. If you also have a few very small skin spots of melanoma nearby (satellite or in-transit metastases), you can still join if these can all be removed with surgery.

Importantly, you must be scheduled to receive specific immune-boosting medicines (like nivolumab or pembrolizumab) before your surgery. These medicines are typically given over about six weeks.

Quick self-check

I am 18 years old or older.
My melanoma has spread to nearby lymph nodes (Stage III), but not further.
My doctors can identify at least one affected lymph node.
I am scheduled to receive specific immune-boosting medicines before surgery.
My melanoma and any small skin spots can be fully removed by surgery.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first receive about six weeks of special immune-boosting medicines before any surgery. After this initial treatment, you will then be assigned to one of two surgery groups: either the removal of only the largest affected lymph node, or the removal of all lymph nodes in that area. Researchers will follow your health and recovery closely after surgery. You will have regular check-ups to monitor your progress, check for any cancer recurrence, and assess your quality of life, including any surgical complications like wound problems or swelling. The total duration of your participation in the study will depend on your follow-up schedule as determined by the research team, typically involving regular appointments over several years to track long-term outcomes.

Potential risks and benefits

Taking part in this study may offer benefits such as receiving cutting-edge immune-boosting therapy before surgery, which has shown good results for Stage III melanoma. You might also be in the group that receives a less extensive surgery, potentially leading to fewer side effects and quicker recovery. However, all medical treatments have risks. Immunotherapy can cause side effects like nausea, skin rashes, or even more serious problems like diabetes or liver issues. Surgery carries its own risks, including pain, infection, wound healing problems, and long-term swelling (lymphoedema). You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Cedars-Sinai Medical Centre
Los Angeles, United States· Not yet recruiting
Calvary Mater Newcastle
Newcastle, Australia· Recruiting
Melanoma Institute Australia
Wollstonecraft, Australia· Recruiting
Fiona Stanley Hospital
Murdoch, Australia· Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Canada· Not yet recruiting
San Maria della Misericordia Hospital
Perugia, Italy· Not yet recruiting
The Royal Marsden
London, United Kingdom· Not yet recruiting

Common questions

What is Stage III melanoma?

Stage III melanoma means the skin cancer has spread from the original spot to nearby lymph nodes, but not to other distant parts of the body.

What are lymph nodes?

Lymph nodes are small, bean-shaped glands that are part of your body's immune system. They help filter harmful substances and fight infections.

What is immunotherapy?

Immunotherapy is a type of medicine that helps your own immune system recognise and attack cancer cells more effectively.

What's the difference between the two surgeries?

One surgery removes just the main affected lymph node, and the other removes all the lymph nodes in the area where the cancer has spread.

Can I choose which surgery I get?

No, you will be assigned to one of the two surgery groups by chance, like flipping a coin, to ensure a fair comparison for the study.

How to find out more

Alexander CJ van Akkooi

alexander.vanakkooi@melanoma.org.au +612 9911 7200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.