RecruitingNot ApplicableNCT07049276

The Multicentre Selective Lymphadenectomy Trial - 3

Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma

Sponsor

Melanoma Institute Australia

Enrollment

1,500 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cutaneous Melanoma, Stage III

Summary

The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \& lymphoedema), an improved quality of life, at a lower healthcare utilisation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (MSLT-3) is studying whether adding immunotherapy after lymph node surgery improves survival in patients with advanced melanoma (stage IIIB, C, or D) that has spread to the lymph nodes. **You may be eligible if...** - You are 18 or older with confirmed resectable (surgically removable) stage IIIB, C, or D melanoma of the skin or from an unknown primary site - You have at least one enlarged or confirmed cancerous lymph node in the groin, armpit, or neck - You have up to 3 satellite or in-transit skin metastases that can be fully removed - A new biopsy from a previously unirradiated lesion is possible **You may NOT be eligible if...** - Your melanoma has spread to distant organs (stage IV) - Your lymph node involvement is beyond the groin, armpit, or neck areas (unless in certain permitted sites) - You have had more than 3 satellite or in-transit metastases, or they cannot be fully removed - You have serious health conditions that prevent surgery or safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIndex lymph node resection

The largest lymph node affected with melanoma

PROCEDURETherapeutic lymph node dissection

Removal of all nodes in the melanoma affected lymph node basin

Locations(7)

Cedars-Sinai Medical Centre

Los Angeles, California, United States

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

San Maria della Misericordia Hospital

Perugia, Italy

The Royal Marsden

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07049276

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