Actively Recruiting
The Multicentre Selective Lymphadenectomy Trial - 3
Led by Melanoma Institute Australia · Updated on 2026-04-23
1500
Participants Needed
7
Research Sites
774 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Multicentre Selective Lymphadenectomy Trial - 3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at the time of consent
- Written informed consent
- Confirmed resectable pathological Stage IIIB, IIIC or IIID cutaneous or unknown primary melanoma
- At least one macroscopic lymph node involved, defined as palpable or enlarged per RECIST 1.1 criteria and confirmed by pathology
- Up to 3 satellite or in-transit metastases allowed if completely resectable
- Lymph node involvement limited to groin, axilla or neck (unilateral or bilateral), with certain fully resectable additional nodes permitted
- Tumour suitable for a new core biopsy
- Scheduled to receive systemic neoadjuvant immunotherapy with at least one PD-(L)-1 checkpoint inhibitor
- Neoadjuvant treatment course no longer than 6 weeks
- ECOG performance status of 0-1
- Anticipated life expectancy greater than 5 years
You will not qualify if you...
- Uveal or mucosal melanoma
- Only isolated satellite or in-transit metastases without lymph node involvement
- Involvement of lymph node basins other than groin, axilla or neck unless fully resectable
- Evidence of distant metastasis
- Prior lymph node surgery more extensive than sentinel lymph node biopsy in the same nodal basin
- Previous radiotherapy to the same nodal basin
- Contraindications to nivolumab, ipilimumab, pembrolizumab or relatlimab
- Prior exposure to certain immunotherapies or chemotherapy
- Planned neoadjuvant targeted therapy, non-checkpoint immunotherapy, or intralesional therapy
- Planned experimental immunotherapy in neoadjuvant setting
- Active additional malignancies within past 3 years except certain treated cancers
- Active autoimmune disease or need for significant immunosuppressive therapy prior to treatment
- History of allogenic tissue or solid organ transplant
- Active Hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding females
- Medical or social conditions preventing attendance to assessments or procedures
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Cedars-Sinai Medical Centre
Los Angeles, California, United States, 90025
Not Yet Recruiting
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Actively Recruiting
3
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
4
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6961
Not Yet Recruiting
5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Not Yet Recruiting
6
San Maria della Misericordia Hospital
Perugia, Italy
Not Yet Recruiting
7
The Royal Marsden
London, United Kingdom
Not Yet Recruiting
Research Team
A
Alexander CJ van Akkooi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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