The Multicentre Selective Lymphadenectomy Trial - 3
NCT07049276 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500
Last updated 2026-04-23
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.
Conditions
- Cutaneous Melanoma, Stage III
Interventions
- PROCEDURE
-
Index lymph node resection
The largest lymph node affected with melanoma
- PROCEDURE
-
Therapeutic lymph node dissection
Removal of all nodes in the melanoma affected lymph node basin
Sponsors & Collaborators
-
Melanoma Institute Australia
lead OTHER
Principal Investigators
-
Alexander CJ van Akkooi · Melanoma Institute Australia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2030-08-31
- Completion
- 2040-08-31
Countries
- United States
- Australia
- Canada
- Italy
- United Kingdom
Study Locations
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