Actively Recruiting
Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma
Led by Melanoma Institute Australia · Updated on 2026-04-23
1500
Participants Needed
7
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical approaches for patients with Stage III melanoma who have undergone six weeks of standard neoadjuvant immunotherapy. The study aims to show that selective index lymph node resection is not worse than the standard therapeutic lymph node dissection in terms of two-year recurrence-free survival. Secondary goals include assessing surgical complications, quality of life, and healthcare costs associated with each surgery. Participants receive immunotherapy with checkpoint inhibitors for up to six weeks before surgery. Afterward, they are randomly assigned to either have only the largest affected lymph node removed (index lymph node resection) or to undergo the standard surgery removing all lymph nodes in the affected area (therapeutic lymph node dissection). If patients do not show a major pathological response to immunotherapy, they will receive the standard surgery. The study will follow patients for up to ten years. Throughout the trial, participants attend regular appointments to monitor for melanoma recurrence and evaluate side effects, quality of life, and economic impact. Various assessments include pathological examination of lymph nodes, patient questionnaires on quality of life, and tracking of surgery-related complications. The main outcome measured is recurrence-free survival at two years, with additional long-term follow-up to observe overall survival and other health outcomes.
CONDITIONS
Brief 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, C or D cutaneous or unknown primary melanoma
- At least one macroscopic lymph node confirmed by pathology, palpable or enlarged per RECIST criteria, or positive on imaging
- Up to 3 satellite or in-transit metastases permitted if completely resectable
- Lymph node involvement limited to groin, axilla, or neck, unilateral or bilateral, with some additional nodes allowed if fully resectable
- Tumour amenable to new core biopsy and archival tissue collection if available
- Scheduled to receive systemic neoadjuvant immunotherapy including at least one PD-(L)-1 checkpoint inhibitor
- Neoadjuvant treatment course no longer than 6 weeks
- Eastern Cooperative Oncology Group (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 nodes outside groin, axilla, or neck except fully resectable popliteal, epitrochlear, or triangular intermuscular space nodes
- Evidence of distant metastasis
- Previous extensive lymph node surgery to the same nodal basin beyond sentinel lymph node biopsy
- Prior radiotherapy to the same nodal basin
- Contraindications to nivolumab, ipilimumab, pembrolizumab, or relatlimab
- Prior exposure to certain immunotherapy or chemotherapy agents
- Planned targeted therapy or experimental immunotherapy in the neoadjuvant setting
- Known additional active malignancies within 3 years except certain treated skin or in situ cancers
- Active autoimmune disease or need for high-dose systemic steroids or immunosuppressive therapy
- History of allogenic tissue or organ transplant
- Active Hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding females
- Medical or social conditions preventing adherence to study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive immune system boosting drugs for up to 6 weeks before surgery to help reduce or remove the tumour in the lymph nodes.
Visits as per treatment schedule
Duration - 1 day
Participants undergo surgery to remove lymph node tissue. Those with a major pathological response may have only the largest affected lymph node removed, while others have a complete removal of all nodes in the affected lymph node area.
1 surgical procedure (in-person)
Duration - Up to 10 years
Participants have regular appointments with their surgeon to monitor for melanoma recurrence and manage any side effects. Follow-up includes assessments of quality of life, adverse events, and health outcomes for up to 10 years.
Regular visits scheduled over 10 years
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
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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