The Multicentre Selective Lymphadenectomy Trial - 3 for Stage III Melanoma

This study is looking at two different surgical approaches for people with Stage III cutaneous melanoma (a type of skin cancer that has spread to lymph nodes). All participants will first receive 6 weeks of immunotherapy (treatment that helps your immune system fight cancer). Then, some will have an index lymph node resection (removal of the largest affected lymph node), while others will have a therapeutic lymph node dissection (removal of all lymph nodes in the affected area). The main goal is to see if these two surgeries lead to similar rates of cancer recurrence (return of cancer) after 2 years. Researchers also want to see if the index lymph node resection leads to fewer surgical problems, better quality of life, and lower healthcare costs. You may be able to join if you are 18 or older and have resectable Stage IIIB, C, or D cutaneous melanoma.

Study design: This interventional study plans to enroll 1500 participants. It compares two surgical procedures after immunotherapy to see if they are equally effective.
What's involved: Participants will receive 6 weeks of neoadjuvant immunotherapy before undergoing one of the two surgical procedures. The study will then assess recurrence-free survival.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed to measure recurrence-free survival at 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The Multicentre Selective Lymphadenectomy Trial - 3

Recruiting

NAAges 18+Interventional

Melanoma Institute Australia

~1,500 participants

Updated 2026-06-29 on ClinicalTrials.gov

What's tested:Index lymph node resectionTherapeutic lymph node dissection

At a glance

Recruiting sites

4 of 8 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Recurrence free survival

Measured over 2 years

Conditions

Cutaneous Melanoma, Stage III

Where it's being run

8 sites across 7 states

New South Wales2

California1

Western Australia1

Ontario1

Tel Aviv1

Italy1

United Kingdom1

Study leadership

Alexander CJ van Akkooi · STUDY_CHAIR · Melanoma Institute Australia

Who to contact

Alexander CJ van Akkooi

[email protected]

+612 9911 7200

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

A palpable node, confirmed by pathology

A non-palpable node, but enlarged per RECIST 1.1 criteria (≥ 15 mm in shortest diameter) and confirmed by pathology

An ultrasound or PET/CT scan positive lymph node of any size, confirmed by pathology. 5. Up to 3 satellite (defined as any foci of clinically evident cutaneous and/or subcutaneous metastases occurring within 2 cm of but discontinuous from the primary melanoma) or in-transit metastases (defined as clinically evident cutaneous and/or subcutaneous metastases occurring \>2 cm from the primary melanoma in the region between the primary and the regional lymph node basin) are permitted if they are completely resectable. 6. Lymph node involvement in the groin (iliac, inguinal or both), axilla or neck only and may be unilateral or bilateral. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable. 7. Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal lesion (if applicable) or tissue taken for current diagnosis will also be collected if available. 8. Systemic neoadjuvant immunotherapy is scheduled for administration with at least one PD-(L)-1 check point inhibitor (e.g. nivolumab, pembrolizumab, cemiplimab). The immunotherapy regimen may include other checkpoint inhibitors (e.g. ipilimumab, relatlimab, fianlimab). The patient should meet the fitness for treatment requirements as detailed in the relevant regulatory-approved Product Information or Summary of Product Characteristics. 9. Neoadjuvant course of treatment to be no longer than 6 weeks (allows for a maximum of 3 cycles at weeks 0, 3 and 6). 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 11. Anticipated life expectancy of \> 5 years.

Exclusion

Basal cell carcinoma of the skin

Squamous cell carcinoma of the skin

Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy

Prostatic intraepithelial neoplasia

In situ melanoma

Atypical melanocytic hyperplasia

Stage I melanoma

Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy. 12. An active autoimmune disease or a requirement for chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. The following are permitted:

Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)

Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose

Non-absorbed intra-articular steroid injections. 13. Has had an allogenic tissue/solid organ transplant. 14. Active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. 15. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority. 16. Pregnant or breastfeeding females. 17. Concurrent medical or social conditions that may prevent the patient from attending assessments or procedures per schedule.

What this trial measures

Recurrence free survival2 years
The proportion of patients with a major pathological response (MPR) alive and disease-free from the time of surgery to the end of 2 years follow up

Trialytics