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The Multicentre Selective Lymphadenectomy Trial - 3

Sponsor: Melanoma Institute Australia

NCT ID: NCT07049276

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Index lymph node resection (procedure), Therapeutic lymph node dissection (procedure)
How long the study runs
Study runs about 178 months (dates as stated)
About the drug or intervention
Index lymph node resection — procedure: The largest lymph node affected with melanoma · Therapeutic lymph node dissection — procedure: Removal of all nodes in the melanoma affected lymph node basin
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the Melanoma Institute Australia, is for adults with stage III melanoma that has spread to lymph nodes and can be removed by surgery. It is listed for cutaneous melanoma, a type of skin cancer, that is stage IIIB, C or D.

Who can take part

  • Adults aged 18 or over who give written permission (consent) to take part
  • Have confirmed stage IIIB, C or D melanoma of the skin (or unknown primary) that can be removed by surgery
  • Have at least one enlarged cancerous lymph node, confirmed by tests, in the groin, armpit or neck (both sides of the body allowed)
  • Up to 3 small areas of spread near or between the primary melanoma and the lymph nodes, if these can be fully removed by surgery
  • Able to have a new tissue sample (biopsy) taken from a tumour that has not had radiotherapy before
  • Due to have immunotherapy before surgery, including at least one checkpoint inhibitor drug (for example nivolumab or pembrolizumab), lasting no longer than 6 weeks
  • Well enough for everyday activity (performance status 0-1) with a life expectancy of more than 5 years

Who may not be able to

  • Melanoma of the eye (uveal) or moist body linings (mucosal)
  • Spread only to skin areas near the melanoma, without any cancerous lymph nodes
  • Lymph node involvement anywhere other than the groin, armpit or neck (small pockets behind the knee, elbow or certain muscle spaces are allowed if fully removable)
  • Any signs that the cancer has spread to distant parts of the body
  • Previous lymph node surgery in the same area beyond a sentinel lymph node biopsy, or previous radiotherapy to that area
  • Reasons why checkpoint inhibitor drugs cannot be given safely
  • Previous treatment with certain immunotherapy drugs, chemotherapy or experimental treatments
  • Plans to use targeted therapy, non-checkpoint immunotherapy, injections into the tumour, or another experimental immunotherapy trial before surgery
  • Another cancer within the last 3 years, unless it was a type that has been successfully cured (for example, some skin cancers)
  • An active autoimmune disease, or needing high-dose steroids or other drugs that damp down the immune system (some exceptions like replacement hormones and inhaled steroids are allowed)
  • Having had a tissue or organ transplant from another person
  • Active hepatitis B or hepatitis C infection, or known HIV
  • Pregnant or breastfeeding
  • Medical or social circumstances that would stop you attending the planned checks and procedures

What taking part involves

  • • Immunotherapy before surgery, including at least one checkpoint inhibitor drug such as nivolumab, pembrolizumab or cemiplimab, possibly with other similar drugs
  • • The immunotherapy course lasts no longer than 6 weeks, with up to 3 treatment cycles at weeks 0, 3 and 6
  • • A new core biopsy (small tissue sample) of a tumour, plus collection of any stored tissue from past tumours if available
  • • Not stated — ask the trial team (details of what happens after treatment)

Time commitment: Taking part involves up to 3 immunotherapy cycles over 6 weeks, a new biopsy, attending scheduled checks and procedures — total study duration not stated, ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,500
Started
2025-10-01
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for cutaneous melanoma, stage iii
  • • NA - 1,500 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cutaneous melanoma, stage iii

Where?

  • • London - The Royal Marsden

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The standard treatment under current guidelines for patients who have melanoma that has spread to the lymph nodes (Stage III disease) is a 'therapeutic lymph node dissection' or 'TLND'. This is the removal of all of the lymph nodes in the affected area, such as in the armpit, neck or groin. TLND surgery Several clinical trials over the past 10 to 15 years have shown that treatment with immune system boosting drugs (known as immunotherapy) can help the body to better identify and attack the tumour cells. This is now used routinely for tumour that has spready beyond the lymph nodes (Stage IV disease) in melanoma and many other cancers. When immunotherapy is given before TLND surgery (known as neoadjuvant therapy) the body can launch an increased immune response against the tumour cells to reduce or remove the amount of tumour before surgery. Neoadjuvant therapy for melanoma is typically given over 6 weeks before surgery. Patients may have further drug therapy and /or radiotherapy after TLND surgery to minimise the risk of recurrence. At surgery after neoadjuvant immunotherapy, the removed lymph node tissue is examined by a pathologist who will then classify the amount of tumour cells left in the lymph nodes. Recent clinical trials have shown that 46-70% of patients have less than 10% of melanoma cells left in the lymph nodes. This is called a 'major pathological response' or 'MPR'. After 5 years, approximately 70% of patients having an MPR do not have a recurrence of melanoma. Neoadjuvant immunotherapy is now standard care for Stage III melanoma in Australia and other countries. Both immunotherapy and TLND surgery have side effects. Some of these are of short duration and some last many months. Some of the side effects from immunotherapy include general nausea, diarrhoea, skin rash but also diabetes, thyroid or liver problems. Surgery may result in some pain, wound infection, wound breakdown, or short and long term lymphoedema - where fluid doesn't drain properly from the arms or legs, depending on where the original lymph node surgery was done. A recent small clinical trial of 99 patients tested if patients who have neoadjuvant therapy can omit the need for TLND surgery, without changing the risk of recurrence. Patients in this study had the largest affected (index) lymph node marked with a clip under ultrasound or X-ray guidance before neoadjuvant therapy. After 6 weeks of neoadjuvant immunotherapy, the index lymph node was removed in a minor operation and the pathological response classified. Sixty-one percent of patients had an MPR and did not have any further surgery. After 2 years, 93% of these patients did not have a recurrence of melanoma. Patients without an MPR had TLND surgery and between 63 and 75% had no recurrence by 2 years. This recent trial was too small to provide sufficient evidence for a change in standard treatment after neoadjuvant immunotherapy for patients having an MPR. We therefore plan to conduct a trial that is large enough to test if the new approach of index lymph node resection is not worse than the current standard care with TLND as measured by the number of people without melanoma recurrence within 2 years. This type of trial is known as a 'non-inferiority' trial. If index node resection is no worse than TLND, we also need to assess if there is a difference in the side effects or each type of surgery and in the quality of life experienced by patients. We also need to examine if there is any difference in the costs to patients and to the healthcare system for either surgery and the long term outcomes. This is a randomised trial which means people are put into one of two groups by chance (randomly, or like tossing a coin). For patients who have an MPR to neoadjuvant therapy, half will have index lymph node removal with no further surgery and half the current standard of TLND surgery. Patients who do not have an MPR will have the standard TLND. All patients will have regular appointments with their surgeon to check for signs if the melanoma has returned and the study team will follow progress for up to 10 years.

Cutaneous Melanoma, Stage III

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

scan positive

What the study is looking for

  • ✓Male or female patients ≥ 18 years of age at the time of consent
  • ✓Written agreement to take part
  • ✓Cytologically or confirmed by a biopsy, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or...
  • ✓A minimum of one macroscopic lymph node, defined as:
  • ✓A palpable node, confirmed by pathology

Who cannot take part

  • ✗Uveal or mucosal melanoma.
  • ✗Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node...
  • ✗Involvement of any lymph node basin other than groin, axilla or neck. Concurrent popliteal, epitrochlear or...
  • ✗Clinical or radiographic evidence of distant metastasis (any AJCC 8th ed M Stage).
  • ✗Previous history of lymph node surgery to the same nodal basin, that was more extensive than a sentinel lymph node...
See the full criteria
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age at the time of consent 2. Written informed consent 3. Cytologically or histologically confirmed, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or N3c) cutaneous or unknown primary melanoma, with or without primary tumour in situ 4. A minimum of one macroscopic lymph node, defined as: * 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 Criteria: 1. Uveal or mucosal melanoma. 2. Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement). 3. Involvement of any lymph node basin other than groin, axilla or neck. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable. 4. Clinical or radiographic evidence of distant metastasis (any AJCC 8th ed M Stage). 5. Previous history of lymph node surgery to the same nodal basin, that was more extensive than a sentinel lymph node biopsy (SLNB). 6. Previous radiotherapy to the same nodal basin. 7. Any contraindication to the administration of nivolumab, ipilimumab, pembrolizumab or relatlimab per regulatory-approved product information and / or medical oncologist. 8. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment. 9. A plan to administer targeted therapy or any non-checkpoint inhibitor immunotherapy, or any intralesional therapy for melanoma in the neoadjuvant setting. 10. A plan to administer any experimental immunotherapy as part of a clinical trial in the neoadjuvant setting. 11. Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted: * 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.

Where Is This Study? (1 UK site)

The Royal Marsden

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Alexander CJ van Akkooi

Sponsor contact

CONTACT

+612 9911 7200 alexander.vanakkooi@melanoma.org.au
Data sourced from ClinicalTrials.gov · Last verified: 2026-06