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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (1 UK site)
The Royal Marsden
London, United Kingdom
How to Get in Touch
Alexander CJ van Akkooi
Sponsor contactCONTACT
