Cutaneous Melanoma, Stage IIIMSLT-3NCT07049276
The Multicentre Selective Lymphadenectomy Trial - 3
A study testing Index lymph node resection and Therapeutic lymph node dissection in people with Cutaneous Melanoma, Stage III, run by Melanoma Institute Australia at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma, Stage III
- What is being tested?
- Index lymph node resection and Therapeutic lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 1 Oct 2025to Aug 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age at the time of consent
- Written informed consent
- 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
- 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
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- An ultrasound or PET/CT scan positive lymph node of any size, confirmed by pathology.
- 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.
- 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.
- 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.
- 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.
- Neoadjuvant course of treatment to be no longer than 6 weeks (allows for a maximum of 3 cycles at weeks 0, 3 and 6).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Anticipated life expectancy of > 5 years.
Who cannot join
- Uveal or mucosal melanoma.
- Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement).
- 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.
- 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 biopsy (SLNB).
- Previous radiotherapy to the same nodal basin.
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- Any contraindication to the administration of nivolumab, ipilimumab, pembrolizumab or relatlimab per regulatory-approved product information and / or medical oncologist.
- 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.
- A plan to administer targeted therapy or any non-checkpoint inhibitor immunotherapy, or any intralesional therapy for melanoma in the neoadjuvant setting.
- A plan to administer any experimental immunotherapy as part of a clinical trial in the neoadjuvant setting.
- 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.
- 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.
- Has had an allogenic tissue/solid organ transplant.
- 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.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.
- Pregnant or breastfeeding females.
- Concurrent medical or social conditions that may prevent the patient from attending assessments or procedures per schedule.
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Australia3 sites, 3 recruiting
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Lydia Warburton, +61 8 6152 2222
- Recruiting
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Adeeb Majid, +61 2 4921 1211
- Recruiting
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065
Alex Van Akkooi
United States1 site, 1 recruiting
- Not yet recruiting
Cedars-Sinai Medical Centre
Los Angeles, California, 90025
Mark Faries
Canada1 site, 1 recruiting
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Frances Wright
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical centre
Ramat Gan, Tel Aviv
Shirly Grynberg, +972 3 5307917, shirly.grynberg@sheba.health.gov.il
Italy1 site, 1 recruiting
- Not yet recruiting
San Maria della Misericordia Hospital
Perugia
Mario Mandala
United Kingdom1 site, 1 recruiting
- Not yet recruiting
The Royal Marsden
London
Myles Smith
About this study
Official title: Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma
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.
Read the detailed description
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.
- Conditions
- Cutaneous Melanoma, Stage III
- Being tested
- Index lymph node resection, Therapeutic lymph node dissection
- Keywords
- Neoadjuvant, Non-inferiority, Randomised controlled trial, Adverse events, Quality of life, Healthcare economics, Index lymph node resection, Therapeutic lymph node dissection, Surgical morbidity
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index lymph node resectionProcedure or surgery
The largest lymph node affected with melanoma
Therapeutic lymph node dissectionProcedure or surgery
Removal of all nodes in the melanoma affected lymph node basin
| Study group | Role | What they receive |
|---|---|---|
| Index Lymph Node | Experimental | The largest affected (index) lymph node marked with a clip under ultrasound or X-ray guidance and then removed after neoadjuvant therapy for the pathological response to be determined. The response then dictates the next step of management Receives: Procedure: Index lymph node resection |
| Therapeutic lymph node dissection | Active comparator | Complete removal of all nodes in the regional lymph node basin Receives: Procedure: Therapeutic lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
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
Measured: 2 years
Secondary outcomes (13)
The rate of escalation to a therapeutic lymph node dissection (TLND) in the ILN arm due to isolated nodal recurrence in the ILN nodal basin
Proportion of patients with a major pathological response (complete pathological response or near complete pathological response) in the index lymph node arm who have disease recurrence involving the same lymph node basin requiring complete dissection
Measured: 2 years
The salvage rate with surgery, radiotherapy or new systemic therapy post operatively for disease recurrence in each surgical arm with a major pathological response (complete pathological response or near complete pathological response)
Proportion of patients requiring any additional treatment for any disease recurrence following a complete or near complete pathological response
Measured: 2 years
Distant metastasis free-survival
Proportion of patients with distant metastases from randomisation to the date of first distant metastases diagnosis in each surgical arm, following a major pathological response (complete pathological response or near complete pathological response)
Measured: 2 years
Overall survival
Proportion of patients who die, from the date of randomisation to the date of death from any cause
Measured: 10 years
Surgery-related adverse events
Surgical related adverse events using CTCAE version 5.0
Measured: 2 years
Surgery-related adverse events
Surgical related adverse events using Clavien-Dindo scale
Measured: 3 weeks, 12 weeks and 48 weeks post surgery
Patient-rated quality of life QLQ C30
Baseline EUROQOL QLQ-C30,scores compared to scores reported over the duration on study
Measured: 6, 12, 24, 36 and 48 weeks
Patient-rated quality of life EQ 5D5L
Baseline EQ-5D-5L compared to scores reported over the duration on study
Measured: 6, 12, 24, 36 and 48 weeks
Patient-rated quality of life FACT-M
Week 6 FACT-M scores compared to scores reported over the duration on study
Measured: 6, 12, 24, 36 and 48 weeks
Concordance of metabolic response with pathological response
The PET results correlated with the pathological response
Measured: week 6
Concordance of metabiolic response with RECIST response
The PET results correlated with the CT response
Measured: week 6
Concordance of metabolic response with circulating ctDNA
The PET results correlated with the volume of circulating tumour DNA in the blood
Measured: week 6
Health-related economic costs
Comparison of the health-related costs related to each surgical procedure and its outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Oct 2025
- Primary completionAug 2030 (estimated)
- Study completionAug 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Melanoma, Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma Institute Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander CJ van Akkooi, Study chair, Melanoma Institute Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049276
- Sponsor's protocol ID
- MIA2024/501
- Acronym
- MSLT-3
- Status last verified
- Jun 2026
- First submitted
- 24 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma
- ClinicalTrials.gov ID
- NCT07049276
- Acronym / sponsor ID
- MSLT-3 / MIA2024/501
- Conditions
- Cutaneous Melanoma, Stage III
- Keywords
- Neoadjuvant, Non-inferiority, Randomised controlled trial, Adverse events, Quality of life, Healthcare economics, Index lymph node resection, Therapeutic lymph node dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Melanoma Institute AustraliaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2040 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority
| Arm | Type | Receives |
|---|---|---|
| Index Lymph Node | Experimental | Procedure: Index lymph node resectionThe largest affected (index) lymph node marked with a clip under ultrasound or X-ray guidance and then removed after neoadjuvant therapy for the pathological response to be determined. The response then dictates the next step of management |
| Therapeutic lymph node dissection | Active comparator | Procedure: Therapeutic lymph node dissectionComplete removal of all nodes in the regional lymph node basin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients ≥ 18 years of age at the time of consent
- Written informed consent
- 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
- A minimum of one macroscopic lymph node, defined as:
- 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.
Key exclusion criteria (28 listed)
- Uveal or mucosal melanoma.
- Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement).
- 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.
- 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 biopsy (SLNB).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Index lymph node resectionThe largest lymph node affected with melanoma | Procedure or surgery | Index Lymph Node |
| Therapeutic lymph node dissectionRemoval of all nodes in the melanoma affected lymph node basin | Procedure or surgery | Therapeutic lymph node dissection |
Primary outcome
Recurrence free survival
Time frame: 2 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
13 secondary outcomes
The rate of escalation to a therapeutic lymph node dissection (TLND) in the ILN arm due to isolated nodal recurrence in the ILN nodal basin
Time frame: 2 years
The salvage rate with surgery, radiotherapy or new systemic therapy post operatively for disease recurrence in each surgical arm with a major pathological response (complete pathological response or near complete pathological response)
Time frame: 2 years
Distant metastasis free-survival
Time frame: 2 years
Overall survival
Time frame: 10 years
Surgery-related adverse events
Time frame: 2 years
Surgery-related adverse events
Time frame: 3 weeks, 12 weeks and 48 weeks post surgery
Patient-rated quality of life QLQ C30
Time frame: 6, 12, 24, 36 and 48 weeks
Patient-rated quality of life EQ 5D5L
Time frame: 6, 12, 24, 36 and 48 weeks
Patient-rated quality of life FACT-M
Time frame: 6, 12, 24, 36 and 48 weeks
Concordance of metabolic response with pathological response
Time frame: week 6
Concordance of metabiolic response with RECIST response
Time frame: week 6
Concordance of metabolic response with circulating ctDNA
Time frame: week 6
Health-related economic costs
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander CJ van Akkooi study chair
Melanoma Institute Australia
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Index lymph node resection and Therapeutic lymph node dissection in people with Cutaneous Melanoma, Stage III, run by Melanoma Institute Australia at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, United States, Canada, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander CJ van Akkooi (+612 9911 7200, alexander.vanakkooi@melanoma.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.