Lymph Node Surgery for Skin Cancer

(MSLT-3 Trial)

Recruiting at 5 trial locations

Overseen By Alexander CJ van Akkooi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Melanoma Institute Australia

Must be taking: Checkpoint inhibitors

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Uveal melanoma, Distant metastasis, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgeries for treating Stage III melanoma, a type of skin cancer. It aims to determine if removing only the largest affected lymph node (index lymph node resection) is as effective as removing all affected nodes (therapeutic lymph node dissection) without impacting the 2-year recurrence-free survival rate. The trial also examines whether the less invasive surgery results in fewer complications and a better quality of life. Individuals with a confirmed diagnosis of Stage IIIB, C, or D melanoma and at least one enlarged lymph node may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain immunosuppressive therapies or have contraindications to the trial's immunotherapy drugs, you may not be eligible.

What prior data suggests that these surgical approaches are safe for treating clinical Stage III melanoma?

Research has shown promising safety in removing the main lymph node. In one study, the response of this main lymph node matched the response of all lymph nodes in 99% of cases, indicating the procedure's reliability and its rare tendency to miss important changes.

Regarding lymph node removal as a treatment, more information is available. One study found that this procedure did not significantly improve survival rates for melanoma, but it had a complication rate of 28%. While generally safe, the procedure carries some risks.

Overall, both surgical treatments are considered safe, each with its own risks and benefits. Participants should consider these factors when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the techniques being explored in lymph node surgery for skin cancer because they offer potentially more targeted and personalized treatment options. Unlike the standard of care, which typically involves the complete removal of all lymph nodes in the affected area, the index lymph node approach focuses on identifying and removing just the largest affected lymph node. This method allows doctors to determine the effectiveness of preceding treatments and tailor further management based on the response, potentially reducing unnecessary surgeries and associated side effects. This personalized approach could lead to more effective and less invasive treatment plans for patients.

What evidence suggests that this trial's surgical approaches could be effective for Stage III melanoma?

This trial will compare two surgical methods for treating melanoma: index lymph node resection and therapeutic lymph node dissection. Research has shown that these methods yield similar results in some key areas. One study found that the response of the main affected lymph node matched the response of all lymph nodes in 99% of cases, suggesting that removing only the largest affected node might suffice. Other research indicated that removing all lymph nodes did not significantly alter patient survival or cancer recurrence rates. While full lymph node removal helped control the disease in specific areas, it did not improve overall survival compared to not having the surgery. These findings suggest that both methods might be equally effective in managing melanoma without affecting long-term survival. ^{1 2 4 5 6}

Who Is on the Research Team?

Alexander CJ van Akkooi

Principal Investigator

Melanoma Institute Australia

Are You a Good Fit for This Trial?

This trial is for individuals with clinical Stage III melanoma who have completed 6 weeks of standard neoadjuvant immunotherapy. Participants must be suitable for surgery and not have any conditions that would exclude them from the surgical procedures being tested.

Inclusion Criteria

Written informed consent

A minimum of one macroscopic lymph node confirmed by pathology

Anticipated life expectancy of > 5 years

Exclusion Criteria

Pregnant or breastfeeding females

Concurrent medical or social conditions that may prevent attendance at assessments or procedures

I have received a transplant from another person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Immunotherapy

Participants receive 6 weeks of standard neoadjuvant immunotherapy before surgery

6 weeks

Surgery

Participants undergo either selective index lymph node resection or therapeutic lymph node dissection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence-free survival and other outcomes

2 years

Regular appointments with surgeon

Long-term Follow-up

Participants are followed for overall survival and long-term outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Index lymph node resection
• Therapeutic lymph node dissection

Trial Overview The study compares two surgical methods after initial immunotherapy in melanoma patients: selective index lymph node resection (ILN) versus the usual therapeutic lymph node dissection (TLND). The main goal is to see if ILN can match TLND's effectiveness without its common complications.

How Is the Trial Designed?

Group I: Index Lymph Node Experimental Treatment 1 Intervention

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

Group II: Therapeutic lymph node dissection Active Control 1 Intervention

Complete removal of all nodes in the regional lymph node basin

Who Is Running the Clinical Trial?

Melanoma Institute Australia

Lead Sponsor

Trials

18

Recruited

3,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12471384/

Rethinking Lymphadenectomy in Cutaneous Melanoma Conclusions: The role of lymphadenectomy in melanoma is increasingly becoming selective, shaped by tumor burden, nodal involvement and response ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1613210

Completion Dissection or Observation for Sentinel-Node ... Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1278321824000994

Outcomes of adjuvant lymph node field radiotherapy and ... It showed no difference for the 3-year rate of melanoma-specific survival. However, the disease-free survival rate was slightly higher in the dissection group ...

4. jprasurg.com jprasurg.com/article/S1748-6815(24)00125-6/fulltext

Complete lymph node dissection in cutaneous melanoma ... Conclusion: We found that CLND had no significant impact on patient survival and MM recurrence rate, thus corroborating the validity of current ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2788700

Representativeness of the Index Lymph Node for Total ... The pathologic response in the ILN was concordant with the response of the total lymph node bed in 99% of cases.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11374908/

Sentinel lymph nodes in melanoma: necessary as ever for ... Recent clinical research has demonstrated that complete lymph node dissection is not clinically beneficial, even for patients with sentinel node metastases.