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New treatment option for Cutaneous Melanoma, Stage III
Official title The Multicentre Selective Lymphadenectomy Trial - 3
ClinicalTrials.gov ID: NCT07049276
What this study is testing
- What it's testing
- 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).
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- A minimum of one macroscopic lymph node, defined as:
- A palpable node, confirmed by pathology
You likely can't join if
- 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)...
- 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.
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newcastle, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
- Murdoch, Western Australia, Australia
- Toronto, Ontario, Canada
- Ramat Gan, Tel Aviv, Israel
- Perugia, Italy
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newcastle, New South Wales, Australia; Wollstonecraft, New South Wales, Australia; Murdoch, Western Australia, Australia; Toronto, Ontario, Canada; Ramat Gan, Tel Aviv, Israel and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.