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Omitting Therapeutic Lymph Node Dissection in Patients With Melanoma (Stage 3) and Major Pathological Response in the Index Lymph Node

RecruitingNAAges 16 Years - anyAllD.J. (Dirk) Grรผnhagen
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In plain words

What the trial is, and whether it could suit you

Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma. In this study, therapeutic lymph node dissection (TLND) was standard of care, showing that patients achieving a major pathological response (MPR, i.e., โ‰ค10% residual viable tumor bed) have an excellent outcome (EFS and Distant Metastasis Free Survival (DMFS)). The PRADO trial indicated that the MPR definition can also be revealed from a surrogate lymph node response, the index lymph node (ILN), allowing sparing the extensive surgery in MPR patients. In these MPR patients the DMFS was 100% after 1 year and 98% after 2 years, and recurrence-free survival (RFS) was 95% after 1 year and 93% after 2 years. Given that TLND is associated with morbidity and has a significant impact on healt

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients must be eligible for neoadjuvant treatment (ipilimumab and nivolumab) * Patients must be 16 years of age or older. * Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B/C/D) with one or more macroscopic lymph node metastase defined as either one: * a palpable node, confirmed as melanoma by pathology; a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology; * a PET scan positive lymph node of any size confirmed as melanoma by pathology; * The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy with immune checkpoint inhibitors * Patients in whom ILN marking is feasible * Written informed consent Exclusion Criteria: * Uveal/ocular or mucosal melanoma * WHO performance status of two or more * In-transit metastases only (without cytological or histological proven lymph node involvement) * Prior targeted therapy targeting BRAF and/or MEK for melanoma * Prior immunotherapy targeting CTLA-4, PD-1 or PD-L1 for melanoma * Patients with (history of) distant metastasis (stage IV melanoma)
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What it tests

  • Omitting TLND
  • Index node procedure
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Where

1 site
Erasmus MC
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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