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

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., ≤10% 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

Trial Details

NCT ID
NCT06754904
Phase
NA
Sponsor
D.J. (Dirk) Grünhagen
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Omitting TLND
  • Index node procedure
Locations (sample)
  • Rotterdam, South Holland, Netherlands|51.9225,4.47917

Key Eligibility 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…
  • 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),…

For full eligibility, visit ClinicalTrials.gov.

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