NCT06754904

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

OMIT Trial: Omitting Therapeutic Lymph Node Dissection in Patients With Stage IIIB/C Melanoma and Major Pathological Response in the Index Lymph Node After Neoadjudvant Immunotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: D.J. (Dirk) Grünhagen · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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 (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 health-related quality of life (HR-QoL) and healthcare costs, this study aims to prospectively investigate the safety of omitting TLND in patients who have an MPR within the ILN after neoadjuvant immunotherapy. Objectives: To investigate whether TLND can be safely omitted in patients with macroscopic resectable stage III (B/C/D) melanoma achieving an MPR within the ILN upon neoadjuvant treatment with immune checkpoint inhibitors (ipilimumab and nivolumab). Study design: This study is a prospective, single-arm phase 2 nationwide multicenter trial. Study population: Inclusion criteria for study participants are as follows: * Patients must be eligible for neoadjuvant treatment * 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 metastasis * The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy Intervention: Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab. Main study endpoints: The two coprimary endpoints are 2-year Local Recurrence Free Survival (LRFS) and 2-year DMFS.

Conditions

• Melanoma, Skin

Interventions

Type	Name	Description
PROCEDURE	Omitting TLND	Omitting TLND in patients who achieve an MPR in the index node following neoadjuvant ipilimumab and nivolumab.
PROCEDURE	Index node procedure	Index node procedure

Timeline

• Start date: 2025-04-23
• Primary completion: 2027-04-01
• Completion: 2032-04-01
• First posted: 2025-01-01
• Last updated: 2025-08-07

Locations

1 site across 1 country: Netherlands