NCT06754904: OMIT

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

Recruiting now NA Last updated 7 August 2025

What this trial tests

NA trial testing Omitting TLND in Melanoma, Skin in 213 participants. Currently enrolling.

Timeline

23 April 2025

Primary endpoint
1 April 2027

1 April 2032

Quick facts

Lead sponsor	D.J. (Dirk) Grünhagen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	213
Start date	23 April 2025
Primary completion	1 April 2027
Estimated completion	1 April 2032
Sites	1 location across Netherlands

Drugs / interventions tested

• Omitting TLND
• Index node procedure

Conditions studied

• Melanoma, Skin — all drugs for Melanoma, Skin →

Sponsor

D.J. (Dirk) Grünhagen

Who can join

16 and older, any sex, with Melanoma, Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.