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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2032-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma, Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omitting TLND

Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.

Group Type EXPERIMENTAL

Omitting TLND

Intervention Type PROCEDURE

Omitting TLND in patients who achieve an MPR in the index node following neoadjuvant ipilimumab and nivolumab.

Index node procedure

Intervention Type PROCEDURE

Index node procedure

Interventions

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Omitting TLND

Omitting TLND in patients who achieve an MPR in the index node following neoadjuvant ipilimumab and nivolumab.

Intervention Type PROCEDURE

Index node procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No