Skipping full lymph node removal for stage III melanoma patients who show a strong response in the index node

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with macroscopic resectable stage III cutaneous melanoma receive neoadjuvant ipilimumab and nivolumab and have an index lymph node (ILN) marked and sampled to determine pathological response. If the ILN shows a major pathological response (≤10% viable tumor), the protocol omits the planned therapeutic lymph node dissection (TLND) and patients are followed closely for recurrence, distant metastasis, and quality of life. The study builds on prior neoadjuvant trials that linked ILN response to excellent short-term distant metastasis-free and recurrence-free outcomes. Outcomes of interest include event-free survival, distant metastasis-free survival, recurrence-free survival, and treatment-related morbidity and health-related quality of life.

Why it matters

Who can join: the full rules

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)

Where it's running

• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Drik Grünhagen, MD, PhD
• Email: d.grunhagen@erasmusmc.nl
• Phone: +31 10 704 19 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.