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New treatment option for Melanoma, Skin
Official title Omitting Therapeutic Lymph Node Dissection in Patients With Melanoma (Stage 3) and Major Pathological Response in the Index Lymph Node
ClinicalTrials.gov ID: NCT06754904
What this study is testing
- What it's testing
- 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)).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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)...
- a PET scan positive lymph node of any size confirmed as melanoma by pathology;
You likely can't join if
- 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)
See the full 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 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.