Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT06754904
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06754904
Study Brief:
Protocol Section:
NCT06754904