OMIT Trial Investigating Safe Omission of Therapeutic Lymph Node Dissection in Stage IIIBCD Melanoma Patients with Major Pathological Response After Neoadjuvant Immunotherapy

What this Trial Is About

Researchers are studying whether it is safe to skip therapeutic lymph node dissection TLND in patients with macroscopic resectable stage III melanoma who show a major pathological response MPR in the index lymph node ILN after receiving neoadjuvant immunotherapy with ipilimumab and nivolumab. This trial builds on previous studies that showed improved event-free survival and excellent outcomes in patients achieving MPR, aiming to reduce surgery-related complications and improve quality of life. Participants will receive neoadjuvant treatment with immune checkpoint inhibitors ipilimumab and nivolumab. Those who achieve an MPR in the ILN will omit the usual extensive lymph node surgery TLND. The study is a prospective, single-arm phase 2 trial conducted across multiple centers, focusing on the safety of avoiding TLND in this patient group. During the study, researchers will monitor local recurrence-free survival and distant metastasis-free survival over two years. They will also evaluate quality of life, surgical morbidity, pathological response rates, and survival outcomes up to five years. Various assessments include radiological evaluations and patient-reported questionnaires. The total participation involves regular follow-ups to track health status and disease progression after neoadjuvant immunotherapy and treatment decisions based on ILN response.

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