Study of ctDNA-Guided Addition of Ipilimumab to Nivolumab and Relatlimab Treatment in Advanced Melanoma

What this Trial Is About

Researchers are investigating the use of circulating tumor DNA ctDNA measurements to guide first-line treatment choices for patients with advanced or metastatic melanoma. The study aims to improve treatment selection by identifying molecular relapse early and comparing outcomes with current standard care, which treats until radiologic progression. The primary goal is to enhance patient outcomes while minimizing unnecessary exposure to ineffective or unneeded therapies. Patients initially receive two doses of nivolumab 480 mg with relatlimab 160 mg every 28 days. Those with undetectable ctDNA continue this treatment until disease progression or death for up to two years. Patients with positive ctDNA at week 6 but no early progression are randomized to either continue nivolumabrelatlimab or add ipilimumab 1 mgkg every 8 weeks alongside the regimen. Patients with positive ctDNA and early progression switch to the triple therapy of ipilimumab, nivolumab, and relatlimab until progression or death. Participants undergo scheduled visits, laboratory tests, imaging including CT and MRI scans, and blood sampling for ctDNA testing. Researchers monitor progression-free survival, objective response rate, and immune-related adverse events up to two years. Treatment adherence and disease status are closely evaluated to assess the impact of ctDNA-guided therapy adjustments throughout the study period.

ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab