Phase 2 Study of Neoadjuvant Nivolumab and Relatlimab for Treating Stage I to III Resectable Merkel Cell Carcinoma

What this Trial Is About

This research aims to evaluate neoadjuvant dual immunotherapy using nivolumab and relatlimab in patients with resectable stage I to stage III Merkel cell carcinoma. The study focuses on treatment-naefve patients and compares the pathological response rate and recurrence-free survival to historical data from nivolumab monotherapy. The trial is phase 2, open-label, and single-arm, conducted at a single center to explore the combined immune checkpoint inhibition of PD-1 and LAG-3 pathways. Participants will receive two doses of a fixed dose combination of nivolumab 480 mg and relatlimab 160 mg administered by infusion on days 1 and 29 before surgery. The treatment regimen is based on prior studies in melanoma patients and aims to assess the safety and efficacy of this dual checkpoint inhibition as neoadjuvant therapy. All enrolled participants will receive the same treatment, with no placebo or comparator group. During the study, participants will be closely monitored for pathological responses, toxicity, tolerability, and objective and metabolic responses at week 6 and week 24. The study will also track recurrence-free survival, event-free survival, overall survival, and patient-reported quality of life for up to 10 years. Surgical-related adverse events and treatment completion rates will be assessed, with overall study duration extending to long-term outcomes and safety follow-up.

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma