Phase 2 Trial of Neoadjuvant Nivolumab and Relatlimab for Treating Stage II to IV Resectable Cutaneous Squamous Cell Carcinoma

What this Trial Is About

This research aims to evaluate neoadjuvant therapy using a combination of two immune checkpoint inhibitors, nivolumab and relatlimab, targeting the PD-1 and LAG-3 pathways in patients with treatment-nafve, resectable stage II to IV cutaneous squamous cell carcinoma. The study is a phase 2, open-label, single-group trial designed to assess pathological response rate and recurrence-free survival compared to historical data from monotherapy with cemiplimab. It focuses on improving outcomes in this patient population by testing dual immune checkpoint inhibition before surgery. 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. Patients who do not achieve a complete pathological response may then receive standard radiotherapy as decided by a multidisciplinary team. This neoadjuvant treatment approach aims to enhance tumor response prior to surgical removal. During the study, participants will undergo tumor biopsies, imaging assessments, and blood tests to evaluate pathological response, toxicity, and tolerability of the therapy. Outcomes measured include pathological complete response rate at week 6, recurrence-free survival over 10 years, quality of life assessments at one year, and overall survival. Safety and completion of treatment are monitored up to week 48. The total study participation includes pre-surgery treatment followed by long-term follow-up for survival and disease recurrence.

Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma