NCT06288191

Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

A Phase 2, Open Label, Single Arm, Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage II To IV (M0) Resectable Cutaneous Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Melanoma Institute Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.

Detailed description

This is a phase 2, open label, single cohort, single centre, clinical trial of neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint pathways. The hypothesis is that neoadjuvant therapy produces a higher pathological response rate (pCR) and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage II to IV (M0) cutaneous squamous cell carcinoma compared to neoadjuvant cemiplimab monotherapy in Checkmate 358 (n=123, NCT02488759, historical control).

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination	Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-09-01
• Completion: 2036-07-01
• First posted: 2024-03-01
• Last updated: 2025-12-16

Locations

1 site across 1 country: Australia